Ledermann, Jonathan AHarter, PhilippGourley, CharlieFriedlander, MichaelVergote, IgnaceRustin, GordonScott, ClareMeier, WernerShapira-Frommer, RonnieSafra, TamarMatei, DanielaFielding, AnitraBennett, BryanParry, DavidSpencer, StuartMann, HelenMatulonis, Ursula2018-05-032018-05-032016-11-22Ledermann, J. A., Harter, P., Gourley, C., Friedlander, M., Vergote, I., Rustin, G., … Matulonis, U. (2016). Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. British Journal of Cancer, 115(11), 1313–1320. https://doi.org/10.1038/bjc.2016.3480007-0920https://hdl.handle.net/1805/16052Background: 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.en-USAttribution-NonCommercial-ShareAlike 3.0 United Statesolaparibquality of lifemaintenance treatmentovarian cancerBRCAFACT-O questionnaireArticle