A Systematic Literature Review of Randomized Controlled Trials Reporting Efficacy and Safety of Treatments in Patients with Advanced Prostate Cancer in Asian Countries
Gutta D1, Shah R2, Kalsey MS1, Gautam R1, Rai MK1
1EVERSANA, Mumbai, India, 2EVERSANA, Mumbai, MH, India
OBJECTIVES:The lack of high-level evidence for prostate cancer (PC) treatment in Asian population may limit the ability to adequately manage advanced PC. We conducted a systematic literature review (SLR) to evaluate the efficacy and safety of treatments available in advanced PC patients in Asian countries.
METHODS: A comprehensive SLR was performed in the PubMed database to identify relevant randomized controlled trials (RCTs) published in English from 2016 to 2021 as full papers. Additional citations were taken from gray literature. Outcomes of interest were progression-free survival (PFS), overall survival (OS), and safety.
RESULTS: Of the 1,277 publication records identified from the database, seven different RCTs were included. Patients in these RCTs were enrolled from China, East Asia, Japan, Malaysia, Russia, South Korea, Taiwan, and Thailand. All RCTs were placebo controlled. Included RCTs had patients with non-metastatic castration-resistant PC (nmCRPC; n=2), metastatic castration-sensitive PC (mCSPC; n=3), and mCRPC (n=2). The sample size in RCTs ranged from 51 to 313. In nmCRPC patients, darolutamide+ADT provided a significant benefit in PFS with a hazard ratio (HR) of 0.13 (95%CI: 0.05−0.33), whereas apalutamide+ADT provides a better survival, compared with placebo. In mCSPC patients, abiraterone acetate (AA)+prednisone conferred benefits for both OS and PFS with HR of 0.61 (95%CI: 0.27−1.42) and 0.32 (95%CI: 0.167−0.620), respectively. In mCRPC patients, enzalutamide provided benefits in OS and PFS with HR of 0.63 (95%CI: 0.36−1.10) and 0.33 (95%CI: 0.19−0.56), respectively. Overall incidence rate of adverse events (AE) was above 60%; however, the incidence of grade ≥3 was low. No new safety signals were observed in Asian patients. CONCLUSION: This SLR provides evidence that could help physicians to make better treatment decisions in the management of PC. The results of these treatment options were in line with the global clinical data.
Conference/Value in Health Info
Clinical Outcomes, Study Approaches
Comparative Effectiveness or Efficacy, Literature Review & Synthesis