Table 3 Adverse events summary of TKIs
From: Neratinib for HER2-positive breast cancer with an overlooked option
Adverse events | All Grade | Grade 3/4 |
|---|---|---|
|  | Neratinib + capecitabine (NALA trial) N = 303, n (%) | |
Diarrhea | 252 (83.2) | 74 (24.4) |
Nausea | 161 (53.1) | 13 (4.3) |
PPE syndrome | 139 (45.9) | 29 (9.6) |
Vomiting | 138 (45.5) | 12 (4.0) |
Decreased appetite | 107 (35.3) | 8 (2.6) |
Fatigue | 104 (34.3) | 9 (3.0) |
Constipation | 94 (31.0) | 4 (1.3) |
Stomatitis | 62 (20.5) | 6 (2.0) |
Weight decreased | 60 (19.8) | 1 (0.3) |
Anemia | 45 (14.9) | 6 (2.0) |
Dizziness | 43 (14.2) | 1 (0.3) |
Cough | 37 (12.2) | 0 |
Abdominal pain | 36 (11.9) | 3 (1.0) |
Asthenia | 36 (11.9) | 8 (2.6) |
Hypokalemia | 35 (11.6) | 14 (4.6) |
Paronychia | 35 (11.6) | 2 (0.7) |
Pyrexia | 33 (10.9) | 0 |
Headache | 32 (10.6) | 1 (0.3) |
Rash | 30 (9.9) | 0 |
|  | Lapatinib + capecitabine (Geyer et al. 2006) N = 164, n (%) | |
Diarrhea | 98 (60) | 21 (13) |
Nausea | 72 (44) | 3 (2) |
Vomiting | 43 (26) | 3 (2) |
Stomatitis | 24 (15) | 0 |
Abdominal pain | 25 (15) | 2(1) |
Constipation | 16 (10) | 0 |
Dyspepsia | 18 (11) | 0 |
Hand–foot syndrome | 80 (49) | 12 (7) |
Rash | 45 (27) | 2 (1) |
Dry skin | 18 (11) | 0 |
Fatigue | 29 (18) | 3 (2) |
Mucosal inflammation | 18 (11) | 0 |
Asthenia | 10 (6) | 0 |
Headache | 15 (9) | 0 |
Pain in extremity | 21 (13) | 1 (< 1) |
Back pain | 17 (10) | 2 (1) |
Anorexia | 25 (15) | 1 (< 1) |
Dyspnea | 18 (11) | 5 (3) |
|  | Pyrotinib + capecitabine (PHENIX trial) N = 185, n (%) | |
Diarrhea | 182 (98.4) | 57 (30.8) |
Hand-foot syndrome | 110 (59.5) | 29 (15.7) |
Nausea | 90 (48.6) | 0 |
Vomiting | 90 (48.6) | 4 (2.2) |
White blood cell decreased | 84 (45.4) | 7 (3.8) |
Aspartate aminotransferase increased | 71 (38.4) | 2 (1.1) |
Neutrophil count decreased | 68 (36.8) | 7 (3.8) |
Alanine aminotransferase increased | 66 (35.7) | 5 (2.7) |
Oral mucositis | 56 (30.3) | 2 (1.1) |
Anemia | 56 (30.3) | 4 (2.2) |
Blood bilirubin increased | 53 (28.6) | 2 (1.1) |
Weight loss | 48 (25.9) | 1 (0.5) |
Appetite loss | 46 (24.9) | 1 (0.5) |
Hypokalemia | 43 (23.2) | 5 (2.7) |
Pigmentation disorder | 40 (21.6) | 0 |
Bilirubin conjugated increased | 35 (18.9) | 0 |
Asthenia | 34 (18.4) | 1 (0.5) |
Hypertriglyceridaemia | 27 (14.6) | 5 (2.7) |
Blood bilirubin unconjugated increased | 26 (14.1) | 1 (0.5) |
Blood creatinine increased | 23 (12.4) | 0 |
Platelet count decreased | 20 (10.8) | 1 (0.5) |
|  | Tucatinib combination (HER2CLIMB trial) N = 404, n (%) | |
Diarrhea | 331 (81.9) | 53 (13.1) |
Nausea | 243 (60.1) | 16 (4.0) |
PPE syndrome | 264 (65.3) | 57 (14.1) |
Vomiting | 152 (37.6) | 13 (3.2) |
Decreased appetite | 105 (26.0) | 3 (0.7) |
Fatigue | 193 (47.8) | 22 (5.4) |
Stomatitis | 105 (26.0) | 10 (2.5) |
Anemia | 88 (21.8) | 17 (4.2) |
Headache | 96 (23.8) | 3 (0.7) |
Aspartate aminotransferase increased | 89 (22.0) | 19 (4.7) |
Alanine aminotransferase increased | 85 (21.0) | 23 (5.7) |
Blood bilirubin increased | 81 (20.0) | 4 (1.0) |
|  | Poziotinib (NOV120101-203 trial) N = 106, n (%) | |
Diarrhea | 102 (96.2) | 15 (14.2) |
Stomatitis | 98 (92.5) | 13 (12.3) |
Pruritus | 67 (63.2) | 0 |
Rash | 67 (63.2) | 4 (3.8) |
Dry skin | 41 (38.7) | 0 |
Dermatitis acneiform | 34 (32.1) | 4 (3.8) |
Decreased appetite | 32 (30.2) | 0 |
Alopecia | 26 (24.5) | 0 |
Nausea | 22 (20.8) | 0 |
Mucosal inflammation | 21 (19.8) | 0 |
Dyspepsia | 16 (15.1) | 0 |
Cough | 16 (15.1) | 0 |
Dyspnea | 14 (13.2) | 2 (1.9) |
Vomiting | 14 (13.2) | 0 |
Constipation | 13 (12.3) | 0 |
Rhinorrhea | 13 (12.3) | 0 |
Myalgia | 13 (12.3) | 0 |
Fatigue | 12 (11.3) | 2 (1.9) |
Upper respiratory tract infection | 12 (11.3) | 0 |
PPE syndrome | 11 (10.4) | 0 |
Abdominal pain | 11 (10.4) | 0 |