[Inflammatory breast carcinoma treated with a combination of chemotherapy and radiation therapy. Results of a randomized trial studying the therapeutic role of an immunotherapy with BCG (author's transl)].

Seventy-seven patients with inflammatory breast carcinoma were included in a randomized trial between march 1977 and september 1979. All patients were treated with the same association of chemotherapy and radiation therapy. Chemotherapy included adriamycin on day 1 (45 mg/m2), vincristine on day 2(1,2 mg/m2), cyclophosphamide on days 3, 4 and 5 (400 mg/m2/day) and 5 fluoro-uracil on days 3, 4, and 5 (500 mg/m2/day). Each course of chemotherapy was repeated every 28 days for one year. Patients were then given a maintenance course of chemotherapy for one year. Radiation therapy with CO60 was applied after 4 courses of intensive chemotherapy. The dose distributed was 70 Gy over seven weeks. During radiation therapy, chemotherapy was administered according the same scheme, but adriamycin was excluded. All the patients were randomly distributed into two groups before treatment: group I patients received chemotherapy and radiation therapy alone; group II patients received chemotherapy and radiation therapy plus living BCG vaccinations. After chemotherapy, inflammatory manifestations disappeared in 51% of cases. The mean of disease-free interval was 26 months and the overall survival mean 34 months. No difference in favor of the BCG treated group was noted. Lymph node involvement, age, hormonal status, response to tuberculin, and disappearance of inflammatory signs after 4 months of chemotherapy are of insignificant prognostic value.