Should capecitabine replace 5-fluorouracil in the first-line treatment of metastatic colorectal cancer?

Table 5 Comparison of treatment efficacy in combination with irinotecan

Clinical trial	Type	Treatment	ORR	PFS (mo)	OS (mo)
Fuchs et al[39] (2007)	Phase III	CapeIRI1vs FOLFIRI vs mIFL	38.6% vs 47.2% vs 43.3%	5.8 vs 7.6 (1) vs 5.9 (2)	18.9 vs 23.1 (3) vs 17.6
Köhne et al[34] (2008)2	Phase III	CAPIRI vs FOLFIRI-2		5.9 vs 9.6	14.75 vs 19.9
		+ Celecoxib	22% vs 32%
		- Celecoxib	48% vs 45%
Souglakos et al[40] (2012)	Phase II	CAPIRI + Bev vs FOLFIRI-2 + Bev	39.8% vs 45.5% (P = 0.32)	8.9 vs 10.0 (P = 0.64)	27.5 vs 25.7 (P = 0.55)
Pectasides et al[41] (2012)	Phase III	XELIRI + Bev vs FOLFIRI + Bev	38.5% vs 40.1% (P = 0.81)	10.2 vs 10.8 (P = 0.74)	20.0 vs 25.3 (P = 0.099)
Ducreux et al[42] (2013)	Phase II	XELIRI-2+ Bev vs FOLFIRI + Bev	62% vs 63%	9 vs 9	23 vs 23

¹Arm excluded after protocol amendment for toxicity;

²Premature termination due to toxicity (inconclusive results). Treatments: CapeIRI (CAPIRI): 250 mg/m² Irinotecan (day 1) + 1000 mg/m² capecitabine (days 1-14), 3-wk regimen cycle; FOLFIRI: 180 mg/m² irinotecan + 400 mg/m² LV + 400 mg/m² 5-FU bolus + 2400 mg/m² 5-FU 46-h continuous infusion, 2-wk regimen cycle; mIFL: 125 mg/m² irinotecan + 20 mg/m² LV + 500 mg/m² 5-FU bolus (days 1 and 8), 3-wk regimen cycle; FOLFIRI-2: 180 mg/m² irinotecan (days 1, 15, 22) + 200 mg/m² LV (days 1, 2, 15, 16, 29, and 30)+ 400 mg/m² bolus 5-FU, 600 mg/m² 22-h continuous infusion 5-FU (1, 2, 15, 16, 29 and 30); XELIRI: 240 mg/m² irinotecan + 1000 mg/m² capecitabine (days 1-14), 3-wk treatment regimen; XELIRI-2: 200 mg/m² irinotecan + 1,000 mg/m² capecitabine (days 1-14), 3-wk treatment regimen. ORR: Overall response rate; PFS: Progression-free survival; OS: Overall survival; HR: Hazard ratio; Bev: Bevacizumab. (1) CapeIRI vs FOLFIRI (P = 0.015); (2) CapeIRI vs mIFL (P = 0.46); and (3) CapeIRI vs FOLFIRI (P = 0.27).