Discussion
TNBC, pembrolizumab, Breast Cancer
BREAST CANCER, RECURRENCE, METASTATIC CANCER
The present analysis was conducted to support the approval of olaparib as adjuvant therapy in Safety data for the subset of patients from Japan were consistent with the known safety profile of olaparib in eBC and in the treatment of other advanced or metastatic cancers [The OlympiA study was designed to assess the efficacy and safety of olaparib in patients with gFor patients with TNBC at high risk of recurrence, pembrolizumab is the only approved treatment option. Pembrolizumab can be used in combination with NACT and continued as a single-agent adjuvant treatment after surgery based on the results of the KEYNOTE-522 trial, which demonstrated a significant difference in pCR rate with the addition of pembrolizumab to NACT (64.8% [95% CI 59.9–69.5%]) compared with CT alone (51.2% [95% CI 44.1–58.3%]), and significant event-free survival (HR, 0.63 [95% CI 0.48–0.82]) [Reflecting the lack of clarity regarding clinical benefit of adjuvant capecitabine, treatment is not approved or reimbursed in Japan, but is recommended by the Japanese Breast Cancer Society clinical practice guidelines and Pan-Asian guidelines as a treatment option for patients with TNBC not achieving pCR following NACT [For patients with high-risk, hormone-receptor-positive/HER2-negative eBC, abemaciclib is a treatment option in Japan based on the results from the monarchE trial. Abemaciclib, when combined with endocrine therapy, resulted in a significant difference in IDFS compared with endocrine therapy alone (HR, 0.70 [95% CI 0.59–0.82]), although survival benefits have not yet been reported [Potential limitations of the present analysis are the relatively small number of patients in the subset from Japan and the fact that the analysis of this subset of patients was not pre-specified and is descriptive. The lower percentage of patients in the subset from Japan who had received prior platinum-based CT compared with the global OlympiA population should also be considered when interpreting the results. This difference likely resulted from the fact that the use of cisplatin is not covered by insurance for patients with eBC in Japan [To our knowledge, this analysis is the first to assess the clinical benefit and safety of a PARP inhibitor for use as adjuvant therapy in patients with g