Clinical Spectrum of Complications Induced by Intravesical Immunotherapy of Bacillus Calmette-Guérin for Bladder Cancer

Yuqing Liu, Jian Lu, Yi Huang, Lulin Ma, Yuqing Liu, Jian Lu, Yi Huang, Lulin Ma

Abstract

Because of its proven efficacy, intravesical Bacillus Calmette-Guérin (BCG) immunotherapy is an important treatment for nonmuscle invasive bladder cancer at high risk of recurrence or progression. However, approximately 8% of patients have to stop BCG instillation as a result of its complications. Complications induced by BCG therapy can have a variety of clinical manifestations. These adverse reactions may occur in conjunction with BCG instillation or may not develop until months or years after BCG cessation. An essential step in the management complications arising from BCG is early establishment of diagnosis, particularly for distant, disseminated, and obscure infections. Therefore we reviewed the literature on the potential complications after intravesical BCG immunotherapy for bladder cancer and provide an overview on the incidence, diagnosis, and treatment modality of genitourinary and systemic BCG-induced complications.

References

    1. Ferlay J., Soerjomataram I., Dikshit R., et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. International Journal of Cancer. 2014;136(5):E359–E386. doi: 10.1002/ijc.29210.
    1. Unda-Urzaiz M., Cozar-Olmos J., Miñana-Lopez B., et al. Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual. Actas Urológicas Españolas. 2018;42(4):238–248. doi: 10.1016/j.acuro.2017.10.003.
    1. Han R. F., Pan J. G. Can intravesical bacillus Calmette-Guérin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology. 2006;67(6):1216–1223. doi: 10.1016/j.urology.2005.12.014.
    1. Shelley M. D., Mason M. D., Kynaston H. Intravesical therapy for superficial bladder cancer: A systematic review of randomised trials and meta-analyses. Cancer Treatment Reviews. 2010;36(3):195–205. doi: 10.1016/j.ctrv.2009.12.005.
    1. Witjes J. A., Palou J., Soloway M., et al. Current clinical practice gaps in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) with emphasis on the use of bacillus Calmette-Guérin (BCG): Results of an international individual patient data survey (IPDS) BJU International. 2013;112(6):742–750. doi: 10.1111/bju.12012.
    1. Lamm D. L., Blumenstein B. A., Crissman J. D., et al. Maintenance bacillus Calmette-Guerin immunotherapy for recurrent Ta, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized southwest oncology group study. The Journal of Urology. 2000;163(4):1124–1129. doi: 10.1016/S0022-5347(05)67707-5.
    1. Sylvester R. J., Brausi M. A., Kirkels W. J., et al. Long-term efficacy results of EORTC genito-urinary group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus calmette-guérin, and bacillus calmette-guérin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladder. European Urology. 2010;57(5):766–773. doi: 10.1016/j.eururo.2009.12.024.
    1. Asín M. A. P.-J., Fernández-Ruiz M., López-Medrano F., et al. Bacillus Calmette-Guérin (BCG) infection following intravesical BCG administration as adjunctive therapy for bladder cancer: incidence, risk factors, and outcome in a single-institution series and review of the literature. Medicine. 2014;93(17):236–254. doi: 10.1097/md.0000000000000119.
    1. Redelman-Sidi G., Glickman M. S., Bochner B. H. The mechanism of action of BCG therapy for bladder cancer-a current perspective. Nature Reviews Urology. 2014;11(3):153–162. doi: 10.1038/nrurol.2014.15.
    1. Bilsen M. P., van Meijgaarden K. E., de Jong H. K., et al. A novel view on the pathogenesis of complications after intravesical BCG for bladder cancer. International Journal of Infectious Diseases. 2018;72:63–68. doi: 10.1016/j.ijid.2018.05.006.
    1. Brausi M., Oddens J., Sylvester R., et al. Side effects of bacillus calmette-guérin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. European Urology. 2014;65(1):69–76. doi: 10.1016/j.eururo.2013.07.021.
    1. Macleod L. C., Ngo T. C., Gonzalgo M. L. Complications of Intravesical Bacillus Calmette-Guérin. Canadian Tax Journal. 2014;8(7-8):E540–E544. doi: 10.5489/cuaj.1411.
