Table 1. Landmark trials in first-line treatment of GEJ and gastric cancers.

Authors, years (study name)	Treatment regimen	Total patients	ORR/CR	mPFS (months); HR, P value	mOS (months), HR, P value
MacDonald et al., 1980	Fluorouracil, doxorubicin & mitomycin (FAM)	62	42%/NR	NR	5.5
Wils et al. 1991	Fluorouracil, doxorubicin & methotrexate (FAMTX) vs. FAM	160	41%/6%; 9%/0%	NR	9.7 vs. 6.7
Webb et al., 1997	Epirubicin, cisplatin, and fluorouracil (ECF) vs. FAMTX	219	45%/6%; 21%/2%	FFS: 7.4 vs. 3.4; P=0.00006	8.9 vs. 5.7, P=0.0009
Van Cutsem et al., 2006 (V325)	Cisplatin & fluorouracil (CF) vs. docetaxel, cisplatin, fluorouracil (DCF)	270	37%/2%; 25%/1%	TTP: 5.6 vs. 3.7; HR 1.47, P<0.001	8.2 vs. 9.6; HR 1.29, P=0.02
Cunningham et al., 2008 (REAL2)	Epirubicin, cisplatin, & fluorouracil (ECF) vs. epirubicin, cisplatin & capecitabine (ECX); epirubicin, oxaliplatin & fluorouracil (EOF) epirubicin, oxaliplatin & capecitabine (EOX)	1,002	41%/4%; 46%/4%; 42%/3%; 48%/4%	6.2 vs. 6.7 vs. 6.5 vs. 7.0†	9.9 vs. 9.9 vs. 9.3 vs. 11.2†
Ajani et al., 2010 (FLAGS)	Cisplatin & fluorouracil vs. cisplatin & S-1	1,053	32%/NR; 29%/NR	5.5 vs. 4.8‡	7.9 vs. 8.6‡
Bang et al., 2010§ (ToGA)	Fluoropyrimidine, cisplatin & trastuzumab vs. fluoropyrimidine, cisplatin & placebo	594	47%/5%; 35%/2%	6.7 vs. 5.5; HR 0.71, P=0.0002	13.8 vs. 11.1; HR 0.74, P=0.0046

^†, non-inferior; ^‡, non-significant; ^§, HER2-positive only. NR, not reported.