Conference Proceedings
Health-related quality of life (HRQOL) and patient-centered outcomes with maintenance olaparib compared with placebo following chemotherapy in patients with germline (g) BRCA-mutated (m) platinum-sensitive relapsed serous ovarian cancer (PSR SOC): SOLO2 phase III trial
Michael Friedlander, Val Gebski, Emma Gibbs, Ralph Bloomfield, Felix Hilpert, Lari B Wenzel, Florence Joly, Daniel Eek, Manuel Rodrigues, Andrew R Clamp, Richard T Penson, Diane M Provencher, Jacob Korach, Tomasz Huzarski, Laura Vidal, Vanda Salutari, Clare L Scott, Maria Ornella Nicoletto, Kenji Tamura, Eric Pujade-Lauraine
JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2017
Abstract
5507 Background: The median PFS after chemotherapy in PSR SOC is less than 6 months in many patients. In SOLO2 (ENGOT Ov-21; NCT01874353), maintenance olaparib (O) given after response to chemotherapy resulted in a significant improvement in PFS vs placebo (P) in patients with g BRCAm PSR SOC (hazard ratio [HR] 0.30, 95% CI 0.22, 0.41; P<0.0001; median 19.1 vs 5.5 months; 63% data maturity; Pujade-Lauraine et al. SGO 2017). Our a priori hypothesis was that maintenance therapy with O would not negatively impact HRQOL compared with P and would be associated with additional patient-centered benefits to support the prolongation of PFS, the primary endpoint of SOLO2. Methods: HRQOL was evaluated..
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