вторник, 26 апреля 2011 г.
New Hereditary Factors, Imaging Techniques Sought By Local Researchers Being Funded By Susan G. Komen For The Cure(R)
The two Komen for the Cure grants are part of a $60 million portfolio of research grants that Komen will be investing with scientists worldwide to find the cures for breast cancer. A third study being funded at the Burnham Institute for Medical Research looks at ways to keep tumors from returning.
"Breast cancer doesn't care about the economy, and with more than 1.3 million new cases of breast cancer expected this year, the need for new research is more urgent than ever," said Hala Moddelmog, Komen's CEO and president.
In Southern California, Komen will award nearly $600,000 to UCLA for research aimed at uncovering genetic mutations other than BRCA1/BRCA2 that indicate a risk for breast cancer. A second study focuses on the development of new breast cancer imaging technology that could detect breast cancer tumors as they are forming. Komen also is investing $180,000 at Burnham Institute for Medical Research in Santa Barbara toward the study of tumor resistance.
"Komen's infusion of millions of dollars into research projects means that promising research that is designed to treat and ultimately eradicate breast cancer will continue," said Eric Winer, M.D., Komen's chief scientific advisor.
In 2009, the Los Angeles County Affiliate of Susan G. Komen for the Cure® will grant critical funds to 32 screening, diagnostic and treatment providers from Antelope Valley to Long Beach. More details can be found at, komenlacounty
During the past 27 years, Komen has invested $400 million to fund research globally, starting with Komen's first grant in 1982 for $28,000. A decade later, the annual total had grown to 21 grants worth $590,000 and 10 years after that, Komen distributed $21 million in research funds. This year, Komen is providing researchers worldwide with $60 million. In the last three years alone, Komen has invested nearly $237 million for breast cancer research.
In 2008, Komen created Promise Grants - a new category of multi-year, multi-million dollar grants designed to discover and deliver cures for breast cancer more quickly.
Here is a list of local institutions, the researchers and the projects Komen is funding this year, pending agreements:
University of California at Los Angeles
*Shehnaz Hussain, $299,912, Nucleotide variation in the prolactin receptor and its agonists and breast cancer risk
Cedars Sinai Medical Center
*V Krishnan Ramanujan, $299,919, Preclinical Fluorescence Lifetime Imaging System for early detection of breast tumors in vivo
Burnham Institute for Medical Research
*Charles Perou, $180,000, targeting therapy-resistant tumor vessels and preventing tumor recurrence
About Susan G. Komen for the Cure®
Nancy G. Brinker promised her dying sister, Susan G. Komen, she would do everything in her power to end breast cancer forever. In 1982, that promise became Susan G. Komen for the Cure and launched the global breast cancer movement. Today, Komen for the Cure is the world's largest grassroots network of breast cancer survivors and activists fighting to save lives, empower people, ensure quality care for all and energize science to find the cures. Thanks to events like the Komen Race for the Cure®, we have invested more than $1.3 billion to fulfill our promise, becoming the largest source of nonprofit funds dedicated to the fight against breast cancer in the world. For more information about Susan G. Komen for the Cure, breast health or breast cancer, visit komen or call 1-877 GO KOMEN.
Source
Susan G. Komen for the Cure
Georgetown Hospital Shuts Lab After Problems With Genetic Testing For Breast Cancer
After the failed inspection, an independent lab retested tissue samples for 249 women and found that the two women were falsely told they did not have HER2-positive breast cancer, which occurs in about 15% to 20% of patients and increases the risk that tumors will spread or recur. According to hospital officials, neither of the women's treatment was adversely affected by the delayed diagnoses.
The alleged improper testing began in May 2009 and lasted for roughly 11 months, according to the Post. Georgetown officials confirmed problems with the tests but said the lab has maintained a 99% accuracy rate overall. Stephen Evans, the hospital's chief medical officer, said this week that the hospital learned earlier this year that staff members did not use proper temperature, timing and tissue embedding methods when processing patient samples. As a result, the lab failed quality-control tests administered by the College of American Pathologists, which accredits medical labs. The hospital is adding more quality-control workers and reviewing the "roles, responsibilities and decision-making" of lab personnel, Evans said, adding that the lab should resume testing in four to eight weeks.
Meanwhile, CMS and CAP are investigating procedures at the lab. Unaddressed deficiencies can lead to a lab's loss of accreditation (Leonnig/Sun, Washington Post, 8/6).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
© 2010 National Partnership for Women & Families. All rights reserved.
BioTheranostics' Breast Cancer Index(SM) Predicts Risk For Late Recurrence In Early Stage ER-Positive Breast Cancer Patients
The company also announced that the Breast Cancer Index is now available to provide quantitative assessment of the risk of distant disease recurrence. The BCI risk assessment is based on data from a recently completed large, randomized, retrospective trial.(1)
"The results presented in San Antonio become part of a substantial and growing body of data supporting the clinical value of the Breast Cancer Index," said Richard Ding, chief executive officer of bioTheranostics. "We are pleased to make this valuable test available to oncologists and pathologists in an enhanced format with clinical data specific for late breast cancer recurrence."
The Breast Cancer Index is a combination of HOXB13:IL17BR (H/I) and Molecular Grade Index (MGI), biomarkers that improve risk stratification in patients with estrogen receptor (ER)-positive, lymph-node negative breast cancer. This population represents the majority of breast cancers diagnosed each year.
Data presented are from the MA.17 study, a previously conducted, randomized prospective trial. This study evaluated the role of adjuvant endocrine therapy with letrozole in reducing the risk of recurrence and improving disease-free survival among women with breast cancer who completed five years of tamoxifen therapy. As part of the study, Massachusetts General Hospital researchers Paul Goss, MD, PhD and Dennis Sgroi, MD retrospectively evaluated the ability of the Breast Cancer Index to distinguish those patients at risk of late recurrence and those who would respond to extended therapy with letrozole.
Data from the study demonstrate that BCI is a prognostic biomarker for late recurrence among ER-positive breast cancer patients. The data also confirm that HOXB13, part of the Breast Cancer Index, predicted patient benefit from letrozole among ER-positive breast cancer patients.
"For breast cancer patients and the medical professionals who treat them, this is a significant finding," said Dennis Sgroi, MD, Massachusetts General Hospital. "It is our understanding that this is the first time a biomarker has been validated exclusively in the 'late recurrence' setting. It will be a valuable tool to help identify those patients whose disease will most likely recur, as well as those who will benefit from extended therapy."
"In combination with data from the Stockholm cohort presented at last year's SABCS, the data presented today reinforce BCI's unique prognostic value and application for long-term risk prognosis in the breast cancer setting," said Mark Erlander, PhD, chief scientific officer of bioTheranostics.
(1) Stal, O., et. al., Validation of prognostic utility of HOXB13:IL17BR and molecular grade index in early stage breast cancer [abstract #77]. 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium. December 2009.
Source: bioTheranostics
Breast Cancer Risk Lingered Years After Women Discontinued Estrogen-Progestin Therapy, Stanford Researcher Says
The new study also shows that while some of the other health risks and benefits diminished after the women had stopped taking the estrogen-progestin combination, the overall health risk was 12 percent higher at the end of eight years (with women on the pills for an average of 5.6 years and then off for 2.4 years) compared with those who took placebos. This was largely due to the high risks of breast cancer, strokes and serious blood clots during the original trial while the women took the hormones.
The Stanford University School of Medicine researcher who is the senior author of the follow-up study said the results indicate that the potential harms from estrogen-progestin therapy still outweigh the benefits, and that women should continue to be cautious in deciding whether to take the hormones to relieve menopausal symptoms.
"Menopausal women really need to think through whether using estrogen-progestin is the right thing to do, particularly if continued for more than a few years," said Marcia Stefanick, PhD, professor of medicine at the Stanford Prevention Research Center, noting that the breast-cancer risks apply only to women who take the combination therapy, and not those who take estrogen alone. A different portion of the WHI study showed that estrogen-only therapy doesn't increase the risk of breast cancer.
The follow-up study will be published in the March 5 issue of the Journal of the American Medical Association.
The WHI is the largest-ever study to examine the health of postmenopausal women ages 50-79. One of its best-known components involved hormone therapy. There were two arms of the hormone therapy study: one for women who had undergone hysterectomies and who were randomly assigned to take either estrogen or placebo, and the other for women who still had a uterus and who took either estrogen-progestin or placebo.
Stefanick was the chair of the WHI steering committee for the duration of the original trial. She is now chair of the WHI Extension Study, which will continue to follow participants through at least 2010.
In 2002, researchers abruptly halted the estrogen-progestin arm of the trial, which involved 16,608 women, when evidence showed that women who had taken the hormones for an average of 5.6 years had a 26 percent higher risk for breast cancer than those in the placebo group. Additionally, they had a greater risk of stroke, blood clots and, in the first year of treatment, heart attack. However, the women taking the hormones also had a lower risk for bone fractures and colon cancer.
