685P - A multicenter phase II study of salvage photodynamic therapy using talaporfin sodium and a diode laser for local failure of esophageal cancer after...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Oesophageal Cancer
Surgery and/or Radiotherapy of Cancer
Presenter Naomi Kakushima
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors N. Kakushima1, T. Yano2, R. Ishihara3, Y. Yamamoto4, H. Kataoka5, H. Isomoto6, T. Horimatsu7, H. Kasai8, S. Morita9, M. Muto7
  • 1Division Of Endoscopy, Shizuoka Cancer Center, 4118777 - Shizuoka/JP
  • 2Department Of Gastroenterology And Gastrointestinal Oncology, Endoscopy Division, National Cancer Center Hospital East, Kashiwa/JP
  • 3Department Of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka/JP
  • 4Gastroenterological Oncology, Hyogo Cancer Center, 6738558 - Hyogo/JP
  • 5Gastroenterology And Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya/JP
  • 6Department Of Gastroenterology And Hepatology, Nagasaki University, Nagasaki/JP
  • 7Department Of Gastroenterology And Hepatology, Kyoto University, 606-8507 - Kyoto/JP
  • 8Institute For Advancement Of Clinical And Translational Science, Kyoto University, 606-8507 - Kyoto/JP
  • 9Department Of Biomedical Statistics And Bioinformatics, Kyoto University, Kyoto/JP

Abstract

Aim

We previously reported that photodynamic therapy (PDT) has a potential to cure local failure after chemoradiotherapy (CRT) for esophageal cancer (EC). However, first-generation PDT using porfimer sodium and an excimer dye laser has several problems: a high occurrence of skin phototoxicity, the requirement of a long light shielding period (6 weeks), and the need for an expensive and large laser generator. Talaporfin sodium (Laserphyrin®) is a second-generation photosensitizer that requires a shorter light shielding period (2 weeks) and induces less phototoxicity. We previously identified the optimum diode laser fluence (100 J/cm2) for PDT using talaporfin sodium in the phase I/IIA study. Therefore, in the present study, we conducted a multicenter phase IIB study to evaluate the efficacy and safety of PDT using talaporfin sodium as a salvage treatment for local failure after CRT or radiotherapy (RT) for EC. (UMIN000009184).

Methods

Eligibility criteria were histologically proven local failure of ≤3 cm in diameter with a clinical depth limited within T2 after definitive CRT or RT (≥50 Gy) for EC. PDT commenced with intravenous administration of 40 mg/m2 of talaporfin sodium, followed by diode laser irradiation with a fluence of 100 J/cm2 and a fluence rate of 150 mW/cm2 4-6 h later. The primary endpoint was the local complete response (L-CR) rate, and the secondary endpoints were confirmed L-CR, local progression-free survival, progression-free survival, local time to treatment failure, and overall survival. The institutional review boards of all institutions approved the study protocol.

Results

Between November 2012 and December 2013, a total of 26 patients were enrolled. The clinical depth of the lesions was diagnosed as T1 in 19 patients and T2 in 7 patients by endosonography. PDT using talaporfin sodium was performed in all patients without any serious adverse events. The patients are currently followed up to assess primary and secondary endpoints.

Conclusions

The efficacy and safety of second-generation PDT using talaporfin sodium for local failure of EC after CRT will be reported.

Disclosure

All authors have declared no conflicts of interest.