Safety and efficacy of apalutamide in Japanese patients with metastatic castration‐sensitive prostate cancer receiving androgen deprivation therapy: Final report for the Japanese subpopulation analysis of the randomized, placebo‐controlled, phase III TITAN study

Abstract

Abbreviations & Acronyms ADT = androgen deprivation therapy BSA = bone sparing agent CI = confidence interval HR = hazard ratio mCSPC = metastatic castrationsensitive prostate cancer NE = not evaluable nmCRPC = non-metastatic castration-resistant prostate cancer OS = overall survival PC = prostate cancer PCWG2 = prostate cancer clinical trials working group 2 PFS2 = progression-free survival 2 PSA = prostate-specific antigen rPFS = radiographic progressionfree survival SAE = serious adverse event TEAE = treatment-emergent adverse event

Editorial Comment to Safety and efficacy of apalutamide in Japanese patients with metastatic castration‐sensitive prostate cancer receiving androgen deprivation therapy: Final report for the Japanese subpopulation analysis of the randomized, placebo‐controlled, phase III TITAN study

“…2 In this current study, analysis of the Japanese subgroup (TITAN trial) did show a trend in overall survival, time to chemotherapy, and time to pain progression favoring the Apalutamide group, although the P-values did not reach significance. 2 This was likely because the trial was not designed or powered to measure statistical significances in smaller subgroups. Perhaps, a larger proportion of Asian patients in the trial may have allowed for more meaningful efficacy analysis.…”

“…3 In the current study, the safety profile of Apalutamide in the Japanese subgroup was comparable to the global population, with the exception of a higher incidence of fracture and rash. 2 The Japanese appeared to have high baseline fracture incidence (13% placebo group) with the risk being higher in the Apalutamide group (28.6%), with a specific preponderance in spinal compression fractures. Factors to be considered include the unknown baseline bone mineral density or fracture risks, and that fewer Japanese men in the Apalutamide group received bone targeting agents compared to the placebo group (14.3% vs 26.1%) or the Apalutamide group in the overall TITAN trial population (14.3% vs 20.2%).…”

“…Uemura et al performed a comprehensive review of the type, severity, and treatment of Apalutamide-related rash in the Japanese subpopulation, thus providing a good management guide for this particular adverse event. 2 Overall, Uemura et al performed a comprehensive overview of the efficacy and adverse events of Apalutamide in the Japanese subpopulation of the TITAL trial. 2 This article highlights the importance of bone health management, informs of Apalutamide-related rash management strategies, and also makes the case for including more Asian patients in international interventional trials, in patients with advanced PCa.…”

“…2 Overall, Uemura et al performed a comprehensive overview of the efficacy and adverse events of Apalutamide in the Japanese subpopulation of the TITAL trial. 2 This article highlights the importance of bone health management, informs of Apalutamide-related rash management strategies, and also makes the case for including more Asian patients in international interventional trials, in patients with advanced PCa.…”

“…The TITAN trial showed that Apalutamide significantly improved survival outcomes compared with ADT alone, for metastatic castration‐sensitive prostate cancer (mCSPC) patients 2 . In this current study, analysis of the Japanese subgroup (TITAN trial) did show a trend in overall survival, time to chemotherapy, and time to pain progression favoring the Apalutamide group, although the P ‐values did not reach significance 2 . This was likely because the trial was not designed or powered to measure statistical significances in smaller subgroups.…”