In the new follow-up study, which tracked 15,730 of the original participants for an average of 2.4 years after the trial ended, the risk of developing breast cancer was 27 percent higher during the follow-up period, with 79 of the women who took the hormones developing invasive breast cancer compared with 60 of the women who took the placebo. Additionally, the risks of developing any type of cancer was 24 percent higher, with 281 women developing cancer in the post-treatment group compared with 218 women in the placebo group.
Stefanick said the follow-up study also contained potentially important findings that didn't reach statistical significance, meaning they could be due to chance, but that may be resolved after continuing to track the women's health. For instance, during the 2.4-year follow-up period there were 15 percent more deaths from all causes among the women who previously took the combined hormones, compared to those who had taken placebo pills.
Also, largely because there were more occurrences of cancer during the follow-up period, the global risk index (a measure of a variety of health outcomes, including deaths) continued to be 11 percent higher after women stopped taking the hormones. Stefanick said a likely reason that the finding didn't reach statistical significance is that most of the cardiovascular risks that arose during the trial diminished after women stopped taking the hormones, as did the benefits of fewer fractures and reduced rates of colorectal cancer.
Nonetheless, Stefanick said the higher risk for breast cancer "appears to continue for women who took estrogen and progestin, even years after stopping the hormones."
Both the estrogen-alone and estrogen-progestin studies turned the conventional wisdom about hormone therapy on its head. For many years, observational studies and other evidence indicated that in addition to relieving menopausal symptoms, hormone therapy helped protect women against heart disease and bolstered their overall health. However, neither trial showed any benefit in preventing heart disease, and both trials showed hormone therapy, while having some benefits, posed substantial health risks. The estrogen-only arm of the study was stopped in 2004, one year before its scheduled conclusion, because of concerns that estrogen increased the risk of stroke and blood clots without providing any protection against heart disease.
Since the results of those trials were announced, the use of hormone therapy has dropped dramatically. Current health guidelines recommend that women seeking relief from menopausal symptoms use the lowest hormone dose necessary and that they limit the duration of the therapy.
"Women are being told to use hormones for 'the shortest time possible,' but we can't really define what 'short' means," Stefanick said. "Clearly, taking estrogen and progestin for 5.6 years is too long because the risk for breast cancer continued to be elevated after the women stopped taking the hormones and remained significant, compared to placebo, after stopping the hormones for 2.4 years."
She encouraged women who are experiencing menopausal symptoms to consider non-estrogen alternatives to manage hot flashes and other discomforts, to consult with their physicians as to the possible use of hormone therapy and to make dietary and lifestyle changes, particularly increasing their physical activity, to reduce their risks for chronic diseases.
Stefanick's co-authors include several WHI investigators from throughout the country; the lead author is Gerardo Heiss, MD, PhD, professor of epidemiology at the University of North Carolina-Chapel Hill.
Both the original WHI study and the follow-up study were funded by the National Heart, Lung and Blood Institute.
Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at mednews.stanford.
Stanford University Medical Center
Sir Bobby Robson Cancer Trial And Research Centre Launched
The new research centre is being built at the Freeman Hospital, Newcastle (England). It will concentrate on early cancer detection and treatment, as well as carrying out clinical trials on new medications. It will have dedicated research facilities, as well as a 12 bed unit.
"I have had cancer five times now but I have had a wonderful life and I feel lucky to be alive. I owe my life to the people who have cared for me and treated me during the last 15 years in which I have had the disease. I think I might be remembered for what I did in football. But the legacy I would like to leave behind is what I tried to do to help people with cancer live longer," Sir Bobby said.
Football celebrities were present at the launch, including Bob Wilson (ex-Arsenal goalkeeper), Des Lynham and Jim Rosenthal (TV presenters).
Sir Bobby Robson and Cancer
-- Sir Bobby Robson was diagnosed with cancer in 1991. He has been diagnosed with cancer five separate times during his life and has undergone several operations.
-- During the 1995-1996 football season he had to miss work as manager of Porto for some months when he developed malignant melanoma.
-- In 2006 he was operated on for a brain tumor - he suffered some swelling in the brain, and according to Sky Sports News, experienced some loss of feeling in his left side. In October 2006 doctors said he was cancer-free.
-- On May 7th 2007 Robson announced that he had been diagnosed with cancer (for the 5th time).
Apart from being manager of the England team, he was also manager of Fulham, Ipswich Town, PSV Einghoven, Sporting Clube de Portugal, F.C. Porto, FC Barcelona, and Newcastle United.
-- Freeman Hospital
-- Donate Now!!
-- Sir Bobby Robson's Biography - officialplayersites
Written by -
How Can Doing Your Will Online Help Cure Breast Cancer?
Cure" campaign for Breast Cancer Awareness month to raise money for breast
cancer research. This is the first fundraising event of its kind. The
campaign asks everyone who wants to help breast cancer research and who has
not completed their will to go to willforacure to learn how
they can complete their will online and leave a gift in their will to their
favorite breast cancer charity. A percentage of proceeds from the campaign
will be donated for breast cancer research. Says attorney James Harris,
founder of the campaign, "'Will for a Cure' is a great way for people to
put their family's affairs in order and feel good about helping a worthy
cause."
"An estimated 70% of people who need a will don't have one. This
amounts to tens of millions of Americans," says Harris. "At the same time,
there are millions of Americans who want to support breast cancer research,
especially during October, Breast Cancer Awareness month. If we can spread
the word and convince people who need a will to leave even 5% of their
estates for breast cancer research, we can easily raise billions of dollars
so future generations won't suffer." People who want to learn more about
how they can make a gift in their wills to benefit breast cancer research
can go to willforacure.
Worldwide, breast cancer is the second most common type of cancer after
lung cancer and the fifth most common cause of cancer death. In 2005,
breast cancer caused 502,000 deaths worldwide (7% of cancer deaths; almost
1% of all deaths).
The "Will for a Cure" campaign is part of a broader effort by Benefact
to popularize the idea of leaving gifts to charities in wills, or "legacy
gifts," as they are called. "Currently, only about one in eight wills
mentions a charity. Imagine the problems that could be solved and diseases
that could be cured if it were a normal thing for everyone to do," says
Harris. "Some people think only the super-rich can leave gifts to charities
in their wills, but anyone can do this in just a few minutes online."
"Will for a Cure" (willforacure) uses the most trusted
online legal will writing website where anyone can create a legally valid
will in minutes. "The service was created by attorneys to be simple, fast,
and affordable," says Harris. According to Harris, more and more people are
doing legal documents online to avoid the expense of paying attorneys.
"People procrastinate when it comes to doing their wills. It's not
something they like to think about. 'Will for a Cure' will hopefully help
motivate people to write their wills now and raise money to cure breast
cancer," says Harris. "Please spread the word about 'Will for a Cure.'"
About Benefact
Benefact created the "Will for a Cure" campaign
(willforacure) to enable people to use online legal will
generation as a tool for supporting breast cancer research. Benefact hopes
to popularize the idea of supporting charities through legacy gifts in
wills.
Benefact
willforacure
Study confirms treatment switch is beneficial for women with early breast cancer
For more than 20 years tamoxifen has been the standard treatment after surgery for postmenopausal women with hormone-responsive early breast cancer. However, research has shown that an aromatase inhibitor called anastrozole is effective and tolerable in this group of patients compared with tamoxifen when used as a first-line treatment. Studies have also suggested that taking anastrozole after two years of tamoxifen could be beneficial.
Raimund Jakesz (Vienna Medical Universit, Vienna, Austria) and colleagues from the Austrian Breast and Colorectal Cancer Study Group and the German Adjuvant Breast Cancer Group combined data from two multicentre, randomised trials looking at the effect of taking anastrozole after tamoxifen. In both trials postmenopausal women who had received two years of tamoxifen treatment were randomised to receive anastrozole (1618 women) or tamoxifen (1606 women) for a further three years. The investigators found that after two years of follow-up there was a 40% decrease in the risk of an event for women in the anastrozole group when compared with women on tamoxifen (67 events with anastrozole vs 110 with tamoxifen). The researchers defined an event as a local or distant recurrence, or cancer arising in the other breast. More patients had bone fractures on anastrozole but there were fewer cases of blood clots than in the tamoxifen group.
Professor Jakesz concludes: "Although further investigation is necessary to ascertain the ideal sequence and duration of adjuvant endocrine therapy, this combined analysis confirms that post-menopausal women who receive tamoxifen as adjuvant therapy should be switched to anastrozole after 2 years of treatment."
In an accompanying comment Anthony Howell (Christie Hospital NHS Trust, Manchester, UK) states: "The aromatase inhibitors show superiority over tamoxifen when used immediately after surgery (anastrozole, letrozole) or after 2-3 years of tamoxifen (anastrozole, exemestane). Letrozole and anastrozole also show superiorly over placebo when given after 5 years of tamoxifen."
