Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: A phase 2, multicentre, open-label, non-randomised study

The Lancet Oncology, 08/23/2011

Gelmon KA et al. – This study suggests that olaparib is a promising treatment for women with ovarian cancer and further assessment of the drug in clinical trials is needed.


  • Phase 2, multicentre, open-label, non-randomised study
  • Women with advanced high-grade serous and/or undifferentiated ovarian carcinoma or triple-negative breast cancer were enrolled and received olaparib 400 mg twice a day
  • Patients were stratified according to whether they had BRCA1 or BRCA2 mutation or not
  • Primary endpoint was objective response rate by Response Evaluation Criteria In Solid Tumors (RECIST)
  • All patients who received treatment were included in analysis of toxic effects, and patients who had measurable lesions at baseline were included in primary efficacy analysis


  • 91 patients enrolled (65 with ovarian cancer and 26 breast cancer) and 90 were treated between July 8, 2008, and Sept 24, 2009
  • In ovarian cancer cohorts, 64 patients received treatment
  • 63 patients had target lesions and therefore evaluable for objective response as per RECIST
  • In these patients, confirmed objective responses were seen in seven (41%; 95% CI 22—64) of 17 patients with BRCA1 or BRCA2 mutations and 11 (24%; 14—38) of 46 without mutations
  • No confirmed objective responses were reported in patients with breast cancer
  • Most common AEs were fatigue (45 [70%] of patients with ovarian cancer, 13 [50%] of patients with breast cancer), nausea (42 [66%] and 16 [62%]), vomiting (25 [39%] and 9 [35%]), and decreased appetite (23 [36%] and 7 [27%])

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