Treatment with a combination of chemotherapy drugs improves survival and should be recommended for most women with local and regional breast cancer, according to the statement emerging from the Consensus Development Conference on Adjuvant Therapy for Breast Cancer, held Nov. 13 at the National Institutes of Health in Bethesda, Md.
The consensus panel also recommended hormonal therapy for women whose tumors have hormone receptors and radiation therapy for women who have had mastectomies and who are at high risk for recurrence.
The consensus conference was convened to consider the large amount of relatively new data on adjuvant therapies. "Clinical trials over the past 10 years have contributed an enormous amount of new information about adjuvant therapies," said panel chairwoman Patricia Eifel, M.D. Making treatment decisions has become a more complex process due to a growing list of effective options, said Eifel, who is a radiation oncologist at the University of Texas M.D. Anderson Cancer Center in Houston.
One of the key issues addressed by the panel concerned the use of predictive and prognostic factors, such as p53 alterations and evidence of vascular invasion, in selecting adjuvant therapies. In particular, speakers discussed the pros and cons of using HER2/neu to predict response to anthracyclines, weighing data that suggest that HER2-positive tumors respond better to this class of chemotherapy drugs. However, the panel decided that while HER2/neu may hold potential, "laboratory methods and the reporting of results require standardization before its predictive performance can be established."
Hormonal therapy was recommended by the panel for women whose breast tumors contain hormone receptors, regardless of age, menopausal status, tumor size, or nodal status. The panel noted that no data so far support the use of tamoxifen for more than 5 years, although this is an important area for investigation. It emphasized that tamoxifen is not indicated for women with hormone receptor-negative tumors.
Combination chemotherapy is recommended for most pre- and postmenopausal breast cancer patients, the panel said, regardless of lymph node involvement or hormone receptor status. It noted that including anthracyclines as part of chemotherapy regimens produces a small but statistically significant survival advantage over regimens that do not contain anthracyclines.
Speakers at the meeting also debated the use of taxanes as adjuvant therapy. Data from two phase III trials, including the first reported data from the National Surgical Adjuvant Breast and Bowel Projects B-28 trial, suggest that taxanes may not have the same impact in the adjuvant setting that they do in metastatic cancer. Available data in the adjuvant setting are "inconclusive and do not permit definitive recommendations regarding the impact of taxanes on either relapse-free or overall survival," the panel wrote in its consensus statement. "There is not evidence to support the use of taxanes in node-negative breast cancer outside the setting of a clinical trial," it added.
Women who have undergone mastectomy and who have four or more cancerous lymph nodes or an advanced primary tumor benefit from adjuvant radiation, the panel said. It noted that whether women with fewer involved lymph nodes can benefit from radiation remains an open question.
The panel endorsed continued development of decision-making tools to help patients and their physicians weigh the risks and benefits of adjuvant treatments, and emphasized the importance of quality of life measures in trials.
Among its other recommendations for future research, the panel called for carefully designed studies of:
combined hormonal therapy
hormonal therapy vs. chemotherapy in premenopausal, hormone receptor-positive patients
high-dose chemotherapy
new drugs, including trastuzumab (Herceptin) and bisphosphonates
radiation techniques that reduce the dose of radiation to heart and lungs
adjuvant therapies in women older than 70.
The full consensus statement is available on the NIH Consensus Development Program Web site at http://consensus.nih.gov. The presentations can be heard by going to the NIH videocast Web site at http://videocast.nih.gov/.
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