Table 2.
Treatment–Related Adverse Events in More Than 15% of Patients Receiving Crizotinib and Erlotinib during Combination Treatment
| n (%) | ||
|---|---|---|
| Adverse Eventa | Any Grade | Grade 3b |
| Dose level 1 (n = 7) | ||
| Diarrhea | 5 (71) | 0 |
| Dry skin | 5 (71) | 0 |
| Fatigue | 3 (43) | 0 |
| Rash | 3 (43) | 1 (14) |
| Vomiting | 3 (43) | 0 |
| Decreased appetite | 2 (29) | 0 |
| Hypokalemia | 2 (29) | 1 (14) |
| Muscle spasm | 2 (29) | 0 |
| Nausea | 2 (29) | 0 |
| Pustular rash | 2 (29) | 0 |
| Dose level −1 (n = 19) | ||
| Diarrhea | 14 (74) | 4 (21) |
| Rash | 13 (68) | 0 |
| Decreased appetite | 10 (53) | 0 |
| Fatigue | 9 (47) | 1 (5) |
| Nausea | 9 (47) | 0 |
| Vomiting | 6 (32) | 1 (5) |
| Dehydration | 4 (21) | 1 (5) |
| Anemia | 3 (16) | 0 |
| Dry skin | 3 (16) | 0 |
| Dyspepsia | 3 (16) | 0 |
| Hypoalbuminemia | 3 (16) | 0 |
| Upper abdominal pain | 3 (16) | 0 |
| Visual impairment | 3 (16) | 0 |
| Weight decreased | 3 (16) | 0 |
Note: Dose level of 1: crizotinib 150 mg twice daily, plus erlotinib, 100 mg once daily. Dose level of 1: crizotinib, 200 mg twice daily, plus erlotinib, 100 mg once daily.
a
Dose-limiting toxicities comprised grade 3 esophagitis (n = 1); dry eye (n = 1); and grade 2 esophagitis, dysphagia. and dyspepsia (n = 1).
b
There were no treatment-related grade 4 or 5 adverse events.