Abstract
3086 Background: Lapatinib is an orally active reversible inhibitor of ErbB1/ErbB2 tyrosine kinases. This study evaluated the safety, tolerability and pharmacokinetics (PK) of daily lapatinib in combination with IR/FU/LV (FOLFIRI) q14d. Methods: Cohorts of 3 patients (pts) each (25 total) with solid tumours received lapatinib (1000 or 1250mg daily) and FOLFIRI (80% or 60% of the standard doses) to determine the optimally tolerated regimen (OTR). Additional pts were enrolled at the OTR to evaluate the PK of lapatinib and FOLFIRI alone and in combination. Results: The standard FOLFIRI doses were reduced to 80% and 60% due to DLTs of diarrhea and/or myelosuppression at the starting doses. Toxicity required the lapatinib dose to be interrupted or reduced at these doses. The OTR was defined as lapatinib 1250mg with IR 120mg/m2, FU 240mg/m2 bolus and 360mg/m2 infusion, plus LV 200mg/m2on days 1 and 2, every 14 days. At the OTR, common non-hematological adverse events were grade 1 or 2 diarrhea, nausea/vomiting,...
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