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Systemic Therapy in Patients with Node-Negative Breast Cancer: A Commentary Based on Two National Surgical Adjuvant Breast and Bowel Project (NSABP) Clinical Trials

Bernard Fisher, MD; Carol Redmond, ScD; D. Lawrence Wickerham, MD; Norman Wolmark, MD; David Bowman, MD; Jean Couture, MD; Nikolay V. Dimitrov, MD; Richard Margolese, MD; Sandra Legault-Poisson, MD; and André Robidoux, MD
[+] Article, Author, and Disclosure Information

Grant Support: Supported in part by Public Health Service grant NCI-U10-CA-12027 from the National Cancer Institute and by grant ACS-RC-13 from the American Cancer Society.

Requests for Reprints: Bernard Fisher, MD, NSABP Headquarters, Room 914 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15261.

Current Author Addresses: Drs. Fisher and Wickerham: NSABP Headquarters, 3550 Terrace Street, Room 914, Pittsburgh, PA 15261.

Dr. Redmond: Graduate School of Public Health, 318 Parran Hall, Pittsburgh, PA 15261.

Dr. Wolmark: Department of Surgery, Montefiore Hospital, 3459 Fifth Avenue, Pittsburgh, PA 15213.

Dr. Bowman: Manitoba Cancer Foundation, 100 Olivia, Winnipeg, Manitoba, Canada R3E 0V9.

Dr. Couture: Hôpital du Saint-Sacrement, 1050, Chemin Ste-Foy, Québec, Québec, Canada G1S 4L8.

Dr. Dimitrov: Michigan State University, B-220 Life Science, East Lansing, MI 48864.

Dr. Margolese: Department of Surgery, Jewish General Hospital, 3755 Cote Street, Catherine Road, Montréal, Québec, Canada H3T 1E2.

Dr. Legault-Poisson: Oncology Center, Hôpital St. Luc, 1058 St. Denis, Montréal, Québec, Canada H2X 3S4.

Dr. Robidoux: Hotel-Dieu de Montréal, 3840 St-Urbain, Montréal, Québec, Canada H2W 1T8.

© 1989 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1989;111(9):703-712. doi:10.7326/0003-4819-111-9-703
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Objective: To determine whether in the previous National Surgical Adjuvant Breast and Bowel Project (NSABP) studies of node-negative breast cancer there were either cohorts of patients with a prognosis favorable enough to preclude using systemic therapy or subsets of patients who failed to benefit from the treatments.

Design: Randomized clinical trials with stratification after surgery.

Setting: NSABP trials at institutions in the United States and Canada.

Patients: Data were collected on 731 eligible patients (Protocol B-13) with estrogen-receptor-negative tumors who randomly received either no therapy after surgery or sequential methotrexate and fluorouracil (M → F) followed by leucovorin. Data were also collected on 2834 patients (Protocol B-14) with estrogen-receptor-positive tumors who randomly received either placebo or tamoxifen treatment. The percentage of patients surviving disease-free was determined through 4 years of follow-up using life-table estimates.

Interventions: Protocol B-13 patients received 12 courses of M → F given intravenously on days 1 and 8 every 4 weeks. Leucovorin therapy was begun 24 hours after M → F administration. Protocol B-14 patients received 5-year treatment with either tamoxifen (10 mg twice daily by mouth) or placebo.

Results: When the outcome of untreated patients in either trial was related to the stratification variables, women were found to have a disease-free survival of less than 80% through 4 years of follow-up. This percentage is apt to decrease because the probability of treatment failure increases with time. In both trials, all subsets of women benefited from M → F or tamoxifen therapy.

Conclusions: The disease-free survival of all cohorts of node-negative patients with estrogen-receptor-negative or estrogen-receptor-positive tumors was poor enough to justify systemic treatment. The benefits of the therapies used are insufficient to eliminate the need for assessing putatively better regimens.





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