2376 - 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

Background

As 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.

Methods

PRO 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.

Results

Baseline 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.

Conclusions

In 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 identification

NCT01945775.

Editorial acknowledgement

Editorial/writing support was provided by Chantel Cadwell, PhD, and Dena McWain at Ashfield Healthcare Communications, Middletown, CT.

Legal entity responsible for the study

Pfizer Inc.

Funding

Pfizer Inc.

Disclosure

J. 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.