Chemo-immunotherapy with levamisole in metastatic breast carcinoma: a controlled clinical trial.

A randomized prospectively controlled trial assessing the value of levamisole in patients receiving chemotherapy for metastatic carcinoma of the breast is reported. Patients randomized to the chemo-immunotherapy group received levamisole 2.5 mg/kg orally for 2 consecutive days each week while off chemotherapy, which consisted of the standard regiment of cyclophosphamide, methotrexate and 5-fluorouracil (CMF). Seventy-seven patients were assessable, 38 patients in the chemo-immunotherapy arm and 39 patients in the chemotherapy alone arm. Of the 38 patients in the chemo-immunotherapy, 18 (47.3%) experienced a complete or partial response compared to 18 (46.1%) in the chemotherapy alone group. The median duration of response in both groups of patients was approximately 15 months. The median duration of survival in the chemo-immunotherapy group was 21 months and in the chemotherapy alone group has not yet been reached but is at least 21 months. Levamisole was generally well tolerated, but in the dosage and scheduling did not appear to improve the results of the chemotherapy. It is suggested that efforts should be directed to increasing the complete response rate with chemotherapy and radiotherapy to provide the best setting for immunotherapy trials.