Adjuvant mitozantrone chemotherapy in advanced prostate cancer

Objective To assess the role of mitozantrone, active in relapsed prostate c ancer, as an adjuvant to hormonal treatment in patients with advanced prost ate cancer. Patients and methods Between October 1990 and May 1995, 96 patients were en tered into a stratified, randomized, single-institution study of hormonal t herapy with a luteinizing hormone-releasing hormone agonist and flutamide, with or without four cycles of adjuvant mitozantrone. Of these, 93 patients were evaluable and the results were analysed in June 1999. Results Patients with localized prostate cancer receiving adjuvant chemothe rapy had a higher initial objective response rate (95% vs 53%, P = 0.008) a nd median survival (80 vs 36 months, P = 0.04) than patients who were treat ed with hormonal therapy alone. There was no advantage to adjuvant chemothe rapy in patients with metastatic prostate cancer. There were insignificant advantages to chemotherapy in overall response rates (55% vs 39%, P = 0.3) and PSA responses (82% vs 64%, P = 0.11). There was no difference between t he patient groups in time to treatment failure. Conclusion There was a survival advantage in using adjuvant mitozantrone in patients with locally advanced prostate cancer. Although the study compris ed relative few patients, the follow-up period was long and the advantage s ignificant. We recommend that the study be extended to include more patient s.