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.
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.
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].
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
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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.
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.