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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).

René-Jean Bensadoun·Karen Bénézery·Olivier Dassonville·Nicolas Magné·Gilles Poissonnet·Alain Ramaïoli·Claire Lemanski·Sylvain Bourdin·Jacques Tortochaux·Frédéric Peyrade·Pierre-Yves Marcy·Emmanuel Chamorey·Jacques Vallicioni·Hang Seng·Claude Alzieu·Bernard Géry·Pierre Chauvel·Maurice Schneider·José Santini·François Demard·Gilles Calais
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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-->D46). Total tumor doses: 80.4 Gy/46 day (oropharynx), 75.6 Gy/44 day (hypopharynx). Chemotherapy (arm B): Cisplatin 100 mg/m2 (D1, D22, D43); 5FU, continuous infusion (D1-->D5), 750 mg/m2/day cycle 1; 430 mg/m2/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.

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AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCisplatinCombined Modality TherapyDose Fractionation, RadiationFemaleFluorouracilFranceHumansHypopharyngeal NeoplasmsMaleMiddle AgedNeck DissectionNeoplasm Recurrence, LocalOropharyngeal NeoplasmsPharyngeal NeoplasmsProspective StudiesSurvival AnalysisClinical Trial, Phase IIIJournal ArticleMulticenter StudyRandomized Controlled Trial

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René-Jean Bensadoun, Karen Bénézery, Olivier Dassonville, Nicolas Magné, Gilles Poissonnet, Alain Ramaïoli, Claire Lemanski, Sylvain Bourdin, Jacques Tortochaux, Frédéric Peyrade, Pierre-Yves Marcy, Emmanuel Chamorey, Jacques Vallicioni, Hang Seng, Claude Alzieu, Bernard Géry, Pierre Chauvel, Maurice Schneider, José Santini, François Demard, Gilles Calais. 2006-01-10. 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).. https://doi.org/10.1016/j.ijrobp.2005.09.041

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