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Table 2 Dose-limiting toxicities in part I, phase A (DLT population)

From: Cetuximab in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) in the initial treatment of metastatic colorectal cancer: a multicentre two-part phase I/II study

Events

No. of patients (%)

 

LD 5-FU (n = 7)

HD 5-FU (n = 16)

No. patients with any event

0 (0)

2 (13)

Leucopenia or neutropenia grade 4

0

1 (6)

Occurrence of any drug-related AE that required treatment interruption within the first six weeks

0

1 (6)*

  1. LD = low-dose; HD = high-dose; AE = adverse event. Seven patients were recruited in the low-dose 5-FU arm due to an overlap in the enrolment of two patients.*Anaphylactic reaction.