Trastuzumab (Herceptin^®, Roche)

TOGA [78]

1st line metastatic HER2+ GEJ/gastriccarcinoma in combination with cisplatin and 5-FU/capecitabine (CF or CX) (584 evaluable)

Initial enrollment (584):

•  Chemotherapy (290) vs. chemotherapy/T (294)

Randomized international multi-center open-label phase III trial of chemotherapy vs. chemotherapy/T Primary: OS Secondary: PFS, RR

Chemotherapy (CF/CX):

Cisplatin/5-FU (CF): IV cisplatin 80 mg/m² D1 + IV 5-FU 800 mg/m² daily D1-5 Cisplatin/ capecitabine (CX) as above Trastuzumab: IV trastuzumab 8 mg/kg induction followed by maintenance IV trastuzumab 6 mg/kg q3 weekly

Analysis (chemotherapy vs. chemotherapy/T):

•  RR (PR/CR): 35% vs 47%

•  DCR (PR/CR/SD): 70% vs. 79%

Analysis (chemotherapy vs. chemotherapy/T):

•  Median OS: 11.1 mths vs. 13.8 mths

•  Median PFS: 5.5 mths vs. 6.7 mths