期刊
JOURNAL OF CLINICAL ONCOLOGY
卷 38, 期 30, 页码 3494-+出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1200/JCO.19.03107
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资金
- Clovis Oncology
- Ann Rife Cox Chair in Gynecology
- Ovarian Cancer Research Fund
- National Institute of Health Research Biomedical Research Centre at University College London
- Memorial Sloan Kettering Cancer Center Support Grant [P30 CA008748]
- US Department of Defense Ovarian Cancer Research Program [OC120506]
- V Foundation Translational Award
- Stand Up To Cancer-Ovarian Cancer Research Fund Alliance-National Ovarian Cancer Coalition Dream Team Translational Research Grant [SU2C-AACR-DT16-15]
- Stand Up to Cancer is a program of the Entertainment Industry Foundation
- Stand Up To Cancer
- CDMRP [OC120506, 542484] Funding Source: Federal RePORTER
PURPOSETo investigate quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in a post hoc exploratory analysis of the phase III ARIEL3 study of rucaparib maintenance treatment versus placebo.PATIENTS AND METHODSPatients with platinum-sensitive, recurrent ovarian carcinoma were randomly assigned to rucaparib (600 mg twice per day) or placebo. QA-PFS was calculated as progression-free survival function x the 3-level version of the EQ-5D questionnaire (EQ-5D-3L) index score function. Q-TWiST analyses were performed defining TOX as the mean duration in which a patient experienced grade >= 3 treatment-emergent adverse events (TEAEs) or the mean duration in which a patient experienced grade >= 2 TEAEs of nausea, vomiting, fatigue, and asthenia. Q-TWiST was calculated as mu TOX x TOX + TWiST, with mu TOX calculated using EQ-5D-3L data.RESULTSThe visit cutoff was Apr 15, 2017. Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib v 189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]); BRCA-mutant cohort (130 rucaparib v 66 placebo; 9.37 months [95% CI, 6.65 to 11.85 months]); homologous recombination deficient (HRD) cohort (236 rucaparib v 118 placebo; 7.93 months [95% CI, 5.93 to 9.53 months]); and BRCA wild-type/loss of heterozygosity (LOH) low patient subgroup (107 rucaparib v 54 placebo; 2.71 months [95% CI, 0.31 to 4.44 months]). With TOX defined using grade >= 3 TEAEs, the difference in mean Q-TWiST (rucaparib v placebo) was 6.88 months (95% CI, 5.71 to 8.23 months), 9.73 months (95% CI, 7.10 to 11.94 months), 8.11 months (95% CI, 6.36 to 9.49 months), and 3.35 months (95% CI, 1.66 to 5.40 months) in the ITT population, BRCA-mutant cohort, HRD cohort, and BRCA wild-type/LOH low patient subgroup, respectively. Q-TWiST with TOX defined using select grade >= 2 TEAEs also consistently favored rucaparib.CONCLUSIONThe significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib versus placebo in all predefined cohorts.
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