642P - Trastuzumab in Combination with Different First-Line Chemotherapies for Treatment of Her2-Positive Metastatic Gastric Cancer: Updated Findings from the German Non-Interventional Study Hermes

Abstract

ABSTRACT Aim: The international phase III study ToGA has shown that trastuzumab (TRA) (Herceptin®) is effective in prolonging survival in HER2-positive metastatic gastric or gastro-oesophageal junction cancer (MGC). However, few data are available for TRA as part of routine clinical practice. Methods: This non-interventional observational study (NCT01220934) aims to evaluate the efficacy, safety and feasibility of TRA in previously untreated pts with HER2-positive MGC. Results: Between Apr 2010 and Apr 2014, we collected data from 360 pts. All pts were evaluable for safety. Baseline pt characteristics were as follows: median age 66 y (range 29–90); gender (male 74%; female 26%); ECOG PS (0: 28%; 1: 47%; 2: 12%; 3: 2%); distant mets (90%): liver (53%), lymph node (35%); peritoneal carcinomatosis (21%); lung (14%). Only 28% of pts received TRA in combination with cisplatin and 5-FU or capecitabine (see table). Most pts (51%) did not receive cisplatin-based therapy. 54 pts (15%) received TRA for more than 12 months. TRA containing regimen n (%) + 5-FU + cisplatin 75 (21) + 5-FU + cisplatin + leucovorin 54 (15) + 5-FU + oxaliplatin (+ leucovorin) 50 (14) + 5-FU + oxaliplatin + docetaxel 36 (10) + capecitabine + cisplatin 25 (7) + capecitabine 20 (6) other combinations * 87 (23) TRA monotherapy 13 (4) cisplatin-free regimen 184 (51) * including cisplatin. Preliminary median PFS was 7.6 m (number of events: n = 282), thus comparable to the ToGA data. Most common AEs (all grades) were diarrhoea (9%), nausea (7%), and fatigue (6%). Most common grade 3/4 AEs were general physical health deterioration (2%), vomiting (1%), and diarrhoea (1%). Health-related quality of life as assessed by EORTC QLQ-C30 and QLQ-STO22 remained stable during observation time. An updated analysis of approx. 400 pts will be presented at the meeting. Conclusions: TRA combined with diverse chemotherapies, including less toxic cisplatin-free schedules, is safe and effective in the routine treatment of MGC. Overall, the results are in line with those from the ToGA trial. TRA is the standard of care for pts with HER2-positive MGC. Disclosure: S. Al-Batran: Receipt of grants / research support from Roche;K. Zielke: employee of Roche;T. Wohlfarth: employee, stock ownership (Roche); P.C. Thuss-Patience: receipt of honoraria from Roche;M. Moehler: 1) receipt of honoraria from Roche for speeches, presentations or appearances 2); consultancy and advisory role compensated by Roche. All other authors have declared no conflicts of interest.