Ito Nobuhito, Funasaka Kohei, Furukawa Kazuhiro, Nishida Kazuki, Furune Satoshi, Hirose Takashi, Suzuki Takahiro, Hida Emiko, Hirai Keiko, Shibata Hiroyuki, Kurata Yoshiyuki, Tanaka Hitoshi, Yamamura Takeshi, Ishikawa Takuya, Nakamura Masanao, Miyahara Ryoji, Kawashima Hiroki
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa, Nagoya, Aichi, 466-8550, Japan.
Department of Endoscopy, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.
Esophagus. 2025 Jun 15. doi: 10.1007/s10388-025-01134-7.
Since the efficacy of salvage photodynamic therapy (PDT) for locally recurrent esophageal cancer after definitive chemoradiotherapy (CRT) was proven for the first time in an investigator-initiated clinical trial, various reports have supported the clinical utility of PDT for these lesions. However, the clinical trial had limited indications, including a luminal circumference of ≤1/2, maximum longitudinal lesion length of 3 cm, and no invasion into the cervical esophagus, and there have been few reports of treatment outcomes for lesions exceeding the indications used in the investigator-initiated clinical trial. Therefore, this study was performed to assess the outcomes of treating lesions exceeding the above indications.
We retrospectively enrolled 34 consecutive esophageal cancer patients with 38 lesions who underwent PDT with talaporfin sodium. Lesions were classified as meeting (within-indications group; 23 patients, 25 lesions) or exceeding (beyond-indications group; 11 patients, 13 lesions) the indications in the investigator-initiated clinical trial. The local complete response rate (L-CR), overall survival (OS), progression-free survival (PFS), and incidence of PDT-related adverse events were compared between the groups.
The L-CR rate was 88.0 and 92.3% in the within- and beyond-indications groups, respectively. The 2-year OS rate was 69.5% and 90.0% and the 2-year PFS rate was 43.3 and 56.6% in the within- and beyond-indications groups, respectively. In terms of adverse events, there were no serious adverse events in either group.
Salvage PDT might be effective for local recurrence after CRT for lesions exceeding the indications in the investigator-initiated clinical trial.
由于在一项研究者发起的临床试验中首次证实了挽救性光动力疗法（PDT）对确定性放化疗（CRT）后局部复发食管癌的疗效，各种报告均支持PDT对这些病变的临床应用价值。然而，该临床试验的适应证有限，包括管腔周长≤1/2、最大纵向病变长度为3 cm且未侵犯颈段食管，对于超出研究者发起的临床试验所用适应证的病变，治疗结果的报道较少。因此，本研究旨在评估治疗超出上述适应证的病变的结果。
我们回顾性纳入了34例连续的食管癌患者，这些患者有38个病变接受了替莫泊芬钠PDT治疗。病变被分类为符合（适应证内组；23例患者，25个病变）或超出（适应证外组；11例患者，13个病变）研究者发起的临床试验中的适应证。比较两组之间的局部完全缓解率（L-CR）、总生存期（OS）、无进展生存期（PFS）以及PDT相关不良事件的发生率。
适应证内组和适应证外组的L-CR率分别为88.0%和92.3%。适应证内组和适应证外组的2年OS率分别为69.5%和90.0%，2年PFS率分别为43.3%和56.6%。在不良事件方面，两组均未出现严重不良事件。
对于超出研究者发起的临床试验适应证的病变，挽救性PDT可能对CRT后的局部复发有效。
