Patterns of treatment of high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients among Arab urologists
https://doi.org/10.4081/aiua.2024.12244
Accepted: January 17, 2024
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Purpose: To understand the treatment plans suggested for BCG-unresponsive non-muscle invasive disease (NMIBC) patients in the Arab countries and therapeutic decisions applied for BCG-naive patients during BCG shortage time.
Methods: A 10-minute online survey was distributed through the Arab Association of Urology (AAU) office to urologists in the Arab countries who treat patients with NMIBC.
Results: One hundred six urologists responded to the survey. The majority of urologists had treated, in the past 6 months, > 10 patients with NMIBC who were considered BCG-unresponsive (55% of respondents). Radical cystectomy (RC) was the most popular treatment option (recommended by 50%) for these patients. This was followed by intravesical chemotherapy (30%), repeat BCG therapy (12%), resection with ongoing surveillance (8%). Clinical trials and intravenous checkpoint inhibitors were never selected. The most preferred intravesical chemotherapy was by ranking: 60% gemcitabine, 19% mitomycin C, 8% docetaxel, 8% gemcitabine/docetaxel, 4% sequential gemcitabine/mitomycin C, and 1% valrubicin. The use of intravesical chemotherapy appears limited by Arab urologists due to concerns regarding clinical efficacy (fear of progression) and the lack of clear recommendations by urology societies. Given the BCG shortage, which may vary per Arab country, Arab urologists have adjusted by prioritizing BCG for T1 and carcinoma in situ (CIS) patients over Ta, adapting intravesical chemotherapy, and reducing the dose/strength of BCG administered. Most physicians report an eagerness to utilize novel therapies to address the BCG deficit, especially to try intravesical chemotherapy.
Conclusions: Even though Arab urologists are in the majority of cases selecting RC for BCG-unresponsive cases, one-third of them are most recently initiating intravesical chemotherapy as an alternative option. To further assist Arab urologists in the appropriate selection of BCG unresponsive high risk NMIBC patient treatments, enhanced education and pathway protocols are needed.
Taylor J, Becher E, Steinberg GD. Update on the guideline of guidelines: non-muscle-invasive bladder cancer. BJU Int. 2020;125:197-205. DOI: https://doi.org/10.1111/bju.14915
van den Bosch S, Alfred Witjes J. Long-term cancer-specific survival in patients with high-risk, non-muscle-invasive bladder cancer and tumour progression: a systematic review. Eur Urol. 2011;60:493-500. DOI: https://doi.org/10.1016/j.eururo.2011.05.045
Roumiguié M, Kamat AM, Bivalacqua TJ, et al. International Bladder Cancer Group Consensus Statement on Clinical Trial Design for Patients with Bacillus Calmette-Guérin-exposed High-risk Nonmuscle- invasive Bladder Cancer. Eur Urol. 2022; 82:34-46. DOI: https://doi.org/10.1016/j.eururo.2021.12.005
Babjuk M, Burger M, Compérat EM, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ) - 2019 Update. Eur Urol. 2019; 76:639-657. DOI: https://doi.org/10.1016/j.eururo.2019.08.016
Yassaie O, Chehroudi C, Black PC. Novel and emerging approaches in the management of non-muscle invasive urothelial carcinoma. Ther Adv Med Oncol. 2021; 13:17588359211039052. DOI: https://doi.org/10.1177/17588359211039052
Bandari J, Maganty A, MacLeod LC, et al. Manufacturing and the Market: Rationalizing the Shortage of Bacillus Calmette-Guérin. Eur Urol Focus. 2018; 4:481-484.
