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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

2016; Impact Journals LLC; Volume: 8; Issue: 13 Linguagem: Inglês

10.18632/oncotarget.14029

1949-2553

Tomonori Yano, Hiroi Kasai, Takahiro Horimatsu, Kenichi Yoshimura, Satoshi Teramukai, Satoshi Morita, Harue Tada, Yoshinobu Yamamoto, Hiromi Kataoka, Naomi Kakushima, Ryu Ishihara, Hajime Isomoto, Manabu Muto,

Lung Cancer Diagnosis and Treatment

// Tomonori Yano 1 , Hiroi Kasai 2 , Takahiro Horimatsu 3 , Kenichi Yoshimura 4 , Satoshi Teramukai 5 , Satoshi Morita 2 , Harue Tada 2 , Yoshinobu Yamamoto 6 , Hiromi Kataoka 7 , Naomi Kakushima 8 , Ryu Ishihara 9 , Hajime Isomoto 10 , Manabu Muto 3 1 Department of Gastroenterology, Endoscopy division, National Cancer Center Hospital East, Kashiwa, Japan 2 Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan 3 Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan 4 Innovative Clinical Research Center (iCREK), Kanazawa University Hospital, Japan 5 Department of Biostatistics, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Japan 6 Department of Gastrointestinal Oncology, Hyogo Cancer Center, Hyogo, Japan 7 Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan 8 Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan 9 Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Disieses, Osaka, Japan 10 Department of Gastroenterology and Hepatology, Nagasaki University Hospital, Nagasaki, Japan Correspondence to: Manabu Muto, email: mmuto@kuhp.kyoto-u.ac.jp Keywords: esophageal cancer, photodynamic therapy, salvage treatment, chemoradiotherapy, talaporfin sodium Received: September 14, 2016 Accepted: October 14, 2016 Published: December 20, 2016 ABSTRACT 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/m 2 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.