TABLE 4.
Treatment-related toxicity by step, arm, and irinotecan starting dose.
| Toxicity Type | No. by step, arm, dose, and toxicity grade
|
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1, Arm A*
|
Step 2
|
Arm B (n = 41) | |||||||||||||
| 125 mg/m2 (n = 13)
|
90 mg/m2 (n = 9)
|
125 mg/m2 (n = 3)
|
90 mg/m2 (n = 8)
|
||||||||||||
| 3 | 4 | 5 | 3 | 4 | 5 | 3 | 4 | 5 | 3 | 4 | 5 | 3 | 4 | 5 | |
| Hemoglobin | 1 | — | — | 3 | — | — | — | — | — | — | — | — | 2 | — | — |
| Leukocytes | 4 | 1 | — | — | — | — | — | — | — | 2 | — | — | 1 | — | — |
| Lymphopenia | 1 | — | — | — | — | — | — | — | — | — | 1 | — | 4 | — | — |
| Neutrophils | 3 | 1 | — | — | — | — | — | — | — | 1 | — | — | 1 | — | — |
| Platelets | 1 | — | — | 3 | — | — | — | — | — | 1 | — | — | — | 1 | — |
| Hypotension | 1 | 1 | — | — | — | — | — | — | — | — | — | — | 2 | — | — |
| Fatigue | — | — | — | — | — | — | 1 | — | — | — | — | — | 7 | — | — |
| Fever without neutropenia | 1 | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Insomnia | — | — | — | 1 | — | — | — | — | — | — | — | — | — | — | — |
| Constitutional, other | 1 | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Death NOS | — | — | 1 | — | — | — | — | — | — | — | — | — | — | — | — |
| Anorexia | 2 | — | — | 1 | — | — | — | — | — | 2 | — | — | — | — | — |
| Constipation | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | — |
| Dehydration | 2 | 1 | — | 1 | — | — | 1 | — | — | 2 | — | — | — | — | — |
| Diarrhea without prior colostomy | 2 | — | — | 3 | — | — | — | — | — | 1 | — | — | 1 | — | — |
| Nausea | 1 | — | — | 2 | — | — | — | — | — | — | — | — | — | — | — |
| Vomiting | 2 | — | — | 1 | — | — | — | — | — | — | — | — | — | — | — |
| Obstruction, small bowel NOS | — | — | — | — | — | — | — | — | — | 1 | — | — | — | — | — |
| Stomach, hemorrhage | 1 | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Infection w/gr3-4 neut, lung | — | 1 | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Infection Gr0-2 neut, lung | — | — | — | 1 | — | — | — | — | — | — | — | — | — | — | — |
| Infection Gr0-2 neut, trachea | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | — |
| Infection Gr0-2 neut, blood | 1 | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Infection w/unk ANC foreign body | — | — | — | 1 | — | — | — | — | — | — | — | — | — | — | — |
| Hypoalbuminemia | 1 | — | — | — | — | — | — | — | — | 1 | — | — | — | — | — |
| Glomerular filtration rate | 1 | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Hypophosphatemia | — | — | — | — | — | — | 1 | — | — | — | — | — | — | — | — |
| Hyperkalemia | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | — |
| Hypokalemia | 1 | — | — | 2 | — | — | — | — | — | 1 | — | — | 2 | — | — |
| Hyponatremia | 3 | — | — | 1 | — | — | — | — | — | — | — | — | 1 | — | — |
| Nonneuropathic generalized weakness | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | — |
| Dizziness | — | — | — | — | — | — | — | — | — | — | — | — | 3 | 1 | — |
| Neuropathy-sensory | — | — | — | — | — | — | — | — | — | — | — | — | 2 | 1 | — |
| Syncope | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | — |
| Abdomen, pain | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | — |
| Aspiration | — | — | 1 | — | — | — | — | — | — | — | — | — | — | — | — |
| Dyspnea | — | 1 | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Hypoxia | — | — | 1 | — | — | — | — | — | — | 1 | — | — | — | — | — |
| Pneumonitis/pulmonary infiltrates | — | — | — | 1 | — | — | — | — | — | — | — | — | — | — | — |
| Vessel injury–carotid | — | — | — | — | 1 | — | — | — | — | — | — | — | — | — | — |
*
One patient started irinotecan at dose 76 mg/m2 and was reported with grade 3 vomiting.