7560 Background: We tested if V, a dual inhibitor of VEGFR and EGFR, could improve PFS in patients (PTS) with NSCLC when given as induction therapy (INRx) with D and C, followed by maintenance V or P. We report updated PFS, OS, and toxicity. Methods: PTS with advanced stage NSCLC were randomized to INRx D (75 mg/m2) + C (AUC 6) on day 1 of a 21-day cycle and daily V (100 mg/day po) for 4 cycles, followed by daily V (300 mg/day po) or P until progression. We designed the study to show an improvement in PFS with the addition of V maintenance to a median of 6.2 months (mos), compared to 4.5 mos for D+C alone. Eligible PTS had measurable disease, ECOG PS 0/1, no prior cytotoxic or targeted agents for advanced disease. PTS with uncontrolled hypertension or history of QT prolongation were ineligible. Results: 162 PTS were randomized from May 2008 to Nov. 2009; 158 began INRx. 91% had Stage IV/recurrent disease; 52% were male. Median age was 63 (36-82). 58 PTS began maintenance V/P (median 3.5 cycles). 4 PTS rem...
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