Treatment with a combination of chemotherapy drugs improves survival and should be recommended for most women with localized breast cancer, according to a consensus panel convened by the National Institutes of Health. The panel also recommended hormonal therapy for women whose tumors have estrogen receptors, and radiation therapy for women who have had mastectomies and who are at high risk for recurrence of cancer.

These and other recommendations emerged from a 3-day NIH Consensus Development Conference on Adjuvant Therapy for Breast Cancer held November 1-3, 2000 at the NIH in Bethesda, Md. Adjuvant therapy — treatments used in addition to surgery to kill cancer cells that may have begun to spread to other organs — includes chemotherapy and hormonal therapy, typically tamoxifen. In addition to these systemic therapies, radiation therapy is sometimes used as a local adjuvant treatment to help destroy breast cancer cells that have spread to nearby tissues.

"Clinical trials over the past ten years have contributed an enormous amount of new information about adjuvant therapies," said panel chair Patricia Eifel, M.D., Professor of Radiation Oncology at M.D. Anderson Cancer Center in Houston. "Women with breast cancer have more treatment options and a better chance of surviving their disease than ever before. At the same time, making treatment decisions has become a more complex process for them and their physicians due to a growing list of effective options."

The conference brought together national and international experts to clarify, for clinicians, patients, and the general public, key questions regarding the selection of treatments, quality of life, and new research directions in adjuvant therapy.

Dr. Eifel and her colleagues noted that decisions about the choice of adjuvant therapy should be based on age, tumor size, presence or absence of hormone receptors, presence or absence of cancerous lymph nodes, and other generally accepted factors. New technologies and molecular markers hold potential but require further study.

Hormonal therapy was recommended by the panel for women whose breast tumors contain estrogen receptors, regardless of age, menopausal status, tumor size, or whether the cancer has spread to nearby lymph nodes. Five years of tamoxifen is currently the standard adjuvant hormonal therapy.

The panel noted that no data support the use of tamoxifen for longer than five years outside of a clinical trial but that this is an important area for investigation. The panel emphasized that hormonal therapy is not indicated for women whose tumors do not have hormone receptors. The panel recommended chemotherapy with a combination of drugs for most pre- and post-menopausal women regardless of lymph node involvement or estrogen receptor status. Including anthracycline drugs as part of chemotherapy regimens produces a small but statistically significant survival advantage over regimens that do not contain anthracyclines. However, there are not enough data to support the routine use of taxanes or dose-intensive chemotherapy.

Women who have undergone mastectomy and who have four or more cancerous lymph nodes or an advanced primary tumor benefit from post-surgical radiation, the panel concluded. The panel added that it is unclear whether women with one to three cancerous lymph nodes benefit from radiation therapy and that this question should be tested in a randomized clinical trial.

Adjuvant treatments often involve serious short- and long-term side effects such as premature menopause, weight gain, mild memory loss, and fatigue. The panel recommended that selected trials of adjuvant therapy include quality-of-life measures. It emphasized that long term follow-up of women in these trials is important to fully understand the effects of adjuvant therapies. It also endorsed continued development of decision-making tools to help patients and their physicians weigh the risks and benefits of adjuvant treatments.

Among its other recommendations for future research, the panel called for carefully designed studies of:

• combined hormonal therapy
• hormonal therapy versus chemotherapy in premenopausal women whose tumors have estrogen receptors
• high dose chemotherapy
• taxanes
• factors that predict the effectiveness of treatments in individual patients
• new drugs, including trastuzumab and bisphosphonates
• radiation techniques that reduce the dose to normal tissue such as the heart and lungs
• the effectiveness and side effects of adjuvant therapies in women older than 70

The National Cancer Institute and the NIH Office of Medical Applications of Research sponsored the conference. Cosponsors included the National Institute of Nursing Research and the NIH Office of Research on Women's Health.

The full NIH Consensus Statement on Adjuvant Therapy for Breast Cancer is available by calling 1-888-NIH-CONSENSUS (1-888-644-2667) or by visiting the NIH Consensus Development Program Web site at http://consensus.nih.gov. (The panel's draft statement will be posted to the Web by the evening of November 3, 2000.)

The consensus statement is the report of an independent panel and is not a policy statement of the NIH or the Federal Government. The NIH Consensus Development Program was established in 1977 to resolve in an unbiased manner controversial topics in medicine. To date, NIH has conducted 113 such conferences addressing a wide range of controversial medical issues important to health care providers, patients, and the general public.

NOTE TO TV EDITORS:
The news conference at 1 p.m. on Friday, November 3 will be broadcast live via satellite on the following coordinates: Telstar 4, Transponder 6; C-Band; Download Frequency=3820; Orbital location=89 Degrees West. (Test time 12:30 - 1:00 p.m.)

NOTE TO RADIO EDITORS:
An audio report of the conference results will be available after 4 p.m. November 3, 2000 from the NIH Radio News Service by calling 1-800-MED-DIAL (1-800-633-3425).

The Office of the Director is a component of the National Institutes of Health, U.S. Department of Health and Human Services.