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Vol. 11, No. 1 · January 2007 · Editor: Martha L. Golar, Esq.
“Legal Considerations for You and Your Family: Post-Cancer Diagnosis DATE: February 13, 2007 TIME: 6:30 - 7:30 P.M. PLACE: Skadden Arps Slate Meagher & Flom Four Times Square (between 6th Avenue & Broadway) New York, NY SPEAKER: Randye Retkin, Esq., Director of LegalHealth · PERSONALIZED VACCINATIONS – A REPORT FROM ANTIGENICS · DATABASE FOR TURF PESTICIDES AND CANCER RISK · UCLA IMAGING STUDY ON “CHEMO BRAIN” · UPCOMING CancerCare PROGRAMS · Calendar of Events PERSONALIZED VACCINATIONS – A REPORT FROM ANTIGENICS At its November 8 program, JALBCA presented the program “Personalized Cancer Vaccines: A Progress Report,” featuring the Chairman and CEO of Antigenics Inc., Garo H. Armen. Mr. Armen described personalized cancer vaccinations as an exploratory area and one which is not the focus of the cancer treatment community. Mr. Armen explained that vaccinations, as most people understand them today, are prophylactic and not therapeutic. That is, vaccinations typically serve a preventative purpose and are given to ward off a prospective condition. Cancer vaccinations, however, are not prophylactic but, rather, are given after a person is already diagnosed. The differences between the two types of vaccinations are based on the two arms of the immune system. The first arm involves antibodies, which are stimulated to resist, in a preventative way, a future condition. Mr. Armen noted that this has historically been the focus of medical research—the “low hanging fruit” approach—whereby antibodies could be generated relatively quickly with prophylactic vaccines in anticipation, for example, of a flu strain. The second arm of the immune system involves activity at the cellular level, the T-cells. Medical researchers have not historically had the tools to stimulate the immune system at this level. It is this level at which the personalized cancer vaccine is directed. Compared with the B cell-driven humoral, or antibody, response, it seems the T-cell, cellular process is far better suited to attacking tumors and virally infected cells. While this explains the difference between the studied personalized vaccines and traditional vaccines, it is also useful to understand the difference between the product used in Antigenics’ research and therapeutic monoclonal antibodies, which have received a lot of recent attention. As further explained in a white paper located on the Antigenics website (entitled “Heat Shock Proteins’ Vaccine Potential: From Basic Science Breakthroughs to Feasible Personalized Medicine”), therapeutic monoclonal antibodies such as Herceptin (made by Genentech) and Rituxan (made by IDEC) are acting as drugs, not as immuno-stimulants. These monoclonal antibodies bind to important disease-associated cell surface receptors, altering their behavior. The product created by Antigenics, by contrast, directly sensitizes the immune response to specific antigens. It is believed that heat shock proteins (HSPs) bind to every peptide in a cell so that HSPs inside a virally infected or cancerous cell are holding onto peptides that healthy cells should have but, in addition, peptides that are foreign, inappropriately expressed or altered. The theory, then, is that when cancer cells rapidly divide and throw off dead necrotic cells, their unwelcome HSP-peptide complexes are exposed and serve as red flags to a Tcell activated immune system. Mr. Armen explained that cancer drugs today are directed to a patient’s quality of life, symptoms and life extension. Cancer drugs are targeted primarily for late-stage and not intermediate stage disease points. The investigational personalized cancer vaccine made by Antigenics, Oncophage, is designed to work on intermediate stage disease points because, in these stages, it is thought that the patient’s immune system is strong enough to combat the cancer. The vaccine is derived from a person’s own cancer tissue and designed to cause the patient’s immune system to recognize the individual genetic pattern of a tumor. No two individuals have the same genetic pattern and, therefore, each patient’s disease is different. The process followed by Antigenics is as follows. After surgical removal and biopsy, tumor tissue is packed in dry ice and shipped overnight to the company’s facility in Massachusetts. There, the tumor cells are broken open. A species of molecules known as “heat shock proteins” (HSP’s) are extracted. The HSP’s are complexed with tumor-specific peptides, as well as many other antigens which are not relevant to the treatment, and this extracted material is purified, frozen and shipped back to be injected