Joe Santangelo
j.santangeloelsevier
1-212-633-3810
Lancet
thelancet
New Taxotere(R) (docetaxel) Injection Concentrate Data To Be Presented At The 30th Annual San Antonio Breast Cancer Symposium (SABCS)
abstracts accepted for presentation at the 30th annual San Antonio Breast
Cancer Symposium (SABCS), six with Taxotere(R) (docetaxel) Injection
Concentrate investigational regimens will be presented in plenary sessions.
-- Plenary Lecture 1 on the opening day of the symposium will review data
for systemic adjuvant therapies being investigated for the treatment
of breast cancer.
"The worldwide overview: New results for systemic adjuvant therapies."
Peto R, Early Breast Cancer Trialists' Collaborative Group (EBCTCG),
University of Oxford, UK.
Thursday, December 13, 2007, 8:55 AM / Plenary lecture 1, Exhibit Hall D
-- The data from studies with Taxotere(R)-based regimens and
anthracycline-based regimens will be discussed through two
presentations:
Abst 12: "Extended follow-up and analysis by age of the US Oncology
Adjuvant trial 9735." Jones S, et al; US Oncology Research, Inc., Houston,
TX.
Thursday, December 13, 2007, 9:45AM / Plenary lecture 1, Exhibit Hall D
This presentation includes the updated analysis (seven years median
follow-up) of a randomized trial comparing four cycles of a standard
anthracycline regimen, doxorubicin/cyclophosphamide (AC), to a non
anthracycline regimen, Taxotere(R)/cyclophosphamide (TC). New
findings regarding overall survival as well as the effect of age on
efficacy and safety will be presented.
Abst 13: "Role of anthracycline-based therapy in the adjuvant treatment
of breast cancer: efficacy analyses determined by molecular subtypes of the
disease." Slamon DJ, et al; Cancer International Research Group (CIRG),
Edmonton, AB, Canada.
Thursday, December 13, 2007, 10:00 AM / Plenary lecture 1, Exhibit Hall D
Based on survival data previously reported for the BCIRG 006 study,
this presentation will describe how molecular subtypes of early stage
breast cancer could be used to identify appropriate Taxotere(R)-based
therapies, either with or without anthracyclines, for women with HER2
positive tumors.
-- Two other oral presentations will discuss studies involving anthracycline regimens with or without Taxotere(R):
Abst 78: "Preliminary results of the UK Taxotere(R) as Adjuvant
Chemotherapy (TACT) Trial." Ellis PA, et al; United Kingdom. Sunday,
December 16, 2007, 10:45 AM / General session 7, Exhibit Hall D The UK TACT
Trial, a large multicenter phase III randomized trial compared four cycles
of sequential FEC* followed by four cycles of Taxotere(R) 100mg/m2 every
three weeks to standard UK operable breast cancer adjuvant chemotherapy
(FEC* or E-CMF*) for eight cycles.
FEC : Fluorouracil 600mg/m squared, Epirubicin 60 mg/m2 , and
Cyclophosphamide 600 mg/m2 q 3wk x 8
E-CMF: Epirubicin 100 mg/m2 q3wk x 4 followed by Cyclophosphamide100
mg/m2 PO d1-14 or 600 mg/m2 IV d1-8, Methotrexate 40 mg/m2, and
Fluorouracil 600 mg/m2 q 4wk x 4
Abst 72: "Three-year follow-up of trastuzumab following adjuvant
chemotherapy in node positive HER2-positive breast cancer patients: results
of the PACS-04 trial." Spielmann M, et al.
Sunday, December 16, 2007, 9:15 AM / General session 7, Exhibit Hall D
Following the PACS-01 trial, the PACS-04 randomized, multicenter,
phase III trial is designed to evaluate concomitant Taxotere(R) and
epirubicin versus a standard French chemotherapy regimen (FEC 100) in
the adjuvant treatment of node-positive early breast cancer, and the
sequential use or not of trastuzumab for HER2 positive patients.
FEC100: Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide
500 mg/m2 q 3 wk x 6
-- Taxotere(R) data in the neoadjuvant setting will also be presented:
Abst 79: "Evaluating the efficacy of capecitabine given concomitantly
or in sequence to epirubicin/cyclophosphamide docetaxel as neoadjuvant
treatment for primary breast cancer. First efficacy analysis of the GBG/AGO
intergroup-study "GeparQuattro". von Minckwitz G, et al.
Sunday, December 16, 2007, 11:00 AM / General session 7, Exhibit Hall D
Prior to surgery, patients were treated with epirubicin and
cyclophosphamide followed by either Taxotere(R) alone
(100 mg/m squared), Taxotere(R) (75 mg/m squared) combined with
capecitabine (1800 mg/m squared), or Taxotere(R) (100mg/m2) followed
by capecitabine (1800mg/m2). The primary endpoint of the study is the
pathologic complete response at surgery.
-- Data from another investigational non-anthracycline Taxotere(R)-based
regimen will be presented from a study in patients with advanced HER2
positive breast cancer:
Abst 309: "Evaluation of trastuzumab, docetaxel and capecitabine as
first- line therapy for HER2-positive locally advanced or metastatic breast
cancer." Wardley A, et al.
Friday, December 14th, 2007 5:00-7:00 PM / Poster discussion session 3,
Antibodies and Immunotherapy - Ballroom B
About Breast Cancer
Breast cancer is the most frequently diagnosed cancer in women. It is
the second-leading cause of cancer death in women after lung cancer, and
since 1990 is increasing predominantly in women 50 and over. It is the
first cause of cancer mortality in women of 40 to 59 years old. According
to the American Cancer Society, an estimated 200,000 women are diagnosed
with breast cancer and approximately 40,000 women die of the disease in the
United States every year. A woman is diagnosed with breast cancer in the
United States every three minutes. The risk of a woman developing breast
cancer during her lifetime is approximately 13 percent (about one in seven
of all women in the United States). In the European Union, more than
191,000 new cases are diagnosed each year and more than 60,000 women will
die. Of women with breast cancer, 20 to 25% of these women will have HER2
positive breast cancers. With earlier screening and diagnosis, early
management of patients may offer better chances of survival.
About Sanofi Aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
Forward-looking statements This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements are statements that are not
historical facts. These statements include financial projections and
estimates and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future events,
operations, products and services, and statements regarding future
performance. Forward-looking statements are generally identified by the
words "expects," "anticipates," "believes," "intends," "estimates," "plans"
and similar expressions. Although sanofi-aventis' management believes that
the expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of which
are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward- looking information and statements. These risks and uncertainties
include those discussed or identified in the public filings with the SEC
and the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2006. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking
information or statements.
Sanofi Aventis
sanofi-aventis.us
Harvard Health Letter Editors Examine Racial Disparities In Breast, Prostate Cancer
According to the authors, researchers still do not know exactly why blacks are more likely than whites to die from the cancers. Young black women with breast cancer are more likely to have triple-negative tumors, which are particularly aggressive and cannot be treated with anti-estrogen drugs or anti-HER2 treatments. Researchers also know that young black women are disproportionately affected by basal-like carcinomas, which have an even worse prognosis than other types of triple-negative breast cancer. Some small-scale research indicates that black men might have androgen receptors that respond more intensely to testosterone, which could stimulate growth of prostate-cancer cells.
Differences in education, income and access to care might be more important in explaining the disparity than scientific findings, some researchers believe. For instance, black women generally experience a longer delay from the time of the discovery of a breast cancer abnormality and follow-up tests than white women, the authors write. In addition, black men are less likely than white men to receive aggressive prostate cancer treatment.
Various efforts are addressing barriers to screening diagnosis and treatment, and some researchers are optimistic about closing the gap, particularly with new knowledge of tumor biology leading to treatment improvements, the authors say. In addition, it is "significant" that the socioeconomic and biological issues behind the disparities are on the agenda at cancer research meetings, according to the authors.
Harold Burstein, a breast cancer specialist at the Dana-Farber Cancer Institute, said, "There is increasing awareness, and people are finally getting motivated to do something about it" (Wehrwein/Komaroff, Newsweek, 6/14).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Susan G. Komen For The Cure(R) Employs Convio Software-As-A-Service In The Fight Against Breast Cancer
"By standardizing on Convio and the Software-as-a-Service model, we can fully integrate our online and offline marketing campaigns and programs, fundraising and advocacy efforts, as well as our multiple websites and constituent data," said Justin Ricketts, vice president of information technology for Susan G. Komen for the Cure. "This will provide us with incredible insight into our organization's most important constituent information, regardless of the channel in which the interaction occurs. It also will provide us with access to new and emerging technologies that empower people anytime, anywhere to be more active and engaged in our promise to save lives and end breast cancer forever."
