Medical management of gastric cancer: A 2014 update

Table 1 Major phase III trials for gastric cancer in the localized setting

Ref.	n	Treatment arms	HR for overall survival or death (P value)	Survival comparison
Macdonald et al[23]	556	Surgery and chemoradiotherapy1vs surgery	1.35 (0.005)	Overall survival: 36 mo vs 27 mo
Cunningham et al[24]	503	ECF, surgery, ECF vs surgery	0.75 (0.009)	5-yr overall survival: 36.3% vs 23%
Fuchs et al[62]	546	5-FU, chemoradiotherapy, 5-FU vs ECF, chemoradiotherapy, ECF	1.03 (0.800)	Overall survival: 37 mo vs 38 mo
Lee et al[31]	458	Surgery and XP vs surgery, XP, XRT, XP	HR for DFS 0.6865 (0.0471)	3-yr DFS: 74.2% vs 78.2%
Sakuramoto et al[25]	1059	Surgery vs surgery and S-1	0.68 (0.003) 5 yr data in JCO 0.669	3-yr overall survival: 70.1% vs 80.1%
				3-yr RFS: 72.2% vs 59.6%
Bang et al[26]	1035	XELOX and surgery vs surgery	0.56 (< 0.0001)	3-yr DFS: 74% vs 59%
Ychou et al[28]	224	Perioperative chemotherapy vs surgery	0.69 (0.02)	5-yr overall survival: 38% vs 24%
Tsuburaya et al[63]	1495	Surgery and UFT vs surgery and S-1 vs surgery, paclitaxel and UFT vs surgery, paclitaxel and S-1	NR	NR
ARTIST II[64]	1000	Surgery and S1Ox vs surgery, S1Ox, XRT and S1Ox	NR	NR
Okines et al[65]	1100	ECX and bevacizumab vs ECX	NR	NR
Leong et al[33]	752	Preoperative chemotherapy vs preoperative chemoradiotherapy	NR	NR

¹Forty-five Gy radiotherapy plus 5-FU. Ongoing trial; Hazard ratio reduced to 0.8 on follow-up analysis. 5-FU: 5-Fluorouracil; ASC: Active symptom control; BSC: Best supportive care; CapeOx: Capecitabine and oxaliplatin; CF: Cisplatin and 5-FU; CX: Cisplatin and capecitabine; DFS: Diseas-free survival; ECF: Epirubicin, cisplatin and 5-FU; ECX: Epirubicin, cisplatin and capecitabine; EOC: Epirubicin, oxaliplatin and capecitabine; HR: Hazard ratio; mEOC–P: EOC plus panitumumab; PFS: Progression-free survival; RFS: Relapse-free survival; UFT: Tegafur and uracil; XELOX: Capecitabine and oxaliplatin; XP: Capecitabine and cisplatin; S1Ox: S1 and oxaliplatin; XRT: Chemoradiation.

Table 2 Major phase III trials for gastric cancer in the advanced setting

Trial	n	Treatment arms	HR for overall survival (P value)	Survival comparison
Advanced gastric cancer - first-line
Bang et al[39]	584	CX, CF and trastuzumab vs CX and CF1	0.74 (0.0046)	Overall survival: 13.8 mo vs 11.1 mo
Ohtsu et al[42]	774	Cisplatin and 5-FU vs cisplatin, 5-FU and bevacizumab	0.87 (0.1002)	Overall survival: 10.1 mo vs 12.1 mo
				PFS: 5.3 mo vs 6.7 mo
Lordick et al[44]	904	CX vs CX and cetuximab	1.004 (0.9547)	Overall survival: 10.7 mo vs 9.4 mo
Waddell et al[45]	553	EOC vs mEOC–P	1.37 (0.013)	Overall survival: 11.3 mo vs 8.8 mo
Van Cutsem et al[37]	445	DCF vs CF	TTP 1.47 (< 0.001) OS 1.29 (0.02)	Time to progression: 5.6 mo vs 3.7 mo, 9.2 mo vs 8.6 mo
Koizumi et al[40]	305	S-1 and cisplatin vs S-1	0.77 (0.04)	Overall survival: 13.0 mo vs 11.0 mo
Ajani et al[66]	1053	Cisplatin and S-1 vs cisplatin and 5-FU	0.92 (0.20)	Overall survival: 8.6 mo vs 7.9 mo
Hecht et al[67]	545	CapeOx and lapatinib vs CapeOx and placebo	0.91 (0.35)	Overall survival: 12.2 mo vs 10.5 mo
Advanced gastric cancer - second-line
Ohtsu et al[51]	656	BSC and placebo vs BSC and everolimus	0.90 (0.1244)	Overall survival: 4.3 mo vs 5.4 mo
Fuchs et al[47]	355	BSC and ramucirumab vs BSC	0.776 (0.047)	Overall survival: 5.2 mo vs 3.8 mo
Bang et al[52]	261	Lapatinib and paclitaxel vs paclitaxel	0.84 (0.2088)	Overall survival: 11.0 mo vs 8.9 mo
Kang et al[50]	202	BSC vs docetaxel or irinotecan	0.657 (0.007)	Overall survival: 3.8 mo vs 5.3 mo
Thuss-Patience et al[48]	40	Irinotecan and BSC vs BSC	0.48 (0.012)	Overall survival: 4.0 mo vs 2.4 mo
Cook et al[49]	168	Docetaxel and ASC vs ASC	0.67 (0.01)	Overall survival: 5.2 mo vs 3.6 mo

¹Hazard ratio reduced to 0.8 on follow-up analysis. 5-FU: 5-Fluorouracil; ASC: Active symptom control; BSC: Best supportive care; CapeOx: Capecitabine and oxaliplatin; CF: Cisplatin and 5-FU; CX: Cisplatin and capecitabine; DFS: Diseas-free survival; ECF: Epirubicin, cisplatin and 5-FU; ECX: Epirubicin, cisplatin and capecitabine; EOC: Epirubicin, oxaliplatin and capecitabine; HR: Hazard ratio; mEOC–P: EOC plus panitumumab; PFS: Progression-free survival; RFS: Relapse-free survival; UFT: Tegafur and uracil; XELOX: Capecitabine and oxaliplatin; XP: Capecitabine and cisplatin; XRT: XP and radiotherapy.