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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