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Prolonged Intravenous Methotrexate Therapy in the Treatment of Acute Leukemia and Solid Tumors

Medical Service, Baltimore Cancer Research Center, National Cancer Institute, Baltimore, Maryland 21211

Five patients with previously treated acute leukemia received 14 courses of a 24-hr i.v. infusion of a 2 mg/kg dose of methotrexate followed by 6 mg of folinic acid. Four additional leukemia patients, previously treated, and 10 other patients with various metastatic solid tumors, largely choriogonadotropin-producing testicular tumors, received 24 courses of methotrexate at 5 mg/kg, with 60% given as a rapid i.v. injection, followed by the remaining 40% given as a 4-hr infusion. This last regimen was repeated on two consecutive days, and no folinic acid was given. Courses were generally repeated at 2-week intervals. Two of the eight evaluable choriogonadotropin-producing tumors had complete remissions lasting 3 months and 18+ months. Four others responded solely with a decrease in urinary gonadotropin levels, while two more exhibited small decreases in the size of metastatic lesions. No complete remissions were seen in the leukemic population, although marked decreases in the number of peripheral and bone marrow blasts were almost always observed. Two elderly leukemia patients tolerated the 24-hr infusion exceptionally well. No response was seen in a patient with squamous cell carcinoma of the lung.

Leukopenia and thrombocytopenia were more pronounced in the leukemia patients than in those with solid tumors, and platelet transfusions were obligatory in 29% of the courses given to leukemic patients. Hepatic dysfunction and stomatitis, both of which were nearly universal and very severe in the shorter infusion regimen, were relatively mild in the 24-hr infusion. Mild nausea and vomiting and occasional erythrodermic rashes were also observed.

A previously undescribed fever pattern, unassociated with infection, was seen in 55% of all the courses. It generally occurred on the 2nd through the 5th day following the infusions and lysed spontaneously without antibiotic or antipyretic therapy. Possible etiology of this fever is discussed.

¹ To whom requests for reprints may be addressed at NCI-Baltimore Cancer Research Center, 3100 Wyman Park Drive, Baltimore, Md. 21211.

Received 2/ 4/70. Accepted 4/30/70.