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SAVE THE DATE
JALBCA ANNUAL DINNER
Monday, May 7, 2012
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.
: 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
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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