title: Fluorouracil-based preoperative chemoradiotherapy with or without oxaliplatin for stage II/III rectal cancer: a 3-year follow-up study.
abstract: BACKGROUND
  Fluorouracil-based preoperative chemoradiotherapy has become the standard treatment for stage II/III rectal cancer. In order to improve the overall survival (OS) and disease-free survival (DFS), we added oxaliplatin to the standard treatment, and compared the effectiveness of these two treatment patterns.
  
  
  METHODS
  A total of 206 patients enrolled in the prospective study had histologically confirmed rectal cancer of clinical stage II/III during July 2007 to July 2010. They were randomized into the experimental group received oxaliplatin and capecitabine in combination with radiotherapy, and the control group received capecitabine in combination with radiotherapy. All patients received surgery in 6-10 weeks after chemoradiotherapy and adjuvant chemotherapy with mFOLFOX6. The primary endpoints were DFS and OS, and the secondary endpoints included toxicity, compliance, and histopathological response.
  
  
  RESULTS
  The 3-year OS in the experimental group and the control group was 90.29% vs. 86.41% (P>0.05), and the 3-year DFS was 80.58% vs. 69.90% (P>0.05). The pathological complete remission (pCR) rates were 23.30% and 19.42%, respectively (P=0.497). The 3-year local recurrence rates were 4.85% vs. 5.83% (P=0.694), and the 3-year distant metastasis rates were 16.50% and 28.16%, respectively (P=0.045). There were no significant differences in most grade 3-4 toxicities between two groups, however, grade 3-4 diarrhea occurred in 16.50% (17/103) of the experimental group, compared with 6.80% (7/103) of the control group (P=0.030). Also, the total grade 3-4 acute toxicity showed a significant difference (10.68% vs. 21.36%, P=0.037).
  
  
  CONCLUSIONS
  The experimental treatment did not lead significantly improved OS and DFS, and thus longer follow-up is warranted for our patient cohort. Adding oxaliplatin to capecitabine-based preoperative chemoradiotherapy can significantly reduce metastasis, but has only minimal impact on local recurrence. Although grade 3-4 toxicity rate increased (primarily gastrointestinal toxicity), patients can stand to be followed up with allopathic treatment.
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Dexin
authors.initials: D
authors.lastname: Jiao
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Zhang
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Zhiqiang
authors.initials: Z
authors.lastname: Gong
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Liu
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Chen
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Qinrui
authors.initials: Q
authors.lastname: Yu
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Sun
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Hongyan
authors.initials: H
authors.lastname: Duan
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Shendong
authors.initials: S
authors.lastname: Zhu
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Liu
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Wang
authors.affiliation: 1 Department of Radiotherapy, 2 Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang 110042, China.
authors.forename: Jianhui
authors.initials: J
authors.lastname: Jia
keywords: Oxaliplatin; capecitabine; preoperative chemoradiotherapy; rectal adenocarcinoma