Combination chemoimmunotherapy of metastatic breast cancer with 5‐fluorouracil, adriamycin, cyclophosphamide, and BCG

One hundred and five patients with metastatic breast cancer were treated with 5‐fluorouracil, Adriamycin, cyclophosphamide and BCG (FAC‐BCG). The results were compared to those observed in a group of 44 patients treated with FAC chemotherapy alone. Although the overall response rates were similar (76% for FAC‐BCG and 73% for FAC), the duration of remission was of 9 months for FAC and 14 months for FAC‐BCG (p = 0.04). Similarly, survival of responding patients treated with FAC‐BCG was significantly longer (24 months) than that observed in the chemotherapy alone treated group (15 months). There was no difference in survival or duration on study for nonresponders. Response rates were not influenced by dominant site of disease, menopausal status or disease‐free interval. The duration of remission and survival, however, were significantly longer for patients with bone and soft tissue involvement than for patients with visceral metastasis. Similarly patients with 1 or 2 metastatic sites survived significantly longer than those with more than 3 organ sites involved (p = 0.02). This chemotherapeutic combination is highly effective in inducing remissions. In addition, nonspecific immunotherapy with BCG appears to prolong duration of remission and survival for responding patients.