Synchronous Chemoradiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck using Capecitabine: a Single-centre, Open-label, Single-group Phase II Study
Synchronous Chemoradiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck using Capecitabine: a Single-centre, Open-label, Single-group Phase II Study
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DOI：
10.1016/j.clon.2010.09.010
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发表时间：
2011-03-01
影响因子：
3.4
通讯作者：
Slevin, N.
中科院分区：
文献类型：
--
作者：
Jegannathen, A.;Mais, K.;Slevin, N.
目的：评价卡培他滨同步口服联合加速低分割根治性放疗治疗局部晚期头颈部鳞状细胞癌(SCCHN)的疗效。材料和方法：2001年至2004年，50例III/IV期(0~2级)头颈部鳞状细胞癌患者纳入本研究。卡培他滨剂量450~550 mg/m~2，每日2次，连续28天。放射治疗剂量5500cGy20次/次，疗程4周。没有使用强度调制辐射。我们评估了完全缓解率、毒性、局部控制率、总生存率、无病生存率和癌症特异性生存率。结果：中位年龄55岁(范围38-76岁)；72%为IV期疾病。30例存活患者的中位随访期为6年。82%的患者完成了卡培他滨的疗程，94%的患者完成了处方放射治疗。没有与治疗相关的死亡，没有3/4级血液学或肾脏毒性。5名患者出现与药物有关的3/4级急性毒性(心脏、皮肤、肠道)；47名患者因化疗和放射治疗而出现3/4级粘膜炎。22例(44%)患者需要管饲，1年时管子依赖率为6%。3个月时完全缓解率为90%(45/50例)。5年后复发率为34%(17/50)。局部区域控制率、总生存率、肿瘤特异性生存率和无瘤生存率3年分别为78%、72%、82%和62%，5年后分别为72%、、75%和56%。结论：卡培他滨同步方案治疗局部晚期SCCHN是安全的。与其他同步放化疗报告相比，本系列中的局部对照效果更好。慢性吞咽困难和管子依赖在这种方法中并不常见。卡培他滨作为靶向治疗，与每周3次的静脉注射顺铂相比，可能具有显著的优势。(C)2010年皇家放射科医师学会。爱思唯尔有限公司出版。保留所有权利。
Aim: To evaluate the efficacy of concurrent oral capecitabine with accelerated hypofractionated radical radiotherapy in locally advanced squamous cell carcinoma of the head and neck (SCCHN).Materials and methods: Between 2001 and 2004, 50 patients with stage III/IV SCCHN (0 to 2 performance status) were enrolled into this study. The capecitabine dose was between 450 and 550 mg/m(2) twice daily, continuously for 28 days. The radiotherapy dose was 5500 cGy in 20 fractions over 4 weeks. No intensity-modulated radiation was used. We evaluated the complete response rate, toxicity, locoregional control, overall survival, disease-free survival and cancer-specific survival.Results: The median age was 55 (range 38-76) years; 72% had stage IV disease. The median follow-up was 6 years on the 30 surviving patients. Eighty-two per cent of patients completed the course of capecitabine and 94% completed prescribed radiotherapy. There were no treatment-related deaths, grade 3/4 haematological or renal toxicity. Five patients developed drug-related grade 3/4 acute toxicity (cardiac, skin, bowel); 47 developed grade 3/4 mucositis from chemoradiotherapy. Twenty-two (44%) patients required tube feeding and the tube dependency rate at 1 year was 6%. The complete response rate at 3 months was 90% (45/50 patients). Relapse occurred in 17/50 (34%) patients by 5 years. The locoregional control, overall survival, cancer-specific survival and disease-free survival rates at 3 years were 78, 72, 82 and 62%, respectively, and at 5 years were 72, 64, 75 and 56%, respectively.Conclusion: This schedule of synchronous capecitabine for locally advanced SCCHN is well tolerated. The local control in this series compares favourably with other synchronous chemoradiotherapy reports. Chronic dysphagia and tube dependence is uncommon with this approach. Capecitabine as targeted therapy given with each fraction of radiotherapy and administered orally may have significant advantages over intravenous, 3 weekly cisplatin. (C) 2010 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.