Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III XXXX .

@entity1 @entity137 @entity5 @entity1398 @entity3 @entity694
OBJECTIVES: The optimal time to initiate adjuvant chemotherapy after surgery in @entity1 with @entity694 is not clear. We investigated the benefit of combined intraportal chemotherapy administered during radical surgery with adjuvant chemotherapy for treating @entity5 . METHODS: @entity1 were randomly assigned to OCTREE arm (intraportal chemotherapy plus mFOLFOX6) or a standard adjuvant chemotherapy arm (mFOLFOX6). The primary study endpoint was disease-free survival. The secondary endpoints included @entity3 -free survival, overall survival, and safety. RESULTS: The intent-to-treat population comprised 237 @entity1 . With a median follow-up of 44 months, the hazard ratio (OCTREE vs mFOLFOX6) was 0.66 (95% confidence interval, 0.43-0.90), a 34% risk reduction in favor of OCTREE (P=0.016). The 3-year disease-free survival rate was 85.2% for OCTREE and 75.6% for mFOLFOX6 alone (P=0.030). The 3-year @entity3 -free survival rates were 87.6% for OCTREE and 78.0% for mFOLFOX6 (P=0.035). @entity1 had lower distant metastatic rate in the OCTREE arm (12.7% vs 22.7%; P=0.044), when compared with the mFOLFOX6 arm. The 3-year overall survival was no significant difference between 2 arms (P=0.178). @entity1398 occurred in 12.7% of the @entity1 receiving OCTREE and in 2.5% of the @entity1 receiving mFOLFOX6 (P=0.003) within 2 weeks of surgery, and grade 3 or 4 @entity137 event was no difference between 2 regimens. CONCLUSIONS: Combination of intraoperative intraportal chemotherapy with mFOLFOX6 reduced the occurrence of distant metastases and improved disease-free survival in @entity1 with @entity5 .
