Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer
dc.contributor.author | Ledermann, Jonathan A | |
dc.contributor.author | Harter, Philipp | |
dc.contributor.author | Gourley, Charlie | |
dc.contributor.author | Friedlander, Michael | |
dc.contributor.author | Vergote, Ignace | |
dc.contributor.author | Rustin, Gordon | |
dc.contributor.author | Scott, Clare | |
dc.contributor.author | Meier, Werner | |
dc.contributor.author | Shapira-Frommer, Ronnie | |
dc.contributor.author | Safra, Tamar | |
dc.contributor.author | Matei, Daniela | |
dc.contributor.author | Fielding, Anitra | |
dc.contributor.author | Bennett, Bryan | |
dc.contributor.author | Parry, David | |
dc.contributor.author | Spencer, Stuart | |
dc.contributor.author | Mann, Helen | |
dc.contributor.author | Matulonis, Ursula | |
dc.contributor.department | Medicine, School of Medicine | en_US |
dc.date.accessioned | 2018-05-03T21:13:49Z | |
dc.date.available | 2018-05-03T21:13:49Z | |
dc.date.issued | 2016-11-22 | |
dc.description.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. | en_US |
dc.eprint.version | Final published version | en_US |
dc.identifier.citation | Ledermann, 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.2016.348 | en_US |
dc.identifier.issn | 0007-0920 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/16052 | |
dc.language.iso | en_US | en_US |
dc.publisher | Nature Publishing group | en_US |
dc.relation.isversionof | 10.1038/bjc.2016.348 | en_US |
dc.relation.journal | British Journal of Cancer | en_US |
dc.rights | Attribution-NonCommercial-ShareAlike 3.0 United States | |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-sa/3.0/us/ | |
dc.source | PMC | en_US |
dc.subject | olaparib | en_US |
dc.subject | quality of life | en_US |
dc.subject | maintenance treatment | en_US |
dc.subject | ovarian cancer | en_US |
dc.subject | BRCA | en_US |
dc.subject | FACT-O questionnaire | en_US |
dc.title | Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer | en_US |
dc.type | Article | en_US |