Enzalutamide with androgen deprivation therapy in Japanese men with metastatic hormone‐sensitive prostate cancer: A subgroup analysis of the phase III ARCHES study

Abstract

To evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy in Japanese men with metastatic hormone-sensitive prostate cancer. Methods: A post-hoc analysis of the Japanese subgroup in the phase III, randomized, multinational ARCHES study (NCT02677896) was carried out. Patients with metastatic hormone-sensitive prostate cancer were randomized to receive enzalutamide or a placebo, plus androgen deprivation therapy, stratified by disease volume and prior docetaxel therapy. The primary end-point was radiographic progression-free survival. Secondary endpoints included time to prostate-specific antigen progression and overall survival. Results: Of 1150 patients, 92 Japanese patients were randomized to enzalutamide (n = 36) or a placebo (n = 56), plus androgen deprivation therapy; none received prior docetaxel. Enzalutamide plus androgen deprivation therapy reduced the risk of radiographic progression or death in Japanese patients by 61% versus the placebo, similar to the overall population. Similar results were observed with secondary endpoints, showing clinical benefit of enzalutamide plus androgen deprivation therapy in Japanese patients. Overall survival data were immature. Grade 3-4 adverse events were reported in 47% and 25% of the enzalutamide and placebo groups, respectively. Nasopharyngitis, hypertension and abnormal hepatic function were reported more frequently in Japanese patients versus the overall population. Conclusions: Enzalutamide plus androgen deprivation therapy has clinical benefit with a tolerable safety profile in Japanese men with metastatic hormone-sensitive prostate cancer, consistent with the overall population.

Efficacy and safety of therapies for advanced prostate cancer in Asia: Evidence from a systematic literature review

“…Forty-seven were removed as duplicates due to overlapping among databases. After screening the titles and abstracts and then the full texts, 27 publications 17 – 43 were shortlisted. No additional studies were identified from the bibliographic search.…”

“…The included studies covered the whole spectrum of PC disease, including patients with nmCRPC ( n = 2), 17 , 18 mCSPC ( n = 4), 19 – 21 , 23 and mCRPC ( n = 19). Population included in all 15 real-world studies was patients with mCRPC.…”

“…One RCT (ARCHES) contributed evidence for enzalutamide in mCSPC. 19 In ARCHES trial, 92 Japanese patients with confirmed diagnosis of metastatic hormone-sensitive PC (mHSPC) were randomized to enzalutamide ( n = 36) or placebo ( n = 56) plus ADT. Treatment with enzalutamide reduced the risk of radiographic progression or death in Japanese patients by 61% compared with placebo (HR 0.39; 95% CI 0.30–0.50), similar to the overall population.…”

“…OS data were immature for both groups, however, favored treatment with enzalutamide plus ADT (HR 0.92; 95% CI 0.15–5.52). 19 …”

Editorial Comment to Treatment strategies and outcomes in a long‐term registry study of patients with high‐risk metastatic hormone‐naïve prostate cancer in Japan: An interim analysis of the J‐ROCK study

“…The prognostic benefit of the early intensive treatment was first introduced by the CHAARTED trial in 2014, followed by LATITUDE trial in 2017, which introduced the concept of “High Volume” and “High Risk”, respectively 1 . In 2019, the concept of upfront ARAT has been shifted to all metastatic prostate cancer patients based on the result of the ARCHES, 2 TITAN, and ENZAMET trials 1 …”