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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

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

  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)
  1. *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.