Feasibility Assessment of Modified FOLFOX-6 as adjuvant treatment after resection of liver metastases from XXXX : analyses of a multicenter phase II clinical trial (Miyagi-HBPCOG Trial-001).

@entity1 @entity901 @entity3329 @entity882 @entity5 @entity566 @entity16 @entity1398 @entity14 @entity694 @entity1487
BACKGROUND/AIMS: This multicenter and single arm phase II clinical trial was performed to examine the safety and efficacy of modified FOLFOX6 (mFOLFOX6) as adjuvant treatment after resection of liver metastases from @entity14 . METHODOLOGY: @entity1 who had undergone R0-1 resection of liver metastases were assigned to 12 cycles of mFOLFOX6. The primary end point was disease-free survival (DFS). RESULTS: We enrolled 49 cases and analyzed adverse events in 48 cases, since in one @entity1 @entity5 recurred before starting treatment. As to the relative dose intensity, @entity1487 was 78.8%, and @entity901 was 75.9%. Adverse events of Grade 3 and above includ- ed 18 cases of @entity1398 (37.5%), 4 cases of @entity16 (8.3%), 4 cases of @entity882 (8.3%) and 4 cases of @entity566 (8.3%), and there were no cases of @entity3329 caused by adverse events. The most difference of adverse event compared with MOSAIC trial (Multicenter International Study of @entity901 / @entity1487 -LV in the Adjuvant Treatment of @entity694 ) was @entity882 . The 2-year DFS was 59.2% (95% CI: 36.7-78.4) in the 49 enrolled cases. CONCLUSION: mFOLFOX6 after hepatectomy was tolerable. And mFOLFOX6 also seemed to improve DFS. mFOLFOX is one of the options for such @entity1 and appears promising as an adjuvant treatment.
