3578 - Patient-reported outcomes (PRO) in patients (pts) with advanced breast cancer and a germline BRCA1/2 mutation (gBRCAm) receiving talazoparib (TALA) vs physician’s choice chemotherapy treatment (PCT): a focus on the EMBRACA triple negative (TNBC) subpopulation

Background

As part of the key subgroup analyses of EMBRACA, a randomised 2:1 open-label phase 3 study, a statistically significant improvement in progression-free survival (PFS) with TALA (n = 130) vs PCT (n = 60) (median PFS 5.8 vs 2.9 mos, HR = 0.60; 95% CI 0.41-0.87, P=.008) was observed in pts with advanced TNBC and gBRCAm; these post hoc analyses evaluated PRO.

Methods

PRO were assessed on day 1 (baseline), at the start of each treatment cycle (every 3 wks), and end of treatment using questionnaires (EORTC QLQ-C30 and breast cancer module, QLQ-BR23). Higher scores indicate better functioning/global health status/quality of life (GHS)/(QoL) or worse symptom severity. Repeated measures mixed-effects analyses were performed to compare overall change from baseline scores between the 2 treatment arms, controlling for baseline. Time to definitive deterioration (TDD) (change of ≥ 10 points) in GHS/QoL and pain symptoms were compared using stratified log-rank test and Cox proportional hazards model.

Results

Baseline scores were similar between arms. A statistically significant overall change from baseline in GHS/QoL favoured TALA vs PCT (12.5 [95% CI 7.1-17.8], P<.0001). Additionally, TALA resulted in a statistically significant favourable difference in overall change from baseline in the following functions: physical, role, social, body image and the symptoms: fatigue, pain, appetite loss, breast and arm. No significant differences were observed between arms for emotional and cognitive functioning, nausea/vomiting, dyspnea, insomnia, constipation, diarrhoea, upset by hair loss, sexual enjoyment and functioning. A statistically significant delay in TTD favouring TALA was observed in GHS/QoL [median 24.3 vs 4.5 mos, hazard ration 0.33 (95% CI 0.19-0.57); P<.0001] and pain [median 22.7 vs 5.6 mos, HR = 0.25 (95% CI 0.14-0.45), P<.0001].

Conclusions

In pts with gBRCAm advanced TNBC, TALA resulted in significantly greater improvement from baseline and delayed TTD in GHS/QoL and pain symptom vs PCT.

Clinical trial identification

NCT01945775.

Legal entity responsible for the study

Pfizer, Inc.

Funding

Pfizer, Inc.

Editorial Acknowledgement

Editorial and medical writing support funded by Pfizer Inc. were provided by Edwin Thrower, PhD, Mary Kacillas and Paula Stuckart of Ashfield Healthcare Communications, Middletown, Connecticut.

Disclosure

H.S. Rugo: Fees for contracted research to the University of California: Eisai, Genentech, GSK, Lilly, Macrogenics, Merck, Novartis, OBI Pharma, Pfizer, Plexxikon; Travel: Lilly, Mylan, Puma R. Quek, H. Bhattacharyya: Employee of Pfizer Inc. J. Ettl: Consulting fees: Novartis, Pfizer, Roche, and Eisai; Contracted research: Celgene; Honoraria: Pfizer, Roche, Teva and Pierre Fabre. S.A. Hurvitz: Contracted research: Amgen, Bayer, BioMarin, BI, Cascadian Therapeutics, Dignitana, Genentech/Roche, GSK, Lilly, Medivation, Merrimack, Novartis, OBI Pharma, Pfizer, Puma Biotechnology and Sanofi; Travel: Bayer, Lilly, Novartis, OBI Pharma. A.L. Hannah: Consulting fees: Basilea, Medivation/Pfizer and Nektar; Ownership interest in NeoGenomics Laboratories. J.K. Litton: Institutional-contracted research: Pfizer, Novartis, EMD-Serono, AstraZeneca, GlaxoSmithKline and Genentech; Advisory board participation: AstraZeneca and Pfizer, both uncompensated.