Komen is standardizing on Convio's integrated suite of online software products for fundraising, advocacy, event fundraising, ecommerce, Web content management and email communication. In addition, Komen will replace all existing donor databases with Convio's new open, Web-based constituent relationship management (CRM) system. The product, code-named Aikido, is built on salesforce's Force Platform for tracking all constituent interactions across all channels, online and offline.
Komen evaluated a number of offerings in the market before deciding on Convio. The complete on-demand model, rich feature set, flexibility, the proven success of products like Convio TeamRaiser™, and the company's understanding of Komen's needs as a nonprofit came together to create a very compelling offering.
"We are excited to expand our partnership with Susan G. Komen for the Cure in the fight to save lives and end breast cancer forever," said Gene Austin, chief executive officer of Convio. "After several successful years of helping power results for more than 50 Komen Affiliates, we are honored that they have selected our team and platform to power the entire Komen system of constituent relationship management applications, both online and offline. By integrating Convio's complete product line across all the Komen entities, we expect to deliver increased efficiencies and effectiveness, as well as work with their talented team to use the openness of our platform to access new and emerging technology in ways that take constituent relationships to new levels and further energize their supporters, care providers and research partners."
About Convio
Convio is the leading provider of on-demand software and services that enable nonprofit organizations to more effectively raise funds, influence public policy and support their missions by leveraging the Internet to build strong relationships with constituents. The Company's online constituent relationship management solution includes a suite of on demand software modules for fundraising, advocacy, email marketing and web content management complemented by a portfolio of best-in-class consulting services.
Convio's clients include American Red Cross, American Diabetes Association, American Society for the Prevention of Cruelty to Animals, National Multiple Sclerosis Society, Sierra Club, Susan G. Komen for the Cure, National Association of Realtors and National Public Radio. For more information, please visit convio.
About Susan G. Komen for the Cure®
Nancy G. Brinker promised her dying sister, Susan G. Komen, she would do everything in her power to end breast cancer forever. In 1982, that promise became Susan G. Komen for the Cure and launched the global breast cancer movement. Today, Komen for the Cure is the world's largest grassroots network of breast cancer survivors and activists fighting to save lives, empower people, ensure quality care for all and energize science to find the cures. Thanks to events like the Susan G. Komen Race for the Cure®, we have invested more than $1 billion to fulfill our promise, becoming the largest source of nonprofit funds dedicated to the fight against breast cancer in the world. For more information about Susan G. Komen for the Cure, breast health or breast cancer, visit komen or call 1-877 GO KOMEN.
Susan G. Komen for the Cure
Genesearch Breast Lymph Node Assay Detects Breast Cancer Metastases With Greater Sensitivity
"These results indicate the potential advantage of the GeneSearch™ BLN Assay as an objective, standardized test that can assess breast cancer metastasis in the lymph nodes rapidly and with greater overall sensitivity than the current standard of care," said study investigator Peter W. Blumencranz, MD, FACS, Medical Director of Comprehensive Breast Health and Cancer Services, Morton Plant Mease Healthcare, and Medical Director of Moffitt Morton Plant Cancer Care, Clearwater, Florida. "This intra-operative test may provide surgeons with critical information that can help them optimize treatment decisions by allowing them to determine the scope of the surgery required."
In the study involving 416 evaluable patients across 11 clinical trial sites, sentinel lymph nodes were tested using the GeneSearch™ BLN Assay and current methods for assessing nodal tissue during surgery (frozen section (FS) or touch preparations (TP)). All nodes were sampled for permanent section hematoxylin/eosin (H&E), and most were also sampled for immunohistochemistry (IHC). The GeneSearch™ BLN Assay, FS and TP results were each compared to permanent section histology results to determine the performance of each method. The test was evaluated in terms of sensitivity and specificity, which measure how well the method correctly identifies nodes with and without clinically relevant metastases. Tests with lower sensitivity have a higher chance of false negatives, and tests with lower specificity have a higher chance of false positives.
In a head-to-head comparison with FS, overall sensitivity of the GeneSearchTM BLN Assay was 95.6 percent - 10 percentage points greater than the overall sensitivity of FS (85.6 percent). In the same patient comparison, overall specificity of the GeneSearchTM BLN Assay remained high with a value of 94.3 percent compared to the 97.8 percent overall specificity of FS. In a head-to-head comparison with TP, overall sensitivity of the GeneSearchTM BLN Assay was 18 percentage points greater than the overall sensitivity of TP. In the same patient comparison, overall specificity of the GeneSearchTM BLN Assay remained at 100 percent for both the assay and TP.
"This innovative test has the potential to improve intra-operative pathology and surgical decision making, reduce the need for second surgeries, and thereby significantly improve patient care," said Mark Myslinski, General Manager, Veridex.
Sentinel lymph node biopsy (SLNB) is a widely used and accepted procedure in the management of breast cancer. SLNB involves removing the first (sentinel) lymph node that filters fluid from the breast, as this node is the most likely to contain cancer cells if the cancer has begun to spread. If there is no evidence of metastases in the sentinel node, it is unlikely that the cancer has spread to other nodes, and there may be no need for further surgery. Results of the GeneSearch™ BLN Assay can typically be reported during the operation within 30 to 40 minutes from the time the sentinel node is removed. The test outcomes are intended to be used to guide the decision to excise additional lymph nodes and to aid in patient staging.
The GeneSearch™ BLN Assay is CE marked to the In Vitro Diagnostic Device Directive in the European Union and became commercially available there on November 6, 2006.
About Veridex
Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors.
Contact: Steve Dnistrian
Veridex, LLC
Patent Awarded For New Procedure To Detect Cancer Spread
Dr. Woltering's patent is based on linking a radioactive iodine molecule to the blue dye commonly used in these sentinel node procedures. One of the major ways to determining the prognosis of a cancer involves determining whether the cancer has metastasized into other areas of the body. As lymphatic fluid flows from the primary tumor, the lymph fluid flows through lymph channels and then into lymph nodes where it often begins to multiply and grow. The first lymph node that is reached by the lymphatic fluid as it drains from the tumor region is called the sentinel lymph node. The sentinel lymph nodes for breast tumors are usually found in the axilla, or armpit.. A tumor may have one or more sentinel lymph nodes.
In contrast to the current two-step sentinel node mapping process, Dr. Woltering's method involves injecting 125I-labeled methylene blue, mixed with an unlabeled dye to determine the location of the sentinel lymph nodes in or near the tumor or tumor site utilizing a hand held Geiger counter -like device. Within about 10 minutes, enough of the dye has accumulated in sentinel nodes to be visible with the naked eye, or detectable using a radiation- detecting device called a gamma probe.
A sentinel lymph node biopsy is used to determine whether all lymph nodes in the drainage area must be removed. This procedure depends upon an effective technique for identifying the sentinel lymph node. If the cancer has spread to the sentinel lymph nodes, the surgeon will then remove all lymph nodes in the region. If the sentinel lymph node is found to be cancer free; all other nodes of the same area are generally cancer-free. The accurate identification and biopsy of the sentinel lymph node (when pathologically negative) means that other nodes will not be removed. The retention of normal lymph nodes benefits the patient by preventing lymphatic fluid accumulation in the arm or other extremity.
Dr. Woltering's new method can be used with solid tumors from a number of cancers including melanoma, breast cancer, head and neck cancers, lung cancer, neuroendocrine cancers, squamous carcinoma and colorectal cancer. The current techniques for identifying the sentinel lymph node involve the use of a radioactive colloid compound, a vital dye, or both. When both a dye and a radiolabeled carrier are used, they have been injected separately. The radiolabeled carrier substance is injected either the afternoon prior to surgery or the morning of surgery while the patient is awake.
Dr. Woltering notes that "many patients consider the injection of the radiolabeled colloid carrier as painful as childbirth."
"This may be the most valuable part of our invention," says Woltering. "It prevents women from having a painful, scary procedure while they are awake and substitutes an equally effective injection performed while they are sedated or asleep."
The usual interval from radioactive injection until surgery is 2-4 hours and with the increasing demand for sentinel lymph node sampling, surgeons have been forced to deal with major delays in surgical schedules.
Next steps along the road to FDA approval of this novel radioactive drug include a Phase II clinical trial to be conducted at University Medical Center in Lafayette, LA.
Source: Leslie Capo
Louisiana State University Health Science Center
First Patient Enrolled In Global Phase III Study Of Bevacizumab And Trastuzumab In Early Breast Cancer
HER2-positive breast cancer is open for enrollment. The pivotal BETH
(BEvacizumab and Trastuzumab Adjuvant Therapy in HER2-positive Breast
Cancer) study is a Phase III clinical research trial that is investigating
the benefits of combining two monoclonal antibodies, the anti-angiogenic,
bevacizumab (Avastin(R)) and the targeted therapy trastuzumab
(Herceptin(R)), together with chemotherapy for the treatment of patients
with early stage HER2-positive breast cancer.
