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J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.

Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial.

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1
Christos E. Kyriakopoulos, Glenn Liu, and David F. Jarrard, University of Wisconsin (UW) School of Medicine and Public Health and UW Carbone Cancer Center, Madison, WI; Yu-Hui Chen and Christopher J. Sweeney, Dana-Farber Cancer Institute; Yu-Hui Chen, Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group; Christopher J. Sweeney, Harvard Medical School, Boston, MA; Michael A. Carducci, Noah M. Hahn, and Mario Eisenberger, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; Daniel H. Shevrin, NorthShore University HealthSystem, Evanston; Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Robert Dreicer, University of Virginia Cancer Center, Charlottesville, VA; Manish Kohli, Mayo Clinic, Rochester, MN; Elizabeth R. Plimack, Fox Chase Cancer Center, Temple Health, Philadelphia, PA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Matthew M. Cooney, Seidman Cancer Center, University Hospitals Cleveland Medical Center; Jorge A. Garcia, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; and Robert S. DiPaola, University of Kentucky College of Medicine, Lexington, KY.

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/m2 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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