Randomized 2 x 2 trial evaluating hormonal treatment and the duration of chemotherapy in node-positive breast cancer patients. German Breast Cancer Study Group
| Autor: | H. F. Rauschecker, Willi Sauerbrei, C. Beyerle, Manfred Olschewski, Claudia Schmoor, K. Hübner, Martin Schumacher, Hans Bojar, R. L. A. Neumann, G. Bastert |
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| Rok vydání: | 1994 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Cyclophosphamide Breast Neoplasms Disease-Free Survival Drug Administration Schedule law.invention Breast cancer Randomized controlled trial law Germany Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Survival rate Aged Gynecology business.industry Middle Aged medicine.disease Survival Rate Clinical trial Tamoxifen Methotrexate Fluorouracil Lymphatic Metastasis Relative risk Multivariate Analysis Patient Compliance Regression Analysis Female Lymph Nodes business Follow-Up Studies medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 12:2086-2093 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | PURPOSE In 1984, the German Breast Cancer Study Group (GBSG) started a multicenter randomized clinical trial to compare the effectiveness of three versus six cycles of 500 mg/m2 cyclophosphamide, 40 mg/m2 methotrexate, and 600 mg/m2 fluorouracil (CMF) on day 1 and 8 starting perioperatively with or without tamoxifen (TAM) (3 x 10 mg/d for 2 years). The aim of the trial was to compare recurrence-free and overall survival between the different treatment modalities. PATIENTS AND METHODS During 5 years, 41 institutions randomized 473 patients (3 x CMF: 145; 3 x CMF + TAM: 93; 6 x CMF 144; 6 x CMF + TAM: 91). Until March 31, 1992, median follow-up time was 56 months with 197 events for disease-free survival and 116 deaths observed. This provides a power of approximately 80% to detect a potential treatment difference corresponding to a relative risk (RR) of 0.67 for recurrence-free survival. Treatment modalities and various patient characteristics were evaluated by means of a multivariate Cox regression analysis. RESULTS No significant difference in recurrence-free survival was observed with respect to hormonal therapy (RR = 0.75 TAM v no TAM; 95% confidence interval [CI], 0.54 to 1.04; P = .08) as well as duration of chemotherapy (RR = 0.90 of 6 x CMF v 3 x CMF; 95% CI, 0.67 to 1.19; P = .45). Similar results were obtained for overall survival. The multivariate analysis revealed a significant prognostic impact of the number of positive lymph nodes and the progesterone receptor level on recurrence-free survival. Compliance with chemotherapy within the range of 85% to 115% of the target dose was achieved in 94% and 78% of the patients randomized to 3 x CMF and 6 x CMF, respectively. Sufficient compliance with TAM was reported for 141 patients (93%). CONCLUSION At this stage of follow-up, six courses of CMF are not superior to three courses with respect to recurrence-free survival. |
| Databáze: | OpenAIRE |
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