A multicentric phase II randomized trial of docetaxel (D) plus enzalutamide (E) vs docetaxel (D) as first-line chemotherapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): CHEIRON study
Journal of Clinical Oncology Mar 04, 2019
Caffo O, et al. - In patients with untreated metastatic castration-resistant prostate cancer (mCRPC) diagnosis, ECOG PS ≤ 2, and adequate renal, hepatic, and hematological functions, researchers assessed the candidate efficacy of docetaxel (D) + enzalutamide (E) vs D as first-line treatment. They administered D 75 mg/m2IV d1 q3w plus prednisone 5 mg PO BID for 8 courses alone or plus E 160 mg PO daily for 24 weeks to patients in a randomized manner. Assessments were performed to determine the rate of patients without disease progression (according to PCWG2) at 6 months after randomization, which was the primary endpoint of the study. This investigation represents the first phase 2 randomized trial assessing the addition of a new generation hormone agent to D. Findings revealed that compared to the standard chemotherapy, the patients who were treated with DE had improved 6-month disease control and a prolonged PFS.
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