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. 2023 Apr 6;23(1):320.
doi: 10.1186/s12885-023-10798-2.

Efficacy and safety of transurethral resection of bladder tumour combined with chemotherapy and immunotherapy in bladder-sparing therapy in patients with T1 high-grade or T2 bladder cancer: a protocol for a randomized controlled trial

Xiangwei Yang #  1 , Shiqiang Zhang #  1 , Yajiao Cui  1 , Yamei Li  1 , Xinyue Song  1 , Jun Pang  2   3
Affiliations

Efficacy and safety of transurethral resection of bladder tumour combined with chemotherapy and immunotherapy in bladder-sparing therapy in patients with T1 high-grade or T2 bladder cancer: a protocol for a randomized controlled trial

Xiangwei Yang et al. BMC Cancer. .

Abstract

Background: Bladder cancer is the tenth most common cancer worldwide. For patients with T1 high-grade or T2 bladder cancer, radical cystectomy is recommended. However, radical cystectomy is associated with various complications and has a detrimental impact on the quality of life. Bladder-sparing therapy has been widely explored in patients with muscle-invasive bladder cancer, and whether a combination of transurethral resection of bladder tumour (TURBT) with chemotherapy and immunotherapy shows definite superiority over TURBT plus chemotherapy is still a matter of debate. The aim of this study is to investigate the efficacy and safety of TURBT combined with chemotherapy and immunotherapy in bladder-sparing therapy in patients with T1 high-grade or T2 bladder cancer who are unwilling or unsuitable to undergo radical cystectomy.

Methods: An open-label, multi-institutional, two-armed randomized controlled study will be performed with 86 patients with T1 high-grade or T2 bladder cancer meeting the eligibility criteria. Participants in the experimental group (n = 43) will receive TURBT combined with chemotherapy (GC: gemcitabine 1000 mg/m2 on the 1st day and the 8th day, cisplatin 70 mg/m2 on the 2nd day, repeated every 21 days) and immunotherapy (toripalimab 240 mg on the 5th day, repeated every 21 days), and those in the control group (n = 43) will receive TURBT plus chemotherapy (GC). The primary outcome is pathological response, and the secondary outcomes include progression-free survival, overall survival, toxicities, and quality of life.

Discussion: To the best of our knowledge, this is the first study to evaluate the efficacy and safety of TURBT combined with GC regimen and toripalimab in bladder-sparing therapy in patients with T1 high-grade or T2 bladder cancer. The expected benefit is that the combination of TURBT with chemotherapy and immunotherapy would be more effective than TURBT plus chemotherapy without compromising the quality of life and increasing the toxicity.

Trial registration: ChiCTR2200060546, chictr.org.cn, registered on June 14, 2022.

Keywords: Bladder cancer; Bladder-sparing therapy; Chemotherapy; Efficacy; Immunotherapy; Safety; Transurethral resection of bladder tumour.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study. BC: Bladder cancer; TURBT: Transurethral resection of bladder tumor; PaR: Pathological response; FISH: Fluorescence in situ hybridization; QoL: Quality of life; CT: Computed tomography; MRI: Magnetic resonance imaging
See this image and copyright information in PMC

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References

    1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and Mortality Worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. doi: 10.3322/caac.21660. - DOI - PubMed
    1. Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, et al. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013;63(2):234–41. doi: 10.1016/j.eururo.2012.07.033. - DOI - PubMed
    1. Rink M, Xylinas E, Babjuk M, Pycha A, Karakiewicz PI, Novara G, et al. Smoking reduces the efficacy of intravesical bacillus Calmette-Guérin immunotherapy in non-muscle-invasive bladder cancer. Eur Urol. 2012;62(6):1204–6. doi: 10.1016/j.eururo.2012.08.057. - DOI - PubMed
    1. Lammers RJ, Witjes WP, Hendricksen K, Caris CT, Janzing-Pastors MH, Witjes JA. Smoking status is a risk factor for recurrence after transurethral resection of non-muscle-invasive bladder cancer. Eur Urol. 2011;60(4):713–20. doi: 10.1016/j.eururo.2011.07.010. - DOI - PubMed
    1. Babjuk M, Burger M, Capoun O, Cohen D, Compérat EM, Dominguez Escrig JL, et al. European Association of Urology Guidelines on non-muscle-invasive bladder Cancer (Ta, T1, and carcinoma in situ) Eur Urol. 2022;81(1):75–94. doi: 10.1016/j.eururo.2021.08.010. - DOI - PubMed

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