PHASE-II STUDY WITH SEQUENTIAL L-ASPARAGINASE AND METHOTREXATE IN ADVANCED REFRACTORY BREAST-CANCER

  • 1 January 1979
    • journal article
    • research article
    • Vol. 63  (1) , 77-83
Abstract
The combination of sequential L-asparaginase and methotrexate (MTX) was evaluated in 33 patients with advanced refractory breast cancer. There were 9 partial responses and 1 complete response, giving an overall response rate of 30% and a median duration of response of 8 mo. Five of 17 patients (28%) who had received prior MTX at doses of < 50 mg/m2 responded. Toxicity was acceptable. Moderate-to-severe stomatitis occurred in most patients and was the dose-limiting factor. Myelosuppression was minimal until the dose of MTX was escalated to .gtoreq. 180 mg/m2. The maximum tolerated dose of MTX was 280 mg/m2 and the median toxic dose was 220 mg/m2. A selective rescue from MTX damage to normal target tissue by L-asaparaginase was indicated. The antitumor effect observed even in patients who had been previously exposed to conventional doses of MTX suggests a possible improved therapeutic index of MTX given sequentially with L-asparaginase in this combination.

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