Ledermann, JA;
Harter, P;
Gourley, C;
Friedlander, M;
Vergote, I;
Rustin, G;
Scott, C;
... Matulonis, U; + view all
(2016)
Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer.
British Journal of Cancer
, 115
(11)
pp. 1313-1320.
10.1038/bjc.2016.348.
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Abstract
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.
| Type: | Article |
|---|---|
| Title: | Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1038/bjc.2016.348 |
| Publisher version: | http://doi.org/10.1038/bjc.2016.348 |
| Language: | English |
| Additional information: | © 2016 Cancer Research UK. All rights reserved. This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Science & Technology, Life Sciences & Biomedicine, Oncology, olaparib, quality of life, maintenance treatment, ovarian cancer, BRCA, FACT-O questionnaire, PATIENT-REPORTED OUTCOMES, PHASE-III, OPEN-LABEL, CLINICAL-TRIALS, BREAST-CANCER, MULTICENTER, BEVACIZUMAB, AZD2281 |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > CRUK Cancer Trials Centre |
| URI: | https://discovery.ucl.ac.uk/id/eprint/1529634 |
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