"Trastuzumab is already the standard of care across all stages of
HER2-positive breast cancer and has a proven survival benefit. Bevacizumab
has been shown to be of benefit when given in combination with chemotherapy
for the treatment of metastatic breast cancer," said Dennis Slamon, MD,
director of clinical/translational research at the University of
California, Los Angeles' (UCLA) Jonsson Comprehensive Cancer Center and
principal investigator, Cancer International Research Group. "The design of
the BETH clinical trial is based on the preclinical and early clinical work
from the Slamon/TRIO Laboratories at UCLA. We are looking forward to
investigating the additional benefit to patients of combining these two
treatments with chemotherapy in the treatment of early breast cancer."
"Despite treatment advances, over 400,000 women worldwide still die
from breast cancer every year, so striving to improve treatment outcomes
remains critical," said Norman Wolmark, MD, chairman of the Department of
Human Oncology at the Allegheny General Hospital, and principal
investigator, NSABP Foundation, Inc., Pittsburgh, Pennsylvania, USA, who
welcomes the start of the study.
In BETH, patients will be randomized to a regimen of chemotherapy
(either 6 cycles of docetaxel/carboplatin or 3 cycles of docetaxel,
followed by 3 cycles of FEC(1)) plus trastuzumab with or without
bevacizumab.
BETH was developed through the collaborative efforts of the NSABP
(National Surgical Adjuvant Breast and Bowel Project) and CIRG (Cancer
International Research Group). The study will be led by the two groups and
will recruit approximately 3,500 patients. The primary outcome measure of
BETH will be invasive disease-free survival. Secondary endpoints for the
study include disease-free survival, overall survival, safety, and
tolerability.
Bevacizumab and trastuzumab are used in the treatment of women with
breast cancer; bevacizumab for metastatic breast cancer and trastuzumab for
both early and late HER2-positive breast cancer. This is the first Phase
III trial to evaluate combining the two therapies in treating early stage
breast cancer.
ABOUT THE CANCER INTERNATIONAL RESEARCH GROUP (CIRG) AND TRANSLATIONAL
RESEARCH IN ONCOLOGY (TRIO)
CIRG is a not-for-profit research organization with offices based in
Paris, France and Alberta, Canada. With an international network of 2000
investigators and 450 cancer centers in over 45 different countries, CIRG
has conducted a number of new and innovative global studies evaluating
systemic therapy for cancer. The BCIRG 001 study led to the registration of
docetaxel in the early breast cancer setting. The BCIRG 006 study showed
that a non-anthracycline Herceptin-containing regimen was as efficacious as
an anthracycline- and Herceptin-containing regimen in the early
HER2-positive breast cancer setting, thus providing an equally effective,
less cardiotoxic alternative to women with this type of breast cancer.
Recently, CIRG has partnered with the UCLA-based investigator network
of Translational Oncology Research International, to form TRIO
(Translational Research in Oncology). In addition to a network of dedicated
investigators and clinical trial services, TRIO also includes the
Slamon/TRIO Laboratories at UCLA. Slamon and fellow scientists have
developed and adapted preclinical models which allow for the validation of
molecular markers, the preclinical assessment of new biologic agents and
the characterization of an agent's mechanisms of action. This preclinical
work, in turn, generates the clinical hypotheses for the group's future
cancer trials in patients. This translational approach has been used in the
BCIRG 006 study and the newly-launched BETH clinical trial.
TRIO is dedicated to advancing translational cancer research by
bringing innovative and targeted therapeutics to clinical practice.
Additional information is available on the Internet at
trioncology.
ABOUT THE NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT (NSABP)
Headquartered in Pittsburgh, Pennsylvania, USA, the National Surgical
Adjuvant Breast and Bowel Project (NSABP) is a clinical trials cooperative
group. The NSABP has a 50-year history of designing and conducting clinical
research trials that have changed the way breast cancer is treated and,
more recently, prevented.
With research sites at nearly 1,000 major medical centers, university
hospitals, large oncology practice groups, and health maintenance
organizations in the United States, Canada, Puerto Rico, and Ireland, the
NSABP has enrolled more than 110,000 women and men in clinical trials in
breast and colorectal cancer. More than 5,000 physicians, nurses, and other
medical professionals conduct NSABP treatment and prevention trials.
NSABP breast cancer studies led to the establishment of lumpectomy plus
radiation over radical mastectomy as the standard surgical treatment for
breast cancer. In addition, the NSABP was the first to demonstrate that
adjuvant therapy could alter the natural history of breast cancer, thereby
increasing survival rates. The group was also the first to conduct large
scale breast cancer prevention studies that showed that the drugs tamoxifen
and raloxifene could reduce the risk of developing invasive breast cancer
by about 50 percent in women at increased risk for the disease; more than
33,000 women participated in the Breast Cancer Prevention Trial (BCPT) and
Study of Tamoxifen and Raloxifene (STAR).
Additional information about the NSABP is available on the Internet at
nsabp.
(1) FEC refers to 5-Fluorouracil, Epirubicin, Cyclophosphamide
National Surgical Adjuvant Breast and Bowel Project
nsabp
Leading Breast Cancer Charity Announces New Strategy To Improve Prevention, Early Diagnosis And Treatment Of The UK's Most Common Cancer
Breakthrough Breast Cancer needs to raise at least ВЈ25 million each year for the next three years to support its vital research, campaigning and education work. Breast cancer is now the most commonly diagnosed cancer in the UK yet a recent study found survival rates in the UK to be among the worst in Europe*.
The Breakthrough Breast Cancer Research Units will be based in Edinburgh, Manchester and London and will each focus on a specific area of breast cancer research. In Scotland, the new unit will aim to improve and develop treatments for breast cancer. In Manchester, the team will focus on developing new ways to detect and prevent early breast cancer and the new London unit will investigate a poorly understood type of breast cancer called basal-like breast cancer, which is more common amongst young women and those of African origin.
Each unit will have strong links with a major cancer hospital or breast unit and research institute or university. The units will complement work already taking place at the internationally renowned Breakthrough Toby Robins Breast Cancer Research Centre based in the Mary-Jean Mitchell Green Building at The Institute of Cancer Research in London, which was the UK's first dedicated breast cancer research facility.
Breakthrough Breast Cancer has a reputation for world-class research. At the Breakthrough Breast Cancer Research Centre 120 scientists work under the directorship of Professor Alan Ashworth. Research so far has led to two international clinical trials, including the world's first clinical trial for women with hereditary breast cancer (the BRCA trial), underpinned the discovery of a potential new drug, called a PARP inhibitor, for women with a type of hereditary breast cancer (currently in Phase II trials) and the setting up of the largest and most comprehensive study into the causes of breast cancer, the Breakthrough Generations Study, in partnership with The Institute of Cancer Research. The charity is also soon to embark on a unique project investigating the role of complementary therapies in helping to alleviate the side effects of breast cancer treatment
Jeremy Hughes, Chief Executive of Breakthrough Breast Cancer, says;
"Breast cancer is now the most common cancer in the UK and, despite 80 percent of breast cancer patients in the UK surviving for at least five years after diagnosis, there is still much to do - survival rates in the UK are among the lowest in Europe. There is much more we must and should be doing. The more we learn and the more we do, the more lives are saved.
"By expanding our research, campaigning and education activities, we aim to tackle breast cancer from all angles and achieve our vision of a future free from the fear of breast cancer."
As part of its strategy, Breakthrough Breast Cancer aims to educate women on the importance of early diagnosis, which can offer the best chances of survival. Since 2004, the charity has promoted its simple yet effective 'Show Your Breasts Some TLC: Touch, Look, Check' message - Touch and Look for any changes and Check anything unusual with your doctor. Breakthrough's education work will focus on women aged 45 to 57 years old and highlight the importance of being breast aware and attending breast screening appointments after 50.
The strategy also sets out Breakthrough's commitment to developing its influencing and campaigning work, in particular extending the reach of Breakthrough's influential Campaigns & Advocacy Network (Breakthrough CAN), and working with breast care units across the UK through Breakthrough's Service Pledge for Breast Cancer - a tool to help patients and health professionals work in partnership to improve local breast cancer services.
Oonagh Wilson, who lives in Scotland, has a family history of breast cancer and is a member of Breakthrough's Campaigns & Advocacy Network. She says;
"As a long-term supporter and campaigner for Breakthrough Breast Cancer, I'm so pleased to hear about the charity's exciting plans, particularly as one of the new research units is in Scotland. Being diagnosed with breast cancer can be devastating for women and their families. Although more women than ever are surviving the disease there is still so much to do to find out about its causes, develop new treatments and make sure everyone affected by cancer has the best possible care so I'm looking forward to helping Breakthrough achieve its goals."
Breakthrough Breast Cancer is the UK's leading charity committed to tackling breast cancer through research, campaigning and education. For more information about Breakthrough Breast Cancer and its work, please visit: breakthrough.uk.
