274O - Health-related quality of life (HRQoL) changes with veliparib in patients (pts) with metastatic or locally advanced breast cancer in the phase III BROCADE 3 study

Background

Veliparib, a poly (ADP-ribose) polymerase 1/2 inhibitor, was evaluated in the phase III BROCADE 3 study (NCT02163694) for efficacy and safety in combination with paclitaxel/carboplatin (VPC) in pts with HER2-negative metastatic or locally advanced unresectable gBRCA-associated breast cancer, in which VPC significantly prolonged progression-free survival (hazard ratio=0.71 [95% CI 0.57, 0.88], P=.002) compared with placebo plus paclitaxel/carboplatin (PPC) (Dieras VC et al. Ann Oncol. 2019:30[suppl 5]:LBA9). In this analysis we investigated the impact of veliparib on HRQoL.

Methods

This double-blind study examined the effect of veliparib (120 mg oral twice daily for 7 days out of each 21-day cycle) added to paclitaxel/carboplatin vs. PPC. HRQoL measures were EORTC-QLQ -C30 and breast cancer (BR23), EQ-5D-5L, and Brief Pain Inventory-Short Form (BPI-SF). Responses were obtained on Day 2 Cycle 1, Day 1 Cycle 2, and every other cycle thereafter starting from Cycle 4 plus final and follow-up visit. Data were analyzed only through Day 1 Cycle 30 due to attrition. For each HRQoL domain, mean change in baseline scores, % responders (improved, stable, declined), and median time to symptom worsening were analyzed across study arms.

Results

504 pts (VPC 334, PPC 170) were included in the analysis. Improvement from baseline in function, disease and treatment symptom burden, and health state was observed for both study arms, with greater benefits for VPC vs. PPC for pain, pain interference, and breast symptoms. Greater proportion of PPC vs. VPC pts declined in global health status, pain, arm symptoms, breast symptoms and pain interference, but here differences were not significant. Median time (months) to symptom worsening was significantly longer (P<0.05) for VPC vs. PPC pts for role functioning (8.2 vs. 6.5), physical functioning (8.8 vs. 7.1), constipation (7.7 vs. 6.2), and future perspectives (10.2 vs. 9.0).

Conclusions

Overall, addition of veliparib to paclitaxel/carboplatin has no detrimental effect on quality of life in pts with gBRCA mutation-associated advanced breast cancer and may be beneficial in some areas of functioning and symptom experience.

Clinical trial identification

NCT02163694.

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

V. Dieras: Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: Novartis; Advisory/Consultancy: Lilly; Advisory/Consultancy: Pfizer; Advisory/Consultancy: AbbVie; Advisory/Consultancy: MSD; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: AstraZeneca. B. Arun: Leadership role, Research grant/Funding (institution), Steering committee (non-paid): AbbVie; Research grant/Funding (institution): PharmaMar; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Invitae. H.S. Han: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Prescient; Research grant/Funding (institution): Horizon; Research grant/Funding (institution): Karyopharm; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Tesaro; Research grant/Funding (institution): TapImmune; Research grant/Funding (institution): Seattle Genetics; Research grant/Funding (institution): Department of Defense; Speaker Bureau/Expert testimony: Lilly. H. Wildiers: Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (institution), Advisory/Consultancy: Lilly; Honoraria (institution), Advisory/Consultancy: Novartis; Honoraria (institution), Advisory/Consultancy: AbbVie; Honoraria (institution), Advisory/Consultancy: Vifor Pharma; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (institution), Advisory/Consultancy: Celldex Therapeutics; Honoraria (institution), Advisory/Consultancy: Janssen-Cilag; Honoraria (institution), Advisory/Consultancy: TRM Oncology; Honoraria (institution), Advisory/Consultancy: PUMA Biotechnology; Honoraria (institution), Advisory/Consultancy: Amgen; Honoraria (institution), Advisory/Consultancy: Orion Corporation. M. Friedlander: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Leadership role, Steering committee (remunerated): MSD; Advisory/Consultancy, Leadership role, Steering committee (non-remunerated): AbbVie; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy: Novartis; Research grant/Funding (institution): BeiGene. J.P. Ayoub: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Boston Biomedical; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Eisai; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy: Puma; Advisory/Consultancy: Roche. S. Puhalla: Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Advisory/Consultancy: MedImmune; Advisory/Consultancy: Celldex; Advisory/Consultancy: Puma; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: Eisai; Advisory/Consultancy: NanoString; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): Covance-Bayer; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Medivation. S. Hudgens: Full/Part-time employment: Clinical Outcomes Solutions. L. Floden: Full/Part-time employment: Clinical Outcomes Solutions. N. Khandelwal: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie. K. Benjamin: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie. R. Kamalakar: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie. D. Maag: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie.