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.
Highlights
Esophageal cancer is the eighth most common cancer worldwide and sixth leading cause of cancer-related death [1]
This study aimed to evaluate the safety and efficacy of Photodynamic therapy (PDT) using second generation photosensitizer, talaporfin sodium for local failure after CRT
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
Summary
Esophageal cancer is the eighth most common cancer worldwide and sixth leading cause of cancer-related death [1]. Locoregional failure after definitive CRT has been the major problem, and its rate was as great as 50-55% [2, 3] For those patients, salvage surgery is indicated, it is associated with a high complication rate (50-77%) and high mortality rate (approximately 15%) [4,5,6,7]. Among the patients with locoregional failure after definitive CRT, some patients don’t have distant or lymph node metastasis. Such patients have the potential to be cured by local treatment such as endoscopic resection (ER) [8, 9], or photodynamic therapy (PDT) [10,11,12]. PDT using the first generation photosensitizer, porfimer sodium, and excimer dye laser has several problems such as a high occurrence of skin phototoxicity, a long sun shade period requirement as approximately 6 weeks, and the necessity of an expensive and large laser system for excitation
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