Cytoreductive surgery and systemic bacillus Calmette-Guerin therapy in metastatic renal cancer: a phase II trial.

A phase II trial has been conducted to determine the effect upon survival of cytoreductive surgery (nephrectomy) and adjuvant active immunotherapy (bacillus Calmette-Guerin) in patients with stage IV renal cancer. A total of 20 patients underwent removal of the primary tumor and received bacillus Calmette-Guerin therapy (adjuvant group). The results were compared to those obtained in 20 historical controls treated with conventional methods (hormones, chemotherapy and radiotherapy with or without nephrectomy) and 16 concurrent controls. All patients in the historical control group were dead within 4 years after the diagnosis of metastases. Seven patients (35 per cent) in the adjuvant group were alive 2 to 5 years after documentation of metastatic disease and onset of therapy. The ratio of observed to expected deaths in the adjuvant group was 0.59 compared to 1.6 in the historical controls. This superior survival was statistically significant (p less than 0.01). A difference in survival between the adjuvant group and concurrent controls also was present but was not statistically significant (0.10 less than p less than 0.20). Other factors suspected to influence survival were investigated. We found that in addition to bacillus Calmette-Guerin therapy a prolonged interval free of disease and better performance status had a better prognosis. Location of metastases, nephrectomy, age and sex are of no significant prognostic value. Definitive answers on the therapeutic value of bacillus Calmette-Guerin and the influence on survival of various biological factors can only be provided by large, controlled, randomized and stratified (phase III) trials.