非肌肉侵襲性膀胱癌患者接受兩種不同BCG菌株膀胱內灌注之副作用比較-單一醫學中心經驗

張家郡、張天佑、張議徽、王又德、蕭博任、陳冠亨、連啟舜、謝博帆、邱鴻傑、鄒頡龍、陳國樑、葉進仲、陳汶吉、張士三、黃志平、張兆祥、楊啟瑞、吳錫金

中國醫藥大學附設醫院泌尿部

Comparison of the adverse events between 2 different BCG strains in patients receiving intravesical therapy for non-muscle invasive bladder urothelial carcinoma: A single center experience

Jia-Jyun Jhang, Tian-Yu Jhang, Yi-Huei Chang, Yu-De Wang, Po-Jen Hsiao, Guan-Heng Chen, Chi-Shun Lien, Po-Fan Hsieh, Hung-chieh Chiu, Chieh-Lung Chou, Kuo-Liang Chen, Chin-Chung Yeh, Wen-Chi Chen, Shih-San Chang, Chi-Ping Huang, Chao-Hsiang Chang, Chi-Rei Yang, Hsi-Chin Wu

Department of Urology, China Medical University Hospital, Taichung, Taiwan

Purpose: Several studies have compared the outcome of different BCG strains in intravesical treatment in bladder urothelial carcinoma patients, the result varies and current guidelines have not yet been able to confirm any BCG strain superior to others. Besides the oncology outcome of the therapy, the rate of adverse event is worthy attention. Adverse events may not only directly lead to discontinuation of the therapy, but could also influence patient’s compliance to our future treatment plan. BCG worldwide shortage have caused our patients to receive intravesical therapy with different BCG strains. Our study aims to compare the adverse events between two different BCG strains: Moscow (SII-ONCO-BCG) and Tice (OncoTice).

Materials and Methods: We retrospectively reviewed patients with intermediate and high-risk bladder non- muscle invasive urothelial carcinoma who received intravesical BCG injection in China medical university hospital (CMUH) during 2020-2022. Adverse events included cystitis, cystitis that required antibiotic treatment, gross hematuria, infection that required anti-tuberculosis medication, epididymo-orchitis, granulomatous prostatitis, fever, fever persisted more than 48 hour and myositis/arthritis.

Results: 101 patients received intravesical treatment with Moscow (SII-ONCO-BCG) and 100 patients received intravesical treatment with Tice (OncoTice). Baseline characteristic including age, sex,  tumor grade, Tumor T stage, con-current Tis, history of previous UTUC, proportion of patients who received maintenance therapy were similar between the two groups of patients. Although 2 patients had epidydimo-orchitis and 1 had Granulomatous prostatitis in the Tice group, while there was none in the Moscow group. Comparing the adverse events between the two groups, there was no significance difference in the prevalence of cystitis, fever, gross hematuria, or infection that required anti-tuberculosis medication. Proportion of patients who discontinued BCG due to adverse event were also similar between the 2 groups.

Conclusions: Despite some rare adverse events found only in the Tice strain group, there was no significance difference of adverse events between patients who receive intravesical therapy with Moscow strain (SII-ONCO-BCG) or Tice strain (OncoTice).