A prospective randomised phase-II trial with XXXX versus @entity136 plus @entity2240 in advanced pancreatic cancer: A study of the CESAR Central European Society for Anticancer Drug Research-EWIV.

@entity1 @entity137 @entity1124 @entity2240 @entity5 @entity1054 @entity1442 @entity1398 @entity136
BACKGROUND: @entity1124 ( @entity1124 ) is one of the most common @entity5 and is still associated with a poor prognosis in @entity1442 . To improve the standard therapy with @entity136 , we initiated a prospective randomised phase-II trial with @entity136 (GEM) versus @entity136 plus @entity2240 (SUNGEM) based on data of in vitro trials and phase-I data for the combination treatment. The rational of adding @entity2240 was its putative antiangiogenic mechanism of action. METHODS: A total of 106 eligible @entity1 with locally advanced, unresectable or metastatic @entity1124 without previous system therapy were randomised to receive GEM at a dosage of 1.000mg/m(2) d1, 8, 15 q28 versus a combination of SUNGEM at a dosage of GEM 1.000mg/m(2) d1+8 and @entity2240 50mg p.o. d1-14, q21d. The primary end-point was progression free survival (PFS), secondary end-points were overall survival (OS), @entity137 and overall response rate (ORR). RESULTS: The confirmatory analysis of PFS was based on the intend-to-treat (ITT) population (N=106). The median PFS was 13.3weeks (95% confidence interval (95%-CI): 10.4-18.1weeks) for GEM and 11.6weeks for SUNGEM (95%-CI: 7.0-18.0weeks; p=0.78 one-sided log-rank). The ORR was 6.1% (95%-CI: 0.7-20.2%) for GEM and for 7.1% (95%-CI: 0.9-23.5%) for SUNGEM (p=0.87). The median @entity1054 ( @entity1054 ) was 14.0weeks (95%-CI: 12.4-22.3weeks) for GEM and 18.0weeks (95%-CI: 11.3-19.3weeks) for SUNGEM (p=0.60; two-sided log-rank). The median OS was 36.7weeks (95%-CI: 20.6-49.0weeks) for the GEM arm and 30.4weeks (95%-CI: 18.1-37.6weeks) for the SUNGEM (p=0.78, one-sided log-rank). In regard to @entity137 , suspected SAEs were reported in 53.7% in the GEM arm and 71.2% in the SUNGEM arm. Grade 3 and 4 @entity1398 was statistically significantly higher in the SUNGEM arm with 48.1% versus 27.8% in the GEM arm (p=0.045, two sided log-rank). CONCLUSIONS: The combination SUNGEM was not sufficient superior in locally advanced or metastatic @entity1124 compared to GEM alone in regard to efficacy but was associated with more @entity137 .
