title: Initial results of a phase II trial of high dose radiation therapy, 5-fluorouracil, and cisplatin for patients with anal cancer (E4292): an Eastern Cooperative Oncology Group study.
abstract: OBJECTIVE
  A prospective clinical trial was performed to assess the response and toxicity associated with the use of high dose radiation therapy, 5-fluorouracil, and cisplatin in patients with anal cancer.
  
  
  METHODS
  Patients with anal cancer without distant metastasis were eligible for this study. Radiation therapy consisted of 59.4 Gy in 33 fractions; a 2 week break in treatment was taken after 36 Gy had been given. A treatment of 5-fluorouracil, 1,000 mg/m2 per day intravenously, was given for the first 4 days of radiation therapy, and cisplatin, 75 mg/m2 intravenously, was given on day 1 of radiation therapy. A second course of 5-fluorouracil and cisplatin was given after 36 Gy of radiation, when the radiation therapy was resumed.
  
  
  RESULTS
  Nineteen patients entered this study and received treatment. Thirteen (68%) had a complete response, 5 (26%) had a partial response, and 1 (5%) had stable disease. The patient with stable disease and one of the patients with a partial response had complete disappearance of tumor more than 8 weeks after completion of radiation therapy. Fifteen patients had toxicity of Grade 3 or higher: the worst toxicity was Grade 3 in eight patients, Grade 4 in six patients, and Grade 5 in one patient. The most common form of toxicity of Grade 3 or higher was hematologic. The one lethal toxicity was due to pseudomembranous colitis, which was a complication of antibiotic therapy for a urinary tract infection.
  
  
  CONCLUSIONS
  Radiation therapy, cisplatin, and 5-fluorouracil resulted in an overall response rate of 95%. Significant toxicity occurred, an indication that this regimen is near the maximal tolerated dose. A Phase III clinical trial is planned in which radiation therapy, cisplatin, and 5-fluorouracil will be used as an experimental arm.
authors.affiliation: Mayo Clinic, Rochester, MN 55905, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Martenson
authors.forename: S R
authors.initials: SR
authors.lastname: Lipsitz
authors.forename: H
authors.initials: H
authors.lastname: Wagner
authors.forename: E H
authors.initials: EH
authors.lastname: Kaplan
authors.forename: L A
authors.initials: LA
authors.lastname: Otteman
authors.forename: L M
authors.initials: LM
authors.lastname: Schuchter
authors.forename: E G
authors.initials: EG
authors.lastname: Mansour
authors.forename: M S
authors.initials: MS
authors.lastname: Talamonti
authors.forename: A B
authors.initials: AB
authors.lastname: Benson
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001005:Anus Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects
chemical_list: D002945:Cisplatin; D005472:Fluorouracil