Federal State Budgetary Educational Institution of Higher Education “Academician I.P. Pavlov First St. Petersburg State Medical University” of the Ministry of Healthcare of Russian Federation 197022, Russia, Saint Petersburg, L'va Tolstogo str. 6/8; phone.: 8 (812) 499-68-95; e-mail: info@1spbgmu.ru
Brief summary
Introduction. Endoscopic photodynamic therapy has demonstrated efficacy and safety in managing symptoms and treatment of locally advanced gastric cancer complicated by subcompensated stenosis. Chlorin E6, a third-generation photosensitizer produced in the Russian Federation, is used at therapeutic doses ranging from 1.0 to 2.5 mg/kg. Based on clinical experience and official dosing data, it is hypothesized that, with standard irradiation parameters, the minimum therapeutic dose will have similar effectiveness to the maximum dose, while reducing adverse events and costs.
Objective. To evaluate the efficacy and safety of various therapeutic doses of Chlorin E6 during endoscopic photodynamic therapy in patients with locally advanced gastric cancer complicated by subcompensated tumor stenosis.
Materials and Methods. The study included 20 patients with locally advanced gastric cancer complicated by subcompensated stenosis (1:1 ratio). All patients received combination therapy: 4 cycles of FLOT chemotherapy and 2 sessions of endoscopic photodynamic therapy. In Group 1, Chlorin E6 was administered at a dose of 1.0 mg/kg (minimum therapeutic dose), and in Group 2 at 2.5 mg/kg (maximum therapeutic dose). The primary endpoint: gastric emptying time of barium suspension. Secondary endpoints: nutritional status, tumor pathology and response according to RECIST 1.1, patients completing treatment, systemic phototoxicity, ophthalmotoxicity, pain on the first day after treatment.
Results. Median barium evacuation time decreased by 4.8 hours (18 to 13.2) in the study group and 1.6 hours (18 to 16.4) in controls; the difference was not statistically significant (p=0.054). All study group patients completed preoperative chemotherapy versus 80% in controls. No significant differences in tumor pathology or response rates were observed. The minimum dose showed lower systemic phototoxicity (20% vs. 70%; p=0.035) and ophthalmic toxicity (20% vs. 80%; p=0.023). Pain severity was similar.
Conclusions. During endoscopic photodynamic therapy of tumor stenosis in patients with locally advanced gastric cancer during the preoperative stage, Chlorin E6 can be used at the minimum therapeutic dose of 1 mg/kg to reduce systemic and ophthalmic phototoxicity without compromising treatment efficacy.
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