title: Induction chemotherapy with docetaxel, cisplatin and capecitabine, followed by combined cetuximab and radiotherapy in patients with locally advanced inoperable squamous cell carcinoma of the head and neck: a phase I-II study.
abstract: OBJECTIVE
  To replace 5-fluorouracil with capecitabine within a trial of induction chemotherapy followed by cetuximab plus radiotherapy (RT) in patients with locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN). Also, to replace cisplatin with cetuximab after induction chemotherapy.
  
  
  METHODS
  Docetaxel and cisplatin were given at 75 mg/m(2), while capecitabine was initially given at 500 mg/m(2) twice a day and subsequently escalated. The maximum tolerated dose was used for the phase II study.
  
  
  RESULTS
  Seven patients were enrolled. At dose level 1, two dose-limiting toxicities were observed in the first 4 patients (grade 4 neutropenia and grade 3 diarrhea). In both patients, capecitabine was withdrawn and toxicities resolved. Dose escalation was halted and a lower capecitabine dose (750 mg/m(2) daily) was selected. Two complete responses and five partial responses were observed after induction chemotherapy. Four patients were evaluable for response after cetuximab-RT (3 complete response and 1 partial response).
  
  
  CONCLUSIONS
  Combined chemoradiotherapy is still the gold standard in LA SCCHN and no studies currently support the use of early induction chemotherapy. Our study did not contribute toward addressing this issue since it was discontinued early because of toxicity.
authors: Head and Neck Medical Oncology Unit, National Tumor Institute of Naples, Naples, Italy. francesco.perri80@alice.it
authors: Francesco
authors: F
authors: Perri
authors: Paolo
authors: P
authors: Muto
authors: Angela
authors: A
authors: Argenone
authors: Franco
authors: F
authors: Ionna
authors: Francesco
authors: F
authors: Longo
authors: Franco
authors: F
authors: Fulciniti
authors: Fabio
authors: F
authors: Sandomenico
authors: Antonio
authors: A
authors: Daponte
authors: Francesco
authors: F
authors: Caponigro
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D000068818:Cetuximab; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D000077195:Squamous Cell Carcinoma of Head and Neck; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D000068818:Cetuximab; D002945:Cisplatin; D005472:Fluorouracil