title: Preoperative chemoradiation with or without induction oxaliplatin plus 5-fluorouracil in locally advanced rectal cancer. Long-term outcome analysis.
abstract: OBJECTIVE
  It has been previously reported that a short FOLFOX-4 induction significantly improves pathologic complete response in locally advanced rectal cancer (LARC) patients treated with preoperative chemoradiation (CRT). In a larger and updated patient series, we analyzed FOLFOX-4 efficacy in terms of sphincter preservation and long-term outcomes.
  
  
  METHODS
  From January 1995 to December 2010, 335 LARC patients were treated with preoperative chemoradiation (4500-5040 cGy). Starting in May 2001, 207 consecutive patients additionally received induction FOLFOX-4. Surgery was performed 6 weeks (range 3-12 weeks) after chemoradiation.
  
  
  RESULTS
  Incidence of total tumor (63 vs. 54 %, p = 0.02) and nodal downstaging (60 vs. 43 %, p = 0.002) was significantly increased by induction FOLFOX-4. In an analysis of tumors located below 5 cm from the anal verge (n = 114, 34 %), sphincter preservation was feasible in 30 % in the FOLFOX-4 versus 13 % in the upfront CRT group (p = 0.04). Median follow-up time for the entire cohort of patients was 72.6 months (range 4-205 months). FOLFOX-4 was not associated with superior locoregional control (HR 0.88, p = 0.78), disease-free survival (HR 0.83, p = 0.55), distant metastases-free survival (HR 0.94, p = 0.81), or cancer-specific survival (HR 0.70, p = 0.15).
  
  
  CONCLUSIONS
  Short-intense induction FOLFOX-4 significantly improves downstaging and sphincter preservation in low rectal tumors. Long-term outcomes were not improved in the FOLFOX-4 group of patients.
authors.affiliation: Department of Oncology, Hospital General Universitario Gregorio Marañón, Ave. Doctor Esquerdo, 46, 28007, Madrid, Spain.
authors.forename: F A
authors.initials: FA
authors.lastname: Calvo
authors.forename: C V
authors.initials: CV
authors.lastname: Sole
authors.forename: J
authors.initials: J
authors.lastname: Serrano
authors.forename: E
authors.initials: E
authors.lastname: Del Valle
authors.forename: M
authors.initials: M
authors.lastname: Rodriguez
authors.forename: A
authors.initials: A
authors.lastname: Muñoz-Calero
authors.forename: J L
authors.initials: JL
authors.lastname: García-Sabrido
authors.forename: P
authors.initials: P
authors.lastname: Garcia-Alfonso
authors.forename: I
authors.initials: I
authors.lastname: Peligros
authors.forename: E
authors.initials: E
authors.lastname: Alvarez
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal / Q000601:surgery; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008207:Lymphatic Metastasis / Q000473:pathology; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D059351:Organ Sparing Treatments; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil