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Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial.
Friedlander, M ; Gebski, V ; Gibbs, E ; Davies, L ; Bloomfield, R ; Hilpert, F ; Wenzel, L ; Eek, D ; Rodrigues, M ; Clamp, Andrew R ... show 10 more
Friedlander, M
Gebski, V
Gibbs, E
Davies, L
Bloomfield, R
Hilpert, F
Wenzel, L
Eek, D
Rodrigues, M
Clamp, Andrew R
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Abstract
In the phase 3 SOLO2 trial (ENGOT Ov-21), maintenance therapy with olaparib tablets significantly prolonged progression-free survival (primary endpoint) compared with placebo in patients with a germline BRCA1 or BRCA2 (BRCA1/2) mutation and platinum-sensitive, relapsed ovarian cancer who had received two or more lines of previous chemotherapy. The most common subjective adverse effects included fatigue, nausea, and vomiting, which were typically low grade and self-limiting. Our a-priori hypothesis was that maintenance olaparib would not negatively affect health-related quality of life (HRQOL) and additionally that the prolongation of progression-free survival with olaparib would be underpinned by additional patient-centred benefits.
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Date
2018-08
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Article
Citation
Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. 2018, 19(8): 1126-1134 Lancet Oncol