Final results of a phase III clinical trial of adjuvant chemotherapy with the modified @entity1487 , @entity632 , and XXXX regimen in resectable @entity356 .

@entity632 @entity1 @entity137 @entity1138 @entity1503 @entity356 @entity1487
PURPOSE: In a randomized clinical trial (European Organization for the Research and Treatment of Cancer [EORTC] no. 40813) on adjuvant chemotherapy in @entity356 , results obtained after administration of the FAM2 regimen ( @entity1487 [ @entity1487 ], @entity632 , and @entity1138 ) were compared with results obtained after surgery alone to assess the effect of this regimen on overall survival, time to progression, and disease-free interval. @entity1 AND METHODS: Three hundred fourteen @entity1 who had undergone curative resection for stage II or stage III (International Union Against Cancer [UICC] 1978) @entity356 were randomized to receive chemotherapy (treatment arm) or no further treatment (control arm). The chemotherapy schedule was repeated every 43 days for seven cycles. The log-rank test and the Cox model were used for statistical analysis. RESULTS: Of 314 @entity1 , 159 comprised the control group and 155 the FAM2 group. Nineteen FAM2 @entity1 never received chemotherapy. The median number of cycles was five. Of the @entity1 started on adjuvant treatment, severe @entity1503 (grades 3 or 4, World Health Organization [WHO] scale) occurred, respectively, in 6% to 9% and in 1% to 29% of cases. The overall 5-year survival rate was 70% for stage II and 32% for stage III @entity1 . No statistically significant difference was found between overall survival of the two treatment arms (P = .295). However, time to progression was significantly delayed in the FAM2 arm (P = .020) and disease-free survival showed borderline significance (P = .068). CONCLUSION: FAM2, in view of its high @entity137 , cannot be advocated as standard adjuvant treatment for @entity356 . Large-scale clinical trials using more active, less toxic regimens are required to demonstrate whether adjuvant chemotherapy provides any real benefit.
