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

Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1308-16. doi: 10.1016/j.ijrobp.2005.10.039. Epub 2006 Feb 7.


Purpose: 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.

Patients and 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Carboplatin / administration & dosage
  • Combined Modality Therapy / methods
  • Dose Fractionation, Radiation
  • Drug Administration Schedule
  • Female
  • Fluorouracil / administration & dosage
  • Granulocyte Colony-Stimulating Factor / therapeutic use
  • Hemoglobin A / analysis
  • Humans
  • Hypopharyngeal Neoplasms / blood
  • Hypopharyngeal Neoplasms / drug therapy*
  • Hypopharyngeal Neoplasms / radiotherapy*
  • Male
  • Middle Aged
  • Oropharyngeal Neoplasms / blood
  • Oropharyngeal Neoplasms / drug therapy*
  • Oropharyngeal Neoplasms / radiotherapy*
  • Prognosis
  • Regression Analysis
  • Survival Analysis
  • Treatment Outcome


  • Granulocyte Colony-Stimulating Factor
  • Hemoglobin A
  • Carboplatin
  • Fluorouracil