PATIENT REPORTED OUTCOMES (PRO) OF TALAZOPARIB (TALA) VERSUS PHYSICIAN'S CHOICE OF CHEMOTHERAPY (PCT) IN PATIENTS (PTS) WITH ADVANCED BREAST CANCER (ABC) AND A GERMLINE BRCA (GBRCA) MUTATION- A FOCUS ON EMBRACA PTS WITH/ WITHOUT PRIOR CHEMO ...
Author(s)
Quek RGW1, Bhattacharyya H2, Goncalves A3, Rugo HS4, Hurvitz SA5, Ettl J6
1Pfizer, Inc., San Francisco, CA, USA, 2Pfizer, Inc., New York, NY, USA, 3Institut Paoli-Calmettes, Marseille, France, 4UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA, 5University of California, Los Angeles (UCLA) Hematology/Oncology, Santa Monica, CA, USA, 6Klinikum rechts der Isar, Technische Universität München, Munich, Germany
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.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PCN491
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Drugs, Oncology