title: 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.
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/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.
authors.affiliation: Department of Gastroenterology, Endoscopy division, National Cancer Center Hospital East, Kashiwa, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Yano
authors.affiliation: Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Hiroi
authors.initials: H
authors.lastname: Kasai
authors.affiliation: Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Horimatsu
authors.affiliation: Innovative Clinical Research Center (iCREK), Kanazawa University Hospital, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Yoshimura
authors.affiliation: Department of Biostatistics, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.affiliation: Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Harue
authors.initials: H
authors.lastname: Tada
authors.affiliation: Department of Gastrointestinal Oncology, Hyogo Cancer Center, Hyogo, Japan.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Kataoka
authors.affiliation: Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Kakushima
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Disieses, Osaka, Japan.
authors.forename: Ryu
authors.initials: R
authors.lastname: Ishihara
authors.affiliation: Department of Gastroenterology and Hepatology, Nagasaki University Hospital, Nagasaki, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Isomoto
authors.affiliation: Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Muto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D059248:Chemoradiotherapy / Q000009:adverse effects; D004938:Esophageal Neoplasms / Q000473:pathology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D054023:Lasers, Semiconductor / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D011379:Prognosis; D011878:Radiotherapy / Q000009:adverse effects; D016879:Salvage Therapy; D015996:Survival Rate
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins; C053434:Talaporfin
keywords: chemoradiotherapy; esophageal cancer; photodynamic therapy; salvage treatment; talaporfin sodium