title: Phase II study of 5-fluorouracil/leucovorin for pediatric patients with malignant solid tumors.
abstract: BACKGROUND
  5-Fluorouracil (5-FU) activity for various carcinomas of adults has been enhanced through the synergistic effect of leucovorin. Few pediatric studies of 5-FU in pediatric patients have been previously reported.
  
  
  METHODS
  Fifty-eight patients were treated with a 4-hour infusion of leucovorin, 400 mg/m2, administered daily for 5 days every 3-4 weeks. 5-Fluorouracil was administered by bolus injection 1 hour into each leucovorin infusion. Eleven adolescent patients with colorectal carcinoma, Stage 3 or 4, were treated with therapeutic intent, and other patients with a variety of drug-resistant pediatric solid neoplasms received similar treatment.
  
  
  RESULTS
  Patients with measurable disease of colorectal carcinoma responded favorably to 5-FU/leucovorin. Stable disease activity was seen with other tumor types. Specifically, there were no objective responses in 12 patients with Ewing's Sarcoma or 11 with osteosarcoma. There were 4 deaths in this study from causes related to toxicity. Nonfatal grade 3/4 toxicities included mucositis, rash, myelosuppression, nausea, vomiting, diarrhea, and infection.
  
  
  CONCLUSIONS
  The authors do not plan further evaluation of 5-FU/leucovorin in additional pediatric patients with colon cancer or other heavily pretreated malignant solid tumors and are presently treating their patients with colon carcinoma with 5-FU/leucovorin/interferon-alpha 2a.
authors.affiliation: Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN 38101-0318.
authors.forename: C B
authors.initials: CB
authors.lastname: Pratt
authors.forename: W H
authors.initials: WH
authors.lastname: Meyer
authors.forename: N
authors.initials: N
authors.lastname: Howlett
authors.forename: E C
authors.initials: EC
authors.lastname: Douglass
authors.forename: L C
authors.initials: LC
authors.lastname: Bowman
authors.forename: D
authors.initials: D
authors.lastname: Poe
authors.forename: K
authors.initials: K
authors.lastname: Mounce
authors.forename: L E
authors.initials: LE
authors.lastname: Kun
authors.forename: J A
authors.initials: JA
authors.lastname: Houghton
mesh_terms: D000293:Adolescent; D002277:Carcinoma / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D015179:Colorectal Neoplasms / Q000188:drug therapy; D004334:Drug Administration Schedule; D004357:Drug Synergism; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D012516:Osteosarcoma / Q000188:drug therapy; D012512:Sarcoma, Ewing / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D002955:Leucovorin; D005472:Fluorouracil