Cytoreductive Surgery and Systemic Bacillus Calmette-Guerin Therapy in Metastatic Renal Cancer: A Phase II Trial

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Abstract
A phase II trial was conducted to determine the effect upon survival of cytoreductive surgery (nephrectomy) and adjuvant active immunotherapy (BCG) in patients with stage IV renal cancer. A total of 20 patients underwent removal of the primary tumor and received BCG 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 yr after the diagnosis of metastases. Seven patients (35%) in the adjuvant group were alive 2-5 yr 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 < 0.01). A difference in survival between the adjuvant group and concurrent controls also was present but was not statistically significant (0.10 < P < 0.20). Other factors suspected to influence survival were investigated. In addition to BCG 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 BCG and the influence on survival of various biological factors can only be provided by large, controlled, randomized and stratified (phase III) trials.