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).
Int J Radiat Oncol Biol Phys
; 64(4): 983-94, 2006 Mar 15.
Article
en En
| MEDLINE
| ID: mdl-16376489
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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Bases de datos:
MEDLINE
Asunto principal:
Carcinoma de Células Escamosas
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Protocolos de Quimioterapia Combinada Antineoplásica
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Neoplasias Faríngeas
Tipo de estudio:
Clinical_trials
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Observational_studies
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Risk_factors_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Europa
Idioma:
En
Revista:
Int J Radiat Oncol Biol Phys
Año:
2006
Tipo del documento:
Article
País de afiliación:
Francia