61 Olaparib in patients with biallelic BRCA1/2 inactivation AstraZeneca had no role in the design or execution of the study and no influence on the study report. RESULTS ACCRUAL IN THE COHORT “OLAPARIB FOR TUMORS WITH A BRCA1 OR BRCA2 MUTATION” Between September 2016 and November 2019, 68 patients with advanced cancer harboring a BRCA1 or BRCA2 alteration, who had exhausted standard treatment options, were submitted to the study team for evaluation for potential study participation in the cohort “Olaparib for tumors with a BRCA1 or BRCA2 mutation”. Forty-five patients were approved by the study team to be screened for treatment with olaparib, 18 patients were ineligible for study participation (Supplementary Figure 1). Twenty-seven patients with nine tumor types were found eligible and started study treatment, of which the majority (41%, N=11) had prostate cancer. Nineteen patients were included despite their current labeled indication (prostate (N=11), breast (N=3), ovarian (N=3) and pancreatic cancer (N=2)), since at the time of enrollment PARPi treatment was still off-label and not reimbursed for their tumor type. Patients had a median number of four prior lines of systemic treatment (Table 1, Supplementary Table 1). The regimens varied greatly due to the different tumor types enrolled. Fifteen of 27 patients were treated with a platinum-containing regimen (carboplatin (N=11), oxaliplatin (N=3) and cisplatin (N=1)). Seven patients who were previously platinum resistant had clinical benefit of olaparib treatment. Three patients were not evaluable for the primary endpoint according to our protocol definition of evaluability and were excluded in the efficacy analysis (two had clinical progression and rapid deterioration (within 4 weeks) before finishing the first complete cycle, one patient suffered from intolerable side effects and stopped study treatment after six days). All 27 patients who received at least 1 dose of study medication were included in the safety analysis. Baseline characteristics are presented in Table 1. Twenty-four patients were evaluated in the efficacy analysis. From here on, only the results and characteristics of these 24 patients are described. Table 1. Baseline characteristics of the 27 patients enrolled in the cohort “Olaparib for tumors with a BRCA1 or BRCA2 mutation”. *All patients were required to have exhausted standard therapies, but six patients refused standard chemotherapy due to fear of toxicity. In addition, occasionally the treating physician had well-argued reasons to refrain from certain standard therapies (i.e. low response rate to standard therapies in specific patient subgroups). Abbreviations: WHO = World Health Organization. n = 27 Gender Male 17 63% Female 10 37% Age (approximately at consent) Median (range) 57 (37 – 79) 3
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