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Improved Therapeutic Index of Methotrexate with "Leucovorin Rescue"¹

Departments of Medicine and Pharmacology, Yale University School of Medicine [M. B. M., R. C. D., L. R. F., R. T. S., J. C. M., M. S. M., J. R. B.] and Department of Medicine, New Haven Veterans' Administration Hospital [R. J. P.], New Haven, Connecticut 06510; Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98105 [E. D. T.], and Department of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada [M. L.]

The effect of "leucovorin rescue" on the therapeutic index of methotrexate in epidermoid carcinomas of the head and neck was studied. Sixteen patients received maximally tolerated doses of methotrexate alone as 30-hr i.v. infusions at 2-week intervals and 44% responded. Significant hematological toxicity and 4 drug-related deaths were incurred. Twenty-five patients received higher doses of methotrexate followed by leucovorin rescue as 36- to 42-hr i.v. infusions every 2 weeks. This group experienced a response rate of 60% with fewer cases of severe toxicity. Seventeen of this group received more than 500 mg/sq m as a maximal dose and had a response rate of 76% with two drug-related deaths, while those receiving smaller doses had a response rate of only 25%. Serum methotrexate levels were proportional to the dose of drug. Leucovorin rescue enhances the therapeutic index of high-dose methotrexate infusions in epidermoid carcinomas of the head and neck.

¹ Supported in part by Grants CA 08341-05 and 5138-09 from the National Cancer Institute. Presented in part at The 63rd Annual Meeting of the American Association for Cancer Research, Boston, Mass., May 5, 1972.

² Fellow of The Leukemia Society of America 1968 to 1970.

³ Scholar of The Leukemia Society of America.

⁴ Supported by Research Career Program Award 1-K6-AI-2425 from the National Institute of Allergy and Infectious Diseases, NIH, USPHS.

⁵ Career Development Awardee, National Cancer Institute. To whom requests for reprints should be addressed, at Department of Internal Medicine, Yale University School of Medicine, 333 Cedar Street, New Haven, Conn. 06510.

Received 7/ 7/71. Accepted 3/28/73.

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