一项针对局部晚期 III 期非小细胞肺癌患者，采用口服表没食子儿茶素-3-没食子酸酯进行保护的同步化疗与胸部放疗的 I 期研究。
A phase I study of concurrent chemotherapy and thoracic radiotherapy with oral epigallocatechin-3-gallate protection in patients with locally advanced stage III non-small-cell lung cancer.
作者信息
Zhao Hanxi, Zhu Wanqi, Xie Peng, Li Huiqin, Zhang Xiqin, Sun Xiaorong, Yu Jinming, Xing Ligang
机构信息
Department of Radiation Oncology, Shandong Cancer Hospital, Shandong Academy of Medical Sciences, Jinan, China.
Department of Radiation Oncology, Shandong Cancer Hospital, Shandong Academy of Medical Sciences, Jinan, China.
出版信息
Radiother Oncol. 2014 Jan;110(1):132-6. doi: 10.1016/j.radonc.2013.10.014. Epub 2014 Jan 17.
BACKGROUND AND PURPOSE
Patients with unresectable stage III non-small-cell lung cancer receiving concurrent chemoradiotherapy often develop esophagitis that may lead to unplanned treatment interruptions, which may severely reduce rates of locoregional tumor control and survival. No effectivetreatment that would reduce the incidence and severity of this complication has been identified up to now. Although acceleration of normal tissue protection using epigallocatechin-3-gallate (EGCG) has been reported, its actual clinical practicability remains obscure.
METHODS AND MATERIALS
This is a phase I study of EGCG in combination with standard chemoradiation in surgically unresectable stage III non-small-cell lung cancer. Chemotherapy (cisplatin and etoposide) was given concurrently with radiation. EGCG solution was swallowed three times a day after the occurrence of grade 2 esophagitis at six concentration levels and dose escalation followed a standard phase I design. Esophageal toxicity and patient-reported pain was recorded weekly.
RESULTS
Twenty-four patients with AJCC stage IIIA (six) and IIIB (eighteen) completed the course of therapy. Twelve had squamous histology, ten adenocarcinoma, and two not specified. Patients were treated in six cohorts at six dose levels of EGCG. RT was not interrupted with a median dose of 64 Gy. There were no dose-limiting toxicities reported in all EGCG dosing tiers. Dramatic regression of esophagitis to grade 0/1 was observed in 22 of 24 patients, whereas grade 2 esophagitis persisted in 2 of 24 patients at the end of radiotherapy. The pain score was also reduced from a mean of 4.58 (N=24), 1.29 (N=24), 1.42 (N=24), 0.96 (N=23) to 1.13 (N=16) every week in turn.
CONCLUSION
We conclude that the oral administration of EGCG is feasible, safe and effective. The phase II recommended concentration is 440 μmol/L.
背景与目的
接受同步放化疗的不可切除Ⅲ期非小细胞肺癌患者常发生食管炎，这可能导致计划外的治疗中断，进而严重降低局部区域肿瘤控制率和生存率。目前尚未发现能降低该并发症发生率和严重程度的有效治疗方法。尽管已有报道称表没食子儿茶素-3-没食子酸酯（EGCG）可加速正常组织保护，但其实际临床实用性仍不明确。
方法与材料
这是一项关于EGCG联合标准放化疗用于不可切除Ⅲ期非小细胞肺癌的Ⅰ期研究。化疗（顺铂和依托泊苷）与放疗同步进行。在出现2级食管炎后，EGCG溶液每天分三次服用，共六个浓度水平，剂量递增遵循标准Ⅰ期设计。每周记录食管毒性和患者报告的疼痛情况。
结果
24例美国癌症联合委员会（AJCC）ⅢA期（6例）和ⅢB期（18例）患者完成了治疗疗程。其中12例为鳞状组织学类型，10例为腺癌，2例未明确。患者按六个EGCG剂量水平分为六个队列进行治疗。放疗未中断，中位剂量为64 Gy。在所有EGCG给药剂量组中均未报告剂量限制性毒性。24例患者中有22例食管炎显著消退至0/1级，而放疗结束时24例患者中有2例仍为2级食管炎。疼痛评分也依次从平均4.58（N = 24）、1.29（N = 24）、1.42（N = 24）、0.96（N = 23）降至每周1.13（N = 16）。
结论
我们得出结论，口服EGCG是可行、安全且有效的。Ⅱ期推荐浓度为440μmol/L。
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