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08-11-2016 | PARP inhibitors | Article

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

Jonathan A Ledermann, Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra, Daniela Matei, Anitra Fielding, Bryan Bennett, David Parry, Stuart Spencer, Helen Mann, Ursula Matulonis



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).


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.


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.


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.

Brit J Cancer 2016;115:1313–1320. doi:10.1038/bjc.2016.348


olaparib; quality of life; maintenance treatment; ovarian cancer; BRCA; FACT-O questionnaire

Health-related quality of life (HRQoL) is a multidimensional concept encompassing: physical, cognitive and emotional wellbeing; social functioning domains; disease-related symptoms; therapy-induced side effects; and potential financial and family burden. These HRQoL measures are a particularly important consideration in the maintenance setting after response to chemotherapy, when the majority of patients do not have any symptoms related to recurrent cancer, as the aim of maintenance treatment is to prolong the time to progression and to delay the need for further chemotherapy without compromising the quality of life of the patients on treatment (Friedlander and King, 2013).

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