Phase II Trial of High Dose Methotrexate with Citrovorum Factor “Rescue” for Hematological Malignancies

Abstract

“High-dose methotrexate (MTX) with citrovorum factor (CF) rescue” treatment was applied to 24 cases of hematological malignancies refractory to other anticancer drugs.
Out of 12 cases with adult acute leukemias, two achieved complete remission (CR) and three, partial remission (PR). Out of 12 cases with malignant lymphomas, two attained CR and six, PR. Among 10 cases who had become refractory to conventional doses of MTX, five showed desirable responses. Two out of 3 cases with T-cell malignancies achieved PR. The duration of remission was shorter than 4 weeks in 10 out of 13 cases.
Main side effects of this treatment were as follows; general fatigue in 54% of patients, nausea in 46%, stomatitis in 24%, neutropenia in 23% and thrombocytopenia in 30%. Severe myelotoxicity was seen in four cases, but in cases given aggressive urine alkalinization, even less toxicity including stomatitis was seen than the conventional MTX administration.
The high-dose MTX with CF rescue treatment would be effective for refractory hematological malignancies without any severe toxicity.