Table 3.
Summary of toxicities associated with gefitinib therapy
| Induction | Induction with dose escalation | Radiation with gefitinib | Maintenance | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade | Grade | Grade | Grade | |||||||||
| Expected Toxicities | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
| Fatigue | 7 | 4 | 3 | 2 | 1 | 1 | 1 | 2 | ||||
| Dry skin | 2 | 2 | 1 | 3 | ||||||||
| Pruritis | 3 | 1 | 1 | 1 | 1 | |||||||
| Rash/desquamation | 3 | 1 | 2 | 1 | 1 | |||||||
| Rash/acneiform | 6 | 1 | 2 | 2 | 1 | 1 | 1 | 3 | ||||
| Anorexia | 1 | 1 | 1 | 1 | 2 | 2 | 1 | |||||
| Diarrhea | 8 | 2 | 3 | 3 | 2 | 1 | ||||||
| Nausea | 6 | 1 | 2 | 1 | ||||||||
| Vomiting | 2 | 1 | 1 | |||||||||
| Elevation of ALT | 1 | 2 | 2 | |||||||||
| Elevation of AST | 2 | 2 | 1 | 1 | 1 | 1 | ||||||
| Elevation of creatinine | 1 | 1 | ||||||||||
| Abdominal pain | 2 | 1 | ||||||||||
| Dry eyes | 1 | 1 | ||||||||||
| Ocular/visual, other | 1 | |||||||||||
| Unexpected Toxicities | ||||||||||||
| Allergic reactiona | 1 | 1 | ||||||||||
| Anemiaa | 3 | 1 | 2 | 2 | 1 | |||||||
| Weight lossa | 1 | 1 | 1 | |||||||||
| Alopeciaa | 1 | 1 | ||||||||||
| Taste alterationa | 1 | |||||||||||
| Epistaxisa | 1 | |||||||||||
| Infection | 1 | |||||||||||
| Elevated BUN | 1 | 1 | ||||||||||
| Elevated WBC | 1 | |||||||||||
| Blurred vision | 1 | 1 | 1 | |||||||||
| Insomnia | 1 | |||||||||||
| Depressiona | 1 | |||||||||||
| Tooth pain | 1 | |||||||||||
NOTE. Each entry represents the number of patients affected. Each adverse event has been considered by investigators to be related to gefitinib treatment. Of the 22 patients receiving induction gefitinib, 6 received dose escalations.
a
These toxicities have been reported in other gefitinib trials, with the relationship to gefitinib still undetermined.
ALT: Alanine transferase; AST: Asparagine transferase; BUN: Blood urea nitrogen; WBC: White blood cell count