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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).
- 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.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Carcinoma, Squamous Cell secondary
Carcinoma, Squamous Cell surgery
Cisplatin administration & dosage
Cisplatin adverse effects
Combined Modality Therapy adverse effects
Combined Modality Therapy methods
Dose Fractionation, Radiation
Female
Fluorouracil administration & dosage
Fluorouracil adverse effects
France
Humans
Hypopharyngeal Neoplasms drug therapy
Hypopharyngeal Neoplasms radiotherapy
Hypopharyngeal Neoplasms surgery
Male
Middle Aged
Neck Dissection
Neoplasm Recurrence, Local
Oropharyngeal Neoplasms drug therapy
Oropharyngeal Neoplasms radiotherapy
Oropharyngeal Neoplasms surgery
Pharyngeal Neoplasms surgery
Prospective Studies
Survival Analysis
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Carcinoma, Squamous Cell drug therapy
Carcinoma, Squamous Cell radiotherapy
Pharyngeal Neoplasms drug therapy
Pharyngeal Neoplasms radiotherapy
Subjects
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