* Studies published in the Lancet Oncology journal on 21 August 2007 highlighted that five-year survival rates from breast cancer in the UK were among the lowest in Europe. The studies focused on 23 countries across Europe and examined the outcome of 2.7m new cases of cancer diagnosed between 1995 and 1999. Currently in the UK, 80% of breast cancer patients are surviving for at least five years after diagnosis.
- The Breakthrough Breast Cancer Research Units will be up and running over the next year with official opening dates to be announced.
- The Breakthrough Breast Cancer Research Unit at The University of Edinburgh will be based at the soon-to-be-launched Institute of Genetics and Molecular Medicine with laboratories adjacent to the Edinburgh Breast Unit of the Western General Hospital. The unit will be led by Mr Mike Dixon, Consultant Surgeon at the Western General Hospital, and Professor David Harrison, Director of the Edinburgh Cancer Research Centre. The team will use the most up-to-date technologies to analyse biological changes in hormone-positive breast cancers, which account for around 80 per cent of all invasive breast cancers. They will develop new treatments for women who do not respond well or who develop resistance to hormone therapies.
- The Breakthrough Breast Cancer Research Unit at King's College London will be based in Guy's Hospital, part of Guy's and St Thomas' NHS Foundation Trust, adjacent to King's College London Academic Breast Unit. Dr Andrew Tutt will develop the Breakthrough Research Unit, King's College London with the aid of Professor Arnie Purushotham, who leads the King's College London Academic Breast Unit. The team will focus on investigating a poorly understood type of breast cancer called basal-like breast cancer.
- The Breakthrough Breast Cancer Research Unit at The University of Manchester will be based within the Manchester Cancer Research Centre in the Paterson Institute for Cancer Research adjacent to the Christie Hospital NHS Foundation Trust. Professor Anthony Howell, Professor of Medical Oncology at Manchester University, will develop and lead this unit. The team will investigate the very earliest stages of breast cancer development to identify new ways to detect breast cancers and new targets for preventing the disease.
Breakthrough's campaigning activities include;
- Left in the Dark - a campaign to ensure all women referred by their GP with breast problems are seen by a specialist within 2 weeks.
- Family History - a campaign to improve access to MRI and mammography screening for women with a family history of breast cancer.
- Screening Saves Lives - a campaign to improve uptake of the NHS Breast Screening Programme and to ensure that the Government has put sufficient resources in place to deal with the expected increased demand on this vital service in the future, as more women born in the post-war 'baby boom' reach their 50th birthdays and as a result, become eligible for routine breast screening.
Since 2004, Breakthrough has been educating women about being breast aware. The charity's campaign, ''Show Your Breasts Some TLC: Touch, Look, Check', aims to raise awareness of the signs and symptoms of breast cancer.
Breakthrough Breast Cancer:
- Breakthrough Breast Cancer is the UK's leading charity committed to fighting breast cancer through research, campaigning and education. Our essence comes from the thousands of people who are committed to a single vision - to work for a future free from the fear of breast cancer. More information can be found at: breakthrough.uk.
- In 1999, Breakthrough Breast Cancer in partnership with The Institute of Cancer Research established the UK's first dedicated breast cancer research centre - The Breakthrough Toby Robins Breast Cancer Research Centre.
- The Breakthrough Toby Robins Breast Cancer Research Centre is situated in the Mary-Jean Mitchell Green Building at the Chester Beatty Laboratories at The Institute of Cancer Research. It is the first dedicated breast cancer research facility in the UK and, under the directorship of Professor Alan Ashworth, its 120 scientists and clinicians are working on a programme of cutting edge biological research that ultimately aims to eradicate breast cancer, by discovering the causes of the disease, finding methods of prevention and developing new treatments and more effective diagnosis.
Breast Cancer:
- Breast cancer is now the most commonly diagnosed cancer in UK women, accounting for nearly 1 in 3 of all female cancers.
- Over 44,000 women are diagnosed with breast cancer every year in the UK and 1,000 women will die every month from this disease.
- 80% of breast cancer patients in the UK are surviving for at least five years after diagnosis. However, studies which were published in the Lancet Oncology journal in August 2007 highlighted that five-year survival rates from breast cancer in the UK were among the lowest in Europe. The studies focused on 23 countries across Europe and examined the outcome of 2.7m new cases of cancer diagnosed between 1995 and 1999.
- Breakthrough has developed a handbag-sized guide - Breast Cancer Risk Factors: The Facts - to help improve our understanding of the known causes of breast cancer.
breakthrough.uk
First Lady Laura Bush's Partnership For Breast Cancer Awareness And Research Extends To Panama
Joining M. D. Anderson in the initiative are the U.S. Department of State and Susan G. Komen for the Cure® who are working closely with the First Lady of Panama to finalize the partnership, which currently brings together leading medical experts and breast cancer awareness advocates in the United States, Mexico, Brazil and Costa Rica.
Breast cancer is the second leading cause of cancer-related deaths among women in Panama. According to the Panamanian Ministry of Health, more than 25 percent of Panama's population of 3.3 million is comprised of women over 40 years old and is at a greater risk of developing the disease since risk increases with age.
First announced by Mrs. Laura Bush in July 2007, the Partnership for Breast Cancer Awareness and Research of the Americas is designed to increase early breast cancer detection and reduce related deaths in the region through improved awareness, clinical resources and world-class research. The Partnership is facilitated by the U.S. Department of State and is initiated and implemented locally by participating countries. M. D. Anderson serves as the Partnership's lead medical adviser.
In Panama, the Partnership will offer the opportunity to advance new and existing initiatives focused on reducing the burden of breast cancer. Collaborative efforts in the areas of research, capacity-building and women's empowerment will be promoted.
Representatives from M. D. Anderson, Susan G. Komen For the Cure® and the U.S. State Department joined Mrs. Laura Bush and Mrs. Vivian FernГЎndez de Torrijos to announce the initiative at an event held at the Ministry of Foreign Affairs in Panama City.
"Breast cancer continues to have a tremendous impact on women in Panama, despite good efforts to raise awareness of early detection and prevention," said Ana Maria Gonzalez-Angulo, M.D., assistant professor in M. D. Anderson's Department of Breast Medical Oncology, who represented M. D. Anderson at the announcement in Panama City. "By working collectively to advance awareness, research, training and community outreach, we can change attitudes and behaviors about breast cancer which will in turn save lives."
A team of 33 M. D. Anderson scientists and physicians serve on an advisory board for the Partnership for Breast Cancer Awareness and Research of the Americas and oversee the contribution of medical and public education resources to the initiative. M. D. Anderson has committed to making available its extensive library of educational materials on a broad spectrum of topics related to breast cancer, much of which is available in Spanish. In addition, M. D. Anderson will explore opportunities to develop specific satellite educational programs on breast cancer topics for the medical community and offer its faculty and staff as a resource to medical personnel in Panama.
John Mendelsohn, M.D., president of M. D. Anderson said, "We are pleased to have the opportunity to extend our work with the Partnership to Panama. Mrs. FernГЎndez de Torrijos is commended for her dedication and commitment to reducing breast cancer and her efforts to engage the Partnership for the benefit of women in Panama, across Latin America and around the world."
To date, M. D. Anderson has established academic and educational relationships with 25 premier cancer centers around the world, and partnered with the Department of State on a similar breast cancer initiative in the Middle East formed in 2006.
About M. D. Anderson
The University of Texas M. D. Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. M. D. Anderson is one of only 39 Comprehensive Cancer Centers designated by the National Cancer Institute. For five of the past eight years, M. D. Anderson has ranked No. 1 in cancer care in "America's Best Hospitals," a survey published annually in U.S. News and World Report.
Source: Robyn Stein
University of Texas M. D. Anderson Cancer Center
Women Should Not Be Deterred From Mammography Screening By Radiation Fears
"Recently, there have been reports in the press focusing on the potential radiation risk from mammography, particularly as used for periodic screening," said the study's lead author, Martin J. Yaffe, Ph.D., senior scientist in imaging research at Sunnybrook Health Sciences Centre, and professor in the departments of medical biophysics and medical imaging at the University of Toronto. "Our study shows that the risk of cancer associated with routine screening in women age 40 and over is very low, especially when compared to the benefits associated with early detection."
Dr. Yaffe and his colleague, James G. Mainprize, Ph.D., developed a model for estimating the risk of radiation-induced breast cancer following exposure of the breast to ionizing radiation from various screening mammography scenarios and estimated the potential number of breast cancers, fatal breast cancers, and years of life lost attributable to mammography screening.
Using a radiation dose estimate of 3.7 milligrays (mGy), which is typical for digital mammography, and a cohort of 100,000 women, the researchers applied the risk model to predict the number of radiation-induced breast cancers attributable to a single examination and then extended the model to various screening scenarios beginning and ending at different ages.
