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)

doi:10.1016/J.IJROBP.2005.0

Title: 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)

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Abstract

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 1more »« less

Authors:

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

Department of Radiation Oncology, Centre Antoine Lacassagne, Nice (France). E-mail: rene-jean.bensadoun@nice.fnclcc.fr
Department of Radiation Oncology, Centre Antoine Lacassagne, Nice (France)
Department of Head and Neck Surgery, Centre Antoine Lacassagne, Nice (France)
Department of Statistics Unit, Centre Antoine Lacassagne, Nice (France)
Centre Val d'Aurelle-Paul Lamarque, Montpellier (France)
Centre Rene-Gauducheau, Nantes (France)
Centre Jean-Perrin, Clermont-Ferrand (France)
Department of Medical Oncology, Centre Antoine Lacassagne, Nice (France)
Department of Radiology, Centre Antoine Lacassagne, Nice (France)
Centre Henri-Becquerel, Rouen (France)
Institut Paoli-Calmettes, Marseille (France)
Centre Francois-Baclesse, Caen (France)
Department of Otolaryngology, University Hospital, Nice (France)
Hopital Jean Bretonneau, Tours (France)

Publication Date:: Wed Mar 15 00:00:00 EST 2006

OSTI Identifier:: 20793373

Resource Type:: Journal Article

Resource Relation:: Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 64; Journal 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)

Country of Publication:: United States

Language:: English

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

Citation Formats


                    Bensadoun, Rene-Jean, Benezery, Karen, Dassonville, Olivier, Magne, Nicolas, Poissonnet, Gilles, Ramaioli, Alain, Lemanski, Claire, Bourdin, Sylvain, Tortochaux, Jacques, Peyrade, Frederic, Marcy, Pierre-Yves, Chamorey, Emmanuel Phar, Vallicioni, Jacques, Seng Hang, Alzieu, Claude, Gery, Bernard, Chauvel, Pierre, Schneider, Maurice, Santini, Jose, Demard, Francois, and Calais, Gilles. 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).  United States: N. p., 2006. 
        Web.  doi:10.1016/J.IJROBP.2005.0.

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                    Bensadoun, Rene-Jean, Benezery, Karen, Dassonville, Olivier, Magne, Nicolas, Poissonnet, Gilles, Ramaioli, Alain, Lemanski, Claire, Bourdin, Sylvain, Tortochaux, Jacques, Peyrade, Frederic, Marcy, Pierre-Yves, Chamorey, Emmanuel Phar, Vallicioni, Jacques, Seng Hang, Alzieu, Claude, Gery, Bernard, Chauvel, Pierre, Schneider, Maurice, Santini, Jose, Demard, Francois, & Calais, Gilles. 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).  United States.  doi:10.1016/J.IJROBP.2005.0.

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                    Bensadoun, Rene-Jean, Benezery, Karen, Dassonville, Olivier, Magne, Nicolas, Poissonnet, Gilles, Ramaioli, Alain, Lemanski, Claire, Bourdin, Sylvain, Tortochaux, Jacques, Peyrade, Frederic, Marcy, Pierre-Yves, Chamorey, Emmanuel Phar, Vallicioni, Jacques, Seng Hang, Alzieu, Claude, Gery, Bernard, Chauvel, Pierre, Schneider, Maurice, Santini, Jose, Demard, Francois, and Calais, Gilles. Wed .  
        "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)".  United States.  
        doi:10.1016/J.IJROBP.2005.0.

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@article{osti_20793373,

  title        = {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)},

  author       = {Bensadoun, Rene-Jean and Benezery, Karen and Dassonville, Olivier and Magne, Nicolas and Poissonnet, Gilles and Ramaioli, Alain and Lemanski, Claire and Bourdin, Sylvain and Tortochaux, Jacques and Peyrade, Frederic and Marcy, Pierre-Yves and Chamorey, Emmanuel Phar and Vallicioni, Jacques and Seng Hang and Alzieu, Claude and Gery, Bernard and Chauvel, Pierre and Schneider, Maurice and Santini, Jose and Demard, Francois and Calais, Gilles},

  abstractNote = {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.},

  doi          = {10.1016/J.IJROBP.2005.0},

  journal      = {International Journal of Radiation Oncology, Biology and Physics},

  number       = 4,

  volume       = 64,

  place        = {United States},

  year         = {Wed Mar 15 00:00:00 EST 2006},

  month        = {Wed Mar 15 00:00:00 EST 2006}

}

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DOI: 10.1016/J.IJROBP.2005.0

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