A multicenter phase II study of XXXX and @entity3003 combination as front-line treatment in advanced @entity1149 .

@entity1 @entity137 @entity5 @entity3003 @entity1149 @entity1398 @entity1205
BACKGROUND: To evaluate the efficacy and safety of @entity1205 in combination with @entity3003 as first-line treatment of @entity1 with inoperable, locally advanced or metastatic @entity1149 ( @entity1149 ). @entity1 AND METHODS: Chemotherapy-naive @entity1 with stage IIIB and IV @entity1149 , age < 75 years, performance status (WHO) 0-2, were enrolled onto the study. @entity1205 was given at a dose of 100 mg/m2 over an 1-hour i.v. infusion. @entity3003 dosed to an area under the time-concentration curve (AUC) of 6 mg/ml.minute, using the Calvert's formula, was administered over a 30-minute i.v. infusion. The regimen was repeated every 3 weeks. RESULTS: Thirty-eight @entity1 received a total of 155 chemotherapy cycles (median 4 cycles/ @entity1 ). All @entity1 were assessable for @entity137 and 34 for response. There was one (2.6%) complete and nine (23.7%) partial responses; in an intention-to-treat analysis the overall response rate was 26.6% (95% CI: 12.3%-40.3%). The median duration of response was 7 months (range: 3-29), the median time to @entity5 progression 7 months (range: 3.5-31), and the median overall survival 9 months (range: 0.5-31.5). The probability for 1-year survival was 44%. Grade 3-4 @entity1398 was the main hematological @entity137 of the regimen occurring in 19 (50%) @entity1 . Four (10.5%) @entity1398 episodes were complicated with fever but there was no septic death. Non-hematological @entity137 was generally mild. CONCLUSION: These results indicate that the @entity1205 - @entity3003 combination is a relatively active and well-tolerated front-line regimen for the treatment of @entity1 with advanced or metastatic @entity1149 .
