title: Cetuximab concomitant with gemcitabine and radiotherapy in advanced squamous cell carcinomas of upper aerodigestive tract: a pilot study.
abstract: OBJECTIVE
  To explore the response and toxicity of advanced non-metastatic squamous cell carcinomas of upper aerodigestive tract (SCC-UADT) to a combination of cetuximab concomitant with gemcitabine and radiotherapy.
  
  
  METHODS
  We managed patients with concomitant treatment of cetuximab (400 mg/m(2) as uploading dose, then 250 mg/m(2), IV) concomitant with gemcitabine (50 mg/m(2)) weekly for seven courses, and radiotherapy in classical fractionation until completion of 70 Gy. Primary endpoints were complete response (CR) to treatment and toxicity. We evaluated patients for toxicity on a weekly basis; evaluation of response included physical examination, endoscopy, computed tomography (CT) scan and biopsy when indicated, and was performed 6 weeks after completion of radiotherapy. Additional evaluations were done every 3 months to document disease status. Between November 2004 and November 2005, 20 patients were included.
  
  
  RESULTS
  CR was 82.4%, overall response was 100%. Neck disease reached CR in 61.5% and partial in 38.5% of patients. The main toxicities were nausea, lymphopenia, neutropenia and mucositis. Grade 3 and 4 side effects were presented in 70.6% of patients, but mucositis, and lymphopenia without clinical repercussions, occurred in 88.2% of patients. Gastrostomy was required in 11.8% of patients to maintain nutrition. Radioepithelitis developed in 76.5%, but only three of these (23.1%) were grade III. Median overall survival was 53 months (range 6-55 months) and median progression-free survival has not yet been reached at the time of evaluation.
  
  
  CONCLUSIONS
  Although toxicity is important, this approach has interesting activity and deserves further investigation.
authors.affiliation: Head and Neck Tumors Department, National Cancer Institute of Mexico (INCan), Mexico City, Mexico. martingranadosmx@yahoo.com.mx
authors.forename: Martín
authors.initials: M
authors.lastname: Granados García
authors.forename: María Fátima
authors.initials: MF
authors.lastname: Chilaca Rosas
authors.forename: Arturo Javier
authors.initials: AJ
authors.lastname: Lavín Lozano
authors.forename: Federico
authors.initials: F
authors.lastname: Maldonado Magos
authors.forename: Mauricio
authors.initials: M
authors.lastname: Frías Mendivil
authors.forename: Gustavo
authors.initials: G
authors.lastname: Cabrera Aquino
authors.forename: Blanca Angélica
authors.initials: BA
authors.lastname: Segura Pacheco
authors.forename: María Montserrat
authors.initials: MM
authors.lastname: Montes Luis
authors.forename: Daniela
authors.initials: D
authors.lastname: Olvera Caraza
authors.forename: José Luis
authors.initials: JL
authors.lastname: Aguilar Ponce
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D000068818:Cetuximab; D003131:Combined Modality Therapy / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068818:Cetuximab; D000093542:Gemcitabine