title: Surgical adjuvant therapy of rectal carcinoma: a controlled evaluation of leucovorin, 5-fluorouracil and radiation therapy with or without interferon-alpha2b.
abstract: BACKGROUND
  The aim of this study was to determine whether the efficacy of the combination of 5-fluorouracil (5-FU), leucovorin (LV) and radiation therapy (RT) could be improved by the addition of interferon-alpha2b (IFN-alpha) in patients who have had a 'curative' resection, for rectal adenocarcinoma (Dukes' B2/C; T3 N0, T4 N0, N1-3).
  
  
  METHODS
  A total of 207 eligible patients with a performance status of 0 or 1 were randomized postoperatively between days 21 and 70 to one of the two treatment groups: group A, LV 20 mg/m2 i.v. bolus and 5-FU 425 mg/m2 i.v. days 1-5 and 29-33, LV 20 mg/m2 and 5-FU 400 mg/m2 days 57-60 and 85-88, LV 20 mg/m2 and 5-FU 380 mg/m2 days 1-5 and 29-33 with the second day 1 occurring 28 days after the completion of RT (45 Gy); group B, LV, 5-FU and RT as in group A, and IFN-alpha 5 x 10(6) IU s.c. three times during each week chemotherapy is given.
  
  
  RESULTS
  104 patients were randomized into group A and 103 into group B. There was no statistically significant difference in either disease-free survival or overall survival between the two groups. Toxicity was also the same, except for the flu-like syndrome associated with the IFN-alpha administration.
  
  
  CONCLUSIONS
  There was no difference in efficacy between the two combinations. Toxicity was greater with the LV + 5-FU + IFN-alpha regimen because of the flu-like syndrome.
authors.affiliation: Second Department of Surgery, Areteion Hospital, University of Athens, Athens, Greece. gennatas@compulink.gr
authors.forename: C
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authors.lastname: Gennatas
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authors.lastname: Dardoufas
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authors.initials: D
authors.lastname: Mouratidou
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authors.lastname: Tsavaris
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authors.lastname: Pouli
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authors.lastname: Androulakis
authors.forename: M
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authors.lastname: Philippakis
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authors.initials: D
authors.lastname: Voros
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authors.initials: T
authors.lastname: Batalis
authors.forename: S
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authors.lastname: Besbeas
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authors.lastname: Hatzistylianos
authors.forename: J
authors.initials: J
authors.lastname: Katsos
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authors.lastname: Komporozos
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authors.initials: N
authors.lastname: Legakis
authors.forename: H
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authors.lastname: Mallas
authors.forename: G
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authors.lastname: Peros
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authors.lastname: Photopoulos
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authors.lastname: Pisiotis
authors.forename: G
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authors.lastname: Polymeneas
authors.forename: G
authors.initials: G
authors.lastname: Retalis
authors.forename: L
authors.initials: L
authors.lastname: Samanidis
authors.forename: V
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authors.lastname: Smyrniotis
authors.forename: A
authors.initials: A
authors.lastname: Stamatiadis
authors.forename: J
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authors.lastname: Vasiliou
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authors.lastname: Andreadis
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authors.lastname: Papadimitriou
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D018714:Radiotherapy, Adjuvant; D011994:Recombinant Proteins; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D002955:Leucovorin; D005472:Fluorouracil