title: Preliminary results of preoperative 5-fluorouracil, low-dose leucovorin, and concurrent radiation therapy for clinically resectable T3 rectal cancer.
abstract: OBJECTIVE
  We report the downstaging, sphincter preservation, acute toxicity, and preliminary local control and survival results of preoperative 5-fluorouracil (5-FU), low-dose leucovorin (LV), and concurrent radiation therapy followed by postoperative LV/5-FU for treatment of patients with clinically resectable T3 rectal cancer.
  
  
  METHODS
  A total of 32 patients received two monthly cycles of preoperative LV/5-FU (bolus daily X 5). Radiation therapy (5,040 cGy) began concurrently on day 1. Postoperatively, patients received a median of two monthly cycles of LV/5-FU (range, 0-10).
  
  
  RESULTS
  The complete response rate was 9 percent pathologic and 13 percent clinical, for a total of 22 percent. Total Grade 3+ acute toxicity during the preoperative combined modality segment was 25 percent (8/32). Of the 20 patients who were thought to initially require an abdominoperineal resection and for whom the intent of treatment was sphincter preservation, 17 (85 percent) were able to undergo sphincter-preserving surgery. With a median follow-up of 22 (3-59) months, none have developed local failure, and the three-year actuarial disease-free survival rate was 60 percent.
  
  
  CONCLUSIONS
  Our data reveal encouraging downstaging, sphincter preservation and acute toxicity with this regimen. Additional follow-up is needed to assess the long-term local control and survival rates.
authors.affiliation: Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: A
authors.initials: A
authors.lastname: Grann
authors.forename: B D
authors.initials: BD
authors.lastname: Minsky
authors.forename: A M
authors.initials: AM
authors.lastname: Cohen
authors.forename: L
authors.initials: L
authors.lastname: Saltz
authors.forename: J G
authors.initials: JG
authors.lastname: Guillem
authors.forename: P B
authors.initials: PB
authors.lastname: Paty
authors.forename: D P
authors.initials: DP
authors.lastname: Kelsen
authors.forename: N
authors.initials: N
authors.lastname: Kemeny
authors.forename: D
authors.initials: D
authors.lastname: Ilson
authors.forename: J
authors.initials: J
authors.lastname: Bass-Loeb
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*
chemical_list: D002955:Leucovorin; D005472:Fluorouracil