French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC)

Journal Article · Wed Mar 15 00:00:00 EST 2006 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/J.IJROBP.2005.0· OSTI ID:20793373

Bensadoun, Rene-Jean ^[1]; Benezery, Karen ^[1]; Dassonville, Olivier ^[2]; Magne, Nicolas ^[1]; Poissonnet, Gilles ^[2]; Ramaioli, Alain ^[3]; Lemanski, Claire ^[4]; Bourdin, Sylvain ^[5]; Tortochaux, Jacques ^[6]; Peyrade, Frederic ^[7]; Marcy, Pierre-Yves ^[8]; Chamorey, Emmanuel Phar ^[3]; Vallicioni, Jacques ^[2]; Hang, Seng ^[9]; Alzieu, Claude ^[10]; Gery, Bernard ^[11]; Chauvel, Pierre ^[1]; Schneider, Maurice ^[7]; Santini, Jose ^[12]; Demard, Francois ^[2] ; Calais, Gilles ^[13]

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1. Department of Radiation Oncology, Centre Antoine Lacassagne, Nice (France)
2. Department of Head and Neck Surgery, Centre Antoine Lacassagne, Nice (France)
3. Department of Statistics Unit, Centre Antoine Lacassagne, Nice (France)
4. Centre Val d'Aurelle-Paul Lamarque, Montpellier (France)
5. Centre Rene-Gauducheau, Nantes (France)
6. Centre Jean-Perrin, Clermont-Ferrand (France)
7. Department of Medical Oncology, Centre Antoine Lacassagne, Nice (France)
8. Department of Radiology, Centre Antoine Lacassagne, Nice (France)
9. Centre Henri-Becquerel, Rouen (France)
10. Institut Paoli-Calmettes, Marseille (France)
11. Centre Francois-Baclesse, Caen (France)
12. Department of Otolaryngology, University Hospital, Nice (France)
13. Hopital Jean Bretonneau, Tours (France)

Background: Unresectable carcinomas of the oropharynx and hypopharynx still have a poor long-term prognosis. Following a previous phase II study, this phase III multicenter trial was conducted between November 1997 and March 2002. Methods: Nontreated, strictly unresectable cases were eligible. Twice-daily radiation: two fractions of 1.2 Gy/day, 5 days per week, with no split (D1{sup {yields}}D46). Total tumor doses: 80.4 Gy/46 day (oropharynx), 75.6 Gy/44 day (hypopharynx). Chemotherapy (arm B): Cisplatin 100 mg/m{sup 2} (D1, D22, D43); 5FU, continuous infusion (D1{sup {yields}}D5), 750 mg/m{sup 2}/day cycle 1; 430 mg/m{sup 2}/day cycles 2 and 3. Results: A total of 163 evaluable patients. Grade 3-4 acute mucositis 82.6% arm B/69.5% arm A (NS); Grade 3-4 neutropenia 33.3% arm B/2.4% arm A (p < 0.05). Enteral nutrition through gastrostomy tube was more frequent in arm B before treatment and at 6 months (p < 0.01). At 24 months, overall survival (OS), disease-free survival (DFS), and specific survival (SS) were significantly better in arm B. OS: 37.8% arm B vs. 20.1% arm A (p = 0.038); DFS: 48.2% vs. 25.2% (p = 0.002); SS: 44.5% vs. 30.2% (p 0.021). No significant difference between the two arms in the amount of side effects at 1 and 2 years. Conclusion: For these unresectable cases, chemoradiation provides better outcome than radiation alone, even with an 'aggressive' dose-intensity radiotherapy schedule.

• OSTI ID: 20793373
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Vol. 64, Issue 4; Other Information: DOI: 10.1016/j.ijrobp.2005.09.041; PII: S0360-3016(05)02712-4; Copyright (c) 2006 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
ARMS
CARCINOMAS
CHEMOTHERAPY
CLINICAL TRIALS
INFUSION
NUTRITION
PATIENTS
RADIOTHERAPY
SIDE EFFECTS
URACILS