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  • Title: Phase II study with sequential L-asparaginase and methotrexate in advanced refractory breast cancer.
    Author: Yap HY, Benjamin RS, Blumenschein GR, Hortobagyi GN, Tashima CK, Buzdar AU, Bodey GP.
    Journal: Cancer Treat Rep; 1979 Jan; 63(1):77-83. PubMed ID: 369695.
    Abstract:
    The combination of sequential L-asparaginase and methotrexate (MTX) was evaluated in 33 patients with advanced refractory breast cancer. There were nine partial responses and one complete response, giving an overall response rate of 30% and a median duration of response of 8 months. Five of 17 patients (28%) who had received prior MTX at doses of less than 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 greater than or equal to 180 mg/m2. The maximum tolerated dose of MTX was 280 mg/m2 and the median toxic dose was 220 mg/m2. These data indicate a selective "rescue" from MTX damage to normal target tissue by L-asparaginase. 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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