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NEW RESEARCH ON BREAST CANCER PROVIDES IMPORTANT INFORMATION FOR CLINICAL MANAGEMENT
-- Studies Document Improved Survival with Combination of Chemotherapy and Tamoxifen; New Insight into Managing Uterine Cancer Risk; Psychological Benefits of Lumpectomy --
-- Press Briefing Monday, May 19, 7:30 AM (MDT) --
Denver, CO -- May 19, 1997-- Breast cancer is the most common form of cancer among women in the United States, with an estimated 180,200 cases expected to be diagnosed this year; worldwide, it will affect over one million women by the year 2000. According to recent data, breast cancer mortality rates are declining, a trend that most researchers have attributed to earlier detection and better treatments.
As treatment options continue to grow -- mastectomy, lumpectomy with radiation therapy, chemotherapy, hormone therapy, immunologic therapy, and combinations of these approaches -- research presented at a press conference at the Thirty-third Annual Meeting of the American Society of Clinical Oncology seeks to answer critical questions to help patients and doctors make informed treatment decisions.
ìThis yearÃs meeting of the American Society of Clinical Oncology will have a significant impact on the treatment of breast cancer,î said Alan P. Lyss, MD, Director of the Missouri Baptist Cancer Center in St. Louis and moderator of the press conference. ìThe results of several long-awaited clinical studies, which relate to thousands of women with breast cancer each year, will be presented. In some cases, the results were unexpected. These studies will have an important impact on the treatment and prognosis of many breast cancer patients worldwide.î
Research presented at the meeting will inform physicians on the most effective utilization of the hormonal treatment tamoxifen as adjuvant therapy -- used after initial treatment to prevent cancer recurrence. Today, tamoxifen is the most widely prescribed anti-cancer agent, with over 20 million women worldwide receiving this antiestrogen. While tamoxifen has helped prevent recurrence and prolong survival, the challenge facing the field today is to develop strategies that will result in even greater survival, and assist doctors and patients in managing the risks associated with this breast cancer therapy.
Other research will address the psychological implications of breast-conserving therapy for early-stage breast cancer, which has been shown to be as clinically effective as total mastectomy for certain patients. Some of the reasons women may choose breast-conserving treatments are clear, yet questions remain regarding the psychological aftermath of this type of treatment: Are women who choose breast conservation as confident that their treatment was successful? Do they experience greater fear of recurrence? Do either women who choose breast conservation or mastectomy regret their decisions with the passage of time?
Chemotherapy and Tamoxifen Found to Be More Effective than Tamoxifen Alone Among Patients not Previously Thought to Benefit from Combination
B. Fisher, et al, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA ìThe Worth of Chemotherapy and Tamoxifen (TAM) Over TAM Alone in Node-Negative Patients with Estrogen-Receptor (ER) Positive Invasive Breast Cancer: First Results From NSABPî (Plenary Session, Monday May 19, 3:00 p.m. [MDT], Hall A, Abstract #1)
For breast cancer patients whose tumors are hormone-receptor positive, but whose cancer has not spread to the lymph nodes (node negative), the value of adding chemotherapy to tamoxifen adjuvant therapy has been unclear. A new study has demonstrated that women with hormone-receptor positive breast cancer that has not spread to the lymph nodes -- 15% - 30% of todayÃs breast cancer patients -- can derive greater benefit from tamoxifen combined with chemotherapy than from tamoxifen alone. The study was conducted by Bernard Fisher, MD, Scientific Director of the National Surgical Adjuvant Breast and Bowel Project -- the first researcher to demonstrate that lumpectomy can be equally as effective as mastectomy.
The 2,363 patients in this study were randomized into three groups: 788 received tamoxifen alone, 786 received tamoxifen and six cycles of M"¡F chemotherapy (methotrexate and 5-fluorouracil followed by leucovorin), and 789 received tamoxifen and CMF chemotherapy (cyclophosphamide, methotrexate, and 5-fluorouracil).
The study determined that women who received either regimen of chemotherapy in combination with tamoxifen were significantly more likely to be disease-free after five years of follow-up -- 90%, compared with 85% [p=0.002] of women treated with tamoxifen alone. Initial results are also suggestive of a survival benefit -- 97%, compared to 94% [p=0.02] at five years. (Note: p-values are an indicator of statistical significance; the lower the p-value, the more statistically significant the finding.)
Tamoxifen/Chemotherapy Combination Confirmed Effective in Treating Common Breast Cancer Population
Kathy Albain, et al, Loyola University Medical Center, ìTamoxifen (T) v. Cyclophosphamide, Adriamycin, and 5-FU (CAF) Plus Either Concurrent or Sequential T in Postmenopausal, Receptor(+) Node(+) Breast Cancer: A Southwest Oncology Group Phase III Intergroup Trialî (Integrated Session, Sunday, May 18, 11:25 a.m. [MDT], Hall A, Abstract # 450)
Anthracycline-based chemotherapy combined with tamoxifen has been confirmed as more effective than tamoxifen alone in treating post-menopausal patients diagnosed with hormone-receptor positive breast cancer that has spread to the lymph nodes. Tamoxifen alone previously has been the standard treatment in this common subgroup of breast cancer survivors. The study presented by Kathy Albain, MD of the Cardinal Bernardin Cancer Center at the Loyola University Medical Center in Illinois, also found that the anthracycline-based chemotherapy is well tolerated and that cardiac side effects are extremely rare.
