title: Comparison between intensified neoadjuvant treatment and standard preoperative chemoradiation for rectal cancer.
abstract: OBJECTIVE
  The aim of the current study was to compare a neoadjuvant regimen containing oxaliplatin with standard preoperative treatment for rectal cancer.
  
  
  METHODS
  From December 2006 to December 2007, 20 patients with rectal cancer were treated at our Institution with the weekly addition of oxaliplatin (50 mg/m(2)) to radiotherapy (50.4-54.0 Gy in 28-30 daily fractions) and continuous infusion of 5-fluorouracil (200 mg/m(2)). The results of the regimen were compared with a historical control group including 21 consecutive patients previously treated with standard 5-fluorouracil treatment from December 2004 to October 2006.
  
  
  RESULTS
  Both the rate of sphincter preservation in low rectal cancer (91.7% vs 36.4%, P = 0.009) and the rate of downstaging (84.2% vs 47.6%, P = 0.023) were higher in the oxaliplatin group than in the control group. Pathological complete response was achieved in 8 patients (42.1%) in the oxaliplatin group and in 4 patients (19.0%) in the control group (P = 0.172). When ypT0-pT1 stages were analyzed together, the P value was 0.051. Acute toxicity was increased in the oxaliplatin group, with a higher incidence of G3 diarrhea and pelvic pain than in the control group (30.0% vs 14.3%, P = NS).
  
  
  CONCLUSIONS
  Our data seem to correlate the addition of oxaliplatin to the standard treatment for rectal cancer with higher rates of sphincter preservation, down-staging and complete response. Toxicity is increased and requires careful monitoring. However, our results refer to a retrospective comparison of a small series of patients and need to be validated by the large, phase III randomized trial currently ongoing.
authors.affiliation: Department of Radiation Oncology, University Sapienza, Rome, Italy. daniela.musio@libero.it
authors.forename: Daniela
authors.initials: D
authors.lastname: Musio
authors.forename: Nicola
authors.initials: N
authors.lastname: Raffetto
authors.forename: Francesco
authors.initials: F
authors.lastname: Dionisi
authors.forename: Eva
authors.initials: E
authors.lastname: Iannacone
authors.forename: Bartolomeo
authors.initials: B
authors.lastname: Dipalma
authors.forename: Francesca
authors.initials: F
authors.lastname: Caparrotti
authors.forename: Ilaria
authors.initials: I
authors.lastname: Meaglia
authors.forename: Rossella
authors.initials: R
authors.lastname: Caiazzo
authors.forename: Caterina
authors.initials: C
authors.lastname: Bangrazi
authors.forename: Enzo
authors.initials: E
authors.lastname: Banelli
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D017699:Pelvic Pain / Q000139:chemically induced; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D012189:Retrospective Studies; D018401:Sample Size; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil