title: Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer.
abstract: OBJECTIVE
  The optimal time to initiate adjuvant chemotherapy after surgery in patients with colon cancer is not clear. We investigated the benefit of combined intraportal chemotherapy administered during radical surgery with adjuvant chemotherapy for treating stage II and III colon cancer.
  
  
  METHODS
  Patients 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 metastasis-free survival, overall survival, and safety.
  
  
  RESULTS
  The intent-to-treat population comprised 237 patients. 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 metastasis-free survival rates were 87.6% for OCTREE and 78.0% for mFOLFOX6 (P = 0.035). Patients 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). Neutropenia occurred in 12.7% of the patients receiving OCTREE and in 2.5% of the patients receiving mFOLFOX6 (P = 0.003) within 2 weeks of surgery, and grade 3 or 4 toxicity 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 patients with stage II and stage III colon cancer.
authors.affiliation: *Department of General Surgery Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China †Colorectal Cancer Diagnosis and Treatment Center Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China ‡Endoscopy Center Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China §Medical Oncology Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China ¶Statistics, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
authors.forename: Wenju
authors.initials: W
authors.lastname: Chang
authors.forename: Ye
authors.initials: Y
authors.lastname: Wei
authors.forename: Li
authors.initials: L
authors.lastname: Ren
authors.forename: Yunshi
authors.initials: Y
authors.lastname: Zhong
authors.forename: Yiyi
authors.initials: Y
authors.lastname: Yu
authors.forename: Jingwen
authors.initials: J
authors.lastname: Chen
authors.forename: Dexiang
authors.initials: D
authors.lastname: Zhu
authors.forename: Lechi
authors.initials: L
authors.lastname: Ye
authors.forename: Chunzhi
authors.initials: C
authors.lastname: Qin
authors.forename: Naiqing
authors.initials: N
authors.lastname: Zhao
authors.forename: Weixin
authors.initials: W
authors.lastname: Niu
authors.forename: Xinyu
authors.initials: X
authors.lastname: Qin
authors.forename: Jianmin
authors.initials: J
authors.lastname: Xu
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D014408:Biomarkers, Tumor; D009944:Organoplatinum Compounds; D005467:Floxuridine; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil