Systemic therapy in patients with node-negative breast cancer. A commentary based on two National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trials
| Autor: | Jean Couture, Norman Wolmark, D. Lawrence Wickerham, Richard G. Margolese, André Robidoux, Nikolay V. Dimitrov, Bernard Fisher, S Legault-Poisson, David M. Bowman, Carol K. Redmond |
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| Rok vydání: | 1989 |
| Předmět: |
medicine.medical_specialty
Leucovorin Breast Neoplasms Placebo Systemic therapy law.invention Breast cancer Randomized controlled trial law Internal medicine Antineoplastic Combined Chemotherapy Protocols Internal Medicine medicine Combined Modality Therapy Humans Survival analysis Randomized Controlled Trials as Topic business.industry General Medicine medicine.disease Survival Analysis Surgery Clinical trial Tamoxifen Methotrexate Receptors Estrogen Female Fluorouracil business medicine.drug Follow-Up Studies |
| Zdroj: | Annals of internal medicine. 111(9) |
| ISSN: | 0003-4819 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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