One versus 2 years of CMFVP adjuvant chemotherapy in axillary node-positive and estrogen receptor-negative patients: a Southwest Oncology Group study
Autor: | C K Osborne, John J. Costanzi, B Metch, Sylvan B. Green, O'Bryan Rm, Saul E. Rivkin, W R Jewell, S J Altman, J P Minton |
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Rok vydání: | 1993 |
Předmět: |
Oncology
Adult Cancer Research medicine.medical_specialty Vincristine Time Factors Cyclophosphamide medicine.medical_treatment Breast Neoplasms Breast cancer Prednisone Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Aged Proportional Hazards Models Chemotherapy business.industry Combination chemotherapy Middle Aged medicine.disease Survival Analysis Methotrexate Receptors Estrogen Fluorouracil Chemotherapy Adjuvant Lymphatic Metastasis Female business medicine.drug |
Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 11(9) |
ISSN: | 0732-183X |
Popis: | PURPOSE To determine if prolonged adjuvant treatment (2 years v 1 year) with combination chemotherapy (cyclophosphamide, methotrexate, fluorouracil [5-FU], vincristine, and prednisone [CMFVP]) in poor-prognosis breast cancer patients (estrogen receptor [ER]-negative, stage II to IIIA) would result in improved disease-free and overall survival rates. PATIENTS AND METHODS Four hundred forty-five women with ER-negative node-positive breast cancer were enrolled by the Southwest Oncology Group (SWOG) over a period of 5 years (1979 to 1984). Randomized assignments were made to either 1 or 2 years of adjuvant CMFVP. Doses were daily oral cyclophosphamide 60 mg/m2, intravenous (i.v.) weekly methotrexate 15 mg/m2, i.v. weekly 5-FU 400 mg/m2, i.v. weekly vincristine .625 mg/m2 for the first 10 weeks, and prednisone weeks 1 through 6 with doses decreasing from 30 mg/m2 to 10 mg/m2. RESULTS The median follow-up duration is 8.6 years, with a maximum of 11.3 years. Treatment arms were not significantly different as regards either survival or disease-free survival rates (P = .33 and P = .24, respectively). The five-year survival rate is 57% on the 1-year arm and 62% on the 2-year arm. Patients with three or fewer nodes and premenopausal status were associated with improved survival. Compliance on the 2-year arm was poor, with only 37% completing the full 2 years of treatment. SWOG grade 3 to 4 toxicity was experienced by 47% of patients on the 1-year arm and by 52% on the 2-year arm. There were no treatment-related deaths. CONCLUSION We conclude that 2-year adjuvant treatment with CMFVP is not an improvement over 1-year treatment. Moreover, 2 years of CMFVP is difficult to complete. However, the results are not definitely negative. A moderate improvement attributed to prolonged chemotherapy, especially among patients with four or more positive nodes, cannot be ruled out. |
Databáze: | OpenAIRE |
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