Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer
AuthorLedermann, JA; Harter, P; Gourley, C; Friedlander, M; Vergote, I; Rustin, G; Scott, C; Meier, W; Shapira-Frommer, R; Safra, T; ...
Source TitleBritish Journal of Cancer
PublisherNATURE PUBLISHING GROUP
University of Melbourne Author/sScott, Clare
AffiliationObstetrics and Gynaecology
Document TypeJournal Article
CitationsLedermann, J. A., Harter, P., Gourley, C., Friedlander, M., Vergote, I., Rustin, G., Scott, C., Meier, W., Shapira-Frommer, R., Safra, T., Matei, D., Fielding, A., Bennett, B., Parry, D., Spencer, S., Mann, H. & Matulonis, U. (2016). Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. BRITISH JOURNAL OF CANCER, 115 (11), pp.1313-1320. https://doi.org/10.1038/bjc.2016.348.
Access StatusOpen Access
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.
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