Lapatinib in HER2+ early breast cancer: Quality of life analysis.

604 Background: IXOshowed acceptable toxicities and promising efficacy in a phase I/II study as 1st-line therapy for aCRC patients (pts). Combination with A might enhance the efficacy of IXOtreatment. Methods: The objectives of the study were to evaluate the recommended dose (RD) of IXOregimen when used in combination with A ( IXO+A), and to document safety and efficacy of the combination. Starting dose was: I 160mg/m2 IV d1, X 950mg/m2 bid PO d2-15, O 100mg/m2 IV d1, A 7.5 mg/kg iv d1, q3w. IXOregimen dose adjustments were planned in case of therapy-attributed severe toxicities. Results: 23 pts enrolled and evaluable for toxicity, 16M/7F, median age 65 years (range 28-77), PS 0/1/2 in 7/16/0, sites of disease (colon 18/rectum 5) received 288 cycles, median 8 (range 1-40). Gr.4 neutropeniaand thromboembolic toxicity in the first 6 pts induced a 15% I and 20% X dose reduction, followed by another 10% I dose reduction in the following 6 pts due to diarrhea and febrile neutropenia. The adjusted regimen w...