title: Phase II study of computed tomography-guided (125)I-seed implantation plus chemotherapy for locally recurrent rectal cancer.
abstract: OBJECTIVE
  This trial evaluated the efficacy and safety of CT guided (125)I-seed implantation (CTII) plus chemotherapy with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment for locally recurrent rectal cancer (LRRC).
  
  
  METHODS
  Patients with LRRC who received one prior chemotherapy regimen were enrolled and divided randomly assigned to FOLFORI alone (Arm A) and FOLFORI plus CTII (Arm B). The primary endpoint was local control time (LCT). Overall survival (OS) and treatment related adverse events (TRAEs) were also observed.
  
  
  RESULTS
  Fifty-seven patients were enrolled from October 2008 and December 2014. Twenty-seven were assigned into Arm A and 30 into Arm B. The overall response rate of locally recurrent tumor was improved to 100% in Arm B versus 29.6% in Arm A (P<0.001). A significant longer LCT was observed in Arm A (P<0.001); median LCT was 12 months in Arm B versus 4 months in Arm A. A borderline significant improvement in OS was also observed in Arm B (P=0.0464); median OS was 25 months in Arm B versus 19 months in Arm A. For patients without distant metastases, median OS was 37 months in Arm B versus 21 months in Arm A (P=0.0101). For patients with (neo)adjuvant radiotherapy (ART), a longer LCT and OS were also found in Arm B (P<0.001 and P=0.0217, respectively). TRAEs were not serious generally. There was no statistically significant difference in treatment related toxicity between Arm A and B both for all patients and patients receiving ART.
  
  
  CONCLUSIONS
  CTII plus FOLFIRI improves the LCT with tolerable toxicities as a second-line treatment in patients with local recurrent rectal cancer, and is helpful to prolong the OS, particularly in patients without distant metastases or with a history of radiotherapy.
authors.affiliation: Department of Oncology, The Third Affiliated Hospital of Soochow University, China; Department of Biological Treatment, The Third Affiliated Hospital of Soochow University, China; Jiangsu Engineering Research Center for Tumor Immunotherapy, China.
authors.forename: Liangrong
authors.initials: L
authors.lastname: Shi
authors.affiliation: Department of Oncology, The Third Affiliated Hospital of Soochow University, China; Department of Biological Treatment, The Third Affiliated Hospital of Soochow University, China; Jiangsu Engineering Research Center for Tumor Immunotherapy, China.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Radiation Oncology, The Third Affiliated Hospital of Soochow University, China. Electronic address: hongleipei@126.com.
authors.forename: Honglei
authors.initials: H
authors.lastname: Pei
authors.affiliation: Department of Oncology, The Third Affiliated Hospital of Soochow University, China.
authors.forename: Jiemin
authors.initials: J
authors.lastname: Zhao
authors.affiliation: Department of Oncology, The Third Affiliated Hospital of Soochow University, China.
authors.forename: Weiguang
authors.initials: W
authors.lastname: Qiang
authors.affiliation: Department of Radiation Oncology, The Third Affiliated Hospital of Soochow University, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Biological Treatment, The Third Affiliated Hospital of Soochow University, China; Jiangsu Engineering Research Center for Tumor Immunotherapy, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Xu
authors.affiliation: Department of Biological Treatment, The Third Affiliated Hospital of Soochow University, China; Jiangsu Engineering Research Center for Tumor Immunotherapy, China.
authors.forename: Lujun
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Oncology, The Third Affiliated Hospital of Soochow University, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of Oncology, The Third Affiliated Hospital of Soochow University, China.
authors.forename: Mei
authors.initials: M
authors.lastname: Ji
authors.affiliation: Department of Gastrointestinal Surgery, The Third Affiliated Hospital of Soochow University, China.
authors.forename: Qicheng
authors.initials: Q
authors.lastname: Lu
authors.affiliation: Department of Gastrointestinal Surgery, The Third Affiliated Hospital of Soochow University, China.
authors.forename: Zhong
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Gastrointestinal Surgery, The Third Affiliated Hospital of Soochow University, China.
authors.forename: Haitao
authors.initials: H
authors.lastname: Wang
authors.affiliation: Department of Biological Treatment, The Third Affiliated Hospital of Soochow University, China; Jiangsu Engineering Research Center for Tumor Immunotherapy, China. Electronic address: jiangjingting@suda.edu.cn.
authors.forename: Jingting
authors.initials: J
authors.lastname: Jiang
authors.affiliation: Department of Oncology, The Third Affiliated Hospital of Soochow University, China; Department of Biological Treatment, The Third Affiliated Hospital of Soochow University, China; Jiangsu Engineering Research Center for Tumor Immunotherapy, China. Electronic address: wcpjjt@163.com.
authors.forename: Changping
authors.initials: C
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001005:Anus Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000532:radiotherapy*; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007457:Iodine Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000532:radiotherapy*; D061089:Radiotherapy, Image-Guided / Q000009:adverse effects / Q000379:methods; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007457:Iodine Radioisotopes; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: Computed tomography-guided (125)I-seed implantation; Efficacy; Locally recurrent rectal cancer; Safety