This analysis includes 406 patients who entered a controlled and stratified study of adjuvant chemotherapy after total mastectomy preceded (177 pts) or followed (229 pts) by breast radiotherapy. Negative lymph node (NO) patients (stage I or II) were randomized between no treatment or alkeran (600 mg/m2 x 5 days every 6 weeks). Out of 92 patients 2 relapses in each arm were observed. Relapse free survival at 4 years is 91%. For patients with one to three positive lymph nodes, there is not difference between alkeran and the combination of Vinblastine, Thiotepa, Methotrexate and 5 Fu (VTMF). Relapse free survival at 4 years is 78% for alkeran and 70% for VTMF. For patients with more than 3 positive lymph nodes there is no difference between cyclophosphamide, Methotrexate, 5 Fu (CMF) and CMF VP (Vincristine and Prednisone). We observe no difference between menopausal and other patients. Among the 49 relapses, 5 were local recurrences. The sites of distant metastasis were bone (24 pts), liver (10 pts), lung (9 pts). Advantage of adjuvant chemotherapy is not proved for NO patients. In the other categories, the optimal strategy of chemotherapy with or without hormonotherapy is still to be established.

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