title: Radioimmunotherapy in patients with head and neck squamous cell carcinoma: initial experience.
abstract: BACKGROUND
  Despite improvements in locoregional treatment of stages III/IV squamous cell carcinoma of the head and neck (HNSCC), local and distant failure rates remain high. An effective adjuvant therapy is required for these patients. Among novel approaches is radioimmunotherapy, in which monoclonal antibodies (MAbs) are used for selective delivery of radiation to tumor cells.
  
  
  METHODS
  The suitability of 186Re-labeled chimeric MAb U36 (186Re-cMAb U36) for radioimmunotherapy was evaluated in a phase I study, with radiation dose escalating steps of 11, 27, and 41 mCi/m2. Tumor targeting was monitored with a gamma camera, and the maximum tolerated dose was established in 13 patients with recurrent or metastatic disease.
  
  
  RESULTS
  Administrations were well tolerated, and excellent targeting of tumor lesions was seen. Myelotoxicity was the only toxicity observed, resulting in dose-limiting toxicity in two patients treated with 41 mCi/m2. The MTD was established at 27 mCi/m2. A marked reduction in tumor size was observed in two patients, another showed stable disease for 6 months.
  
  
  CONCLUSIONS
  Radioimmunotherapy with 186Re-cMAb U36 seems to be well tolerated, with bone marrow being the dose-limiting organ. The observation of antitumor effects is encouraging for further development of radioimmunotherapy for HNSCC.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, University Hospital Vrije Universiteit, De Boelelaan 1117, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
authors.forename: D R
authors.initials: DR
authors.lastname: Colnot
authors.forename: J J
authors.initials: JJ
authors.lastname: Quak
authors.forename: J C
authors.initials: JC
authors.lastname: Roos
authors.forename: R
authors.initials: R
authors.lastname: de Bree
authors.forename: A J
authors.initials: AJ
authors.lastname: Wilhelm
authors.forename: G B
authors.initials: GB
authors.lastname: Snow
authors.forename: G A
authors.initials: GA
authors.lastname: van Dongen
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy*; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000532:radiotherapy; D016499:Radioimmunotherapy; D011868:Radioisotopes / Q000493:pharmacokinetics / Q000627:therapeutic use; D011879:Radiotherapy Dosage; D011993:Recombinant Fusion Proteins; D012211:Rhenium / Q000493:pharmacokinetics / Q000627:therapeutic use; D015899:Tomography, Emission-Computed, Single-Photon
chemical_list: D000911:Antibodies, Monoclonal; D011868:Radioisotopes; D011993:Recombinant Fusion Proteins; D012211:Rhenium