Hospitalization and supportive care medication (SCM) utilisation in patients (pts) with advanced breast cancer (ABC) and a germline BRCA1/2 mutation (gBRCAm) in EMBRACA
Authors: J. Ettl, R.G.W. Quek, S.A. Hurvitz, A. Goncalves, I.C. Tudor, H.S. Rugo
Journal: Annals of Oncology (2019)

Background: EMBRACA, a randomized 2:1 open-label Phase 3 trial (NCT01945775), showed a significant improvement in progression-free survival with talazoparib (TALA) vs physician's choice of chemotherapy (PCT) (HR = 0.54; 95%CI: 0.41,0.71; P<.0001) in pts with HER2-negative ABC and a gBRCAm. This analysis evaluated the hospitalization and SCM utilisation while accounting for TALA/PCT–treatment-emergent period in EMBRACA. Methods: From EMBRACA safety population (while pts were on TALA or PCT), serious adverse event (SAE)-associated hospitalization rates (per 100 patient-years), number of pts with ≥1 platelet/red blood cell (RBC) transfusion(s) and 7 types of SCM (opiate, antiemetic/anti-nauseant, antidiarrheal, appetite stimulant, bone disease treatment, antianemic, immunostimulant) utilisation ratios (total duration of each SCM type/treatment-emergent period) were compared between TALA vs PCT-treated pts. Results: EMBRACA safety population consisted of 286 TALA and 126 PCT-treated pts. Lower rates of SAE-associated hospitalization were observed with TALA vs PCT-treated pts (39.5 vs 64.0 per 100 patient-years). Nine TALA-treated pts (3.1%) had ≥1 platelet transfusion(s) vs 0 PCT-treated pts; 109 TALA-treated pts (38.1%) had ≥1 RBC transfusion(s) vs 7 (5.6%) PCT-treated pts. Across all 7 other types of SCM, the mean SCM utilisation ratios for TALA-treated pts were lower than PCT-treated pts (Table).Table162PSCM TypeTalazoparib Mean SCM Utilization Ratio (SD) n = 286Overall PCT Mean SCM Utilization Ratio (SD) n = 126Antianemic8.0 (40.6)14.3 (26.6)Antidiarrheal1.3 (1.8)5.0 (14.7)Antiemetic/Anti-nauseant5.5 (11.2)5.9 (8.8)Appetite Stimulant1.2 (2.1)9.9 (12.6)Bone Disease Treatment4.5 (4.8)6.6 (6.1)Immunostimulant0.1 (0.2)0.8 (1.5)Opiate6.2 (10.9)13.7 (17.4) Open table in a new tab Conclusions: Pts with HER2-negative ABC and a gBRCAm treated with TALA had lower SAE-associated hospitalization rates and lower SCM utilization ratios vs PCT. More TALA-treated patients had ≥1 platelet/ RBC transfusion(s) vs PCT. These results may support the favorable clinical and patient reported outcomes observed with TALA vs PCT-treated pts in EMBRACA. Legal entity responsible for the study: Pfizer. Funding: Pfizer, Inc. Disclosure: J. Ettl: Consulting fees: Lilly, Novartis, Pfizer, Roche, Tesaro, Eisai; Contracted research: Celgene; Honoraria: Pfizer, Roche, Teva, Lilly, AstraZeneca; Travel support: Celgene, Novartis, Pfizer. R.G.W. Quek: Employee: Pfizer Inc.; Stock ownership: Pfizer Inc., Amgen Inc. S.A. Hurvitz: Grants: Ambryx, Amgen, Bayer, BI Pharma, Biomarin, Cascadian, Daiichi Sankyo, Dignitana, Genentech, GSK, Lilly, Macrogenics, Medivation, Merrimack, Novartis, OBI Pharma, Pfizer, Pieris, Puma, Roche, Seattle Genetics; Travel: Lilly, Novartis, OBI Pharma. A. Goncalves: Travel/accommodation/meeting registration fees: Pfizer, AstraZeneca, Roche, Novartis, Amgen, Cellgene, MSD, Boehringer Ingelheim. H.S. Rugo: Research funding to the University of California: Eisai, Genentech, GlaxoSmithKline, Lilly, Macrogenics, Merck, Novartis, OBI Pharma, Pfizer, Plexxikon; Travel expenses: Lilly, Mylan, Puma. All other authors have declared no conflicts of interest.