Abstract | BACKGROUND: 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:
|
Authors | Tomonori Yano, Manabu Muto, Kenichi Yoshimura, Miyuki Niimi, Yasumasa Ezoe, Yusuke Yoda, Yoshinobu Yamamoto, Hogara Nishisaki, Koji Higashino, Hiroyasu Iishi |
Journal | Radiation oncology (London, England)
(Radiat Oncol)
Vol. 7
Pg. 113
(Jul 23 2012)
ISSN: 1748-717X [Electronic] England |
PMID | 22824179
(Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Photosensitizing Agents
- Porphyrins
- Talaporfin
|
Topics |
- Aged
- Aged, 80 and over
- Chemoradiotherapy
- Esophageal Neoplasms
(drug therapy)
- Humans
- Lasers, Semiconductor
(therapeutic use)
- Male
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy)
- Photochemotherapy
(adverse effects, methods)
- Photosensitizing Agents
(therapeutic use)
- Porphyrins
(therapeutic use)
- Salvage Therapy
(methods)
|