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/mm2 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 47.2months 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.

Document Type

Article

Publication Date

4-10-2018

Notes/Citation Information

Published in Journal of Clinical Oncology, v. 36, no. 11, p. 1080-1087.

© 2018 by American Society of Clinical Oncology

The copyright holder has granted the permission for posting the article here.

Digital Object Identifier (DOI)

https://doi.org/10.1200/JCO.2017.75.3657

Funding Information

Supported in part by Public Health Service Grants No. CA180790, CA180794, CA180795, CA180799, CA180801, CA180802, CA180820, CA180821, CA180833, CA180847, CA180853, CA180867, CA180888, and CA189829 and by the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services and coordinated by the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group. Sanofi provided docetaxel and a grant to ECOG-ACRIN.

Related Content

Clinical trial information: NCT00309985

Data Supplements: https://doi.org/10.1200/JCO.2017.75.3657

Disclosures provided by the authors are available with this article at jco.org.

Additional Files
ds_2017.753657.docx (235 kB)
Data Supplement
protocol_2017.753657.pdf (6081 kB)
Study Protocol
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