Clinical Research Papers:
A multicenter phase II study of salvage photodynamic therapy using talaporfin sodium (ME2906) and a diode laser (PNL6405EPG) for local failure after chemoradiotherapy or radiotherapy for esophageal cancer
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Tomonori Yano1, Hiroi Kasai2, Takahiro Horimatsu3, Kenichi Yoshimura4, Satoshi Teramukai5, Satoshi Morita2, Harue Tada2, Yoshinobu Yamamoto6, Hiromi Kataoka7, Naomi Kakushima8, Ryu Ishihara9, Hajime Isomoto10, Manabu Muto3
1Department of Gastroenterology, Endoscopy division, National Cancer Center Hospital East, Kashiwa, Japan
2Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan
3Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan
4Innovative Clinical Research Center (iCREK), Kanazawa University Hospital, Japan
5Department of Biostatistics, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Japan
6Department of Gastrointestinal Oncology, Hyogo Cancer Center, Hyogo, Japan
7Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
8Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan
9Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Disieses, Osaka, Japan
10Department of Gastroenterology and Hepatology, Nagasaki University Hospital, Nagasaki, Japan
Manabu Muto, email: [email protected]
Keywords: esophageal cancer, photodynamic therapy, salvage treatment, chemoradiotherapy, talaporfin sodium
Received: September 14, 2016 Accepted: October 14, 2016 Published: December 20, 2016
Photodynamic therapy (PDT) showed promising efficacy for local failure after chemoradiotherapy (CRT) for esophageal cancer. However, PDT required long sun shade period. This study aimed to evaluate the safety and efficacy of PDT using second generation photosensitizer, talaporfin sodium for local failure after CRT. This was the multi-institutional non-randomized phase II study. Patients with histologically proven local failure limited within the muscularis propria after 50Gy or more radiotherapy (RT) for esophageal cancer were eligible. We set the primary endpoint as local complete response (L-CR) per patients. And, secondary endpoints were confirmed L-CR, local progression free survival (L-PFS), progression free survival (PFS), overall survival (OS), L-CR per lesions (Lesion L-CR), and confirmed Lesion L-CR. The PDT procedure commenced with intravenous administration of a 40 mg/m2 dose of talaporfin sodium followed by diode laser irradiation at a 664 nm wavelength. 26 eligible patients were enrolled and all were treated with PDT. Twenty three patients with 25 lesions were assessed L-CR after PDT; the L-CR rate per patients was 88.5% (95% CI: 69.8%-97.6%). No skin phototoxicity was observed, and no grade 3 or worse non-hematological toxicities related to PDT were observed. PDT using talaporfin sodium and a diode laser is a safe and curative salvage treatment for local failure after CRT or RT for patients with esophageal cancer.
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