A phase I study of salvage photodynamic therapy (PDT) using talaporfin sodium and a diode laser for local failure of esophageal carcinoma (EC) after chemoradiotheapy (CRT)

Autor: Yasumasa Ezoe, Yusuke Yoda, Takashi Yamamoto, Tomonori Yano, Koji Higashino, Hiroyasu Iishi, Kengo Nagai, Miyuki Niimi, Manabu Muto, Kenichi Yoshimura, Hogara Nishizaki, Yoshinobu Yamamoto
Rok vydání: 2012
Předmět:
Zdroj: Journal of Clinical Oncology. 30:123-123
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2012.30.4_suppl.123
Popis: 123 Background: We recently reported that porfimer sodium (Photofrin)-based PDT was a less invasive, curative treatment option for carefully selected patients with locally residual EC after CRT (Endoscopy 2011:43:657-63). However, porfimer sodium-based PDT has some problems (long light shielding and skin phototoxicities). Conversely, talaporfin sodium (Laserphyrin)-based PDT using a diode laser system can overcome these problems. Therefore, we conducted a phase I study to establish the recommended dose of laser irradiation and to evaluate safety of talaporfin sodium-based PDT as a salvage treatment after CRT. (UMIN000003970). Methods: We recruited patients with residual or recurrent EC at primary site and who were treated with more than 50 Gy of (chemo)radiotherapy. To determine the dose limiting toxicity (DLT) according to the energy of the diode laser, dose escalation was set at three energy levels (50,75 and 100J/cm2). The DLT was defined as follows; 1) severe pain, 2) ≥ grade 2 CTC-AE fever, 3) esophageal fistulae or stenosis, 4) ≥ grade 3 CTC-AE hemorrhage, and 5) ≥ grade 4 CTC-AE non-hematologic toxicity. Results: Between Oct. 2010 and May 2011, a total of 9 patients (9 men, median age of 72 y-o) were recruited and were treated using up to the third energy level in groups of three individuals. The initial T stage was T1/T2/T3(4/2/3) and recurrent T stage was T1/T2(6/3). None of the patients experienced DLT at all energy levels. A complete response was achieved in 5 of 9 patients (56%). Conclusions: Based on the results of our phase I study, we concluded that irradiation at 100J/cm2 appeared to be a recommended dose for talaporfin sodium-based PDT as a salvage treatment for locally residual esophageal carcinoma after CRT. We are currently running a phase II part of the study to investigate efficacy of salvage talaporfin sodium-based PDT.
Databáze: OpenAIRE
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