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16 Quality-adjusted (QA) progression-free survival analyses of veliparib + carboplatin/paclitaxel (CP) vs CP alone in patients with newly diagnosed ovarian cancer
  1. A Alvarez Secord1,
  2. M Bookman2,
  3. R Coleman3,
  4. M Dinh4,
  5. N Khandelwal4,
  6. K Benjamin4,
  7. R Kamalakar4,
  8. D Sullivan4 and
  9. D Cella5
  1. 1Department of Obstetrics and Gynecology, Duke University School of Medicine, Duke Cancer Institute, USA
  2. 2Department of Medicine, University of Arizona Health Sciences, USA
  3. 3Department of Gynecologic Oncology and Reproductive Medicine, Division of Surgery, MD Anderson Cancer Center, USA
  4. 4Abbvie Inc, USA
  5. 5Department of Medical Social Sciences, Northwestern University, USA


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<0.0001). Mean Q-TWiST was longer for patients in Vel throughout arm compared to CP alone (20.82 months vs 18.06 months; 95% CI 1.09, 4.47; p<0.001). Similar differences in mean Q-TWiST were observed for sensitivity and subgroup analyses.

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.

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