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Kyriakopoulos CE , Chen YH , Carducci MA , Liu G , Jarrard DF , Hahn NM , Shevrin DH , Dreicer R , Hussain M , Eisenberger M , Kohli M , Plimack ER , Vogelzang NJ , Picus J , Cooney MM , Garcia JA , DiPaola RS , Sweeney CJ
Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial
J Clin Oncol. 2018 Apr 10;36(11) :1080-1087
PMID: 29384722    PMCID: PMC5891129   
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Abstract
Purpose Docetaxel added to androgen-deprivation therapy (ADT) significantly increases the longevity of some patients with metastatic hormone-sensitive prostate cancer. Herein, we present the outcomes of the CHAARTED (Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer) trial with more mature follow-up and focus on tumor volume. Patients and Methods In this phase III study, 790 patients with metastatic hormone-sensitive prostate cancer were equally randomly assigned to receive either ADT in combination with docetaxel 75 mg/m(2) for up to six cycles or ADT alone. The primary end point of the study was overall survival (OS). Additional analyses of the prospectively defined low- and high-volume disease subgroups were performed. High-volume disease was defined as presence of visceral metastases and/or >/= four bone metastases with at least one outside of the vertebral column and pelvis. Results At a median follow-up of 53.7 months, the median OS was 57.6 months for the chemohormonal therapy arm versus 47.2 months for ADT alone (hazard ratio [HR], 0.72; 95% CI, 0.59 to 0.89; P = .0018). For patients with high-volume disease (n = 513), the median OS was 51.2 months with chemohormonal therapy versus 34.4 months with ADT alone (HR, 0.63; 95% CI, 0.50 to 0.79; P < .001). For those with low-volume disease (n = 277), no OS benefit was observed (HR, 1.04; 95% CI, 0.70 to 1.55; P = .86). Conclusion The clinical benefit from chemohormonal therapy in prolonging OS was confirmed for patients with high-volume disease; however, for patients with low-volume disease, no OS benefit was discerned.
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1527-7755 Kyriakopoulos, Christos E Chen, Yu-Hui Carducci, Michael A Liu, Glenn Jarrard, David F Hahn, Noah M Shevrin, Daniel H Dreicer, Robert Hussain, Maha Eisenberger, Mario Kohli, Manish Plimack, Elizabeth R Vogelzang, Nicholas J Picus, Joel Cooney, Matthew M Garcia, Jorge A DiPaola, Robert S Sweeney, Christopher J UG1 CA189829/CA/NCI NIH HHS/United States P50 CA180995/CA/NCI NIH HHS/United States U10 CA180802/CA/NCI NIH HHS/United States U10 CA180821/CA/NCI NIH HHS/United States U10 CA180801/CA/NCI NIH HHS/United States U10 CA180795/CA/NCI NIH HHS/United States U10 CA180847/CA/NCI NIH HHS/United States U10 CA180790/CA/NCI NIH HHS/United States U10 CA180820/CA/NCI NIH HHS/United States U10 CA180833/CA/NCI NIH HHS/United States U10 CA180794/CA/NCI NIH HHS/United States U10 CA180799/CA/NCI NIH HHS/United States U10 CA180867/CA/NCI NIH HHS/United States U10 CA180888/CA/NCI NIH HHS/United States U10 CA180853/CA/NCI NIH HHS/United States Clinical Trial, Phase III Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't United States J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.