when the patient has recovered from surgery. It is not necessary to know the specific antigenic peptide associated with the cancer. The object of heat shock protein immunotherapy is that, when injected into the patient, the material will activate an immune response which is targeted to unique antigens that characterize the patient’s tumor. The vaccine, unlike chemotherapy drugs, would work with any type of cancer and would target only cancer (and not healthy) cells. Antigenics’ vaccines for kidney cancer and melanoma have progressed to Phase III trials. Mr. Armen described the renal cell carcinoma trial to attendees. This disease was chosen by Antigenics for trial purposes, in part, because not much research activity is going on in this area. Half of the 700 patients in the trial underwent surgery (kidney removal) and were given Oncophage; the other half followed the standard of care, which involves just surgery. The trial outcome did not show a statistically significant trend toward Oncophage so the company then divided the patients into cohorts, i.e., layers of people at different stages of health. The company reported a clinically significant improvement in recurrence-free survival associated with Oncophage in a well defined subgroup of better-prognosis FAS patients. FAS stands for “full analysis set”, which represents the true adjuvant patient population intended for the trial. While cancer vaccines present a fascinating potential method of cancer treatment, Mr. Armen described the challenges of working in this area in the regulatory context, and the enormous cost associated with financing clinical trials. Antigenics’ website cites the fact that Oncophage has been granted fast track and orphan drug designations from the US Food and Drug Administration for kidney cancer and metastatic melanoma. DATABASE FOR TURF PESTICIDES AND CANCER RISK The BCERF program (Cornell University program on Breast Cancer and Environmental Risk Factors) has recently launched an online database that provides cancer risk information for chemicals found in over 2,800 turf and lawn care pesticide products. The cite integrates information on chemicals evaluated for carcinogenicity by the US Environmental Protection Agency with 111 active ingredients found in turf and lawn care pesticides registered for use in NY. Users can search for information in three ways: by product, by active ingredient, or by cancer risk category. Cancer risk information is not available for all chemicals because Federal pesticide registration laws, in the past, only required full evaluations of cancer risk for chemicals that both will be used in pesticides and which have food-crop uses. However, effective October 1, 2006, new Federal legislation requires that all chemicals proposed for pesticide registration or re-registration be evaluated for a variety of health risks, including cancer. To access the database, go to http://envirocancer.cornell.edu/turf/. UCLA IMAGING STUDY ON “CHEMO BRAIN” The results of a new UCLA study on brain function in cancer patients who undergo chemotherapy were reported October 5, 2006 in the online edition of the journal Breast Cancer Research and Treatment. The Breast Cancer Research Foundation and American Cancer Society supported the study. The study showed that chemotherapy causes changes to the brain’s metabolism and blood flow that can linger at least 10 years after treatment. Dr. Daniel Silverman, the study’s lead author and head of neuronuclear imaging and associate professor of molecular and medical pharmacology at the David Geffen School of Medicine at UCLA, noted that people with ‘chemo brain’ often complain of difficulty focusing, remembering things or multi-tasking the way they did prior to chemotherapy and that this UCLA study “demonstrates for the first time that patients suffering from these cognitive symptoms have specific alterations in brain metabolism”. The team of researchers used positron emission tomography (PET) to scan the brains of 21 former breast cancer patients who had tumors surgically removed between five to 10 years prior to the study. Sixteen of the women had been treated with chemotherapy regimens near the time of their surgeries to reduce the risk of cancer recurrence; five had surgery only. The team compared PET images evaluating the chemotherapy patients’ brain function to PET scans from the five breast cancer patients who underwent surgery only and 13 control subjects (women of similar age and backgrounds) who had no history of breast cancer or chemotherapy. The women performed short-term memory exercises, during which the UCLA researchers measured blood flow to their brains. After the exercises, the researchers also measured the