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

dc.contributor.authorLedermann, Jonathan A
dc.contributor.authorHarter, Philipp
dc.contributor.authorGourley, Charlie
dc.contributor.authorFriedlander, Michael
dc.contributor.authorVergote, Ignace
dc.contributor.authorRustin, Gordon
dc.contributor.authorScott, Clare
dc.contributor.authorMeier, Werner
dc.contributor.authorShapira-Frommer, Ronnie
dc.contributor.authorSafra, Tamar
dc.contributor.authorMatei, Daniela
dc.contributor.authorFielding, Anitra
dc.contributor.authorBennett, Bryan
dc.contributor.authorParry, David
dc.contributor.authorSpencer, Stuart
dc.contributor.authorMann, Helen
dc.contributor.authorMatulonis, Ursula
dc.contributor.departmentMedicine, School of Medicineen_US
dc.date.accessioned2018-05-03T21:13:49Z
dc.date.available2018-05-03T21:13:49Z
dc.date.issued2016-11-22
dc.description.abstractBackground: 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.versionFinal published versionen_US
dc.identifier.citationLedermann, 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.2016.348en_US
dc.identifier.issn0007-0920en_US
dc.identifier.urihttps://hdl.handle.net/1805/16052
dc.language.isoen_USen_US
dc.publisherNature Publishing groupen_US
dc.relation.isversionof10.1038/bjc.2016.348en_US
dc.relation.journalBritish Journal of Canceren_US
dc.rightsAttribution-NonCommercial-ShareAlike 3.0 United States
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/3.0/us/
dc.sourcePMCen_US
dc.subjectolapariben_US
dc.subjectquality of lifeen_US
dc.subjectmaintenance treatmenten_US
dc.subjectovarian canceren_US
dc.subjectBRCAen_US
dc.subjectFACT-O questionnaireen_US
dc.titleQuality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian canceren_US
dc.typeArticleen_US
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