Olaparib as Adjuvant Therapy in Breast Cancer

  • The safety and efficacy of olaparib as adjuvant therapy was evaluated in the phase 3 OlympiA trial:
    • That enrolled patients with a germline BRCA mutation and HER2 negative, high-risk, early-stage breast cancer:
      • Who had completed definitive local treatment and at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, a taxane, or both (prior platinum for previous cancer or as adjuvant /neoadjuvant breast cancer treatment was permitted)
  • Patients were randomly assigned (1:1) to receive:
    • Olaparib tablets 300 mg orally twice daily or placebo
  • Treatment was continued for up to 1 year or until disease recurrence or unacceptable toxicity occurred
  • In this study, patients with high-risk, early stage breast cancer were identified using the following criteria: 
    • Patients who received prior neoadjuvant chemotherapy:
      • Triple-negative breast cancer (TNBC):
        • They needed to have residual invasive cancer in the breast and / or the resected lymph nodes (nonpathologic complete response) at the time of surgery
      • Hormone receptor–positive breast cancer:
        • They needed to have residual invasive cancer in the breast and / or the resected lymph nodes (nonpathologic complete response) at the time of surgery:
          • Additionally, they needed a score of 3 or more based on pretreatment clinical and post-treatment pathologic stage, ER status, and histologic grade (Table)
    • Patients who received prior adjuvant chemotherapy:
      • TNBC:
        • They needed to have node-positive disease or node-negative disease with the primary tumor measuring 2 cm or more
      • Hormone receptor–positive, HER2 negative breast cancer:
        • They needed to have 4 or more pathologically-confirmed positive lymph nodes
Early Breast Cancer Stage, Receptor Status, and Grade Scoring Requirements for OlympiA Enrollment
  • Updated results, representing a median follow up of 3.5 years, were published in October 2022:
    • A significant improvement in OS was observed in the olaparib group compared to the placebo group:
      • HR, 0.68; 98.5% CI, 0.47-0.97; P = 0.009:
        • Four-year OS rates were 89.8% with olaparib and 86.4% with placebo
    • Continued benefit in terms of invasive disease free survival (IDFS) and distant DFS (DDFS) were demonstrated with olaparib versus placebo
    • In subset analyses, OS, IDFS, and DDFS benefits were observed across major subgroups
#Arrangoiz #BreastSurgeon #CancerSurgeon #SurgicalOncologist #MountSinaiMedicalCenter #MSCM #Miami #Mexico #BreastCancer

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