title: A phase II trial of 10-ethyl-10-deaza-aminopterin, a novel antifolate, in patients with advanced and/or recurrent squamous cell carcinoma of the head and neck. The EORTC Head and Neck Cancer Cooperative Group.
abstract: Forty-seven patients with advanced and/or recurrent squamous cell carcinoma of the head and neck were treated with 10-ethyl-10-deaza-aminopterin (10-EdAM), a new analogue of methotrexate. The drug was given as a weekly i.v. bolus injection, starting at 80 mg/m2 with two dose increments of 10% if no toxicity was observed after two weeks. Only patients with tumors of the larynx, oral cavity, oropharynx and hypopharynx were included in the trial. Eighty-two percent of the patients had had prior surgery and/or radiotherapy. Forty-four patients were evaluable for response and toxicity. Five CR (12%) and five PR were obtained, yielding a response rate of 24% (CR+PR). The toxicity was similar to that usually seen with methotrexate; stomatitis and skin toxicity were rather pronounced. The data suggest that 10-EdAM has activity similar to that of methotrexate in patients with head and neck cancer.
authors.affiliation: Netherlands Cancer Institute, Amsterdam.
authors.forename: J H
authors.initials: JH
authors.lastname: Schornagel
authors.forename: J
authors.initials: J
authors.lastname: Verweij
authors.forename: P H
authors.initials: PH
authors.lastname: de Mulder
authors.forename: F
authors.initials: F
authors.lastname: Cognetti
authors.forename: J B
authors.initials: JB
authors.lastname: Vermorken
authors.forename: P
authors.initials: P
authors.lastname: Cappelaere
authors.forename: J P
authors.initials: JP
authors.lastname: Armand
authors.forename: J
authors.initials: J
authors.lastname: Wildiers
authors.forename: M
authors.initials: M
authors.lastname: Clavel
authors.forename: A
authors.initials: A
authors.lastname: Kirkpatrick
mesh_terms: D000328:Adult; D000368:Aged; D000630:Aminopterin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D004341:Drug Evaluation; D005260:Female; D005493:Folic Acid Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D000970:Antineoplastic Agents; D005493:Folic Acid Antagonists; C040210:edatrexate; D000630:Aminopterin