title: Concurrent chemoradiation with weekly cisplatin, docetaxel and gefitinib: A study to assess feasibility, toxicity and immediate response.
abstract: OBJECTIVE
  Addition of docetaxel in the treatment regimen has shown improvement in survival of head and neck squamous cell carcinoma (HNSCC) patients. This study was conducted to evaluate the maximum tolerated dose of weekly docetaxel when combined with concurrent administration of weekly cisplatin, daily gefitinib, and radiation therapy.
  
  
  METHODS
  21 patients with newly diagnosed HNSCC were included. Radiation therapy was planned to a dose of 66 Gy/33 fractions. Doses of cisplatin and gefitinib were kept constant at 30 mg/m(2) and 250 mg respectively. Dose of weekly docetaxel started with 5 mg/m(2) and escalated 5 mg/m(2) up to a maximum of 20 mg/m 2 . Serious adverse event was defined as grade 3/4 hematological and non-hematological toxicities.
  
  
  RESULTS
  All patients (three in dose level 1 [5 mg/m(2)], level 2 [10 mg/m(2)] and level 3 [15 mg/m(2)]) did not experience any hematological serious adverse events. Weekly docetaxel of 20 mg/m(2) could not be tolerated with the combination, and we encountered two hematological (neutropenia) serious grade 4 adverse event and one grade 3 mucositis at level 4. Six patients were treated by omitting week 3 chemotherapy reducing the number of weekly cycles to a minimum of four. Gefitinib was continued throughout the treatment period. All patients tolerated the treatment well although with grade 2 hematological/non hematological toxicities.
  
  
  CONCLUSIONS
  The maximal tolerated dose of weekly docetaxel added to weekly cisplatin and daily gefitinib during concurrent chemoradiation is 15 mg/m(2). Toxicity profile is tolerable with a break in the chemotherapy regimen during radiation therapy. Aggressive nutritional support is essential prior to this regimen.
authors.affiliation: Department of Medical Oncology, Madras Medical College, Chennai, Tamil Nadu, India.
authors.forename: Prasad
authors.initials: P
authors.lastname: Eswaran
authors.forename: Kumaravelu S
authors.initials: KS
authors.lastname: Azmi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D000077156:Gefitinib; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage; D000077195:Squamous Cell Carcinoma of Head and Neck; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D011799:Quinazolines; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D000077156:Gefitinib