Randomized Multicenter Phase II Study of Modified @entity1205 , XXXX , and @entity1487 (DCF) Versus DCF Plus Growth Factor Support in @entity1 With Metastatic Gastric Adenocarcinoma: A Study of the US Gastric Cancer Consortium.

@entity1 @entity137 @entity900 @entity420 @entity1205 @entity1487
PURPOSE: @entity1205 , @entity900 , and @entity1487 (DCF) is a standard first-line three-drug chemotherapy regimen for advanced gastric or gastroesophageal junction (GEJ) @entity420 and is associated with significant @entity137 . We examined the safety and efficacy of a modified DCF (mDCF) regimen in a randomized multicenter phase II study. @entity1 AND METHODS: Previously untreated @entity1 with metastatic gastric or GEJ @entity420 were randomly assigned to receive either mDCF ( @entity1487 2,000 mg/m(2) intravenously [IV] every 48 hours, @entity1205 40 mg/m(2) IV on day 1, @entity900 40 mg/m(2) IV on day 3, every 2 weeks) or parent DCF ( @entity1205 75 mg/m(2), @entity900 75 mg/m(2), and @entity1487 750 mg/m(2) IV over 5 days with granulocyte colony-stimulating factor, every 3 weeks). The study had 90% power to differentiate between 6-month progression-free survival of 26% and 43%, with type I and II error rates of 10% each. An early stopping rule for @entity137 was included, defined as grade 3 to 4 adverse event rate > 70% in the first 3 months. RESULTS: From November 2006 to June 2010, 85 evaluable @entity1 were enrolled (male, n = 61; female, n = 24; median age, 58 years; Karnofsky performance status, 90%; GEJ, n = 28; gastric, 57). mDCF (n = 54) @entity137 rates included 54% grade 3 to 4 @entity137 (22% hospitalized) within the first 3 months and 76% grade 3 to 4 @entity137 over the course of treatment. The DCF arm (n = 31) closed early because of @entity137 , with rates of 71% grade 3 to 4 @entity137 (52% hospitalized) within 3 months and 90% grade 3 to 4 @entity137 over the course of treatment. Six-month PFS was 63% (95% CI, 48% to 75%) for mDCF and 53% (95% CI, 34% to 69%) for DCF. Median overall survival was improved for mDCF (18.8 v 12.6 months; P = .007). CONCLUSION: mDCF is less toxic than parent DCF, even when supported with growth factors, and is associated with improved efficacy. mDCF should be considered a standard first-line option for @entity1 with metastatic gastric or GEJ @entity420 .
