Evaluation of the efficacy and safety of salvage photodynamic therapy by talaporfin sodium for cervical esophageal cancers and lesions larger than 3 cm

Esophagus ◽  
2020 ◽  
Author(s):  
Tomoyuki Hayashi ◽  
Yoshiro Asahina ◽  
Hiroyoshi Nakanishi ◽  
Takeshi Terashima ◽  
Koichi Okamoto ◽  
...  
2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 129-129
Author(s):  
Yusuke Amanuma ◽  
Shinya Ohashi ◽  
Masashi Tamaoki ◽  
Takahiro Horimatsu ◽  
Manabu Muto

Abstract Background We previously conducted an investigator-initiated trial of photodynamic therapy (PDT) using talaporfin sodium (talaporfin-PDT) and laser irradiation (PD-laser) against local failure after chemoradiotherapy (CRT) in patients with esophageal cancer (EC) and reported a high local complete response rate (L-CR) (88.5%) (Yano et al., Oncotarget 2017). Thereafter, talaporfin-PDT has been applied clinically as a salvage treatment for local failure after CRT in Japan since October 2015. The current study retrospectively reviewed the efficacy and safety of talaporfin-PDT in patients who underwent this treatment in our clinical practice. Methods This study was a single-center retrospective observational study. Patients who received salvage talaporfin-PDT for local failure of EC limited to T1–2 after definitive CRT or radiotherapy from May 2011 to July 2017 in our hospital were included. PDT was applied with an intravenous administration of talaporfin sodium (40 mg/kg) followed 4 h later by diode laser irradiation at 100 J/cm2. The primary and secondary endpoints were the rate of L-CR and the safety of PDT, respectively. The criteria for L-CR were as follows: 1) no residual tumor, 2) disappearance of post-PDT ulcer and scar formation, and 3) disappearance of cancer cells as assessed histologically. Results Thirty-one patients were analyzed in this study (26 men, 5 women, median age: 68 years). Histological types were squamous cell carcinoma and adenocarcinoma (30 and 1 patients, respectively). The failure patterns of lesions after CRT were recurrence after achieving a CR and residual lesion just after CRT (25 and 6 patients, respectively). The recurrent T stages were T1a, T1b, and T2 (1, 18, and 12 patients, respectively). The median total laser exposure dose was 500 J (range: 200–900). The L-CR rates were 84.2% (16/19), 41.7% (5/12), and 61.3% (19/31) in patients with T1, T2, and all stages, respectively. No severe adverse events greater than grade 3 related to PDT were observed. Although four patients had grade 2 esophageal stenosis after PDT, the stenosis was controlled by endoscopic balloon dilation. Conclusion Salvage talaporfin-PDT is a safe and curative treatment for local failure, especially stage T1, after CRT in patients with EC. Disclosure All authors have declared no conflicts of interest.


PLoS ONE ◽  
2014 ◽  
Vol 9 (8) ◽  
pp. e103126 ◽  
Author(s):  
Shinya Ohashi ◽  
Osamu Kikuchi ◽  
Mihoko Tsurumaki ◽  
Yukie Nakai ◽  
Hiroi Kasai ◽  
...  

2021 ◽  
Author(s):  
Fei Chen ◽  
Zoltán Novák ◽  
Christian Dannecker ◽  
Long Sui ◽  
Youzhong Zhang ◽  
...  

AbstractIntroductionHigh-risk human papilloma virus (HPV)-associated cervical cancer is the fourth most common cancer in women worldwide. Current treatments of high grade squamous intraepithelial lesion (HSIL) of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality.ObjectiveAPRICITY is a multicentre, prospective, double-blind, randomised controlled Phase 3 study further evaluating the efficacy and safety of Cevira®, an integrated drug- and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive therapy for women with HSIL.Methods and analysisPatients with biopsy-confirmed HSIL histology are invited to participate in the study currently being conducted at 47 sites in China and 25 sites in Ukraine, Russia and European Union. The aim is to include at least 384 patients which will be randomised to either Cevira® or placebo group (2:1). All patients will be assessed 3 months after first treatment and a second treatment will be administered in patients who are HPV positive or have at least low grade squamous intraepithelial lesion (LSIL). Primary endpoint is the proportion of the responders at 6 months after first treatment. Secondary efficacy endpoints and safety endpoints will be assessed at 6 months, and data for secondary performance endpoints for Cevira® device will be collected at 3 months and 6 months, in case second treatment was administered. All patients in the Cevira® group will be enrolled in an open, long-term extension study following patients for further 6 months to collect additional efficacy and safety data (study extension endpoints).ConclusionDue to its non-invasiveness and convenient application, Cevira® may be a favourable alternative to surgical methods in treatment of patients with HSIL.Ethics and disseminationThe study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. Findings will be disseminated through peer review publications and conference presentations.Trial registration numberclinicaltrials.govNCT04484415


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