A randomized phase III trial of adjuvant chemotherapy with @entity2600 , @entity4181 and XXXX versus @entity4181 and @entity1487 for @entity5 : a Hellenic Cooperative Oncology Group study.

@entity1 @entity4181 @entity1210 @entity137 @entity2600 @entity5 @entity294 @entity1398 @entity694 @entity1487 @entity34
BACKGROUND: @entity694 is a public health problem worldwide. Adjuvant chemotherapy after surgical resection for @entity5 has been shown to improve both progression-free and overall survival, and is currently recommended as standard therapy. However, its value for @entity1 with @entity34 remains controversial. When this study was designed @entity1487 (5FU) plus @entity4181 (LV) was standard adjuvant treatment for @entity694 . @entity2600 ( @entity2600 ) is a topoisomerase I inhibitor with activity in metastatic disease. In this multicenter adjuvant phase III trial, we evaluated the addition of @entity2600 to weekly 5FU plus LV in @entity1 with @entity5 . METHODS: The study included 873 eligible @entity1 . The treatment consisted of weekly administration of @entity2600 80 mg/m2 intravenously (i.v.), LV 200 mg/m2 and 5FU 450 mg/m2 bolus (Arm A) versus LV 200 mg/m2 and 5FU 500 mg/m2 i.v. bolus (Arm B). In Arm A, treatments were administered weekly for four consecutive weeks, followed by a two-week rest, for a total of six cycles, while in Arm B treatments were administered weekly for six consecutive weeks, followed by a two-week rest, for a total of four cycles. The primary end-point was disease-free survival (DFS) at three years. RESULTS: The probability of overall survival (OS) at three years was 0.88 for @entity1 in Arm A and 0.86 for those in Arm B, while the five-year OS probability was 0.78 and 0.76 for @entity1 in Arm A and Arm B, respectively (P = 0.436). Furthermore, the probability of DFS at three years was 0.78 and 0.76 for @entity1 in Arm A and Arm B, respectively (P = 0.334). With the exception of @entity1210 and @entity1398 , which were higher in @entity1 in Arm A, there were no significant differences in Grades 3 and 4 toxicities between the two regimens. The most frequently recorded Grade 3/4 @entity137 was @entity294 in both treatment arms. CONCLUSIONS: @entity2600 added to weekly bolus 5FU plus LV did not result in @entity5 , but did increase @entity137 . TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12610000148077.
