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Trimetrexate in malignant mesothelioma: A Cancer and Leukemia Group B Phase II study.

AbstractPURPOSE:
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.
AuthorsN J Vogelzang, L B Weissman, J E Herndon 2nd, K H Antman, M R Cooper, J M Corson, M R Green
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 12 Issue 7 Pg. 1436-42 (Jul 1994) ISSN: 0732-183X [Print] United States
PMID8021735 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Trimetrexate
Topics
  • Adult
  • Aged
  • Female
  • Humans
  • Male
  • Mesothelioma (drug therapy)
  • Middle Aged
  • Survival Analysis
  • Treatment Outcome
  • Trimetrexate (adverse effects, therapeutic use)

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