357P - Patient Reported Outcomes (PRO) in patients (pts) with HER2- advanced breast cancer (ABC) and a germline BRCA1/2 mutation (gBRCAm) receiving talazoparib (TALA) vs physician’s choice chemotherapy (PCT) in the EMBRACA trial: A focus on subgroups with/ without visceral disease

Abstract

BackgroundAs part of the key subgroup analyses of EMBRACA, a randomized 2:1 open-label phase 3 study (NCT01945775), improvements in PFS with TALA vs PCT were observed in both subgroups: HER2- gBRCAm ABC pts with/without visceral disease at baseline; these post hoc analyses evaluated PRO. MethodsPRO was assessed on baseline, at start of each 3-week cycle, and at end of treatment, using the EORTC QLQ-C30 and breast cancer module, QLQ-BR23. Higher scores indicate better functioning/global health status (GHS)/QoL or worse symptom severity. PRO analyses performed separately in pts with/without visceral disease, for GHS/QoL, functional and symptom scales include: Overall mean change from baseline (per longitudinal repeated measures mixed-effects model) and time to definitive clinically meaningful deterioration (TTD) (per survival analysis methods). Between-arm comparisons of TTD were made using stratified log-rank test and Cox proportional hazards model. ResultsBaseline scores were similar between arms. A statistically significant estimated overall change from baseline in GHS/QoL favored TALA vs PCT for both subgroups with {8.8 [95%CI: (4.1, 13.5)] P<0.001} and without {7.4 [95%CI: (0.4, 14.3)] P=0.04} visceral disease. A statistically significant estimated overall change from baseline in patient reported pain symptoms favored TALA vs PCT for both subgroups with (P<0.001) and without (P=0.03) visceral disease. A statistically significant delay in TTD favoring TALA was observed in GHS/QoL for both subgroups with [median: 21.1 vs 6.0 mos, HR=0.36 (95%CI: 0.23, 0.57); P<0.001] and without [median: 26.3 vs 12.2 mos, HR=0.38 (95%CI: 0.18, 0.80); P=0.009] visceral disease. A statistically significant delay in TTD favoring TALA was observed in pain symptoms for both subgroups with (P<0.001) and without (P=0.002) visceral disease. ConclusionsIn HER2- gBRCAm ABC, TALA (vs PCT) resulted in significantly better change from baseline and delayed TTD in GHS/QoL and pain in both pts subgroups with/without visceral disease. Clinical trial identificationNCT01945775. Editorial acknowledgementEditorial/writing support was provided by Chantel Cadwell, PhD, and Dena McWain at Ashfield Healthcare Communications, Middletown, CT. Legal entity responsible for the studyPfizer Inc. FundingPfizer Inc. DisclosureJ. Ettl: Honoraria (self), Advisory / Consultancy: Lily; Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Eisai; Research grant / Funding (self), Travel / Accommodation / Expenses: Celgene; Honoraria (self): TEVA; Honoraria (self): AstraZeneca. R.G.W. Quek: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. H. Bhattacharyya: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. H.S. Rugo: Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): MacroGenics; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): OBI Pharma; Research grant / Funding (institution): Pfizer Inc.; Research grant / Funding (institution): Plexxikon; Travel / Accommodation / Expenses: Mylan; Travel / Accommodation / Expenses: Puma; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): MacroGenics; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): OBI Pharma; Research grant / Funding (institution): Pfizer Inc.; Research grant / Funding (institution): Plexxikon; Travel / Accommodation / Expenses: Mylan; Travel / Accommodation / Expenses: Puma. S.A. Hurvitz: Research grant / Funding (institution): Ambryx; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): BI Pharma; Research grant / Funding (institution): Biomarin; Research grant / Funding (institution): Cascadian; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Dignitana; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): Macrogenics; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Merrimack; Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution), Travel / Accommodation / Expenses: OBI Pharma; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Pieris; Research grant / Funding (institution): PUMA; Research grant / Funding (institution): Roche, Seattle Genetics. A. Gonçalves: Travel / Accommodation / Expenses: Pfizer Inc.; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Boehringer Ingelheim.