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)
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DOI：
10.1016/j.ijrobp.2005.09.041
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发表时间：
2006-03-15
影响因子：
7
通讯作者：
Calais, G
中科院分区：
文献类型：
--
作者：
Bensadoun, RJ;Bénézery, K;Calais, G
背景：不能切除的口咽部和下咽部癌的长期预后仍然很差。本研究是在1997年11月至2002年3月间进行的一项II期临床试验的基础上进行的。每日两次放疗：1.2戈伊/天，每周5天，分两次（D1->D46）。肿瘤总剂量：80.4戈伊/46天（口咽），75.6戈伊/44天（下咽）。化疗（B组）：顺铂100 mg/m2（D1，D22，D43）; 5 FU，持续滴注（D1->D5），750 mg/m2/d，第1周期; 430 mg/m2/d，第2、3周期。3-4级急性粘膜炎B组82.6%/A组69.5%（NS）; 3-4级中性粒细胞减少B组33.3%/A组2.4%（p < 0.05）。B组在治疗前和治疗6个月时通过胃造口管进行肠内营养的频率更高（p < 0.01）。24个月时，B组的总生存期（OS）、无病生存期（DFS）和特异性生存期（SS）显著更好。OS：B组37.8% vs. A组20.1%（p = 0.038）; DFS：48.2% vs. 25.2%（p = 0.002）; SS：44.5% vs. 30.2%（p = 0.021）。两组在1年和2年时的副作用数量没有显着差异。结论：对于这些不可切除的病例，即使采用“积极”剂量强度放疗方案，放化疗也比单独放疗提供更好的结局。(C)2006年爱思唯尔公司
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/m(2) (D1, D22, D43); 5FU, continuous infusion (D1-->D5), 750 mg/m(2)/day cycle 1; 430 mg/m(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. (C) 2006 Elsevier Inc.