title: Update of carcinoembryonic antigen radioimmunotherapy with (131)I-labetuzumab after salvage resection of colorectal liver metastases: comparison of outcome to a contemporaneous control group.
abstract: BACKGROUND
  We tested whether adjuvant radioimmunotherapy (RAIT) given after R0 resection of liver metastases (LM) of colorectal cancer is safe and can improve survival. Resection of LM from colorectal cancer is the standard of care in this setting, yet two thirds will eventually relapse, and adjuvant systemic chemotherapy has failed to improve survival.
  
  
  METHODS
  Twenty-three patients who underwent R0 resection for LM of colorectal cancer received a dose of 40 to 60 mCi/m(2) (131)I-labetuzumab, a humanized monoclonal antibody against carcinoembryonic antigen. Safety (n = 23), disease-free survival, and overall survival (n = 19) were analyzed, and efficacy was then compared retrospectively with a similar contemporaneous group of control patients (n = 19) treated at the same institution during the same time period but without RAIT.
  
  
  RESULTS
  At a median follow-up of 91 months (95% confidence interval [CI], 68.0 months to infinity), the median overall survival for RAIT patients was 58.0 months (95% CI, 55.0 months to infinity), versus 31.0 months (95% CI, 26.0 months to infinity) at a 51-month median follow-up for the controls (P = .032). The median disease-free survival for RAIT patients was 18.0 months (95% CI, 11.0-31.0 months), versus 12.0 months (95% CI, 6.5-27.0 months) for the controls (P = .565). Corresponding survival rates (Kaplan-Meier analyses) were estimated to be 94.7% at 1 year, 78.9% at 2 years, 68.4% at 3 years, and 42.1% at 5 years with RAIT and 94.7%, 68.4%, 36.8%, and 15.8%, respectively, for the controls. RAIT was beneficial independently of bilobar involvement, size and number of LM, or resection margins. Transient myelosuppression was the principal adverse effect.
  
  
  CONCLUSIONS
  This first evidence of a promising survival advantage of adjuvant RAIT after long-term follow-up of colorectal cancer patients given salvage resection of LM warrants confirmation in a prospective randomized trial.
authors.affiliation: Department of General Surgery, University of Göttingen, Göttingen, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Liersch
authors.forename: Johannes
authors.initials: J
authors.lastname: Meller
authors.forename: Michael
authors.initials: M
authors.lastname: Bittrich
authors.forename: Bettina
authors.initials: B
authors.lastname: Kulle
authors.forename: Heinz
authors.initials: H
authors.lastname: Becker
authors.forename: David M
authors.initials: DM
authors.lastname: Goldenberg
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002272:Carcinoembryonic Antigen / Q000276:immunology*; D016022:Case-Control Studies; D015179:Colorectal Neoplasms / Q000473:pathology*; D003131:Combined Modality Therapy; D004307:Dose-Response Relationship, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use; D007150:Immunohistochemistry; D007457:Iodine Radioisotopes / Q000627:therapeutic use; D008113:Liver Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011379:Prognosis; D016499:Radioimmunotherapy / Q000379:methods; D016879:Salvage Therapy; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D002272:Carcinoembryonic Antigen; D018796:Immunoconjugates; D007457:Iodine Radioisotopes; C110010:labetuzumab