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Vol. 9, No. 2 · March 2005 · Editor: Martha L. Golar, Esq.
· Latest ASCO Guidelines for Hormonal Therapy · NYS Attorney General -- Health Care Bureau Activities · Report on JALBCA January Program · Update on Integrative Medicine Service of MSKCC · To Life! · Calendar of Events
Latest ASCO Guidelines for Hormonal Therapy The American Society of Clinical Oncologists (ASCO) has updated its guidelines for hormonal therapy. This update was presented at the December 2004 San Antonio Breast Cancer Symposium. ASCO’s prior hormonal therapy update was in 2002. The ASCO experts reviewed the latest research on hormonal therapy for early-stage breast cancer and their conclusions are set forth in the following questions and answers, taken from the Journal of Clinical Oncology of January 20, 2005: 1. Should an aromatase inhibitor be the first-choice treatment for post-menopausal women with early-stage, hormone-receptor-positive breast cancer? The few studies done so far show that aromatase inhibitors tend to be more effective and have fewer serious side effects than tamoxifen. Studies are needed that look at the long-term risks and benefits of aromatase inhibitors compared to those of tamoxifen. Experts presently say that an aromatase inhibitor is: 2. Should post-menopausal women with hormone-receptor-positive breast cancer use an aromatase inhibitor after taking tamoxifen for five years? One study looked at this question. In that study, women who took tamoxifen for five years and then Femara for two to three years improved their chances of survival more than women who just took tamoxifen for five years. The improved survival was especially striking in the women with lymph node–positive breast cancer. Based on those findings, the experts recommend that women who finish taking tamoxifen for five years should consider taking an aromatase inhibitor for at least two and a half years. They noted, however, that such extended hormonal therapy could increase the risk of developing bone fractures and other complications. Therefore, it is recommended that women and their doctors weigh the individual risk of recurrence against the risk of developing complications from extended hormonal therapy. This balance is likely to be tipped in favor of taking tamoxifen PLUS an aromatase inhibitor if you have lymph node–positive cancer. 3. Should post-menopausal women with hormone-receptor-positive breast cancer take an aromatase inhibitor after taking tamoxifen for two to three years? Women who take tamoxifen for two to three years and then switch to an aromatase inhibitor—Arimidex or Aromasin—until they’ve completed five years of hormonal therapy have a reduced risk of breast cancer recurrence compared to women who take tamoxifen for five years. Based on those findings, the experts recommended that post-menopausal women consider switching to an aromatase inhibitor after taking tamoxifen for two to three years; and, if you do not switch or cannot tolerate an aromatase inhibitor, you should continue taking tamoxifen for a full five years. 4. How long should post-menopausal women with hormone-receptor-positive breast cancer take an aromatase inhibitor following surgery, or following treatment with tamoxifen? More results are needed from current studies. In the meantime, taking an aromatase inhibitor for more than five years is not warranted unless you are part of a clinical trial to test its effectiveness. It is not yet known whether you can get the full benefit of hormonal therapy if you take it for less than five years. 5. Is there any reason to take tamoxifen after an aromatase inhibitor? If you cannot tolerate taking an aromatase inhibitor for five years, it makes sense to switch to tamoxifen to complete your five years of hormonal therapy. But there have not been many studies on this. 6. Should women with hormone-receptor-negative breast cancer take an aromatase inhibitor? No. There is overwhelming evidence that these medications are NOT effective in women whose breast cancers are estrogen-receptor negative or progesterone-receptor negative. 7. Should women who appear to have had their menopause brought on early by chemotherapy take an aromatase inhibitor? Women often find that their periods stop, sometimes permanently, during and after they take chemotherapy for breast cancer. For some women, however, chemotherapy only triggers a temporary menopause, and they start menstruating again within a year or so of stopping chemotherapy. It is hard to tell if you are truly menopausal after chemotherapy. Even if you do not get your periods, your ovaries can still make estrogen that can turn on the growth of hormone-receptor-positive breast cancer. The experts thought there was not enough evidence to answer this question. 