patients’ resting brain metabolism. The PET scans revealed a link between ‘chemo-brain’ symptoms and lower metabolism in a key region of the frontal cortex. When the patient’s resting brain metabolism was lower, the woman had more difficulty performing the memory test. When patients performed the memory tests, the PET scans showed that blood flow to the frontal cortex and cerebellum spiked, indicating a rapid hike in the activity level in these brain regions. Dr. Silberman explained that, “(i)n effect, these women’s brains were working harder than the control subjects’ to recall the same information”. In addition, the UCLA researchers discovered that women who underwent hormonal therapy in addition to chemotherapy displayed changes in a region of the brain known as the basal ganglia. This part of the brain works to bridge thought and action. On average, these women showed an 8 percent drop in resting metabolism in this brain region. “Chemotherapy used to be prescribed primarily to treat metastatic disease”, observed Silverman. “Now it’s common for doctors to administer chemotherapy to patients near the time of surgery to prevent metastasis. As many of these patients become long-term survivors, doctors are recognizing lasting side-effects of chemotherapy, and, in particular, the kind of chemobrain symptoms we are studying.” The National Cancer Institute recently awarded a five-year grant to oncologist Dr. Patricia Ganz, who is organizing a long-term study on ‘chemo brain’ of a larger group of breast cancer survivors with Dr. Silverman and their colleagues at UCLA. At this time, physicians do not know the mechanism that causes ‘chemo brain’ and, therefore, more studies are necessary to discern how the damage occurs and whether chemotherapy drug treatment could be modified to avoid this result. (Source: http://www.physorg.com/news79282045.html; based on UCLA news release) Author’s note: An online search located a June 8, 2005 news release from the University of Cincinnati which reported that researchers led by that institution’s Elyse Lower, MD report a possible new treatment for the chemo-brain problem using the drug dexmethyphenidate (d-MPH). The research was funded by Celgene Corporation, based in Warren, N.J. UPCOMING CancerCare PROGRAMS CancerCare 275 Seventh Avenue NY NY 10001 212.712.8080 www.cancercare.org teled@cancercare.org The following are free telephone education workshops for people living with cancer, their families, friends and health care professionals, available during February 2007 and presented by CancerCare. The contact information for this organization is located on the back of this Newsletter. Medicare Part D for People Living With Cancer Time: 1:30 – 2:30 pm Date: Friday, February 9, 2007 New Diagnostic Technology in the Treatment of Breast Cancer Time: 1:30 – 2:30 pm Date: Tuesday, February 13, 2007 Nutrition and Cancer -- Beyond Calories: Building Lean Body Mass Time: 1:30 – 2:30 pm Date: Wednesday, February 21, 2007 Calendar of Events ADELPHI NY STATEWIDE BREAST CANCER Hotline & Support Program Adelphi University School of Social Work Garden City, NY 11530 www.adelphi.edu/nysbreastcancer/index.html CancerCare 275 Seventh Avenue NY NY 10001 212.712.8080 www.cancercare.org teled@cancercare.org MEMORIAL SLOAN-KETTERING CANCER CENTER Memorial Sloan-Kettering Cancer Center Post-Treatment Resource Program Educational Forums 215 E. 68th Street, Ground Floor New York, NY 10021 212-717-3527 www.mskcc.org/mskcc/html/59513.cfm SHARE Self-Help for Women with Breast or Ovarian Cancer) 1501 Broadway, 704A New York, NY 11530 www.sharecancersupport.org 212-719-0364 Sexuality after Treatment Speaker: Mary Gratch, MD, St. Barnabas Hospital Dr. Gratch will describe the physical aspects of the female sexual response and, together with those in attendance, the mental and emotional aspects within the context of a cancer diagnosis. Location: The Jewish Community Center in Manhattan Time: 6:30 – 8:30 pm Date: January 25 What Cancer Survivors Need to Know about Long Term Care Insurance Speaker: Vivian P. Gallo, CLU, CSA, AEP, CHOICES For Long Term Care Insurance Ms. Gallo will discuss the pros and cons of buying such a policy. She will focus on the basic features of each policy and the companies that provide them, the role of Medicare and Medicaid in long-term coverage, and what factors affect the insurability of cancer survivors. Location: SHARE Main Office Time: 6 – 7:30 pm Date: February 5 JALBCA does not endorse the content or efficacy of any workshops or programs listed in the Calendar of Events; listings are for informational purposes only, so that our readership is aware of current offerings. |
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