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卡培他滨在局部晚期头颈部鳞癌同步放化疗中的应用:一项单中心、开放标签、单组、Ⅱ期研究。

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.

机构信息

Department of Clinical Oncology, Christie NHS Foundation Trust, Manchester, UK.

出版信息

Clin Oncol (R Coll Radiol). 2011 Mar;23(2):149-58. doi: 10.1016/j.clon.2010.09.010. Epub 2010 Oct 14.

DOI:10.1016/j.clon.2010.09.010
PMID:20951012
Abstract

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.

摘要

目的

评估同期口服卡培他滨联合加速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。

材料与方法

2001 年至 2004 年间,50 例 III/IV 期 SCCHN(0 至 2 表现状态)患者入组本研究。卡培他滨剂量为 450-550mg/m²,每日 2 次,连续 28 天。放疗剂量为 5500cGy,20 次分割,4 周完成。未使用调强放疗。我们评估完全缓解率、毒性、局部区域控制、总生存率、无病生存率和癌症特异性生存率。

结果

中位年龄为 55 岁(范围 38-76 岁);72%的患者为 IV 期疾病。30 例存活患者的中位随访时间为 6 年。82%的患者完成了卡培他滨疗程,94%的患者完成了规定的放疗。无治疗相关死亡,无 3/4 级血液学或肾功能毒性。5 例患者发生药物相关 3/4 级急性毒性(心脏、皮肤、肠道);47 例患者发生放化疗 3/4 级黏膜炎。22 例(44%)患者需要管饲,1 年时管饲依赖率为 6%。3 个月时完全缓解率为 90%(50 例患者中有 45 例)。5 年内,50 例患者中有 17 例(34%)复发。3 年时的局部区域控制、总生存率、癌症特异性生存率和无病生存率分别为 78%、72%、82%和 62%,5 年时分别为 72%、64%、75%和 56%。

结论

这种局部晚期 SCCHN 的同步卡培他滨方案耐受性良好。本系列的局部控制与其他同步放化疗报告相比具有优势。采用这种方法,慢性吞咽困难和管饲依赖并不常见。卡培他滨作为靶向治疗,与每次放疗分次同时给予,并口服给药,与静脉给予、每周 3 次顺铂相比可能具有显著优势。

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