Response of disseminated breast cancer to combined modality treatment with chemotherapy and levamisole with or without Bacillus Calmette-Guérin.

One hundred and fourteen evaluable patients with measurable metastatic breast cancer were treated with a combination chemoimmunotherapy program (5-fluorouracil, adriamycin, and cyclophosphamide [FAC-levamisole [LSM]). An additional 117 patients with similar characteristics were treated with the same program with the addition of bacillus Calmette-Guérin (BCG) by scarification (FAC-BCG-LMS). The results were compared to those observed in 44 evaluable patients treated with FAC chemotherapy alone. Overall remission rates were identical in the three studies (72%, 73%, and 72%). The median duration of remission was 9 months for FAC, 13 months for FAC-LMS (P = 0.07), and 14 months for FAC-BCG-LMS (P = 0.05). The median duration of survival was 17 months for FAC and 28.6 months for FAC-LMS (P = 0.01). Although the median survival for the FAC-BCG-LMS group has not been reached, it is significantly superior to FAC alone (P = 0.009). These three sequential studies suggest that the addition of nonspecific immunotherapy with LMS or the combination of BCG and LMS prolongs the duration of remission and survival of responding patients treated with chemotherapy. Combination immunotherapy with BCG and LMS did not seem superior to LMS alone in this study.