Table 3.
All adverse events (of toxicity grades 1–4) occurring in ≥10 % patients (ITT and crossover populations)
| Number of patients (%) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Lapatinib 1,250 mg QD plus vinorelbine 20 mg/m2 | Lapatinib 1,250 mg QD plus capecitabine 2,000 mg/m2 | |||||||||
| ITT population (N = 75) | ITT population (N = 37) | |||||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
| Palmar-plantar erythrodysesthesia syndrome | 3 (4) | 1 (1) | 2 (3) | 0 | 6 (8) | 10 (27) | 8 (22) | 6 (16) | 0 | 24 (65) |
| Diarrhea | 15 (20) | 15 (20) | 5 (7) | 0 | 35 (47) | 9 (24) | 8 (22) | 5 (14) | 0 | 22 (59) |
| Neutropenia | 2 (3) | 12 (16) | 14 (19) | 9 (12) | 37 (49) | 1 (3) | 1 (3) | 1 (3) | 0 | 3 (8) |
| Rash | 13 (17) | 5 (7) | 0 | 0 | 18 (24) | 6 (16) | 3 (8) | 0 | 0 | 9 (24) |
| Nausea | 10 (13) | 6 (8) | 2 (3) | 0 | 18 (24) | 2 (5) | 0 | 1 (3) | 0 | 3 (8) |
| Fatigue | 10 (13) | 5 (7) | 2 (3) | 0 | 17 (23) | 2 (5) | 1 (3) | 0 | 0 | 3 (8) |
| Anemia | 7 (9) | 6 (8) | 1 (1) | 0 | 14 (19) | 1 (3) | 1 (3) | 0 | 0 | 2 (5) |
| Vomiting | 4 (5) | 4 (5) | 5 (7) | 0 | 13 (17) | 2 (5) | 1 (3) | 1 (3) | 0 | 4 (11) |
| Hyperbilirubinemia | 0 | 1 (1) | 0 | 0 | 1 (1) | 0 | 5 (14) | 1 (3) | 0 | 6 (16) |
| Leukopenia | 5 (7) | 1 (1) | 5 (7) | 1 (1) | 12 (16) | 2 (5) | 0 | 0 | 0 | 2 (5) |
| Decreased appetite | 7 (9) | 4 (5) | 1 (1) | 0 | 12 (16) | 2 (5) | 0 | 0 | 0 | 2 (5) |
| Pyrexia | 9 (12) | 2 (3) | 0 | 0 | 11 (15) | 0 | 1 (3) | 0 | 0 | 1 (3) |
| Asthenia | 6 (8) | 3 (4) | 1 (1) | 0 | 10 (13) | 2 (5) | 1 (3) | 2 (5) | 0 | 5 (14) |
| Cough | 7 (9) | 3 (4) | 0 | 0 | 10 (13) | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Peripheral sensory neuropathy | 4 (5) | 4 (5) | 1 (1) | 0 | 9 (12) | 0 | 0 | 0 | 0 | 0 |
| Mucosal inflammation | 4 (5) | 3 (4) | 1 (1) | 1 (1) | 9 (12) | 0 | 0 | 0 | 0 | 0 |
| Headache | 3 (4) | 5 (7) | 0 | 0 | 8 (11) | 2 (5) | 0 | 0 | 0 | 2 (5) |
| Arthralgia | 6 (8) | 2 (3) | 0 | 0 | 8 (11) | 1 (3) | 2 (5) | 0 | 0 | 3 (8) |
| Aspartate aminotransferase increased | 5 (7) | 3 (4) | 0 | 0 | 8 (11) | 2 (5) | 1 (3) | 1 (3) | 0 | 4 (11) |
| Alanine aminotransferase increased | 4 (5) | 3 (4) | 1 (1) | 0 | 8 (11) | 0 | 2 (5) | 1 (3) | 0 | 3 (8) |
| Blood bilirubin increased | 0 | 0 | 0 | 0 | 0 | 0 | 3 (8) | 1 (3) | 0 | 4 (11) |
| Paronychia | 0 | 2 (3) | 0 | 0 | 2 (3) | 1 (3) | 2 (5) | 1 (3) | 0 | 4 (11) |
| Number of patients (%) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Lapatinib 1,250 mg QD plus vinorelbine 20 mg/m2 | Lapatinib 1,250 mg QD plus capecitabine 2,000 mg/m2 | |||||||||
| Crossover population (N = 13) | Crossover population (N = 29) | |||||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
| Neutropenia | 1 (8) | 2 (15) | 1 (8) | 1 (8) | 5 (38) | 0 | 0 | 0 | 0 | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 0 | 0 | 0 | 0 | 0 | 4 (14) | 1 (3) | 2 (7) | 0 | 7 (24) |
| Diarrhea | 1 (8) | 0 | 1 (8) | 0 | 2 (15) | 1 (3) | 2 (7) | 2 (7) | 0 | 5 (17) |
| Fatigue | 1 (8) | 1 (8) | 0 | 0 | 2 (15) | 1 (3) | 0 | 0 | 0 | 1 (3) |
| Febrile neutropenia | 0 | 0 | 0 | 2 (15) | 2 (15) | 0 | 0 | 0 | 0 | 0 |
| Pyrexia | 2 (15) | 0 | 0 | 0 | 2 (15) | 1 (3) | 1 (3) | 0 | 0 | 2 (7) |
| Alanine aminotransferase increased | 0 | 0 | 1 (8) | 0 | 1 (8) | 0 | 3 (10) | 0 | 0 | 3 (10) |
| Aspartate aminotransferase increased | 0 | 0 | 1 (8) | 0 | 1 (8) | 1 (3) | 2 (7) | 0 | 0 | 3 (10) |
ITT intent-to-treat; QD once daily