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

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/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.

• Authors: 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
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 60 Issue 1 Pg. 61-7 (Jun 2007) ISSN: 0344-5704 [Print] Germany
• PMID: 17009032 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural)

Chemical References

• Antineoplastic Agents
• edatrexate
• Aminopterin

Topics

• Adult
• Aged
• Agranulocytosis (chemically induced)
• Alopecia (chemically induced)
• Aminopterin (adverse effects, analogs & derivatives, therapeutic use)
• Anemia (chemically induced)
• Antineoplastic Agents (adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, secondary)
• Disease Progression
• Female
• Humans
• Leukopenia (chemically induced)
• Middle Aged
• Nausea (chemically induced)
• Survival Analysis
• Time Factors
• Treatment Outcome