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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).

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).

Authors :
Bensadoun RJ
Bénézery K
Dassonville O
Magné N
Poissonnet G
Ramaïoli A
Lemanski C
Bourdin S
Tortochaux J
Peyrade F
Marcy PY
Chamorey E
Vallicioni J
Seng H
Alzieu C
Géry B
Chauvel P
Schneider M
Santini J
Demard F
Calais G
Source :
International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2006 Mar 15; Vol. 64 (4), pp. 983-94. Date of Electronic Publication: 2006 Jan 10.
Publication Year :
2006

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.<br />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.<br />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.<br />Conclusion: For these unresectable cases, chemoradiation provides better outcome than radiation alone, even with an "aggressive" dose-intensity radiotherapy schedule.

Details

Language :
English
ISSN :
0360-3016
Volume :
64
Issue :
4
Database :
MEDLINE
Journal :
International journal of radiation oncology, biology, physics
Publication Type :
Academic Journal
Accession number :
16376489
Full Text :
https://doi.org/10.1016/j.ijrobp.2005.09.041