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- Title
Systemic therapy in patients with node-negative breast cancer. A commentary based on two National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trials.
- Authors
Fisher, Bernard; Redmond, Carol; Wickerman, D. Lawrence; Wolmark, Norman; Bowman, David; Couture, Jean; Dimitrov, Nikolay V.; Margolese, Richard; Legault-Poisson, Sandra; Robidoux, Andre; Fisher, B; Redmond, C; Wickerham, D L; Wolmark, N; Bowman, D; Couture, J; Dimitrov, N V; Margolese, R; Legault-Poisson, S; Robidoux, A
- Abstract
<bold>Objective: </bold>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.<bold>Design: </bold>Randomized clinical trials with stratification after surgery.<bold>Setting: </bold>NSABP trials at institutions in the United States and Canada.<bold>Patients: </bold>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.<bold>Interventions: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
BREAST cancer; FOLINIC acid; THERAPEUTICS
- Publication
Annals of Internal Medicine, 1989, Vol 111, Issue 9, p703
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-111-9-703