Phase I study of photodynamic therapy using talaporfin sodium and diode laser for local failure after chemoradiotherapy for esophageal cancer.
Phase I study of photodynamic therapy using talaporfin sodium and diode laser for local failure after chemoradiotherapy for esophageal cancer.
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DOI：
10.1186/1748-717x-7-113
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发表时间：
2012-07-23
期刊：
影响因子：
--
通讯作者：
Iishi H
中科院分区：
文献类型：
--
作者：
Yano T;Muto M;Yoshimura K;Niimi M;Ezoe Y;Yoda Y;Yamamoto Y;Nishisaki H;Higashino K;Iishi H
光动力学疗法（PDT）是食管癌放化疗后局部失败的一种微创、有效的补救治疗方法，但其皮肤光毒性发生率高，且需要长时间的遮阳。他拉泊芬钠是一种快速清除的光敏剂，预期光毒性较小。本研究旨在阐明食管癌CRT或放疗（RT）后局部失败患者使用他拉泊芬钠和二极管激光进行PDT的最佳激光能量密度率。这项I期激光剂量递增研究在CRT或RT（≥ 50戈伊）后局部衰竭限于T2的患者中，在照射前4 - 6小时静脉注射固定剂量（40 mg/m2）的他拉泊芬钠。主要终点是评估PDT的剂量限制性毒性（DLT），次要终点是评估PDT相关的不良事件和毒性。664 nm二极管激光器的起始能量密度为50 J/cm 2，逐步增加计划为75 J/cm 2和100 J/cm 2。9例CRT或RT治疗ESCC后局部失败的患者入组，3人一组治疗至第三剂量水平。在任何剂量水平下均未观察到DLT。未观察到光毒性，但1例受试者出现1级发热，3例出现1级食管痛，1例出现1级吞咽困难。9例患者中有5例（55.6%）在PDT后获得完全缓解。PDT使用他拉泊芬钠和半导体激光是安全的局部失败后，食管癌患者的RT。以下II期研究的推荐能量密度为100 J/cm 2。
Photodynamic therapy (PDT) is a less invasive and effective salvage treatment for local failure after chemoradiotherapy (CRT) for esophageal cancer, however it causes a high rate of skin phototoxicity and requires a long sun shade period. Talaporfin sodium is a rapidly cleared photosensitizer that is expected to have less phototoxicity. This study was undertaken to clarify the optimum laser fluence rate of PDT using talaporfin sodium and a diode laser for patients with local failure after CRT or radiotherapy (RT) for esophageal cancer. This phase I, laser dose escalation study used a fixed dose (40 mg/m2) of intravenous talaporfin sodium administered 4 to 6 hours before irradiation in patients with local failure limited to T2 after CRT or RT (≥ 50 Gy). The primary endpoint was to assess the dose limiting toxicity (DLT) of PDT, and the secondary endpoints were to evaluate the adverse events and toxicity related to PDT. The starting fluence of the 664 nm diode laser was 50 J/cm2, with an escalation plan to 75 J/cm2 and 100 J/cm2. 9 patients with local failure after CRT or RT for ESCC were enrolled and treated in groups of 3 individuals to the third fluence level. No DLT was observed at any fluence level. Phototoxicity was not observed, but one subject had grade 1 fever, three had grade 1 esophageal pain, and 1 had grade 1 dysphagia. Five of 9 patients (55.6%) achieved a complete response after PDT. PDT using talaporfin sodium and a diode laser was safe for local failure after RT in patients with esophageal cancer. The recommended fluence for the following phase II study is 100 J/cm2.