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.
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.
Semrau
Robert
R
Department of Radiation Oncology, University of Cologne, Cologne, Germany. Robert.Semrau@uk-koeln.de
Mueller
Rolf-Peter
RP
Stuetzer
Hartmut
H
Staar
Susanne
S
Schroeder
Ursula
U
Guntinas-Lichius
Orlando
O
Kocher
Martin
M
Eich
Hans Theodor
HT
Dietz
Andreas
A
Flentje
Michael
M
Rudat
Volker
V
Volling
Peter
P
Schroeder
Michael
M
Eckel
Hans Edmund
HE
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
D016179:Granulocyte Colony-Stimulating Factor; D006441:Hemoglobin A; D016190:Carboplatin; D005472:Fluorouracil