Randomized multicenter Phase II trial of two different schedules of @entity2600 combined with @entity416 as first-line treatment in metastatic XXXX .

@entity1 @entity2600 @entity416 @entity294 @entity8566 @entity14 @entity490
BACKGROUND: The aim of the current randomized Phase II study was to investigate the efficacy and safety of @entity416 combined with @entity2600 as first-line treatment in metastatic @entity14 ( @entity14 ). METHODS: A total of 140 @entity1 received @entity416 at a dose of 1250 mg/m(2) twice daily on Days 2-15 and @entity2600 at a dose of either 300 mg/m(2) on Day 1 (Arm A) or 150 mg/m(2) on Days 1 and 8 (Arm B) every 3 weeks. During the course of the study, enrollment was continued using lower doses of @entity416 (1000 mg/m(2) twice daily) and @entity2600 (Arm A: 240 mg/m(2); Arm B: 120 mg/m(2)) to improve the safety profile of the combinations. RESULTS: Efficacy was evaluable in 134 @entity1 (68 in Arm A, 66 in Arm B). Objective responses were observed in 46% of the @entity1 (8% complete response [CR]), including 47% in Arm A (9% CR; 38% partial response [PR]) and 44% in Arm B (8% CR; 36% PR). The median progression-free survival was 8.3 months in Arm A and 7.6 months in Arm B. Among the first 52 @entity1 treated with the higher doses, the most frequent Grade 3-4 adverse event was @entity294 (27%). The lower doses adopted in the subsequent 88 @entity1 led to better @entity294 control, particularly in Arm A, and significant reductions in the incidence of all-grade @entity8566 and @entity490 . CONCLUSIONS: The @entity416 and @entity2600 combination was a highly active first-line therapy in metastatic @entity14 . An acceptable safety profile was observed after dose reduction, particularly when @entity2600 was administered on 1 day.
