Table 2.
Treatment-related AEs observed in ≥10% of patients on study
| AEs | Cohort 1 Afatinib 40 mg + paclitaxel 80 mg/m2 + bevacizumab 5 mg/kg | Cohort 2 Afatinib 30 mg + paclitaxel 80 mg/m2 + bevacizumab 5 mg/kg | Cohort 3 Afatinib 20 mg + paclitaxel 80 mg/m2 + bevacizumab 5 mg/kg | Cohort 4 Afatinib 20 mg + paclitaxel 80 mg/m2 + bevacizumab 7.5 mg/kg | Cohort 5 Afatinib 20 mg + paclitaxel 80 mg/m2 + bevacizumab 10 mg/kg | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N = 7 | N = 5 | N = 3 | N = 6 | N = 8 | N = 29 (100%) | |||||||
| All | Grade 3 | All | Grade 3 | All | Grade 3 | All | Grade 3 | All | Grade 3 | All | Grade 3 | |
| Any | 6 | 2 | 5 | 3 | 3 | 0 | 6 | 3 | 8 | 2 | 28 (97) | 10 (34) |
| Diarrhea | 6 | 1 | 4 | 1 | 2 | 0 | 5 | 2 | 7 | 0 | 24 (83) | 4 (14) |
| Rash/acne+ | 6 | 0 | 4 | 0 | 3 | 0 | 4 | 0 | 7 | 0 | 24 (83) | 0 |
| Fatigue | 5 | 2 | 5 | 1 | 3 | 0 | 4 | 0 | 6 | 0 | 23 (79) | 3 (10) |
| Mucosal inflammation | 5 | 0 | 2 | 0 | 2 | 0 | 3 | 1 | 5 | 0 | 17 (59) | 1 (3) |
| Nausea | 2 | 0 | 5 | 0 | 1 | 0 | 4 | 0 | 5 | 0 | 17 (59) | 0 |
| Alopecia | 1 | 0 | 3 | 0 | 1 | 0 | 4 | 0 | 4 | 0 | 13 (45) | 0 |
| Epistaxis | 1 | 0 | 3 | 0 | 2 | 0 | 4 | 0 | 3 | 0 | 13 (45) | 0 |
| Decreased appetite | 3 | 0 | 3 | 0 | 0 | 0 | 3 | 0 | 2 | 0 | 11 (38) | 0 |
| Dry skin | 3 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 8 (28) | 0 |
| Dysphonia | 0 | 0 | 3 | 0 | 2 | 0 | 0 | 0 | 3 | 1 | 8 (28) | 1 (3) |
| Constipation | 0 | 0 | 0 | 0 | 2 | 0 | 3 | 0 | 2 | 0 | 7 (24) | 0 |
| Dyspepsia | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 6 (21) | 0 |
| Vomiting | 1 | 0 | 2 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 6 (21) | 1 (3) |
| Anemia | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 2 | 0 | 4 (14) | 1 (3) |
| Nasal congestion | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 4 (14) | 0 |
| Rhinitis | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 3 (10) | 0 |
| Dehydration | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 3 (10) | 2 (7) |
| Headache | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 3 (10) | 0 |
| Cough | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 3 (10) | 0 |
| Dyspnea | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 3 (10) | 0 |
| Oropharyngeal pain | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 3 (10) | 0 |
| Dry mouth | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 (10) | 0 |
| Hyperhidrosis | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 3 (10) | 0 |
| Palmar-plantar erythrodysaesthesia syndrome | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (10) | 0 |
| Myalgia | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 (10) | 0 |
| Pyrexia | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 (10) | 0 |
| ALT increased | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 3 (10) | 0 |
+, grouped term
ALT alanine aminotransferase