Phase II trial of 10-EDAM in the treatment of metastatic breast cancer.
Beinart GA,
Gonzalez-Angulo AM,
Broglio K,
Frye D,
Walters R,
Holmes FA,
Gunale S,
Booser D,
Rosenthal J,
Dhingra K,
Young JA,
Hortobagyi GN.
Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
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/m(2) 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.
PMID: 17009032 [PubMed - indexed for MEDLINE]