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.
J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.
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 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.
多西他赛联合去势治疗（ADT）显著延长了部分转移性激素敏感前列腺癌患者的生存期。在此，我们报告了 CHAARTED（化疗联合雄激素剥夺治疗与单纯雄激素剥夺治疗广泛转移前列腺癌随机试验）试验的结果，随访时间更成熟，并重点关注肿瘤体积。
在这项 III 期研究中，790 例转移性激素敏感前列腺癌患者被平均随机分为接受 ADT 联合多西他赛 75 mg/m2 治疗 6 个周期或 ADT 单药治疗。研究的主要终点是总生存期（OS）。对前瞻性定义的低体积和高体积疾病亚组进行了额外分析。高体积疾病定义为存在内脏转移和/或≥4 处骨转移，至少有 1 处位于脊柱和骨盆以外。
在中位随访 53.7 个月时，化疗联合激素治疗组的中位 OS 为 57.6 个月，ADT 单药治疗组为 47.2 个月（风险比[HR]，0.72；95%置信区间，0.59 至 0.89；P =.0018）。对于高体积疾病患者（n = 513），化疗联合激素治疗组的中位 OS 为 51.2 个月，ADT 单药治疗组为 34.4 个月（HR，0.63；95%置信区间，0.50 至 0.79；P <.001）。对于低体积疾病患者（n = 277），未观察到 OS 获益（HR，1.04；95%置信区间，0.70 至 1.55；P =.86）。
对于高体积疾病患者，化疗联合激素治疗在延长 OS 方面的临床获益得到了证实；然而，对于低体积疾病患者，未观察到 OS 获益。
