Phase II trial of 10-EDAM in the treatment of metastatic breast cancer

Garth A. Beinart, Ana M. Gonzalez-Angulo, Kristine Broglio, Debbie Frye, Ronald Walters, Frankie Ann Holmes, Shivaji Gunale, Daniel Booser, Julian Rosenthal, Kapil Dhingra, James A. Young, G. N. Hortobagyi

Research output: Contribution to journalArticle

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)61-67
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume60
Issue number1
DOIs
StatePublished - Jun 2007

Keywords

  • Chemotherapy
  • Clinical trial
  • Folic acid antagonist
  • Toxicity

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

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