Journal of Clinical Oncology, Vol 12, 1436-1442, Copyright © 1994 by American Society of Clinical Oncology
Trimetrexate in malignant mesothelioma: A Cancer and Leukemia Group B Phase II study
NJ Vogelzang, LB Weissman, JE Herndon 2nd, KH Antman, MR Cooper, JM Corson and MR Green
Department of Medicine, University of Chicago, IL 60637-1470.
PURPOSE: Folic acid antagonists are reported to have activity against
mesothelioma. The Cancer and Leukemia Group B (CALGB) undertook this phase
II study of the new antifolate, trimetrexate (TMTX), to evaluate its
response rate and toxicity in chemotherapy-naive patients with malignant
mesothelioma. PATIENTS AND METHODS: Fifty-two patients were accrued to this
protocol. Because of concerns about TMTX toxicity in patients with
malignant effusions and/or hypoalbuminemia, the first 17 patients were
treated at a dose of 6 mg/m2 daily for 5 days every 21 days. Because
minimal toxicity was observed, the subsequent 35 patients were treated at a
dose of 10 mg/m2. RESULTS: Two of 17 patients (12%) in the 6-mg/m2
treatment group had a partial response (PR) and four of 34 eligible
patients (12%) in the 10-mg/m2 treatment group had a PR or regression (R)
of assessable disease. No patient achieved a complete response (CR). Median
survival durations were 5.0 and 8.9 months in the 6- and 10-mg/m2 treatment
groups, respectively, while the 2-year survival rates were identical at
18%. At the 10-mg/m2 dose, toxicity was tolerable, with one toxic death
from sepsis and a 12% rate of grade 4 thrombocytopenia and
granulocytopenia. CONCLUSION: In this large trial, TMTX showed minor
activity in the treatment of malignant mesothelioma. Myelosuppression was
mild and dose-related. Future studies of higher doses of TMTX should be
considered.
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