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

• Published in: Journal of clinical oncology Vol. 36; no. 11; pp. 1080 - 1087
• Main Authors: 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.
• Format: Journal Article
• Language: English
• Published: United States American Society of Clinical Oncology 10.04.2018
• Subjects: Androgen Antagonists - administration & dosage; Androgen Antagonists - adverse effects; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Docetaxel - administration & dosage; Docetaxel - adverse effects; Humans; Male; Neoplasm Metastasis; Neoplasms, Hormone-Dependent - drug therapy; Neoplasms, Hormone-Dependent - mortality; Neoplasms, Hormone-Dependent - pathology; ORIGINAL REPORTS; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms - mortality; Prostatic Neoplasms - pathology; Time Factors; Treatment Outcome
• ISSN: 0732-183X; 1527-7755; 1527-7755
• DOI: 10.1200/JCO.2017.75.3657

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.