224O Patient centred outcomes with maintenance olaparib in newly diagnosed patients with advanced ovarian cancer (OC) and a BRCA mutation in the phase III SOLO1 trial to …

ML Friedlander,KN Moore,N Colombo,G Scambia,BG Kim, A Oaknin, A Lisyanskaya,A Floquet,A Leary,GS Sonke,C Gourley,S Banerjee,A Oza, A González-Martín,C Aghajanian,W Bradley, E Lowe, R Hettle, E Flood, P Disilvestro

Annals of Oncology(2019)

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摘要
Background In SOLO1 (NCT01844986; GOG-3004), maintenance olaparib significantly improved PFS vs placebo (HR 0.30; 95% CI 0.23–0.41; Moore et al. NEJM 2018) in patients with newly diagnosed advanced OC, a BRCA mutation and clinical complete or partial response after platinum-based chemotherapy. Most patients in the maintenance setting are well following first-line treatment; thus, it is important to show that extending PFS is not at the expense of decreased health-related quality of life because of toxicity. We assessed the duration of ‘good quality of life’ while on maintenance therapy based on time without significant symptoms of toxicity (TWiST) and quality-adjusted PFS (QAPFS) which both incorporate the adverse effects experienced by patients on maintenance therapy. Methods Patients were randomized 2:1 to olaparib tablets 300 mg bid or placebo. Patient …
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