title: Efficacy of intensified hyperfractionated and accelerated radiotherapy and concurrent chemotherapy with carboplatin and 5-fluorouracil: updated results of a randomized multicentric trial in advanced head-and-neck cancer.
abstract: OBJECTIVE
  To prove an expected benefit of concurrent radiochemotherapy (RCT), a two-arm randomized multicentric study was performed. In a subgroup analysis the influence of pretherapeutical hemoglobin level (p-Hb) on survival under locoregional control (SLC) was tested.
  
  
  METHODS
  The study included primarily untreated Stage III/IV (International Union Against Cancer [UICC]) oropharyngeal and hypopharyngeal carcinomas. Patients were randomized to receive either hyperfractionated (hf) and accelerated (acc) RCT with two cycles 5-fluorouracil (600 mg/m(2)/day) and carboplatin (70 mg/m(2)/day) on Days 1-5 and 29-33 or hf-acc radiotherapy (RT) alone. Total RT dose in both arms was 69.9 Gy in 38 days in concomitant boost technique.
  
  
  RESULTS
  After a median follow-up time of 57 months, SLC is significantly better in RCT than in RT (p = 0.01), with median SLC of 17 months and 11 months, respectively. Also overall survival (OS) shows a benefit for RCT (p = 0.016), with a median survival of 23 months for RCT and 16 months for RT. However, the benefit in SLC and OS is not seen in hypopharyngeal carcinomas. In a multivariate analysis of oropharyngeal cancer patients, p-Hb levels lower than 12.7 g/dL resulted in lower SLC compared with higher p-Hb levels up to 13.8 g/dL. P-Hb levels >13.8 g/dL did not further improve SLC.
  
  
  CONCLUSIONS
  Hyperfractionated-accelerated RCT is superior to hf-acc RT in oropharyngeal carcinomas. P-Hb levels >13.8 g/dL do not further improve SLC.
authors.affiliation: Department of Radiation Oncology, University of Cologne, Cologne, Germany. Robert.Semrau@uk-koeln.de
authors.forename: Robert
authors.initials: R
authors.lastname: Semrau
authors.forename: Rolf-Peter
authors.initials: RP
authors.lastname: Mueller
authors.forename: Hartmut
authors.initials: H
authors.lastname: Stuetzer
authors.forename: Susanne
authors.initials: S
authors.lastname: Staar
authors.forename: Ursula
authors.initials: U
authors.lastname: Schroeder
authors.forename: Orlando
authors.initials: O
authors.lastname: Guntinas-Lichius
authors.forename: Martin
authors.initials: M
authors.lastname: Kocher
authors.forename: Hans Theodor
authors.initials: HT
authors.lastname: Eich
authors.forename: Andreas
authors.initials: A
authors.lastname: Dietz
authors.forename: Michael
authors.initials: M
authors.lastname: Flentje
authors.forename: Volker
authors.initials: V
authors.lastname: Rudat
authors.forename: Peter
authors.initials: P
authors.lastname: Volling
authors.forename: Michael
authors.initials: M
authors.lastname: Schroeder
authors.forename: Hans Edmund
authors.initials: HE
authors.lastname: Eckel
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000379:methods; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006441:Hemoglobin A / Q000032:analysis; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009959:Oropharyngeal Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000532:radiotherapy*; D011379:Prognosis; D012044:Regression Analysis; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D006441:Hemoglobin A; D016190:Carboplatin; D005472:Fluorouracil