Olaparib monotherapy for Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer: OlympiAD randomized trial subgroup analysis

Sci Rep. 2020 May 29;10(1):8753. doi: 10.1038/s41598-020-63033-4.

Abstract

The OlympiAD Phase III study (NCT02000622) established the clinical benefits of olaparib tablet monotherapy (300 mg twice daily) over chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA1/2 mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who had received ≤2 chemotherapy lines in the metastatic setting. Here, we report pre-specified analyses of data from Asian (China, Japan, Korea and Taiwan) patients in the study. All patients were randomized 2:1 to olaparib tablets (300 mg twice daily) or single-agent chemotherapy TPC (21-day cycles of either capecitabine, eribulin or vinorelbine). The primary endpoint was progression-free survival assessed by blinded independent central review. The prevalence of gBRCAm in the OlympiAD Asian subgroup screened for study recruitment was 13.5%. Patient demographics and disease characteristics of the Asian subgroup (87/302 patients) were generally well balanced between treatment arms. Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population. Findings on secondary efficacy and safety/tolerability outcome measures in Asian patients were also similar to those observed in the global OlympiAD study population. The OlympiAD study was not powered to detect race-related differences between treatment groups; however, the consistency of our findings with the global OlympiAD study population suggests that previously reported findings are generalizable to Asian patients.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / therapeutic use*
  • Asian People
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / genetics
  • Capecitabine / therapeutic use
  • Carcinoma / drug therapy
  • Carcinoma / genetics
  • Carcinoma / secondary*
  • Female
  • Furans / therapeutic use
  • Gastrointestinal Diseases / chemically induced
  • Genes, BRCA1*
  • Genes, BRCA2*
  • Genes, erbB-2
  • Germ-Line Mutation
  • Hematologic Diseases / chemically induced
  • Humans
  • Kaplan-Meier Estimate
  • Ketones / therapeutic use
  • Middle Aged
  • Phthalazines / adverse effects
  • Phthalazines / therapeutic use*
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Poly(ADP-ribose) Polymerase Inhibitors / therapeutic use*
  • Progression-Free Survival
  • Single-Blind Method
  • Vinorelbine / therapeutic use

Substances

  • Antineoplastic Agents
  • Furans
  • Ketones
  • Phthalazines
  • Piperazines
  • Poly(ADP-ribose) Polymerase Inhibitors
  • Capecitabine
  • eribulin
  • Vinorelbine
  • olaparib