Phase II study of weekly edatrexate as first-line chemotherapy for metastatic breast cancer: a National Cancer Institute of Canada Clinical Trials Group study.

Abstract

PURPOSE:

The National Cancer Institute of Canada (NCIC) Clinical Trials Group conducted a phase II study to assess the efficacy and toxicity of edatrexate, a folate antagonist, in 35 patients with metastatic breast cancer.

PATIENTS AND METHODS:

The planned dose of edatrexate was 80 mg/m2/wk administered intravenously as first-line therapy. Prior adjuvant chemotherapy was allowed provided at least 12 months had elapsed from the completion of treatment to the development of recurrence.

RESULTS:

Mucositis was the dose-limiting toxicity in 34 assessable patients, resulting in a mean delivered dose-intensity of 57 mg/m2/wk. Other toxicities included myelosuppression, rash, pneumonitis, and increased AST. Side effects were generally mild to moderate. The complete plus partial remission rate (13 patients; 41%) was impressive.

CONCLUSION:

Edatrexate is an active agent against metastatic breast cancer, with acceptable toxicity. A lower than planned delivered dose-intensity was mainly due to mucositis.

• Authors: T A Vandenberg, K I Pritchard, E A Eisenhauer, M E Trudeau, B D Norris, P Lopez, S S Verma, R A Buckman, A Muldal
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 11 Issue 7 Pg. 1241-4 (Jul 1993) ISSN: 0732-183X [Print] United States
• PMID: 8315420 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Folic Acid Antagonists
• edatrexate
• Aminopterin

Topics

• Adult
• Aged
• Aged, 80 and over
• Aminopterin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Breast Neoplasms (drug therapy, pathology)
• Drug Administration Schedule
• Female
• Folic Acid Antagonists (administration & dosage, adverse effects, therapeutic use)
• Humans
• Injections, Intravenous
• Middle Aged
• Neoplasm Metastasis
• Treatment Outcome