Chang SS, Boorjian SA, Chou R, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016; 196:1021-1029. DOI: https://doi.org/10.1016/j.juro.2016.06.049
Nazmifar M, Williams C, Naser-Tavakolian A, et al. Clinical and Preclinical Therapies for Bladder Cancer Following Bacillus Calmette-Guérin Failure. J Urol. 2023; 209:32-48. DOI: https://doi.org/10.1097/JU.0000000000002957
Goldberg IP, Lichtbroun B, Singer EA, et al. Pharmacologic Therapies for Non-Muscle Invasive Bladder Cancer: Current and Future Treatments. Arch Pharmacol Ther. 2022; 4:13-22. DOI: https://doi.org/10.33696/Pharmacol.4.030
Abou Chakra M, Shore ND, Dillon R, et al. US Clinical Practice Patterns of Intravesical Chemotherapy for Bacillus Calmette-Guérin- Unresponsive and Bacillus Calmette-Guérin-Exposed Nonmuscle-Invasive Bladder Cancer. Urol Pract. 2024; 11:97-107. 1. DOI: https://doi.org/10.1097/UPJ.0000000000000481
Collacott H, Krucien N, Heidenreich S, et al. Patient Preferences for Treatment of Bacillus Calmette-Guérin unresponsive Non-muscle-invasive Bladder Cancer: A Cross-country Choice Experiment. Eur Urol Open Sci. 2023;49:92-99. DOI: https://doi.org/10.1016/j.euros.2022.12.016
Joudi FN, Smith BJ, O'Donnell MA, et al. Contemporary management of superficial bladder cancer in the United States: a pattern of care analysis. Urology. 2003; 62:1083-8. DOI: https://doi.org/10.1016/S0090-4295(03)00765-9
Broughton EI, Gooden KM, Mycock KL, et al. Multi-country clinical practice patterns, including use of biomarkers, among physicians' treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). BMC Urol. 2022;22:27. DOI: https://doi.org/10.1186/s12894-022-00959-z
Broughton EI, Chun DS, Gooden KM, et al. Treatment and disease management patterns for bacillus Calmette Guérin unresponsive nonmuscle invasive bladder cancer in North America, Europe and Asia: A real-world data analysis. Curr Urol. 2022; 16:147-153. DOI: https://doi.org/10.1097/CU9.0000000000000072
Abou Chakra M, Packiam VT, O'Donnell MA. Real-world efficacy of adjuvant single-agent intravesical gemcitabine for non-muscle invasive bladder cancer (published online ahead of print, 2023 Oct 16). Expert Opin Pharmacother. 2023; 1-11.
Jarow JP, Lerner SP, Kluetz PG, et al. Clinical trial design for the development of new therapies for nonmuscle invasive bladder cancer: report of a Food and Drug Administration and American Urological Association public workshop. Urology. 2014; 83:262-4. DOI: https://doi.org/10.1016/j.urology.2013.10.030
Wettstein MS, Naimark D, Hermanns T, et al. Required efficacy for novel therapies in BCG-unresponsive non muscle invasive bladder cancer: Do current recommendations really reflect clinically meaningful outcomes?. Cancer Med. 2020; 9:3287-3296. DOI: https://doi.org/10.1002/cam4.2980
Bandari J, Maganty A, MacLeod LC, et al. Manufacturing and the Market: Rationalizing the Shortage of Bacillus Calmette-Guérin. Eur Urol Focus. 2018;4:481-484. DOI: https://doi.org/10.1016/j.euf.2018.06.018
McElree IM, Steinberg RL, Mott SL, et al. Comparison of Sequential Intravesical Gemcitabine and Docetaxel vs Bacillus Calmette-Guérin for the Treatment of Patients With High-Risk Non-Muscle-Invasive Bladder Cancer. JAMA Netw Open. 2023 6:e230849. DOI: https://doi.org/10.1001/jamanetworkopen.2023.0849
Katoue MG, Cerda AA, García LY, Jakovljevic M. Healthcare system development in the Middle East and North Africa region: Challenges, endeavors and prospective opportunities. Front Public Health. 2022; 10:1045739. DOI: https://doi.org/10.3389/fpubh.2022.1045739
World Bank. GDP Per Capita, PPP (Current International $). World Development Indicators Database. World Bank, 2023. https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD
Chen J, Yao Z, Qiu S, et al. Comparing intra-arterial chemotherapy combined with intravesical chemotherapy versus intravesical chemotherapy alone: a randomised prospective pilot study for T1G3 bladder transitional cell carcinoma after bladder-preserving surgery. Cardiovasc Intervent Radiol. 2013; 36:1521-1526. DOI: https://doi.org/10.1007/s00270-013-0594-2
Huang B, Huang G, Li W, et al. Intra-arterial chemotherapy combined with intravesical chemotherapy compared with intravesical BCG immunotherapy retrospectively in high-risk non-muscle-invasive bladder cancer after transurethral resection of the bladder tumor. J Cancer Res Clin Oncol. 2021; 147:1781-1788. DOI: https://doi.org/10.1007/s00432-020-03453-x
Lian F, Chen W, Liu Y, et al. Intra-arterial chemotherapy combined with intravesical chemotherapy is effective in preventing recurrence in non-muscle invasive bladder cancer. J Cancer Res Clin Oncol. 2019; 145:1625-1633. DOI: https://doi.org/10.1007/s00432-019-02900-8
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