title: Evaluation of Tomudex in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: a Southwest Oncology Group study.
abstract: A phase II trial of Tomudex (raltitrexed, ZD 1694), a new thymidylate synthase inhibitor, was performed in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. This trial demonstrated that Tomudex was well tolerated in this patient population. Nausea and vomiting were minimal, and hematologic toxicities were relatively infrequent. Only one patient was withdrawn from the study due to toxicity (grade 4 diarrhea). One patient exsanguinated from a rent in the carotid artery in an area of tumor involvement, and was categorized as a grade 5 toxicity. Thus 25/27 patients were able to complete at least 2 cycles of treatment. Tomudex demonstrated a 3.7% response rate (95% CI 0.1-19%), with a median survival of 6 months in this highly resistant disease population. Tomudex is not considered active enough as monotherapy for further evaluation in this disease population.
authors.affiliation: University of Utah Medical Center, Salt Lake City, USA.
authors.forename: W E
authors.initials: WE
authors.lastname: Samlowski
authors.forename: D
authors.initials: D
authors.lastname: Lew
authors.forename: P J
authors.initials: PJ
authors.lastname: Kuebler
authors.forename: M A
authors.initials: MA
authors.lastname: Kolodziej
authors.forename: J E
authors.initials: JE
authors.lastname: Medina
authors.forename: K F
authors.initials: KF
authors.lastname: Mangan
authors.forename: D F
authors.initials: DF
authors.lastname: Moore
authors.forename: D E
authors.initials: DE
authors.lastname: Schuller
authors.forename: J F
authors.initials: JF
authors.lastname: Ensley
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011799:Quinazolines / Q000627:therapeutic use*; D016019:Survival Analysis; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D011799:Quinazolines; D013876:Thiophenes; C068874:raltitrexed