title: 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: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Ontario Cancer Treatment and Research Foundation, London Regional Cancer Centre, London, Canada.
authors.forename: T A
authors.initials: TA
authors.lastname: Vandenberg
authors.forename: K I
authors.initials: KI
authors.lastname: Pritchard
authors.forename: E A
authors.initials: EA
authors.lastname: Eisenhauer
authors.forename: M E
authors.initials: ME
authors.lastname: Trudeau
authors.forename: B D
authors.initials: BD
authors.lastname: Norris
authors.forename: P
authors.initials: P
authors.lastname: Lopez
authors.forename: S S
authors.initials: SS
authors.lastname: Verma
authors.forename: R A
authors.initials: RA
authors.lastname: Buckman
authors.forename: A
authors.initials: A
authors.lastname: Muldal
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000630:Aminopterin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D005493:Folic Acid Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome
chemical_list: D005493:Folic Acid Antagonists; C040210:edatrexate; D000630:Aminopterin