Phase III Study of Mitoxantrone Plus Low Dose Prednisone Versus Low Dose Prednisone Alone in Patients With Asymptomatic Hormone Refractory Prostate Cancer (2002)

No AccessJournal of UrologyCLINICAL UROLOGY: Original Articles1 Dec 2002Phase III Study of Mitoxantrone Plus Low Dose Prednisone Versus Low Dose Prednisone Alone in Patients With Asymptomatic Hormone Refractory Prostate Cancer WILLIAM BERRY, SHAKER DAKHIL, MANUEL MODIANO, MARYANN GREGURICH, and LINA ASMAR WILLIAM BERRYWILLIAM BERRY , SHAKER DAKHILSHAKER DAKHIL , MANUEL MODIANOMANUEL MODIANO , MARYANN GREGURICHMARYANN GREGURICH , and LINA ASMARLINA ASMAR View All Author Informationhttps://doi.org/10.1016/S0022-5347(05)64163-8AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We compared median time to treatment failure of men with asymptomatic, hormone refractory, progressive prostate cancer treated with mitoxantrone plus prednisone versus prednisone alone. Materials and Methods: In a multicenter phase III trial 120 men with asymptomatic, progressive, hormone refractory prostate cancer were randomly assigned to treatment with mitoxantrone and prednisone or prednisone alone. Patients received 12 mg./m.2 mitoxantrone intravenously once every 3 weeks for 6 cycles and 5 mg. prednisone twice daily with or without mitoxantrone. Time to treatment failure was assessed as an aggregate end point comprised of time to disease progression, time to toxicity or death, or time to initiation of alternate therapy. Results: Median followup was 21.8 months. Median time to treatment failure and median time to progression were the same: time to treatment failure and time to progression in the mitoxantrone and prednisone group was 8.1 months compared to 4.1 months in the prednisone alone group (p = 0.017 versus p = 0.018). More patients (27 or 48%) treated with mitoxantrone and prednisone achieved a 50% or greater reduction in prostate specific antigen levels than those who received only prednisone (15 or 24%, p = 0.007). There was no significant difference in median survival between the 2 groups, which was 23 and 19 months, respectively. Death was mainly attributable to disease progression. Conclusions: Patients with hormone refractory prostate cancer who are asymptomatic but had progressive disease had a significantly higher response rate when treated with mitoxantrone and prednisone as demonstrated by the 50% or greater decrease in prostate specific antigen compared to treatment with prednisone alone. Time to treatment failure was significantly prolonged in the chemotherapy treated group but survival rates were not different. References 1 : Drug development in prostate cancer. Semin Oncol1999; 26: 217. Google Scholar 2 : Chemotherapy for hormone refractory prostate cancer. 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Volume 168Issue 6December 2002Page: 2439-2443 Advertisement Copyright & Permissions© 2002 by American Urological Association, Inc.Keywordsprostatic neoplasmsmitoxantronecomparative studyantineoplastic agentstreatment outcomeMetricsAuthor Information WILLIAM BERRY Financial interest and/or other relationship with Bristol Myers Squibb; Immunex and Aventis. More articles by this author SHAKER DAKHIL More articles by this author MANUEL MODIANO More articles by this author MARYANN GREGURICH More articles by this author LINA ASMAR More articles by this author Expand All Advertisement PDF downloadLoading ...