title: Phase I study of photodynamic therapy using talaporfin sodium and diode laser for local failure after chemoradiotherapy for esophageal cancer.
abstract: 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.
authors: Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
authors: Tomonori
authors: T
authors: Yano
authors: Manabu
authors: M
authors: Muto
authors: Kenichi
authors: K
authors: Yoshimura
authors: Miyuki
authors: M
authors: Niimi
authors: Yasumasa
authors: Y
authors: Ezoe
authors: Yusuke
authors: Y
authors: Yoda
authors: Yoshinobu
authors: Y
authors: Yamamoto
authors: Hogara
authors: H
authors: Nishisaki
authors: Koji
authors: K
authors: Higashino
authors: Hiroyasu
authors: H
authors: Iishi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D059248:Chemoradiotherapy; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D006801:Humans; D054023:Lasers, Semiconductor / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D016879:Salvage Therapy / Q000379:methods
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins; C053434:Talaporfin