| Autor: |
David Cella, N. Khandelwal, K. Benjamin, Danielle Sullivan, Robert L. Coleman, M. A. Bookman, Minh H. Dinh, Rajesh Kamalakar, Angeles Alvarez Secord |
| Rok vydání: |
2020 |
| Předmět: |
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| Zdroj: |
Oral Plenary. |
| DOI: |
10.1136/ijgc-2020-igcs.16 |
| Popis: |
Objective Veliparib, a poly (ADP-ribose) polymerase inhibitor, was evaluated in a Phase 3 trial (VELIA, NCT02470585) among patients with newly diagnosed stage III/IV high-grade serous epithelial ovarian/fallopian tube/primary peritoneal cancer. VELIA examined veliparib added to CP followed by veliparib maintenance compared to placebo added to CP followed by placebo maintenance. This analysis compared QA progression-free survival among patients enrolled in VELIA. Methods Patient-centered outcomes were assessed in 344 Veliparib+ CP and 351 CP alone subjects. Progression-free survival (PFS) time was partitioned into two health states: time with toxicity (Tox) and time without Tox. Tox included three clinically meaningful adverse events (AEs) including nausea, vomiting and fatigue. QA-PFS was assessed for duration of good quality of life, incorporating PFS and health states. Q-TWiST (QA time without disease symptoms or treatment Tox) was calculated as utility-weighted sums of mean health state durations. Sensitivity analyses were conducted utilizing Grade 2+ or Grade 3+ AEs. Similar analyses were conducted on HRD and BRCA-deficient subgroups. Results A significant difference in mean QA-PFS was seen in favor of Vel throughout compared to CP alone (19.5 months vs 16.5 months; 95% CI 1.42, 4.61; p Conclusion Compared to CP alone, Veliparib added to CP and continued as maintenance had significant patient-centered benefits in terms of QA-PFS and on-treatment Q-TWiST. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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