Phase I study of photodynamic therapy using talaporfin sodium and diode laser for local failure after chemoradiotherapy for esophageal cancer

Radiation Oncology

Hiroyasu Iishi⁴  Koji Higashino⁴  Hogara Nishisaki⁶  Yoshinobu Yamamoto⁶  Yusuke Yoda³  Yasumasa Ezoe²  Miyuki Niimi⁵  Kenichi Yoshimura⁵  Manabu Muto¹  Tomonori Yano³ 

[1] Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan;Department of multidisciplinary cancer treatment, Kyoto University Graduate School of Medicine, Kyoto, Japan;Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan;Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan;Translational Research Center, Kyoto University Hospital, Kyoto, Japan;Department of Gastroenterological oncology, Hyogo Cancer Center, Hyogo, Japan

关键词: Phase I study;    Salvage treatment;    Talaporfin sodium;    Esophageal cancer;    Photodynamic therapy;   

Others  :  1160803
DOI  :  10.1186/1748-717X-7-113

 received in 2012-04-04, accepted in 2012-07-23,  发布年份 2012

【 摘 要 】

Background

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.

Methods

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.

Results

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.

Conclusions

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.

【 授权许可】

   
2012 Yano et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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