8. Should women who are pre-menopausal take an aromatase inhibitor combined with a treatment that stops their ovaries from producing estrogen? One of the main treatment goals for women with hormone-receptor-positive breast cancers who are still menstruating is to reduce the amount of estrogen reaching any tumor cells that could be left behind. This can be done either by taking tamoxifen, which blocks estrogen receptors on tumor cells, or by taking a treatment that stops the ovaries from producing estrogen. One way to stop the ovaries from producing estrogen is to take a drug called Zoladex (chemical name: goserelin). This medicine stops the brain from signaling the ovaries to make estrogen. Another way is to have the ovaries removed by surgery. Neither option, however, would stop the body from converting androgen into estrogen, which would be accomplished by an aromatase inhibitor. In theory, taking an aromatase inhibitor along with Zoladex, or after having the ovaries removed, would rid the body of nearly all the estrogen and significantly hamper the growth of breast cancer cells that are hormone-receptor-positive. But researchers have not adequately studied whether this treatment regimen is more effective than tamoxifen. Presently, the experts do not recommend combining an aromatase inhibitor with a treatment to stop ovaries from producing estrogen, except in a clinical trial designed to test the safety and effectiveness of this regimen. 9. Are aromatase inhibitors bad for your bones and muscles? Several studies show that each of the three aromatase inhibitors increases the risk of bone thinning that results in a bone fracture more than does tamoxifen or a placebo. The bone thinning linked to taking an aromatase inhibitor may be prevented or treated with other medicines. An aromatase inhibitor slightly increases the risk of developing muscle or joint pains or aches compared to taking tamoxifen or a placebo. 10. Do aromatase inhibitors affect your risk of getting blood-clotting problems or uterine cancer, as tamoxifen does? Women who take tamoxifen have a slightly increased risk of three life-threatening events: uterine cancer, blood clots in the lungs, and strokes (blood clots in the brain). The risk of these side effects is much lower with an aromatase inhibitor than it is with tamoxifen. 11. How do aromatase inhibitors affect women’s quality of life and sexual functioning? The limited evidence available suggests that aromatase inhibitors do not significantly hamper women’s quality of life. These drugs are usually well tolerated, and fewer women stop taking them compared to the number of women who stop taking tamoxifen. However, they can affect women’s sex lives. One study found poorer sexual functioning in women who took Arimidex compared to those who took tamoxifen. In another study, women taking tamoxifen reported less vaginal dryness than those who took Aromasin. The expert panel concluded by noting that the best treatment following surgery for post-menopausal women with early-stage, hormone-receptor-positive breast cancer should include an aromatase inhibitor. The inhibitor could be taken right after surgery, or after taking tamoxifen for a few years for a total of five years of treatment. The panel cautioned, however, that each patient and her doctor should weigh the risks and benefits of aromatase inhibitor treatment compared to tamoxifen or other treatments. For certain women, the risks and side effects of an aromatase inhibitor will outweigh the potential benefits. NYS Attorney General -- Health Care Bureau Activities During Spring 2004, New York Attorney General Eliot Spitzer released a report describing a survey which indicated that health plans fails to disclose information that could help consumers obtain medically necessary coverage. The survey involved 22 health plans. Members of the A.G.’s staff posed as prospective enrollees and sent letters to these plans requesting information on the standards used to determine whether or not treatment for five different conditions was medically necessary and, therefore, covered by insurance. This information is known as “clinical review criteria,” and its disclosure is required under NYS’s “Managed Care Consumer Bill of Rights.” None of the plans received an “A” grade and half received an “F” grade, which meant they made no satisfactory responses, never sending the requested clinical review criteria. The A.G. Health Care Bureau followed up with letters to each of the plans, identifying violations and requesting immediate compliance. The report can be obtained by visiting the Health Care Bureau at the A.G. website, www.oag.state.ny.us. Report on JALBCA January Program On the evening of January 25, Dr. Maura Dikler, a physician with the Memorial Sloan-Kettering Breast Cancer Service, and Alice Yaker, the director of SHARE, reported on the 27th Annual San Antonio Breast Cancer Symposium, at which approximately 6,000 doctors and scientists gathered. The report centered upon five topics: hormonal therapy, bisphosphomates, oncotype Dx, chemotherapy trials and sentinel node biopsy. Dr. Dikler explained that the results of several hormonal trials were discussed at the symposium. One such trial, the ATAC trial, compared the efficacy of arimidex to tamoxifen. After 5 1/2 years, arimidex was found to be more effective than tamoxifen in reducing tumor recurrence, but no benefit was found in the survival rate of the patients. A second randomized trial compared exemestane (aromasin) and tamoxifen in post-menapausal women with early breast cancer who had remained disease free after 2 to 3 years of tamoxifen therapy. Again, the patients taking the aromatase inhibitor did better in regard to recurrence of tumors, but their survival rate did not differ from those taking tamoxifen. On the other hand, patients who had lymph node involvement and who had completed five years of tamoxifen therapy, did experience a survival benefit when given letrozole (femara) as compared to patients given a placebo. Dr. Dikler pointed out that aromatase inhibitors are only effective in post-menopausal women. The side effects of tamoxifen as compared to those of aromatase inhibitors were discussed. The reports