HER2-pos metastatic cancer of GEJ or stomach are indications with a high medical need. TRA plus standard chemotherapy (CT) has been approved as 1L therapy in HER2-pos mGC or mGEJ-C pts according to ToGA-study. HerMES (NCT01220934) was designed to collect data on clinical routine practice in 171 specialist centers in Germany.
Between January 2010 and July 2016, 434 pts were identified. 364 pts matched criteria for TRA-therapy and were treated accordingly (population of the present analysis). Another 39 pts did not match criteria for HER2-positivity with TRA-therapy and will be evaluated separately. Main parameters of interest were overall response rate (ORR), progression free survival (PFS), safety and overall survival (OS). QoL and patient reported outcomes will be presented later.
Mean age was 65 years, 75% were male, and 51% had mGEJ-C. TRA was given at an average dose of 5.73 mg/kg. Mean treatment duration for TRA was 7 months (mos) and 61 pts (17%) received TRA-therapy for more than 1 year. CT regimen frequently used were cisplatin/5-FU (21%), oxaliplatin/5-FU/docetaxel (10%), and cisplatin/capecitabine (8%). ORR was 43% [95%CI 0.38;0.49], median PFS was 7 mos [6.3;7.6], and median OS was 10 mos [8.8;11.1]. Most frequent related AEs (reported in > 5% of pts) were diarrhea in 29 (8%), nausea in 24 (6.6%) and fatigue in 22 cases (6%). TRA-rel cardiac AEs occurred in 21 pts (6%).
To our knowledge this is the largest prospective observational trial on TRA in the daily clinical routine care of metastatic GC/GEJ-C. Chemotherapy backbones were diverse. The outcome was similar to ToGA, taking into account the unselected patient population.
Clinical trial identification
Legal entity responsible for the study
Roche Pharma AG
Roche Pharma AG
S-E. Al-Batran: Membership on advisory board or board of directors: Lilly Pharma, BMS, Roche, Astellas C. Maintz: Membership on advisory board or board of directors: Roche, Shire P. Thuss-Patience: Membership on advisory board or board of directors: Roche, Lilly, MSD, BMS, Nordic Corporate-sponsored research: Novartis V. Gaillard: Other substantive relationship such as employment with a pharmaceutical company: Roche Pharma AG (Employment) All other authors have declared no conflicts of interest.