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Table 4 Most common grade 3–4 non-haematological toxicity possibly or probably related to irinotecan combined with 5-FU/FA Mayo Clinic schedule according to dose levels (worst grade by patient)

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

Dose level Phase I Phase II
  I II Overall  
Irinotecan (mg/m2) 250 300 250/300 250
5-FU (mg/m2) 425 425 425 425
FA (mg/m2) 20 20 20 20
Number of patients 6 8 14 49
Delayed diarrhoea 4 4 8 (57%) 16 (33%)
Fatigue 2 3 5 (36%) 11 (22%)
Pain 3 1 4 (29%) 9 (18%)
Stomatitis 4 1 5 (36%) 13 (26%)
Alopecia 1 0 1 (7%) 2 (4%)
Nausea 2 0 2 (14%) 8 (16%)
Anorexia 1 1 2 (14%) 0
Vomiting 1 0 1 (7%) 7 (14%)
Fever 0 1 1 (7%) 0
Infection 0 0 0 8 (16%)