seem to indicate that the aromatase inhibitors are better tolerated than tamoxifen. However, they do cause joint pain and bone thinning. Moreover, unlike tamoxifen which has a 30-year track record, there are no long-term studies on these aromatase inhibitors. Finally, they are costly. Dr. Dikler also spoke to the oncotype Dx test, a topic which apparently provoked a great deal of excitement among doctors and researchers. The test, which analyzes 21 genes in a particular patient’s tumor, is a good predictor of tumor recurrence and a patient’s prognosis. It, therefore, can be used to make a decision as to whether chemotherapy should be employed. In addition, the test can be performed on tumor tissue that has been stored in parrafin. The test, unfortunately, has one drawback -- its cost. It is performed by Genomic Health and costs $3500, an amount not presently reimbursable by health insurance. Another area of interest discussed was chemotherapy. One new chemotherapy drug, abraxane (a mixture of taxol and algomine), was found to be more likely to enter tumor cells than taxol alone. A second chemotherapy study concentrated on neo-adjuvent therapy before surgery. It was found that there was no difference in results whether the chemotherapy was administered before or after surgery. The sole difference in effectiveness occurred when all of the chemotherapy was administered in one period of time, rather than being broken up before and after surgery. Lastly, in studies of sentinal node biopsies, it was found that in 9% to 10% of the cases positive lymph nodes were missed in this procedure. Update on Integrative Medicine Service of MSKCC The Integrative Medicine Service of Memorial Sloan-Kettering is conducting several studies addressing symptoms associated with breast cancer such as hot flashes and fatigue. In addition, a study of the effects of Maitake mushroom extract on the immune system in post-treatment breast cancer patients is currently underway. For more information call 212-639-8610. AWARE – The Integrative Medicine Service at Memorial Sloan-Kettering offers this four-week program specifically for women who are high-risk for breast cancer. It addresses prevention, education and anxiety management. Each weekly two-hour class provides presentations/discussions with clinicians and researchers, on topics spanning breast oncology, nutrition, herbology and fitness. In addition, it also covers stress-management skills developed through yoga, meditation, self-hypnosis and self-expression. For more information call 212-639-8629. Focused Fitness for Women – The Integrative Medicine Service of Memorial Sloan-Kettering offers this therapeutic exercise program for breast cancer patients to help reduce the risk of lymphedema and frozen shoulder. These exercises improve range of motion and enhance physical and psychological well-being. For more information call 212-639-4700. The Bendheim Integrative Medicine Center – program offerings are designed to enhance quality of life, increase self-awareness and help prevent health-related problems through healing regimens that address the body, mind and spirit. Some of the services offered in this beautiful “spa-like” setting are massage, acupuncture, reflexology, hypnotherapy, nutritional counseling, etc. For more information or to schedule an appointment call 212-639-4700. To Life! On January 5, 2004, To Life! moved into its new home at 410 Kenwood Avenue, Delmar, New York. The organization serves women with breast cancer and their families in a ten-county region. Its service area includes: Albany, Columbia, Fulton, Greene, Montgomery, Rensselaer, Saratoga, Schenectady, Warren and Washington counties. For more information, contact them at www.tolife.org or 518.439.5975. MEDICARE MODERNIZATION ACT OF 2003 – (from ASCO website of August 4, 2004) ASCO is following the new Medicare Modernization Act of 2003 (“MMA”) and the impact it may have on cancer care. In August 2004, ASCO summarized certain changes in payments by Medicare under the MMA which may impact cancer care, based on the 2005 payment schedule for physician services and drugs which has been released by Medicare. ASCO states that the cuts under MMA will reduce cancer care resources by more than $500 million in 2005 and, further, that this will put access to cancer care at risk. Specifically, ASCO identified the following consequences in the oncology area for 2005: Payments for administration of chemotherapy to patients will decline by about 21 percent, or about $150 million. Chemotherapy administration includes: services of highly trained oncology nurses; on-site mixing of chemotherapy agents by pharmacists; psychosocial services; nutritional counseling; and supportive care by social workers—all of which are necessary for quality cancer care. Medicare payment for chemotherapy drugs also will experience sharp declines. Calendar of Events SHARE (SELF-HELP FOR WOMEN WITH BREAST OR OVARIAN CANCER) 1501 Broadway, Suite 704A NY, NY 10036 www.sharecancersupport.org 212.719.0364 SHARE HOTLINE: Breast: 212.382.2111 Ovarian: 212.719.1204
MEMORIAL SLOAN-KETTERING POST-TREATMENT RESOURCE PROGRAM Post-Treatment Resource Program Educational Forums 1275 York Avenue, Room M107 NY, NY 10021 www.mskcc.org 212.717.3527 ADELPHI NY STATEWIDE BREAST CANCER HOTLINE & SUPPORT PROGRAM Adelphi University School of Social Work Garden City, NY 11530 800.877.8077
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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