Cancer UrologyCancer UrologyОнкоурология1726-97761996-1812Publishing House ABV Press177310.17650/1726-9776-2025-21-1-84-91DIAGNOSIS AND TREATMENT OF URINARY SYSTEM TUMORS. URINARY BLADDER CANCERДИАГНОСТИКА И ЛЕЧЕНИЕ ОПУХОЛЕЙ МОЧЕПОЛОВОЙ СИСТЕМЫ. Рак мочевого пузыряComparative study between intravesical gemcitabine versus bacillus Calmette– Guérin in high risk superficial bladder cancerСравнительное исследование внутрипузырного введения гемцитабина и бациллы Кальметта– Герена для лечения поверхностного рака мочевого пузыря высокого рискаAliM. H.
Egypt
dr.mh-soliman@hotmail.comElazabM. E.
Egypt

Mohamed Elsayed Elazab

mohamed.alazab@med.helwan.edu.egSalemT. A.
Egypt
tareksalem00@gmail.comHussienN. M.
Egypt
Hassannervana5455@yahoo.comZazaM. M.
Egypt
zazaurology5@gmail.comHelwan University, Faculty of Medicine, Urology Department & Oncology Unit0905202521184911402202408032025https://oncourology.abvpress.ru/oncur/article/view/1773

Objectives. To study the efficacy and safety of intravesical gemcitabine (GEM) in comparison to intravesical bacillus Calmette–Guérin (BCG) for patients with high risk non-muscle invasive tumors.

Methods. 100 patients with histologically confirmed non-muscle invasive bladder cancer (carcinoma in situ, Ta, T1), in the high-risk group of urothelial carcinoma, treated in the outpatient clinic of the Urology between 2021 and 2023 who received adjuvant intravesical therapy were simply randomized to group A (BCG group) and group B (GEM group) following single postoperative intravesical instillation of (GEM) chemotherapy after transurethral resection of bladder tumor, each group contained 50 patients were evaluated.

Results. All patients were evaluated for a follow-up of 24 months after treatment. There is no significant statistical difference in clinical and pathological characteristics between the groups. There was no statistically significant difference in the recurrence rate and progression rate of the disease in each group respectively (p = 0.2, 0.06) also overall diseasefree rate (p = 0.128). Regarding safety, free cases of any adverse events were clinically and statistically significant between both groups (p = 0.002). There were statistically significant differences between groups A and B in grade II (hematuria, fever) and grade III (allergy, BCGosis) adverse effects respectively (p = 0.001, 0.003). Although grade I complications were more in the BCG arm, but it was not statistically significant.

Conclusion. The adjuvant intravesical GEM chemotherapy has equal efficacy for BCG immuno-therapy in the treatment of high-risk superficial bladder cancer patients following transurethral resection of bladder tumor. In addition, GEM is associated with reduced local and systemic toxicity compared with BCG.

Цель. Изучить эффективность и безопасность внутрипузырного введения гемцитабина (GEM) в сравнении с внутрипузырным введением бациллы Кальметта–Герена (BCG) у пациентов с немышечно-инвазивным раком мочевого пузыря высокого риска.

Методы. В исследовании 100 пациентов с гистологически подтвержденным немышечно-инвазивным раком мочевого пузыря (карцинома in situ, Ta, T1) и уротелиальной карциномой высокого риска, получавшие амбулаторное лечение в клинике урологии в период с 2021 по 2023 г., были рандомизированы в группу A (группа BCG) и группу B (группа GEM) после трансуретральной резекции опухоли мочевого пузыря и единственной послеоперационной внутрипузырной дозы (GEM) химиотерапии. В каждой группе было по 50 пациентов.

Результаты. Срок наблюдения за всеми пациентами после лечения составил 24 мес. Статистически значимых различий в клинических и патологических характеристиках между группами не обнаружено. Также не было значимых различий в частоте рецидивов и прогрессирования заболевания (p = 0,2; 0,06) и общей безрецидивной выживаемости (p = 0,128). В отношении безопасности между группами наблюдались клинически и статистически значимые различия по количеству нежелательных явлений (p = 0,002). Между группами A и B выявлены значимые различия по количеству нежелательных явлений II (гематурия, лихорадка) и III (аллергия, диссеминированная BCG-инфекция) степеней тяжести (p = 0,001; 0,003, соответственно). Осложнения I степени тяжести встречались чаще в группе BCG, но различия не были статистически значимыми.

Заключение. Адъювантная внутрипузырная химиотерапия GEM по эффективности близка к иммунотерапии BCG у пациентов с поверхностным раком мочевого пузыря высокого риска после трансуретральной резекции опухоли. Более того, химиотерапия GEM обладает меньшей локальной и системной токсичностью, чем BCG.

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