The results showed that in 100,000 women, each receiving a dose of 3.7 mGy to both breasts, annual screening from age 40 to 55 years and biennial screening thereafter to age 74 years would result in 86 radiation-induced cancers, including 11 fatal cancers, and 136 life years lost.
Conversely, for the same cohort it was estimated that 497 lives and 10,670 life years would be saved by earlier detection.
"The predicted risk of radiation-induced breast cancer from mammography screening is low in terms of the numbers of cancers induced, the number of potential deaths, and the number of years of life lost," Dr. Yaffe said. "For women over 40, the expected benefits afforded by routine screening in terms of lives saved or years of life saved greatly exceeds this risk. For these women, radiation risk should not be a deterrent from screening."
"Risk of Radiation-induced Breast Cancer from Mammographic Screening."
Source:
Linda Brooks
Radiological Society of North America
GSK Reports Positive Results On Breast Cancer Drug Trial, Plans To File For Regulatory Approval In U.S., Europe
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Herceptin; Tykerb.
Journal Of Clinical Investigation Early Table Of Contents: Feb. 2, 2009
Reza Zarnegar and colleagues, at the University of Pittsburgh, Pittsburgh, have determined that genetic variation in a piece of DNA that regulates activity of the HGF gene might be a useful marker to identify individuals with an increased risk of developing breast cancer.
The HGF gene is not active in normal breast epithelial cells. However, its activity is not repressed in tumor samples from many patients with breast cancer. In the study, the authors identified a DNA region that controls the activity of the HGF gene and named it DATE (deoxyadenosine tract element). Functional studies determined that shortening the DATE region led to activation of the HGF gene in cell lines. Further analysis indicated that a substantial proportion of patients with breast cancer have shortened DATE regions, and that these patients were markedly younger than patients with a DATE region of normal length. Given these data, the authors suggest that future studies should investigate whether shortened DATE regions are also associated with other cancers that overexpress HGF, such as some forms of colon, stomach, pancreatic, endometrial, and cervical cancer.
TITLE: Somatic mutation and functional polymorphism of a novel regulatory element in the HGF gene promoter causes its aberrant expression in human breast cancer
AUTHOR CONTACT:
Reza Zarnegar
University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
View the PDF of this article at: https://the-jci/article.php?id=36640
METABOLIC DISEASE: Biological evidence for why diet and exercise are the best therapy for type II diabetes
A high fat diet can attenuate the body's sensitivity to insulin, a hormone that regulates blood sugar levels, and can lead to type II diabetes. While this process is known to be mediated by cellular components called mitochondria and by cellular oxidative stress, the mechanisms underlying their involvement are poorly understood. A new study in rodents, by Darrell Neufer and colleagues, at East Carolina University, Greenville, now sheds light on this issue and provides a biological explanation as to why diet and exercise is the best strategy for treating type 2 diabetes.
In rodents, a high-fat diet induced mitochondrial release of hydrogen peroxide, a damaging oxidative chemical, and reduced cellular resistance to oxidative stress. Treatment of the animals with a novel antioxidant protected them from insulin resistance. Animals that were genetically manipulated to produce the compound catalase, which breaks down hydrogen peroxide, in their muscle mitochondria, were also protected. In addition to providing a potential explanation for the most effective way to reduce an individual's risk of developing type 2 diabetes, the authors suggest that their data indicate that mitochondrial-targeted antioxidants might prove more effective at combating reduced insulin sensitivity than general antioxidants, which have thus far had little effect.
TITLE: Mitochondrial H2O2 emission and cellular redox state link excess fat intake to insulin resistance in both rodents and humans
AUTHOR CONTACT:
P. Darrell Neufer
East Carolina University, Greenville, North Carolina, USA.
.
View the PDF of this article at: https://the-jci/article.php?id=37048
OPHTHALMOLOGY: Antioxidants help prevent some forms of loss of visual function in mice
Abnormal growth of blood vessels in the eye can result in impaired vision. In a number of diseases (including macular telangiectasia and retinal angiomatous proliferation), this abnormal growth of blood vessels is associated with local degeneration of nerve cells, including those that detect the light that enters the eye (photoreceptors). In a mouse model of diseases such as macular telangiectasia and retinal angiomatous proliferation, Martin Friedlander and colleagues, at The Scripps Research Institute, La Jolla, have managed to prevent photoreceptor loss caused by abnormal growth of blood vessels without correcting the blood vessel defect. Prevention of photoreceptor loss was achieved by both oral antioxidant supplementation and by cell-based delivery of factors that enhance nerve cell survival, development, and function. The authors therefore suggest that both these approaches might help preserve visual function.
TITLE: Antioxidant or neurotrophic factor treatment preserves function in a mouse model of neovascularization-associated oxidative stress
AUTHOR CONTACT:
Martin Friedlander
The Scripps Research Institute, La Jolla, California, USA.
View the PDF of this article at: https://the-jci/article.php?id=35977
IMMUNOLOGY: Th17 cells convert to IFN-gamma secretion to cause diabetes
Immune cells that secrete the soluble molecule IL-17 (so called Th17 cells) have been implicated as central to several autoimmune diseases. However, whether they contribute to the autoimmune disease type 1 diabetes, which is commonly linked to immune cells that secrete the soluble molecule IFN-gamma (so called Th1 cells), has not been clearly determined. While investigating this in a mouse model of type 1 diabetes, Anne Cooke and colleagues, at the University of Cambridge, United Kingdom, found that highly purified Th17 cells could cause diabetes in NOD/SCID mice, but that they converted to IFN-gamma secreting cells to do this, indicating that Th17 cells show substantial plasticity.
TITLE: Highly purified Th17 cells from BDC2.5NOD mice convert into Th1-like cells in NOD/SCID recipient mice
AUTHOR CONTACT:
Anne Cooke
University of Cambridge, Cambridge, United Kingdom.
View the PDF of this article at: https://the-jci/article.php?id=37865
METABOLIC DISEASE: Resistin arrest: new approach shows human resistin contributes to insulin resistance
Individuals who are obese have an increased risk of developing type 2 diabetes, in part because they often become resistant to the effects of the hormone insulin. Resistin is a soluble factor produced by fat cells (adipocytes) that is linked to the development of insulin resistance in mice. However, studies have thus far failed to determine such a clear association in humans. But now, Mitchell Lazar and colleagues, at the University of Pennsylvania, Philadelphia, have determined that human resistin contributes to the development of insulin resistance in mice.
One factor that has complicated studies attempting to determine the role of resistin in the development of insulin resistance in humans, is that resistin is produced mainly by immune cells known as macrophages in humans, whereas it is produced by adipocytes in mice. To overcome this issue, the authors generated mice lacking mouse resistin and expressing human resistin in macrophages. When these mice were fed a high-fat diet, they developed inflammation of the fat tissue, which led to altered levels of fats in the blood and, ultimately, to insulin resistance. It is hoped that future studies using these mice will help determine the therapeutic potential of modulating levels of human resistin.
TITLE: Macrophage-derived human resistin exacerbates adipose tissue inflammation and insulin resistance in mice
AUTHOR CONTACT:
Mitchell A. Lazar
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
View the PDF of this article at: https://the-jci/article.php?id=37273
Source: Karen Honey
Journal of Clinical Investigation
Early stage breast-cancer rates are rising as incidence of invasive cases are leveling
Since 1980, the incidence of ductal carcinoma in situ, or DCIS, one of the most common kinds of early stage breast cancer,
has increased more than sevenfold. This sharp increase in DCIS - which is a tumor that contains cancer-like cells but is not
considered "true" cancer because the cells have not invaded normal breast tissue - has been accompanied by a flattening in
the incidence of true invasive breast cancer.
Both trends suggest that widespread mammography screening, along with improvements in imaging technology and increased biopsy
rates, among other factors, are catching breast cancer earlier, before it starts to spread and becomes more life-threatening,
according to a new study by Christopher Li, M.D., Ph.D., and colleagues at Fred Hutchinson Cancer Research Center, published
in the April issue of Cancer Epidemiology, Biomarkers and Prevention.
"The results of this study suggest that our public-health efforts to increase the use of breast-cancer screening -
mammography, primarily - appear to have altered the types of breast cancer that are being diagnosed most frequently in the
United States, as we have found that the number of invasive cases being diagnosed has stabilized, while more cases of in situ
breast cancer are being diagnosed," said Li, an assistant member of Fred Hutchinson's Public Health Sciences Division.
Li and colleagues also found a sixfold increase in a less aggressive form of ductal carcinoma in situ, a condition called
noncomedo DCIS, while incidence rates of a potentially more aggressive type, called comedo DCIS, have declined during the
last five years.
"This suggests a further downshifting of severity within in situ cancers themselves," Li said.
The researchers also found that rates of a less common precancerous condition called lobular carcinoma in situ, or LCIS, has
increased nearly fourfold in postmenopausal women since 1980.
