809MO - Health-related quality of life (HRQoL) in patients (pts) with newly diagnosed stage III or IV ovarian cancer treated with veliparib (vel) + chemotherapy followed by vel maintenance (maint)

Background

Vel, a poly (ADP-ribose) polymerase inhibitor, is being evaluated for efficacy and safety in pts with newly diagnosed stage III or IV high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. We investigated the effect of Vel + chemotherapy followed by Vel maint on HRQoL in this population.

Methods

A phase III study (NCT02470585) examined efficacy of Vel (150 mg oral BID) plus carboplatin/paclitaxel (CP) for 6 cycles followed by maint with Vel 300/400 mg (Vel-throughout) or placebo (pbo) (Vel-comb only) or pbo with CP followed by pbo maint (CP alone). HRQoL measures were the NCCN Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18) and the EuroQoL-5D-5L. HRQoL was measured at screening, Cycle 1 Day 1, and every other cycle until discontinuation. Exploratory analysis included on-treatment comparisons of mean change from baseline (BL) in HRQoL scores and median time to symptom worsening (TSW) across the primary study arms, Vel-throughout and CP alone.

Results

This analysis included 1069 pts (Vel-throughout n=351, Vel-comb only n=363, CP alone n=355). HRQoL score improvements from BL were observed across both study arms. Smaller, non-statistically significant improvements in the Vel-throughout vs CP alone arms were noted for most domains, except NFOSI-18 Treatment Side Effects (TSE) where negative mean changes in the initial 7 cycles (indicating higher treatment burden) followed by improvements in later cycles were seen in both arms. TSW was not significantly different between the arms for any NFOSI-18 domain. Median TSW (months) for Vel-throughout vs CP alone was 10.5 vs 10.1 for ‘disease-related symptom’ and 8.1 vs 8.1 for ‘functional well-being’ domains.

Conclusions

Compared to CP alone, addition of Vel to CP followed by Vel maint showed smaller improvements in HRQoL scores from baseline. While early differences in TSE changes were noted, improvements were observed across both study arms in later cycles. TSW for HRQoL domains were similar across study arms. Thus, the addition of Vel to CP followed by Vel maint does not substantially affect HRQoL compared to CP alone.

Clinical trial identification

NCT02470585.

Editorial acknowledgement

Medical writing services, provided by Alan Saltzman of JK Associates, Inc., were funded by AbbVie.

Legal entity responsible for the study

AbbVie Inc.

Funding

AbbVie.

Disclosure

D. Cella: Advisory/Consultancy: AbbVie; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy: Astellas; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: Pled Pharma; Advisory/Consultancy: Puma Biotechnology; Research grant/Funding (institution), Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Astellas; Shareholder/Stockholder/Stock options: FACIT.org; Research grant/Funding (institution): Genentech. M. Bookman: Leadership role, Member, international protocol steering committee: AbbVie GOG3005; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Immunogen; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: Tesaro; Advisory/Consultancy: Bayer; Advisory/Consultancy: Merck; Advisory/Consultancy: Pfizer. K. Dahl Steffensen: Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): AstraZeneca. R.L. Coleman: Research grant/Funding (institution): NCI-SPORE; Leadership role, Research grant/Funding (institution), Scientific Steering Committee: AstraZeneca; Leadership role, Research grant/Funding (institution), Scientific Steering Committee: Clovis; Leadership role, Research grant/Funding (institution), Scientific Steering Committee: Roche/Genentech; Research grant/Funding (institution): V-Foundation; Leadership role, Research grant/Funding (institution), Scientific Steering Committee: Janssen; Leadership role, Research grant/Funding (institution), Scientific Steering Committee: Merck; Research grant/Funding (institution): Novartis; Leadership role, Scientific Steering Committee: AbbVie; Leadership role, Scientific Steering Committee: Biomarin; Leadership role, Scientific Steering Committee: GamaMab; Leadership role, Scientific Steering Committee: Genmab; Leadership role, Scientific Steering Committee: Immunogen; Leadership role, Scientific Steering Committee: Pfizer; Leadership role, Scientific Steering Committee: Tesaro/GSK. M. Dinh, N. Khandelwal, K. Benjamin, R. Kamalakar, D. Sullivan: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie. L. Floden, S. Hudgens: Full/Part-time employment: Clinical Outcomes Solutions.