Effectiveness and Safety of S-1-Based Therapy Compared with 5-Fluorouracil-Based Therapy for Advanced Colorectal Cancer: A Meta-Analysis

Table 1

Main characteristics of the studies included in the meta-analysis.

Study	Country	Duration	Number of Patients (A/B)	Regimen (group A and group B)	Outcome measures	Study design
			PS (score)
Muro et al. 2010 [9], Baba et al. 2011 [18]	Japan	Jan. 2006–Jan. 2008	213/213; 0-1	A: irinotecan 125 mg/m^2 d1d15, S-1 40–60 mg (according to body surface area) bid d1–14, q4 w; B: LV 200 mg/m^2 d1, irinotecan 150 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, q2 w	ORR, PFS, OS, toxicities	Randomized phase II/III study
Kato et al. 2011 [8]	Japan	July 2007–Mar. 2010	30/30; 0-1	A: irinotecan 150 mg/m^2 d1, S-1 80 mg/m^2 d3–16, bevacizumab 7.5 mg/kg, q3 w; B: irinotecan 150 mg/m^2 d1, LV 200 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, bevacizumab 5 mg/kg, q2 w	ORR, toxicities	Randomized pilot study
Ojima et al. 2011 [10], Otsuji et al. 2012 [19]	Japan	July 2008–July 2009	56/49; 0-1	A: S-1 40–60 mg bid d1–7, oral LV 25 mg bid d1–7, oxaliplatin 85 mg/m^2 d1, q2 w; B: oxaliplatin 85 mg/m^2 d1, LV 200 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, q2 w	ORR, PFS, SR, OS, toxicities	Randomized phase II trial
Yamada et al. 2013 [16]	Japan	Feb. 2009–Mar. 2011	256/255; 0-1	A: oxaliplatin 130 mg/m^2 d1, S-1 40–60 mg (according to body surface area) bid d1–14, bevacizumab 7.5 mg/kg, q3 w; B: bevacizumab 5 mg/kg, LV 200 mg/m^2 d1, oxaliplatin 85 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, q2 w	ORR, PFS, OS, toxicities	Randomized phase III trial
Yang and Li 2013 [17]	China	Jan. 2010–Jun. 2012	30/28; 0–2	A: irinotecan 180 mg/m^2 d1, S-1 80 mg/m^2 d1–14, q3 w; B: irinotecan 180 mg/m^2 d1, LV 200 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, q2 w	ORR, toxicities	Randomized controlled trial
Xie et al. 2013 [14]	China	Mar. 2009–Sep. 2012	23/22; 0–2	A: S-1 80 mg/m^2 d1–14, oxaliplatin 100 mg/m^2 d1, q3 w; B: oxaliplatin 100 mg/m^2 d1, LV 400 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, q2 w	ORR, TTP, toxicities	Randomized controlled trial
Wang et al. 2013 [13]	China	Mar. 2008–Dec. 2012	22/21; 0–2	A: S-1 80 mg/m^2 d1–14, oxaliplatin 130 mg/m^2 d1, q3 w; B: oxaliplatin 130 mg/m^2 d1, LV 200 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, q3 w	ORR, toxicities	Randomized controlled trial
Wang et al. 2012 [12]	China	NA	18/18; ≥70^a	A: S-1 80 mg/m^2 d1–14, oxaliplatin 85 mg/m^2 d1, q4 w; B: oxaliplatin 85 mg/m^2 d1, LV 200 mg/m^2 d1, 5-FU 300 mg/m^2 d1–5, q4 w	ORR, TTP, MST, toxicities	Randomized controlled trial
Tian 2011 [11]	China	Jun 2009–May 2011	25/24; 0-1	A: irinotecan 125 mg/m^2 d1d15, S-1 40–60 mg (according to body surface area) bid d1–14, q4 w; B: irinotecan 150 mg/m^2 d1, LV 200 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, q2 w	ORR, TTP, toxicities	Randomized controlled trial
Bian et al. 2013 [6]	China	Jan. 2011–Dec. 2012	90/90; 0-1	A: S-1 80 mg/m^2 d1–14, oxaliplatin 85 mg/m^2 d1, q4 w; B: oxaliplatin 85 mg/m^2 d1, LV 200 mg/m^2 d1, 5-FU 300 mg/m2 d1–5, q4 w	ORR, toxicities	Randomized controlled trial
Xiong et al. 2012 [15]	China	Mar. 2010–Jun 2011	35/30; ≥70^a	A: S-1 80 mg/m^2 d1–14, oxaliplatin 100 mg/m^2 d1, q3 w; B: oxaliplatin 100 mg/m^2 d1, LV 400 mg/m^2 d1, 5-FU 400 mg/m^2 d1 and 2400 mg/m^2 civ 46 h, q2 w	ORR, toxicities	Randomized controlled trial
Gao et al. 2013 [7]	China	Jan. 2010–Jun 2012	31/33; ≥70^a	A: irinotecan 100 mg/m^2 d1d8, S-1 40 mg/m^2 d1–14, q3 w; B: irinotecan 180 mg/m^2 d1, LV 200 mg/m^2 d1, 5-FU 400 mg/m^2 iv d1d2 and 600 mg/m^2 civ 22 h, d1d2, q2 w	ORR, toxicities	Randomized controlled trial

Note: LV: leucovorin; 5-FU: 5-fluorouracil; PS: performance status; ORR: overall response rate; OS: overall survival; PFS: progression-free survival; MST: median survival time; TTP: time to progression; SR: survival rate; d1–14: days 1–14; q3 w: every 3 weeks; q4 w: every 4 weeks; q6 w: every 6 weeks; bid: twice a day; NA: not available; civ: continuous intravenous infusion; ^aKarnofsky method.