1. Patients receiving less than 8 mg/kg of 5-fluorouracil given as a single intravenous injection per day for 5 days showed minimal toxic effects.

  2. Severe toxicity was not observed with doses of 15 mg/kg/day × 5, provided alkylating agents or deep x-ray and/or radium therapy had not been given previously.

  3. The two deaths in this series might have been avoided if stomatitis had been used as a guide for termination of therapy.

  4. The effects of 5-fluorouracil toxicity are of relatively short duration once the drug is withdrawn.

  5. Tumor regression was noted only in those patients manifesting severe toxicity.

  6. Nine patients in the group of 35 receiving what we presently consider adequate therapeutic dosage showed objective regression of neoplasms.

  7. Analgesics were no longer required for the relief of pain in the majority of patients following treatment with 5-fluorouracil.

  8. Thus far in patients with solid tumors that have responded to repeated courses of 5-fluorouracil therapy, no development of resistance to the drug has been observed.

  9. The results obtained in our series of solid neoplasms suggest a continuation and extension of this study.

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