Table 3.
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.
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