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

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1313-1320
Number of pages8
JournalBritish Journal of Cancer
Volume115
Issue number11
DOIs
StatePublished - Nov 22 2016

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Platinum
Ovarian Neoplasms
Quality of Life
Placebos
Therapeutics
Maintenance
Mutation
Germ-Line Mutation
olaparib
Population
Compliance
Disease-Free Survival
Capsules

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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

Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. / Ledermann, Jonathan A.; Harter, Philipp; Gourley, Charlie; Friedlander, Michael; Vergote, Ignace; Rustin, Gordon; Scott, Clare; Meier, Werner; Shapira-Frommer, Ronnie; Safra, Tamar; Matei, Daniela; Fielding, Anitra; Bennett, Bryan; Parry, David; Spencer, Stuart; Mann, Helen; Matulonis, Ursula.

In: British Journal of Cancer, Vol. 115, No. 11, 22.11.2016, p. 1313-1320.

Research output: Contribution to journalArticle

Ledermann, JA, 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, vol. 115, no. 11, pp. 1313-1320. https://doi.org/10.1038/bjc.2016.348
Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G et al. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. British Journal of Cancer. 2016 Nov 22;115(11):1313-1320. https://doi.org/10.1038/bjc.2016.348
Ledermann, Jonathan A. ; Harter, Philipp ; Gourley, Charlie ; Friedlander, Michael ; Vergote, Ignace ; Rustin, Gordon ; Scott, Clare ; Meier, Werner ; Shapira-Frommer, Ronnie ; Safra, Tamar ; Matei, Daniela ; Fielding, Anitra ; Bennett, Bryan ; Parry, David ; Spencer, Stuart ; Mann, Helen ; Matulonis, Ursula. / Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. In: British Journal of Cancer. 2016 ; Vol. 115, No. 11. pp. 1313-1320.
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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.",
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AU - Vergote, Ignace

AU - Rustin, Gordon

AU - Scott, Clare

AU - Meier, Werner

AU - Shapira-Frommer, Ronnie

AU - Safra, Tamar

AU - Matei, Daniela

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