Intravesical Gemcitabine versus Intravesical Bacillus Calmette-Guerin for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial
Purpose: The most common adjuvant therapy known for non-invasive muscle bladder cancer (NMIBC) is intravesical Bacillus Calmette-Guerin (BCG). Intravesical chemotherapy drugs like gemcitabine can also be used post-TURBT, which is considered as a good alternative for BCG, or can be used as a second-line treatment. Due to the common side effects of BCG, the use of chemotherapy drugs as intravesical treatments is currently increasing.
Materials and Methods: 117 intermediate-risk NMIBC cases were included in this study. All the patients underwent TURBT surgery and received 1 gr intravesical gemcitabine immediately after performing the surgery. The patients were then divided into two groups, either receiving intravesical gemcitabine or intravesical BCG weekly for 6 weeks. The patients were followed up with cystoscopy.
Results: Most patients were men who had smoking risk factors. The youngest patient was 36 years old and the oldest one was 88 years old. The rate of side effects in the group receiving gemcitabine (13.6%) was much lower than the group receiving BCG (44.8%). (P-value = 0.016). The recurrence rate during a one year period was lower in the group consisting of patients receiving gemcitabine compared to the group receiving BCG (19 patients vs. 23 patients) (p-value = 0.401)
Conclusion: The efficacy of intravesical gemcitabine and intravesical BCG was almost equal in the treatment of intermediate-risk NMIBCs. The adverse effects of gemcitabine were found to be significantly lower than BCG. Due to causing fewer complications, gemcitabine can be known as a good alternative, especially among elderly patients with comorbidities.
- BCG , bladder cancer , gemcitabine , intravesical therapy
How to Cite
Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 May;71:209-49.
Saginala K, Barsouk A, Aluru JS, Rawla P, Padala SA, Barsouk A. Epidemiology of bladder cancer. Med Sci. 2020 Mar;8:15.
Lenis AT, Lec PM, Chamie K. Bladder cancer: a review. JAMA. 2020 Nov 17;324:1980-91.
Chang SS, Boorjian SA, Chou R, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. 2016 Oct;196:1021-9.
Cumberbatch MG, Jubber I, Black PC, et al. Epidemiology of bladder cancer: a systematic review and contemporary update of risk factors in 2018. Eur Urol. 2018 Dec 1;74:784-95.
Wang TW, Yuan H, Diao WL, Yang R, Zhao XZ, Guo HQ. Comparison of gemcitabine and anthracycline antibiotics in prevention of superficial bladder cancer recurrence. BMC Urol. 2019 Dec;19:1-5.
Woldu SL, Bagrodia A, Lotan Y. Guideline of Guidelines–Non-Muscle Invasive Bladder Cancer. BJU Int. 2017 Mar;119:371.
Patel VG, Oh WK, Galsky MD. Treatment of muscle‐invasive and advanced bladder cancer in 2020. CA Cancer J clin. 2020 Sep;70:404-23.
Alhunaidi O, Zlotta AR. The use of intravesical BCG in urothelial carcinoma of the bladder. Ecancermedicalscience. 2019;13.
Prasanna T, Craft P, Balasingam G, Haxhimolla H, Pranavan G. Intravesical gemcitabine versus intravesical Bacillus Calmette–Guérin for the treatment of non-muscle invasive bladder cancer: an evaluation of efficacy and toxicity. Front Oncol. 2017 Nov 2;7:260.
Zhang J, Li M, Chen Z, OuYang J, Ling Z. Efficacy of Bladder Intravesical Chemotherapy with Three Drugs for Preventing Non-Muscle-Invasive Bladder Cancer Recurrence. J Healthc Eng. 2021 Nov 30;2021.
Peyton CC, Chipollini J, Azizi M, Kamat AM, Gilbert SM, Spiess PE. Updates on the use of intravesical therapies for non-muscle invasive bladder cancer: how, when and what. World J Urol. 2019 Oct;37:2017-29.
Li R, Li Y, Song J, et al. Intravesical gemcitabine versus mitomycin for non-muscle invasive bladder cancer: a systematic review and meta-analysis of randomized controlled trial. BMC Urol. 2020 Dec;20:1-8.
Mukherjee N, Julián E, Torrelles JB, Svatek RS. Effects of Mycobacterium bovis Calmette et Guérin (BCG) in oncotherapy: Bladder cancer and beyond. Vaccine. 2021 Dec 8;39:7332-40.
Felipe LM. Review of Urological Complications in BCG Immunotherapy for Nonmuscle Invasive Bladder Cancer. Immunome Res. 2021;17:1-2.
Koch GE, Smelser WW, Chang SS. Side effects of intravesical BCG and chemotherapy for bladder cancer: What they are and how to manage them. Urology. 2021 Mar 1;149:11-20.
Steinberg RL, Thomas LJ, O’Donnell MA. Combination intravesical chemotherapy for non–muscle-invasive bladder cancer. Eur Urol Focus. 2018 Jul 1;4:503-5.
Das AK, Mishra DK, Gopalan SS. Effect of intravesical chemotherapy on the survival of patients with non-muscle-invasive bladder cancer undergoing transurethral resection: a retrospective cohort study among older adults. medRxiv. 2021 Jan 1.
Tabayoyong WB, Kamat AM, O’Donnell MA, et al. Systematic Review on the Utilization of Maintenance Intravesical Chemotherapy in the Management of Non–muscle-invasive Bladder Cancer. Eur Urol Focus. 2018 Jul 1;4:512-21.
Han MA, Maisch P, Jung JH, et al. Intravesical gemcitabine for non-muscle invasive bladder cancer: An abridged Cochrane Review. Investig Clin Urol. 2021 Nov;62:623.
Ye Z, Chen J, Hong Y, Xin W, Yang S, Rao Y. The efficacy and safety of intravesical gemcitabine vs Bacille Calmette-Guerin for adjuvant treatment of non-muscle invasive bladder cancer: a meta-analysis. Onco Targets Ther. 2018;11:4641.
Kuperus JM, Busman RD, Kuipers SK, et al. Comparison of Side Effects and Tolerability Between Intravesical Bacillus Calmette-Guerin, Reduced-Dose BCG and Gemcitabine for Non-Muscle Invasive Bladder Cancer. Urology. 2021 Oct 1;156:191-8.
- Abstract Viewed: 0 times
- Just Accepted/7194 Downloaded: 0 times