Phase I/II study of first-line irinotecan combined with 5-fluorouracil and folinic acid Mayo Clinic schedule in patients with advanced colorectal cancer

Table 5 Efficacy of irinotecan 250 mg/m² combined with 5-FU 425 mg/m² and FA 20 mg/m² Mayo Clinic schedule in patients in phase II study

	Evaluable population (n = 36)		ITT population (n = 49)
	No.	%	No.	%
Complete response	3	8	3	6
Partial response	10	28	11	22
Minor response	7	19	7	14
Stable disease	9	25	10	20
Progressive disease	7	19	8	16
Not evaluable*	-	-	10	20
Overall response rate (95% CI), %	36 (21–54)		29 (16–42)
Median duration of response (95% CI), months	10.4 (5.9–11.1)		10.4 (4.5–11.1)
Median duration of stabilisation (95% CI), months	5.8 (4.0–8.3)		6.4 (4.0–8.3)
Median time to progression (95% CI), months	7.0 (4.5–10.1)		5.9 (4.0–8.1)
Median time of survival (range), months	-		12.0 (8.0–15.2)

*Nine patients did not receive two full cycles and had method of measurement different from baseline and one patient had method of measurement different from baseline.