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April 2003-1-up

SAVE THE DATE
JALBCA ANNUAL DINNER
Monday, May 7, 2012
Honoring
Hon. Gail A. Prudenti
Sul ivan & Cromwel LLP
SAVE THE DATE
ELLEN P. HERMANSON FOUNDATION EVENTS
The El en P. Hermanson Foundation is planning the fol owing two events for Summer 2012: Celebrity chef dinner at a private home on the water.
August 19, 2012 - 17th Annual El en’s Run (5K Walk) Southampton Hospital, Southampton, NY.
NOTE: The El en P. Hermanson Foundation has relocated to 200 West End Avenue, Suite 12G, NY NY 10023.
SAN ANTONIO 2011 ANNUAL CANCER SYMPOSIUM
In December 2011, the annual San The study included women whose trastuzumab were given together with Antonio cancer symposium took place. cancer had previously progressed on chemotherapy, they were more It was designed to provide state-of-the- treatment with an aromatase inhibitor effective art information on the experimental (either anastrozole or letrozole). chemotherapy plus trastuzumab alone.
prevention, Everolimus is an oral medication. The diagnosis, and therapy of breast cancer Women who received the combination progression-free and premalignant breast disease to an of exemestane plus everolimus approximately six months, and this international audience of academic and experienced a much longer time until improvement was achieved with only a the cancer progressed. The median small increase in side effects.
A limitation with any cancer therapy is difference in time to progression Pertuzumab for patients with resistance. That is, when a new therapy between the two groups was about five metastatic HER2-positive breast is applied, patients either do not months and, for some women in the cancer is presently available only as respond from the outset or initial y combined treatment group, the time to part of a clinical trial. It was reported benefit from the therapy but later progression exceeded one year.
that, if these findings persist, they are Everolimus did have added side likely to change clinical practice for instituted to examine whether various effects, however, including fatigue, patients with advanced breast cancer if combinations of existing therapies gastrointestinal difficulties, skin rashes and when this drug receives FDA would overcome resistance and and lung problems. Everolimus is not approval.
improve results for patients. Highlights presently FDA-approved for breast from several important studies with cancer indication (though it is FDA- Averel Trial Did Not Support potential impact for women with approved for other diseases). Until it is Bevacizumab for Treatment of HER2+ breast cancer and metastatic approved for breast cancer, it wil be a Metastatic Breast Cancer disease are described below. These challenge for patients to obtain include results from two large-scale, insurance coverage.
Phase III, international clinical trials, The BOLERO study is noteworthy trastuzumab-based therapy in women because it demonstrated that a targeted with HER2+ metastatic breast cancer.
therapy can add benefit to a hormonal Unfortunately, the improvement in The drug everolimus (Affinitor®) Pertuzumab as a New Treatment is an mTOR inhibitor, a class of Option for Metastatic Breast Cancer Pertuzumab is a new targeted New Test for Ductal Carcinoma In is focused on a specific molecular antibody therapy that, like trastuzumab Situ (DCIS) pathway in cancer cel s) studied as a (also a targeted antibody therapy), way to increase the benefit of hormone binds to the HER2 receptor. It wil be a Score, was developed by Genomic therapy (such as aromatase inhibitors). treatment available for patients with Health (in conjunction with other, mTor is an intracel ular signal thought HER2-positive cancer. academic partners) to identify women to be important in most hormone Pertuzumab works differently from with DCIS. There seems to be receptor positive (HR+) breast cancers. trastuzumab.
The CLEOPATRA (Clinical with DCIS are over-treated but, before Trials of Oral Everolimus) study is a Evaluation of Pertuzumab and now, there was not a reliable method to Phase III randomized clinical trial of Trastuzumab) international trial looked distinguish which patients were at the postmenopausal women diagnosed at the benefit of combining lowest risk and, therefore, good with metastatic HR+ breast cancer trastuzumab and pertuzumab. It prospects for minimal treatment. This from 195 sites worldwide. The study compared pertuzumab in combination new test at empts to identify the low- results demonstrated that, for these with trastuzumab and chemotherapy risk patients. To date, however, the patients, everolimus in combination (with docetaxel) to trastuzumab and DCIS Recurrence Score has only had inhibitor chemotherapy alone in women with limited use.
