OBJECTIVES: Despite having been used in routine clinical practice for over three years, reports on the uptake of olaparib, its utilization patterns, and real-world clinical outcomes are negligible. This study aimed to examine real-world use and outcomes of olaparib treatment in Swedish patients during the first three years following regulatory approval.

METHODS: This was a population-based observational study using data from the Swedish national registers. All individuals initiating olaparib treatment from 25 February 2015 (the date when olaparib was included in the pharmaceutical benefits scheme in Sweden) to 31 December 2017 were included. The extent of off-label use was assessed based on recorded diagnoses. Ovarian cancer patients were followed until death or the end of the study period. Starting dose and dose adjustments were assessed. Time to olaparib discontinuation was plotted using Kaplan-Meier survival curves.

RESULTS: We identified 109 patients to whom olaparib was dispensed in Sweden during the study period. Nine of these were prescribed olaparib off-label for either breast or prostate cancer and were thus excluded from further analyses. Median age among the remaining 100 patients with ovarian cancer was 59 (range: 42 to 83) years. Almost all patients (96%) started on the recommended dose (400 mg [eight capsules] taken twice daily). Dose reductions were explicitly recorded for 14% of patients. Median time to discontinuation was 289 days (95% confidence interval: 226, 338).

CONCLUSIONS: To our knowledge, this is the first population-based study of olaparib real-world use and outcomes. In the first three years following regulatory approval, olaparib was mainly prescribed to ovarian cancer patients; however, some off-label use occurred in breast and prostate cancer patients. Ovarian cancer patients stayed on olaparib for a median of 9.5 months and the treatment appeared to be well tolerated.