Table 3 Treatment-related adverse events by afatinib starting dose and reported as NCI CTCAE grades (patients with at least 1 grade ≥3 adverse event; treated set)
Afatinib 50 mg + letrozole 2.5 mg, n = 7 | Afatinib 40 mg + letrozole 2.5 mg, n = 13 | Afatinib 30 mg + letrozole 2.5 mg, n = 8 | All afatinib doses + letrozole 2.5 mg, n = 28 | |||||
|---|---|---|---|---|---|---|---|---|
n (%) | n (%) | n (%) | n (%) | |||||
All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
Patients with any treatment-related adverse event | 7 (100.0) | 7 (100.0) | 13 (100.0) | 8 (61.5) | 8 (100.0) | 4 (50.0) | 28 (100.0) | 19 (68) |
Adverse event | ||||||||
Diarrhea | 7 (100.0) | 1 (14.3) | 12 (92.3) | 4 (30.8) | 7 (87.5) | 1 (12.5) | 26 (92.9) | 6 (21.5) |
Rash | 5 (71.4) | 5 (71.4) | 5 (38.5) | 0 | 6 (75.0) | 0 | 16 (57.1) | 5 (17.9) |
Asthenia | 4 (57.1) | 2 (28.6) | 7 (53.8) | 1 (7.7) | 5 (62.5) | 2 (25.0) | 16 (57.1) | 5 (17.9) |
Mucosal inflammation | 5 (71.4) | 2 (28.6) | 4 (30.8) | 2 (15.4) | 2 (25.0) | 0 | 11 (39.3) | 4 (14.3) |
Nausea | 3 (42.9) | 0 | 4 (30.8) | 0 | 3 (37.5) | 1 (12.5) | 10 (35.7) | 1 (3.6) |
Acne | 5 (71.4) | 3 (42.9) | 3 (23.1) | 1 (7.7) | 0 | 0 | 8 (28.6) | 4 (14.3) |
Dermatitis acneiform | 0 | 0 | 5 (38.5) | 1 (7.7) | 1 (12.5) | 0 | 6 (21.4) | 1 (3.6) |
Vomiting | 1 (14.3) | 0 | 3 (23.1) | 1 (7.7) | 1 (12.5) | 1 (12.5) | 5 (17.9) | 2 (7.1) |
Paronychia | 1 (14.3) | 0 | 1 (7.7) | 1 (7.7) | 2 (25.0) | 0 | 4 (14.3) | 1 (3.6) |
Dehydration | 0 | 0 | 1 (7.7) | 1 (7.7) | 1 (12.5) | 0 | 2 (7.1) | 1 (3.6) |
Cheilitis | 1 (14.3) | 0 | 1 (7.7) | 1 (7.7) | 0 | 0 | 2 (7.1) | 1 (3.6) |
Skin toxicity | 0 | 0 | 1 (7.7) | 1 (7.7) | 0 | 0 | 1 (3.6) | 1 (3.6) |
Arthritis bacterial | 0 | 0 | 1 (7.7) | 1 (7.7) | 0 | 0 | 1 (3.6) | 1 (3.6) |
Pneumococcal sepsis | 0 | 0 | 1 (7.7) | 1 (7.7) | 0 | 0 | 1 (3.6) | 1 (3.6) |
Renal failure acute | 0 | 0 | 1 (7.7) | 1 (7.7) | 0 | 0 | 1 (3.6) | 1 (3.6) |