OBJECTIVES

In EMBRACA, a randomized 2:1 open-label Phase 3 study (NCT01945775), significant improvements in PFS with TALA vs PCT were observed in HER2- gBRCAm ABC pts with and without prior lines of CT in the advanced setting; these post hoc analyses evaluated PRO.

METHODS

PRO was assessed at baseline, at start of treatment cycle (every 3 weeks), and 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 or without prior CT in the advanced setting, 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 significant estimated overall change from baseline in GHS/QoL favored TALA vs PCT for both subgroups with (8.2 [95%CI: (3.0, 13.3)] P=0.002) and without (8.8 [95%CI: (2.6, 14.9)] P=0.005) prior CT. A significant estimated overall change from baseline in pain symptoms favored TALA vs PCT for both subgroups with (P<0.001) and without (P =0.01) prior CT.

A significant delay in TTD favoring TALA was observed in GHS/QoL for both subgroups with [median: 24.9 vs 10.3 mth, HR=0.48 (95%CI: 0.29, 0.79); P=0.003] and without [median: 24.3 vs 6.0 mth, HR=0.27 (95%CI: 0.15, 0.49); P<0.001] prior CT. A significant delay in TTD favoring TALA was observed in pain symptoms for both subgroups with (P<0.001) and without (P=0.002) prior CT.

CONCLUSIONS

In HER2- gBRCAm ABC, TALA (vs PCT) resulted in significantly better change from baseline and delayed TTD in GHS/QoL and patient reported pain symptoms in both pts subgroups with or without prior CT.