Table 2. Dose-limiting toxicity (CTCAE, v3.0) according to dose level.
| Dose level | LPT (mg per day) | VNR (mg m−2) i.v. on day 1 and day 8 | N (%) | Dose-limiting toxicity |
|---|---|---|---|---|
| 1 | 750 | 20 | 3 (9.1) | |
| 2 | 1000 | 20 | 5a (15.2) | |
| 3 | 1000 | 22.5 | 11 (33.3) | |
| 4 | 1000 | 25 | 3 (9.1) | 1 febrile neutropenia 1 grade 4 neutropenia >7 days |
| 3′ | 1250 | 22.5 | 11b (33.3) | 1 grade 4 neutropenia >7 days 1 grade 4 neutropenia and diarrhoea with confusion, multivisceral failure and pancreatitis |
Abbreviations: i.v.=intravenous; LPT=lapatinib; NCI CTCAE, v3.0=National Cancer Institute Common Terminology Criteria for Adverse Events version 3; VNR=vinorelbine.
a
Two non-evaluable patients: brain metastasis requiring corticotherapy and gastric metastases interfering with treatment intake.
b
Two non-evaluable patients: concomitant prohibited medication and brain metastases.