Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer.

Background: Maintenance monotherapy with the poly(ADP-ribose) polymerase inhibitor olaparib significantly prolongs progression-free survival over placebo in patients with platinum-sensitive relapsed serous ovarian cancer, with greatest benefit seen in patients with a BRCA1/2 mutation (BRCAm). Preservation of health-related quality of life (HRQoL) is important during maintenance therapy; we evaluated the effect of olaparib on HRQoL in this Phase II trial (NCT00753545, Study 19).
Methods: Patients received olaparib 400 mg b.i.d. (capsules) or placebo until progression. Patient-reported HRQoL and disease-related symptoms were evaluated using the FACT-Ovarian (FACT-O) questionnaire (completed at baseline and every 28 days until progression), the FACT/NCCN Ovarian Symptom Index (FOSI) and the Trial Outcome Index (TOI). TOI of the FACT-O was the primary measure.
Results: Overall, 265 women were randomised to maintenance olaparib (n=136) or placebo (n=129). Compliance for HRQoL assessment was high (∼80% over time). Most patients in both arms reported a best response of 'no change' on TOI (81%) and other HRQoL measures. There were no statistically significant differences in time to worsening or improvement rates of TOI, FOSI and FACT-O scores in the overall, BRCAm and germline BRCAm populations.
Conclusions: Maintenance treatment with olaparib was well tolerated and had no adverse impact on HRQoL in this study of patients with platinum-sensitive relapsed serous ovarian cancer who had responded to their most recent platinum-based therapy (partial or complete response). Interpretation of the HRQoL results in this population may differ from patients who have not responded to their most recent platinum-based therapy.
Competing Interests: JAL has participated in an advisory board for AstraZeneca. PH has acted in an advisory role for AstraZeneca and received honoraria from AstraZeneca. CG has acted in an advisory role for AstraZeneca, Clovis, Roche and Nucana, received honoraria from AstraZeneca and Roche, and received research funding from AstraZeneca, Novartis and Aprea. MF has participated in advisory boards for AstraZeneca, Clovis, Pfizer and Roche and received honoraria from AstraZeneca, Pfizer and Roche. IV has acted in an advisory role for AstraZeneca. GR has participated in advisory boards for AstraZeneca and Clovis. CS has acted in an advisory role for AstraZeneca, Clovis and Eisai Australia, received honoraria from AstraZeneca and Roche, provided expert testimony on behalf of AstraZeneca and received remuneration for travel from AstraZeneca. RS-F has participated in an advisory board for AstraZeneca. TS has acted in an advisory role for AstraZeneca and Clovis and received honoraria from AstraZeneca and Clovis. DM has acted in an advisory role for AstraZeneca and received honoraria from AstraZeneca. AF, DP, SS and HM are employees of AstraZeneca and own stock. UM has acted in an advisory role for AstraZeneca and Tesaro. All remaining authors declare no conflicts of interest.