Phase II study of 5-fluorouracil/leucovorin for pediatric patients with malignant solid tumors.
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.
Pratt
C B
CB
Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN 38101-0318.
Meyer
W H
WH
Howlett
N
N
Douglass
E C
EC
Bowman
L C
LC
Poe
D
D
Mounce
K
K
Kun
L E
LE
Houghton
J A
JA
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
D002955:Leucovorin; D005472:Fluorouracil