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. Conclusion. 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‐α2a. Copyright © 1994 American Cancer Society