These findings, based on the most comprehensive assessment to date of age-specific incidence rates of in situ breast cancer,
while encouraging, also pose a particular challenge to health-care professionals.
"There is good news in that it appears we are detecting breast cancer at an earlier stage. However, the increasing number of
in situ cancers presents an important clinical challenge, since in some cases the treatments that should be given to women
with these conditions, primarily LCIS, is unclear," Li said. "Another problem is that we are not very good at predicting
which women with these precancerous lesions will develop invasive breast cancer and which will not," said Li, also a research
assistant professor in the Department of Epidemiology at the University of Washington School of Public Health and Community
Medicine.
Since lobular carcinoma in situ, or LCIS, is very rare, accounting for only about 4,200 cases annually in the United States,
it has not been possible to gather enough cases to conduct randomized clinical trials to determine whether women would
benefit from treatment.
"Some small studies do indicate that women with LCIS are equally likely to develop cancer in one or both breasts, so
oftentimes it is considered a nonsurgical disease, because the only logical treatment would be a bilateral mastectomy, which
would be unnecessary in the vast majority of cases," Li said. "However, if we could develop new tools to predict which women
with LCIS are more likely to develop invasive cancer we could better counsel them on what might be appropriate treatment
options," he said.
LCIS is characterized by precancerous changes in the cells that line the milk-producing lobules, or lobes, of the breast. The
condition cannot be felt during an exam or seen on a mammogram, and so it is typically found by chance during a breast biopsy
performed for another reason.
In contrast, because ductal carcinoma in situ, or DCIS, is common, accounting for more than 14 percent of U.S. breast-cancer
cases, clinical randomized trials have shown that women benefit from treatment. The most common treatments for DCIS are
either breast-conserving surgery with radiation or total mastectomy.
In DCIS, the cells lining the milk ducts have cancer-like characteristics. If left untreated, DCIS may, over time, become
cancerous and begin to spread, or invade, the surrounding milk ducts.
"Given that rates of DCIS and LCIS continue to increase in the United States, clinically useful tools that improve our
abilities to stratify these patients based on their risk of invasive cancer are needed," Li and colleagues wrote.
According to the American Cancer Society, more than 58,400 new cases of in situ breast cancer are expected to occur among
women this year. Of these, approximately 85 percent will be DCIS.
The study was based on data from 32,990 women diagnosed with DCIS and 5,462 women diagnosed with LCIS between 1980 and 2001.
Cases were identified through nine population-based cancer registries that participate in the Surveillance, Epidemiology, and
End Results, or SEER, Program, which is funded by the National Cancer Institute. The registries represented women from
Connecticut, Hawaii, Iowa, New Mexico, Utah, and the metropolitan areas of Atlanta, Detroit, San Francisco-Oakland and
Seattle-Puget Sound. The NCI funded the research.
Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution
dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases.
Fred Hutchinson receives more funding from the National Institutes of Health than any other independent U.S. research center.
Recognized internationally for its pioneering work in bone-marrow transplantation, the center's four scientific divisions
collaborate to form a unique environment for conducting basic and applied science. Fred Hutchinson, in collaboration with its
clinical and research partners, the University of Washington and Children's Hospital and Regional Medical Center, is the only
National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest and is one of 40 nationwide. For
more information, visit the center's Web site at fhcrc.
Contact: Kristen Lidke Woodward
kwoodwarfhcrc
206-667-5095
Fred Hutchinson Cancer Research Center
fhcrc
Prospects Uncertain For Calif. Breast, Cervical; Cancer Screening Program
The state stopped paying for the screenings July 1, when the new fiscal year began, because the state budget had not been enacted, according to the Mercury News. Some county-level agencies that coordinate the program have shut down or are considering furloughs. In an effort to operate the program on a reduced budget, California officials in January imposed a six-month ban on new enrollment in the program and increased the qualifying age from 40 to 50. Officials had hoped to end the restrictions by June 30. However, the program's services were reliant on the Legislature reaching a budget deal by July, which has not yet happened (Women's Health Policy Report, 6/30).
Advocates are concerned that thousands of women could be turned away if no budget deal is reached. The economic downturn has increased demand for the no-cost screenings, and advocates say many women are unsure whether they will be able to obtain care. Miesha Hardy -- a spokesperson for the Community Health Partnership, which serves three California counties -- said more than 4,500 women from Santa Clara County have been enrolled in the program since 2009. "This will have dire consequences for women across the state," Hardy said.
State lawmakers have introduced a bill (AB 1640) designed to operate the program more efficiently. The legislation aims to increase oversight of the program and restore eligibility to women ages 40 and older. In addition, the bill would require the state Department of Public Health to provide 90 days' notice about any changes to the program. Although the Senate Health Committee unanimously approved the bill last month, lawmakers might opt to shelve the measure to keep state spending down.
Department of Public Health officials said they are working to cut costs and reopen enrollment in the program by offering mammograms less often and reducing the reimbursement rates for negative tests, which usually require less follow-up care, according to the Mercury News. Even with such changes, funding for the program would be $41.6 million for fiscal 2010, about $14 million short of the $55 million needed to reopen enrollment and maintain annual screening services, the Mercury News reports (San Jose Mercury News, 7/10).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
© 2010 National Partnership for Women & Families. All rights reserved.
GlaxoSmithKline Seeks U.S. Approval For Tykerb(R) (Lapatinib Ditosylate) For The Treatment Of Advanced Breast Cancer
New Drug Application (NDA) to the United States Food and Drug
Administration (FDA) for approval to market Tykerb(R) (lapatinib
ditosylate), in combination with Xeloda(R) (capecitabine), for the
treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in
women who have received prior therapy, including Herceptin(R)
(trastuzumab). The compound has been granted Fast Track status by the FDA
in this patient population. TYKERB is a small molecule dual kinase
inhibitor developed by GSK as an oral therapy, and is currently being
investigated in breast cancer and other solid tumors. TYKERB is an
investigational drug and has not been approved for marketing by any
regulatory body.
"This filing is the result of many years of tremendous research and
development work by the scientists at GSK. It is truly an outstanding
milestone, especially for the many thousands of women who are facing the
devastating effects of advanced breast cancer," said Paolo Paoletti, M.D.,
Senior Vice President of the Oncology Medicine Development Center at GSK.
"Many of these women are desperately in need of alternative treatments, and
this filing demonstrates that we have turned the corner toward a new era of
targeted agents."
GSK plans to submit the Marketing Authorization Application (MAA) for
TYKERB in Europe during the 4th quarter of this year.
About the Data Submitted(1)
A planned interim analysis of the Phase III international, multicenter,
open-label trial randomized 324 women who had advanced or metastatic breast
cancer with documented HER2 overexpression and whose disease progressed
following treatment with Herceptin and other cancer therapies, to TYKERB
and Xeloda or Xeloda alone. In this pivotal trial, the combination of
TYKERB and Xeloda versus Xeloda alone nearly doubled median time to
progression (36.7 weeks [8.5 months] in the combination arm versus 19.1
weeks [4.4 months] with Xeloda alone, p=0.00008).
The most common adverse events (>25%) during therapy with TYKERB plus
Xeloda were gastrointestinal (diarrhea, nausea, and vomiting) or
dermatologic (palmer-plantar erythrodysesthesia and rash). The majority of
adverse events and laboratory abnormalities were mild to moderate in
severity.
The study was originally presented by trial principal investigator
Charles Geyer, M.D., Director of Breast Medical Oncology at Allegheny
General Hospital (Pittsburgh, Pennsylvania) at the 2006 American Society of
Clinical Oncology (ASCO) annual meeting in Atlanta, Georgia, in June.
In March 2006, an Independent Data Monitoring Committee (IDMC) made a
unanimous recommendation to stop enrollment of the study based on the early
success of the trial. The study met its primary endpoint of time to disease
progression, and exceeded the predetermined stopping criteria outlined in
the committee charter. GSK stopped enrollment to the study in April 2006.
About TYKERB
TYKERB, a small molecule that is administered orally, inhibits the
tyrosine kinase components of EGFR (ErbB1) and HER2 receptors. Stimulation
of EGFR and HER2 is associated with cell proliferation and with multiple
processes involved in tumor progression, invasion, and metastases.
Overexpression of these receptors has been reported in a variety of human
tumors and is associated with poor prognosis and reduced overall survival.
GSK is using advanced technologies, including pharmacogenetics, to
better define patient populations that may respond to TYKERB.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better, and live
longer. For company information, visit GlaxoSmithKline at
gsk.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, including
those made in this announcement, are subject to risks and uncertainties
that may cause actual results to differ materially from those projected.
Factors that may affect the Group's operations are described under 'Risk
Factors' in the Operating and Financial Review and Prospects in the
company's Annual Report on Form 20-F for 2005.
GlaxoSmithKline
gsk
gskcancermedia
View drug information on Herceptin; Tykerb; Xeloda.