Charles E. Geyer, Jr., MD, FACP, Deputy Director of the Houston Methodist Cancer Center, and Study Co-Chair speaks about ASCO 2021 – Abstract – OlympiA: A randomized phase III trial of olaparib as adjuvant therapy in patients with high-risk HER2-negative breast cancer (BC) and a germline BRCA1/2 mutation (gBRCAm).
Link to Abstract:
https://meetinglibrary.asco.org/record/115571/abstract
Background information:
Treatment with the PARP inhibitor olaparib (Lynparza; 400 mg twice daily [bid]; capsules) resulted in antitumor efficacy in patients (pts) with advanced BC harboring a gBRCAm in a Phase II proof-of-concept study (NCT00494234) (objective response rate: 41 percent; Tutt et al Lancet 2010). Olaparib as adjuvant monotherapy has been started in patients with gBRCAm-associated triple-negative BC (TNBC) who have completed local treatment and neoadjuvant or adjuvant chemotherapy in an AstraZeneca-sponsored Phase III trial (OlympiA; NCT02032823; coordinated by BIG, NRG Oncology, Frontier Science, and AstraZeneca) (CT).
Methodologies:
OlympiA is a 12-month double-blind experiment in which patients with TNBC who are at high risk of recurrence are randomized (1:1) to receive olaparib (300 mg tablets daily [2 x 150 mg]) or placebo. Patients must have completed definitive local therapy and at least 6 cycles of neoadjuvant CT (without a pathological full response) or adjuvant CT to be eligible. Before entering the experiment, participants must have a known or suspected detrimental gBRCAm, which will be validated retrospectively by Integrated BRACAnalysis (Myriad Genetic Laboratories). Prior neoadjuvant versus adjuvant CT, as well as whether pts had undergone prior platinum treatment for current BC, are also stratification criteria. The fundamental goal is to live a disease-free life (IDFS). Mammograms/breast MRI scans will be performed yearly for 10 years, commencing 6 months after randomization, and medical history/physical examinations will be performed every 3 months for 2 years, then every 6 months for another 3 years, and then yearly afterward. Overall survival, distant DFS, new cancer incidence, HRQoL, safety, and tolerability are secondary goals. A stratified log-rank test will be used to perform the principal IDFS analysis after 330 IDFS occurrences (25 percent maturity). Enrollment for patients began in April of 2014. The total number of patients to be randomly assigned is 1320, spread over 550 locations in 25 countries.
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NCT02032823 is a clinical trial that may be found at http://clinicaltrials.gov/show/NCT02032823