Bevacizumab plus XXXX and @entity901 as first-line therapy for metastatic or locally @entity788 : a phase II trial.

@entity901 @entity1 @entity788 @entity137 @entity390 @entity64 @entity101 @entity5 @entity136
PURPOSE: The @entity136 and @entity901 (GEMOX) has yielded among the longest progression-free survival durations in @entity1 with @entity788 ( @entity788 ). We postulated that adding bevacizumab would increase the effectiveness of GEMOX. METHODS: Eligible @entity1 had stage III or IV @entity788 , ECOG PS 0-2, and no prior @entity136 . Treatment included 1,000 mg/m(2) intravenous @entity136 over 100 min on day 1, 10 mg/kg intravenous bevacizumab on day 1, and 100 mg/m(2) @entity901 given on day 2. Cycles were repeated every 2 weeks. CT imaging was performed every 6 weeks. RESULTS: Fifty @entity1 were enrolled: 14 had @entity5 , the remainder stage IV. Median age was 59 years. Fourty-five @entity1 were ECOG 0-1. The grade 3-4 @entity137 rate was 94%; fatigue (47%) and @entity390 (40%) were frequent. One @entity1 died after a bowel perforation; a second died of a @entity64 . The median PFS was 4.9 months; median survival was 11.9 months; 1 year survival was 42%. Locally advanced @entity1 lived 12.8 months; metastatic @entity1 lived 10.2 months. @entity1 developing grade 3 @entity101 were more likely to have a radiologic response (P = .012); survival among the top and bottom quintiles of @entity101 was 14.7 and 6.2 months, respectively. Survival correlated with baseline CA 19-9 (P = .004) and radiologic response. The overall response rate was 36%; 34% demonstrated stable disease. CONCLUSIONS: The GEMOX/bevacizumab regimen demonstrated an excellent median overall survival but did not meet our objective of a 14 month median survival. @entity137 was significant. We do not recommend further evaluation of this regimen.