exemestane slowed the growth of metastatic HER2-positive breast tumors bet er than exemestane alone. cancer. When pertuzumab and These women also were more likely to among the various breast cancer Brachytherapy is a form of experience radiation-related side subtypes; and a report on the data from radiotherapy where a radiation source effects, such as breast pain, fat The Cancer Genome Atlas (TCGA) is placed inside or next to the area necrosis, and rib fracture.
outcomes were studied of 130,535 Laboratory Advances The San Antonio Symposium also identify the most frequent genomic invasive breast cancer who were featured several presentations focused changes in breast tumors, and treated with brachytherapy. It was on basic research, e.g., an overview of determine which genomic changes are reported that, compared with women the use of proteomics (the study of linked to better outcomes or may treated with whole-breast irradiation, proteins) in breast cancer research; predict recurrence or metastasis or women treated with brachytherapy reports on investigations that assessed may predict response to different kinds experienced an increased risk (4% vs. the type and prevalence of mutations of therapies.) 2.2%) for subsequent mastectomy. in cancer-related genes, which differed NEWS ITEMS
Health Drugs and the Drug Safety and BONIVA (ibandronate sodium) tablets Advisory and injection, Roche Therapeutics, Committee voted 17 to 6 to Inc.; RECLAST (zoledronic acid) recommend that the labeling for injection, Novartis Pharmaceuticals bisphosphonates for the treatment of Corporation; When breast cancer spreads, it osteoporosis become more specific equivalents for these products, if any.
often spreads first to the bones. Bone about how long the drugs should be The manufacturers made presentations metastases can lead to complications used. The discussion included to the panel, in essence, arguing that such as pain, fractures, spinal cord consideration of other issues as wel , bisphosphonates prevent fractures and marrow including the strength of the available reduce mortality. Researchers theorize suppression, and hypercalcemia - and reportedly growing - evidence that although these drugs slow the (abnormally high blood calcium). that bisphosphonates increase the risk breakdown of bone associated with Biphosphonates are a widely for atypical subtrochanteric and aging (they work by inhibiting bone prescribed class of drugs for femoral fractures, osteonecrosis of the resorption to prevent loss of bone osteoporosis which are being jaw (jawbone death), and esophageal mass), they may also make the the cancer, and whether to recommend remaining bone brit le and susceptible prevention of bone metastases and to that patients takes a break from their to thigh fractures and jaw-bone decay.
prevent and treat cancer therapy- use of these drugs. The joint induced osteoporosis. The relationship commit ee was convened to discuss warnings are already in place. In 2005, is this: breast cancer cel s stimulate the safety of long-term (greater than the FDA added a warning on bone cel s cal ed osteoclasts, these three to five years) use of bisphosphonates about osteonecrosis osteoclasts in turn stimulate the growth biphosphonates.
The four currently approved makers of bisphosphonate drugs to add bisphosphonate would be used to bisphosphonates for the treatment and a warning to their labels about a smal interrupt the relationship between prevention of osteoporosis include the increased risk of atypical femur osteoclasts and breast cancer cel s. fol owing: FOSAMAX (alendronate fractures after an American Society for sodium) tablets and solution and Bone and Mineral Research task force FOSAMAX PLUS D (alendronate concluded that the risk is real, though sodium/cholecalciferol) tablets, Merck smal . In 2011, the FDA required that A joint advisory panel to the FDA & Co., Inc.; ACTONEL (risedronate al bisphosphonates used to prevent or in September 2011 found that there is sodium) ATELVIA treat osteoporosis warn on their labels insufficient data to make long-term (risedronate sodium) delayed release that optimal duration of use has not treatment recommendations about tablets, and ACTONEL WITH been determined, and that al patients whether the use of biphosphonates for CALCIUM (Copackaged) (risedronate on bisphosphonate therapy should osteoporosis should be limited. The sodium with calcium carbonate) have their need for continued therapy Advisory Commit ee for Reproductive tablets, Warner Chilcott, LLC; re-evaluated periodical y.
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Source: http://jalbca.org/oldnewsletter/February_2012.pdf

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