title: Phase II trial: concurrent radio-chemotherapy with weekly docetaxel for advanced squamous cell carcinoma of head and neck.
abstract: BACKGROUND
  Standard fractionation radiation therapy (RT) combined with concomitant chemotherapy (CT) based on cisplatin schemes is actually the standard treatment for locally advanced non-resectable squamous cell carcinoma of head and neck (SCCHN). The appearance of taxoids has introduced a new kind of treatment with high antitumoral power. The aim of this study is to add more information about the role of this new approach.
  
  
  METHODS
  Twenty-six patients with locally advanced non-resectable SCCHN were recruited at six institutions in Spain, between January 2001 and January 2003. Docetaxel was administered weekly, for 6 weeks, concurrently with RT.
  
  
  RESULTS
  The mean total delivered dose of RT was 70'2 Gy (range 64-74 Gy). The median and mean duration of time were 63 days and 61 days (range 49-103 days) respectively. After a median time control of 19 months (range 3.3-42.2 months), the response rate was 83.4%. The median time to local progression was 16.4 months (95% confidence interval [CI]=4.4-28.4 months). The median survival time was 26.9 months, with one- and two-year overall survival of 66.9% (95% CI=48.1-85.7%) and 57.5% (95% CI=37.3-77.7%) respectively. The median duration time response was 15.1 months (95% CI=3.7-26.5 months). The median time until treatment failure was 9.4 months (95% CI=4.7-14.1). Incidence of grade III-IV mucositis was 88%, neutropenia 72% and skin toxicity 92% (24% grade III-IV). The incidence of severe late toxicity (grade III and IV) due to RT/CT was 31.4%.
  
  
  CONCLUSIONS
  Although therapeutics results are equivalent to cisplatin schemes of concurrent CT-RT, mucositis and cutaneous toxicity registered in this trial must be considered as limiting factors to application of this new approach.
authors.affiliation: Servicio de Oncología Radioterápica, Institut Clínic de Malaties Hemato-Oncològiques (ICMHO), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. abiete@clinic.ub.es
authors.forename: A
authors.initials: A
authors.lastname: Biete Solà
authors.forename: J
authors.initials: J
authors.lastname: Marruecos Querol
authors.forename: F A
authors.initials: FA
authors.lastname: Calvo Manuel
authors.forename: E
authors.initials: E
authors.lastname: Verger Fransoy
authors.forename: A
authors.initials: A
authors.lastname: Rovirosa Casino
authors.forename: J J
authors.initials: JJ
authors.lastname: Grau de Castro
authors.forename: M
authors.initials: M
authors.lastname: de Las Heras González
authors.forename: A
authors.initials: A
authors.lastname: Ramos Aguerri
authors.forename: A
authors.initials: A
authors.lastname: Palacios Eito
authors.forename: C
authors.initials: C
authors.lastname: Veiras Candal
authors.forename: Maria V
authors.initials: MV
authors.lastname: Solano López
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D016001:Confidence Intervals; D000077143:Docetaxel; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D017567:Karnofsky Performance Status; D007822:Laryngeal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D007830:Larynx / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009378:Neoplasms, Multiple Primary / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy; D010610:Pharyngeal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D010614:Pharynx / Q000473:pathology; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel