Hannes Cash1, Ursula Steiner1, Axel Heidenreich2, Theodor Klotz3, Peter Albers4, Sebastian Melchior5, Peter Martus6, Florian Fuller1, Ahmed Magheli1, Stefan Hinz1, Carsten Kempkensteffen1, Kurt Miller1. 1. Department of Urology, Charité, University Medicine Berlin, Berlin, Germany. 2. Department of Urology, University Hospital Cologne, Cologne, Germany. 3. Department of Urology, Weiden Hospital, Weiden, Germany. 4. Department of Urology, University Hospital Düsseldorf, Düsseldorf, Germany. 5. Department of Urology, Hospital Bremen-Mitte, Bremen, Germany. 6. Institute for Clinical Epidemiology and Applied Biometrics, Tübingen University Hospital, Tübingen, Germany.
Abstract
OBJECTIVE: To investigate non-inferiority of intermittent docetaxel compared to continuous docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). PATIENT AND METHODS: The investigator initiated randomised phase III study included 187 chemotherapy-naïve patients with mCRPC who were allocated to two treatment arms: intermittent docetaxel and continuous docetaxel. Docetaxel was applied in both arms as weekly (35 mg/m2 ) or 3-weekly (75 mg/m2 ). The primary endpoint was 1-year survival, which was tested for non-inferiority (margin δ = 0.125). The secondary endpoints were: overall survival (OS), progression-free survival (PFS), median time to treatment failure (TTF), and toxicity. RESULTS: Of 156 eligible patients, 78 were allocated to each arm. The intermittent treatment met the non-inferiority criteria for 1-year survival (two-sided 95% confidence interval, -0.12, 18, P = 0.022), but not for OS, according to the result of a post hoc analysis. The differences between the study arms in PFS and TTF were not significant. The median (range) treatment holiday in the intermittent arm was 110 (13-486) days, or 38% of the overall treatment duration. Safety profiles of both study arms were comparable. The main limitation of this study was that the planned number of patients could not be recruited. CONCLUSION:Intermittent docetaxel chemotherapy was non-inferior to continuous therapy for 1-year survival; non-inferiority in regard to OS was not reached.
RCT Entities:
OBJECTIVE: To investigate non-inferiority of intermittent docetaxel compared to continuous docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). PATIENT AND METHODS: The investigator initiated randomised phase III study included 187 chemotherapy-naïve patients with mCRPC who were allocated to two treatment arms: intermittent docetaxel and continuous docetaxel. Docetaxel was applied in both arms as weekly (35 mg/m2 ) or 3-weekly (75 mg/m2 ). The primary endpoint was 1-year survival, which was tested for non-inferiority (margin δ = 0.125). The secondary endpoints were: overall survival (OS), progression-free survival (PFS), median time to treatment failure (TTF), and toxicity. RESULTS: Of 156 eligible patients, 78 were allocated to each arm. The intermittent treatment met the non-inferiority criteria for 1-year survival (two-sided 95% confidence interval, -0.12, 18, P = 0.022), but not for OS, according to the result of a post hoc analysis. The differences between the study arms in PFS and TTF were not significant. The median (range) treatment holiday in the intermittent arm was 110 (13-486) days, or 38% of the overall treatment duration. Safety profiles of both study arms were comparable. The main limitation of this study was that the planned number of patients could not be recruited. CONCLUSION: Intermittent docetaxel chemotherapy was non-inferior to continuous therapy for 1-year survival; non-inferiority in regard to OS was not reached.
Authors: Shawn Malone; Bobby Shayegan; Naveen S Basappa; Kim Chi; Henry J Conter; Robert J Hamilton; Sebastien J Hotte; Fred Saad; Alan I So; Laura Park-Wyllie; Huong Hew; Deanna McLeod; Geoffrey Gotto Journal: Can Urol Assoc J Date: 2019-04-26 Impact factor: 1.862
Authors: Christian Thomas; Maximilian P Brandt; Stephanie Baldauf; Igor Tsaur; Sebastian Frees; Hendrik Borgmann; Wolfgang Jäger; Georg Bartsch; Meike Schneider; Robert Dotzauer; Andreas Neisius; Axel Haferkamp Journal: Int Urol Nephrol Date: 2018-08-17 Impact factor: 2.370