Table A1.
Safety Profile of the Cetuximab/Irinotecan Combination by Dose Cohort
| Adverse Event | 75 mg/m2 C, 20 mg/m2 I (n = 14) |
150 mg/m2 C, 20 mg/m2 I (n = 10) |
150 mg/m2 C, 16 mg/m2 I (age 1-12 years only, n = 3) |
250 mg/m2 C, 16 mg/m2 I (ages 1-12 years only, n = 12) |
250 mg/m2 C, 20 mg/m2 I (ages 13-18 years only, n = 7) |
|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any |
Grade 3/4 |
Any |
Grade 3/4 |
Any |
Grade 3/4 |
Any |
Grade 3/4 |
Any |
Grade 3/4 |
|||||||||||
| No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | |
| Hematologic* | ||||||||||||||||||||
| Neutropenia | 9 | 12 | 6 | 12 | 5 | 7 | 4 | 7 | 3 | 3 | 0 | 3 | 8 | 10 | 3 | 10 | 5 | 6 | 4 | 6 |
| Leukopenia | 10 | 13 | 5 | 13 | 7 | 10 | 5 | 10 | 2 | 3 | 0 | 3 | 12 | 12 | 4 | 12 | 6 | 7 | 4 | 7 |
| Thrombocytopenia | 6 | 13 | 1 | 13 | 4 | 10 | 3 | 10 | 2 | 3 | 0 | 3 | 6 | 12 | 2 | 12 | 5 | 7 | 4 | 7 |
| Anemia | 10 | 13 | 4 | 13 | 7 | 10 | 1 | 10 | 3 | 3 | 2 | 3 | 11 | 12 | 2 | 12 | 5 | 7 | 0 | 7 |
| Nonhematologic | ||||||||||||||||||||
| Diarrhea | 12 | 14 | 4 | 14 | 8 | 10 | 4 | 10 | 2 | 3 | 0 | 3 | 11 | 12 | 3 | 12 | 6 | 7 | 0 | 7 |
| Nausea | 11 | 14 | 2 | 14 | 5 | 10 | 3 | 10 | — | — | 7 | 12 | 1 | 12 | 6 | 7 | 1 | 7 | ||
| Vomiting | 11 | 14 | 3 | 14 | 5 | 10 | 1 | 10 | 1 | 3 | 0 | 3 | 10 | 12 | 3 | 12 | 6 | 7 | 0 | 7 |
| Abdominal pain | 7 | 14 | 0 | 14 | 6 | 10 | 2 | 10 | 1 | 3 | 0 | 3 | 9 | 12 | 2 | 12 | 2 | 7 | 0 | 7 |
| Headache | 9 | 14 | 1 | 14 | 4 | 10 | 0 | 10 | 2 | 3 | 0 | 3 | 7 | 12 | 0 | 12 | 4 | 7 | 0 | 7 |
| Fatigue | 5 | 14 | 1 | 14 | 4 | 10 | 0 | 10 | 1 | 3 | 0 | 3 | 4 | 12 | 0 | 12 | 1 | 7 | 1 | 7 |
| Anorexia | 6 | 14 | 3 | 14 | 3 | 10 | 2 | 10 | — | — | 6 | 12 | 1 | 12 | 2 | 7 | 1 | 7 | ||
| Dehydration | 3 | 14 | 2 | 14 | 3 | 10 | 1 | 10 | — | — | 3 | 12 | 3 | 12 | 2 | 7 | 0 | 7 | ||
| Special Interest | ||||||||||||||||||||
| Acneform rash | 8 | 14 | 0 | 14 | 4 | 10 | 0 | 10 | 3 | 3 | 0 | 3 | 8 | 12 | 0 | 12 | 7 | 7 | 0 | 7 |
| Infusion reaction | 3 | 14 | 2 | 14 | 1 | 10 | 1 | 10 | 2 | 3 | 0 | 3 | 2 | 12 | 0 | 12 | 2 | 7 | 0 | 7 |
| Hypomagnesemia* | 4 | 12 | 0 | 12 | 3 | 9 | 0 | 9 | 0 | 3 | 0 | 3 | 4 | 12 | 1 | 12 | 2/6 | 0/6 | ||
Abbreviations: C, cetuximab; I, irinotecan.
*
Indicated relative to the number of patients who underwent the laboratory tests.