title: Phase II trial of carcinoembryonic antigen radioimmunotherapy with 131I-labetuzumab after salvage resection of colorectal metastases in the liver: five-year safety and efficacy results.
abstract: OBJECTIVE
  Although complete resection (R0) of liver metastases (LM) remains the treatment of choice for colorectal cancer (CRC) patients amenable to curative therapy, only approximately one third survive for 5 years. The objective of this phase II study was to evaluate the safety and efficacy of radioimmunotherapy (RAIT) after salvage resection of LM.
  
  
  METHODS
  Twenty-three patients who underwent surgery for LM of CRC received a dose of 40 to 60 mCi/m2 of 131I-labetuzumab, which is a humanized monoclonal antibody against carcinoembryonic antigen. Safety (n = 23), disease-free survival (DFS; n = 19), and overall survival (OS; n = 19) were determined.
  
  
  RESULTS
  With a median follow-up of 64 months, the median OS time from the first liver resection for RAIT patients was 68.0 months (95% CI, 46.0 months to infinity), and the median DFS time was 18.0 months (95% CI, 11.0 to 31.0 months). The 5-year survival rate was 51.3%. RAIT benefited patients independently of bilobar involvement, size and number of LM, and resection margins. The major adverse effect was transient myelosuppression, resulting mostly in grade < or = 3 neutropenia and/or thrombocytopenia.
  
  
  CONCLUSIONS
  Because both the median OS and 5-year survival rates seem to be improved with adjuvant RAIT after complete LM resection in CRC, compared with historical and contemporaneous controls not receiving RAIT, these results justify further evaluation of this modality in a multicenter, randomized trial.
authors.affiliation: Department of General Surgery, University of Göttingen, Germany. tliersc@gwdg.de
authors.forename: Torsten
authors.initials: T
authors.lastname: Liersch
authors.forename: Johannes
authors.initials: J
authors.lastname: Meller
authors.forename: Bettina
authors.initials: B
authors.lastname: Kulle
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Behr
authors.forename: Peter
authors.initials: P
authors.lastname: Markus
authors.forename: Claus
authors.initials: C
authors.lastname: Langer
authors.forename: B Michael
authors.initials: BM
authors.lastname: Ghadimi
authors.forename: William A
authors.initials: WA
authors.lastname: Wegener
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Kovacs
authors.forename: Ivan D
authors.initials: ID
authors.lastname: Horak
authors.forename: Heinz
authors.initials: H
authors.lastname: Becker
authors.forename: David M
authors.initials: DM
authors.lastname: Goldenberg
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000556:secondary* / Q000601:surgery; D000328:Adult; D000368:Aged; D001707:Biopsy, Needle; D002272:Carcinoembryonic Antigen / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006498:Hepatectomy / Q000379:methods; D006801:Humans; D007150:Immunohistochemistry; D007457:Iodine Radioisotopes / Q000627:therapeutic use; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000556:secondary*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D016499:Radioimmunotherapy / Q000379:methods; D018570:Risk Assessment; D016879:Salvage Therapy; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002272:Carcinoembryonic Antigen; D007457:Iodine Radioisotopes