Abstract
Introduction
This phase II trial was conducted to assess the efficacy and safety of 10-Ethyl-10-Deaza-Aminopterin (10-EDAM), a folate antagonist, in metastatic breast cancer patients who had received no more than one prior chemotherapy regimen.
Methods
Fifty-five patients were treated on an initial weekly dose 80 mg/m2 of 10-EDAM. Patients who had received a prior chemotherapy regimen in the adjuvant setting (group 1) were considered separately from patients who had received a prior chemotherapy regimen in the metastatic setting (group 2).
Results
The response rate for both groups combined was 18%, and median time to progression was 3 months. Median overall survival was 12 months. Treatment was associated with common chemotherapy-related toxicities, such as 25% grade three or four neutropenia and 20% grade three or four stomatitis.
Conclusion
In patients with metastatic breast cancer who had received one prior chemotherapy regimen, 10-EDAM was well tolerated. In general, while definite antitumor activity was documented, time to progression was brief.
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Funding: supported by grants UO1 CA70172 and 2P30 CA016672 of the National Cancer Institute and by the Nellie B. Connally Breast Cancer Research. All authors have read and approved the manuscript. All participants in the study signed an IRB-approved informed consent form, in keeping with institutional and federal regulations. There are no other conflicts-of-interest present.
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Beinart, G.A., Gonzalez-Angulo, A.M., Broglio, K. et al. Phase II trial of 10-EDAM in the treatment of metastatic breast cancer. Cancer Chemother Pharmacol 60, 61–67 (2007). https://doi.org/10.1007/s00280-006-0348-9
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DOI: https://doi.org/10.1007/s00280-006-0348-9