Chemotherapy Plus Tamoxifen May Be Better Than Tamoxifen Alone—NSABP Study

Researchers from the National Surgical Adjuvant Breast and Bowel Project (NSABP) announced the results of a large-scale trial designed to determine a more effective treatment for women with breast cancer. Results from this study, published in the November 19th issue of the Journal of the National Cancer Institute, indicate that women whose breast cancer is estrogen-receptor-positive and has not metastasized to their lymph nodes were less likely to have a recurrence of cancer when treated with both chemotherapy and tamoxifen (Nolvadex) than with tamoxifen alone. This type of breast cancer is diagnosed in 15% to 30% of women with the disease.

 “In less than a decade, we have now shown the benefit of a unified approach to the management of women with breast cancer. All women with breast cancer benefit from chemotherapy regardless of their menopausal, nodal, and/or receptor status.” said Bernard Fisher, MD, Scientific Director of the NSABP and Distinguished Service Professor in the Department of Surgery at the University of Pittsburgh.

Study Results

The study involved 2,363 patients who were randomly assigned to one of three treatment groups: 788 women received tamoxifen alone, 786 women were given tamoxifen and methotrexate and fluorouracil followed by leucovorin, and 789 women received tamoxifen combined with cyclophosphamide (Cytoxan, Neosar), methotrexate, and fluorouracil.

After 5 years of follow-up, patients who received any combination of chemotherapy plus tamoxifen were significantly more likely to be disease-free than those who received only tamoxifen (90% vs 85%).

New Study Underway

“This study clearly shows that women with node-negative, estrogen-receptor-positive breast cancer benefit from the addition of chemotherapy. Based on this observation, the NSABP has begun a new trial to determine whether the addition of octreotide [Sandostatin] to tamoxifen alone or to tamoxifen and chemotherapy will enhance the benefit from chemotherapy further,” stated Norman Wolmark, MD, chairperson of the NSABP and chairperson of the Allegheny University of the Health Sciences Institute of Human Oncology. Octreotide inhibits the activity or production of proteins that stimulate breast cancer cell growth and decreases the development of blood vessels that supply the tumor with nutrients.