The study of 1,470 eligible patients illustrated that the drug combination of tamoxifen and anthracycline-based chemotherapy (a combination of cyclophosphamide, doxorubicin, and 5-FU) significantly improved the rate of disease free survival compared to tamoxifen alone. After four years, of the women receiving tamoxifen alone, 72% had disease free survival, while 79% of women receiving tamoxifen and chemotherapy were disease free. Previous individual studies combining tamoxifen with non-anthracycline chemotherapy have shown no increased benefits over tamoxifen alone in this population.
Nearly a third of the study participants were over the age of sixty-five. Prior to this study, it was believed that many of these women could not tolerate anthracycline-based chemotherapy, because of the many potential side effects, including cardiac risks. All patients were screened for cardiac problems; those with cardiac disease were excluded from the study.
Aggressive Monitoring for Uterine Cancer Among Patients on Tamoxifen Therapy Found to Be Unnecessary
G. Bertelli, et al, National Institute for Cancer Research, Italy ìAre Ultrasound Examination or Endometrial Sampling Necessary in Asymptomatic Breast Cancer Patients During Adjuvant Tamoxifen?î (Oral Session, Tuesday May 20, 11:30 a.m. [MDT], Ballrooms 2-3, Abstract #1267)
The anti-estrogen tamoxifen has been associated with an increased risk of uterine cancer and it is recommended that women on adjuvant tamoxifen therapy be routinely monitored for the development of uterine malignancy. The current recommended methods of surveillance are annual pelvic examination and prompt evaluation of unexpected vaginal bleeding, but some researchers have suggested that ultrasound and/or endometrial sampling (removing tissue samples from the uterus) may be more effective in early detection of uterine abnormalities.
In a study conducted by Gianfilippo Bertelli, MD, of the National Institute for Cancer Research in Italy, data indicated that ultrasound examination may provide deceptive results among post-menopausal women receiving adjuvant tamoxifen therapy, leading to unnecessary invasive endometrial biopsies. Among 164 asymptomatic breast cancer patients, ultrasound revealed significant increases in endometrial thickness -- a potential indicator of the presence of uterine cancer -- among 53% of the 89 post-menopausal patients undergoing adjuvant tamoxifen therapy. Increased endometrial thickness, however, did not correlate with abnormal findings at biopsy. Furthermore, endometrial sampling was refused or was not possible due to cervical stenosis, or constriction, in 24% of the original 164 patients.
The data suggest that in one out of two gynecologically asymptomatic postmenopausal breast cancer patients, tamoxifen may induce ultrasound abnormalities that would normally mandate the use of invasive diagnostic procedures, but would be unnecessary in these cases. Therefore, the study authors conclude that routine ultrasound surveillance cannot be recommended among this patient population and that invasive diagnostic procedures are not always feasible. Instead, prompt evaluation of unexpected vaginal bleeding may be the most effective way to monitor for uterine cancer.
No Increased Fear of Recurrence Associated with Breast Conserving Therapy over Modified Radical Mastectomy
D. Curran, et al, European Organization for Research and Treatment of Cancer, Belgium, ìQuality of Life of Early-stage Breast Cancer Patients Treated with Mastectomy or Breast Conserving Procedures: Results of EORTC Trialî (Poster Session, Monday May 19, 8:00 a.m. [MDT], Currigan A, Abstract #151)
In a quantitative psychological analysis comparing quality of life among early stage breast cancer patients treated with modified radical mastectomy versus breast conserving therapy, Desmond Curran and colleagues on behalf of the Breast Group of the European Organization for Research and Treatment of Cancer in Brussels, found that women who undergo breast conserving therapy not only have significantly better body image and are more satisfied with their treatment, but also have no greater fear of recurrence than women who have undergone modified radical mastectomy.
This randomized, multicenter, multinational study surveyed 278 breast cancer patients diagnosed with stage I and II breast cancer, 127 of whom received modified radical mastectomy, and 151 of whom received breast conserving therapy. A quality of life questionnaire, administered two years after initial treatment, included two multi-item scales (body image and fear of recurrence) and two single items (satisfaction with treatment and cosmetic result).
Mastectomy has been in use as treatment for breast cancer since 1890; it is only within the last two decades that breast conserving therapy, involving removal of the cancer tumor only, followed by radiation therapy, has been a treatment option for women diagnosed with early stage breast cancer.
Several studies have indicated that, for women diagnosed with early stage cancer, there is no significant difference in overall survival between modified radical mastectomy and breast conserving therapy. This study provides quantitative evidence that breast conserving therapy adds some quality of life benefits to the clinical outcome, as well.
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