Post-hoc analyses of patient-reported outcomes (PROs) from the randomized, open-label, phase III EMBRACA study were presented at the San Antonio Breast Cancer Symposium.
Researchers observed significantly improved progression-free survival with talazoparib versus physician’s choice of chemotherapy among patients with human epidermal growth factor receptor 2-germline BRCA1/2-mutated (gBRCA1/2mut) advanced breast cancer. The present study reported PROs in gBRCA1/2mut advanced breast cancer patients who were placed in one of two subgroups based on Eastern Cooperative Oncology Group (ECOG) performance status (grade 0 vs. ≥1).
Patients underwent PRO assessments at baseline, the start of each treatment cycle (every three weeks), and at the end of treatment; PROs were evaluated per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and breast cancer module QLQ-BR23. Higher scores on the global health status (GHS)/quality of life (QoL) scale are associated with better GHS/QoL, and higher functional scale scores indicate better functioning. Higher scores on the symptom scales correlate with worse symptom severity. PRO analyses were conducted separately for the two ECOG performance subgroups; these analyses were conducted to evaluate for GHS/QoL, functional, and symptom scales and included overall mean change from baseline and time to definitive clinically meaningful deterioration (TTD).
The groups had similar baseline scores. Improvements from baseline in GHS/QoL were significantly in favor of talazoparib compared with physician’s choice of chemotherapy for both ECOG grade 0 (8.1; 95% confidence interval [CI], 3.3-13.0; P<0.001) and grade ≥1 (9.4; 95% CI, 2.8-16.0; P=0.005). Improvements in patient-reported pain symptoms from baseline were also significantly better in the talazoparib group both for ECOG grade 0 (-13.3; 95% CI, –18.9 to –7.8; P<0.001) and grade ≥1 (-16.4; 95% CI, –25.3 to –7.5; P<0.001), as were improvements in patient-reported fatigue: grade 0, –9.5 (95% CI, –15.4 to –3.6; P=0.002) and grade ≥1, –19.4 (95% CI, –28.8 to –10.1; P<0.001).
The researchers also reported a significant delay in TTD in favor of talazoparib over physician’s choice of chemotherapy in GHS/QoL for both ECOG grade 0 (median, 24.3 vs. 10.3 months; hazard ratio [HR]=0.40; 95% CI, 0.24-0.67; P<0.001) and grade ≥1 (median, 21.1 vs. 6.0 months; HR=0.34; 95% CI, 0.19-0.61; P<0.001). This was also the case for patient-reported pain symptoms (median, 21.5 vs. 5.9 months; hazard ratio [HR] = 0.29; 95% CI, 0.17-0.49; P<0.001; and median, not reached vs. 7.5 months; HR=0.36; 95% CI, 0.19-0.68; P=0.001, respectively) and patient-reported fatigue (median, 17.1 vs. 6.1 months; HR=0.40; 95% CI, 0.25-0.65; P<0.001; and median, 16.9 vs. 7.1 months; HR=0.41; 95% CI, 0.24-0.69; P<0.001, respectively).