    1. Koya M. P., Simon M. A., Soloway M. S. Complications of intravesical therapy for urothelial cancer of the bladder. The Journal of Urology. 2006;175(6):2004–2010. doi: 10.1016/S0022-5347(06)00264-3.
    1. Johnson M. H., Nepple K. G., Peck V., et al. Randomized controlled trial of oxybutynin extended release versus placebo for urinary symptoms during intravesical bacillus calmette-guérin treatment. The Journal of Urology. 2013;189(4):1268–1274. doi: 10.1016/j.juro.2012.10.070.
    1. Colombel M., Saint F., Chopin D., Malavaud B., Nicolas L., Rischmann P. The effect of ofloxacin on bacillus calmette-guerin induced toxicity in patients with superficial bladder cancer: results of a randomized, prospective, double-blind, placebo controlled, multicenter study. The Journal of Urology. 2006;176(3):935–939. doi: 10.1016/j.juro.2006.04.104.
    1. Decaestecker K., Oosterlinck W. Managing the adverse events of intravesical bacillus Calmette-Guérin therapy. Research and Reports in Urology. 2015;(7):157–163.
    1. Garcia C., Jina H., Bergersen P., Chalasani V. Bladder contracture – a rare and serious side effect of intravesical bacillus calmette-guérin therapy. Urology Case Reports. 2016;4:22–24. doi: 10.1016/j.eucr.2015.10.003.
    1. Nieder A. M., Sved P. D., Stein J. P., Skinner D. G., Soloway M. S. Cystoprostatectomy and orthotopic ileal neobladder reconstruction for management of bacille Calmette Guérin-induced bladder contractures. Urology. 2005;65(5):909–912. doi: 10.1016/j.urology.2004.11.053.
    1. Witjes J. A., Palou J., Soloway M., et al. Clinical practice recommendations for the prevention and management of intravesical therapy–associated adverse events. European Urology Supplements. 2008;7(10):667–674. doi: 10.1016/j.eursup.2008.08.001.
    1. Numakura K., Tsuchiya N., Tsuruta H., et al. Efficacy and safety of bladder hydrodistension for decreased bladder capacity induced by intravesical BCG therapy. Scandinavian Journal of Urology. 2016;50(6):429–432. doi: 10.1080/21681805.2016.1236399.
    1. Wittes R., Klotz L., Kosecka U. Severe bacillus Calmette-Guerin cystitis responds to systemic steroids when antituberculous drugs and local steroids fail. The Journal of Urology. 1999;161(5):1568–1569. doi: 10.1016/S0022-5347(05)68961-6.
    1. Vetorazzo Filho J. E., Bahia L. A., Vedovato B. C., et al. Cistectomia com reconstrução de neobexiga ortotópica ileal para tratamento de bexiga contraída após aplicação de bacilo de Calmette-Guérin intravesical. Einstein (São Paulo) 2014;12(4):502–504. doi: 10.1590/S1679-45082014RC2794.
    1. Ströck V., Dotevall L., Sandberg T., Gustafsson C. K., Holmäng S. Late bacille Calmette-Guérin infection with a large focal urinary bladder ulceration as a complication of bladder cancer treatment. BJU International. 2011;107(10):1592–1597. doi: 10.1111/j.1464-410X.2010.09923.x.
    1. Aslan G., Sevinc C., Tuna B., Ozkal S., Yorukoglu K. Penile lesion with inguinal adenopathy after intravesical Bacillus Calmette-Guerin instillation therapy. Indian Journal of Urology. 2013;29(1):70–72. doi: 10.4103/0970-1591.109991.
    1. Lestre S. I. A., Gameiro C. D., João A., Lopes M. J. P. Granulomas of the penis - A rare complication of intravesical therapy with Bacillus Calmette-Guerin. Anais Brasileiros de Dermatologia. 2011;86(4):759–762. doi: 10.1590/S0365-05962011000400021.
    1. Sharma V., Sethy P., Dogra P., Singh U., Das P. Primary tuberculosis of glans penis after intravesical bacillus calmette guerin immunotherapy. Indian Journal of Dermatology, Venereology and Leprology. 2011;77(1):47–50. doi: 10.4103/0378-6323.74979.
    1. Colomba C., Di Carlo P., Guadagnino G., et al. A Case of Epididymo-orchitis after intravesical bacille Calmette-Guérin therapy for superficial bladder carcinoma in a patient with latent tuberculosis infection. Infectious Agents and Cancer. 2016;11(1, article 25) doi: 10.1186/s13027-016-0072-y.
    1. Salvador R., Vilana R., Bargalló X., Araque X., Nicolau C. Tuberculous epididymo-orchitis after intravesical BCG therapy for superficial bladder carcinoma: Sonographic findings. Journal of Ultrasound in Medicine. 2007;26(5):671–674. doi: 10.7863/jum.2007.26.5.671.
    1. Demers V., Pelsser V. ‘BCGitis’: a rare case of tuberculous epididymo-orchitis following intravesical bacillus Calmette-Guerin therapy. Journal of Radiology Case Reports. 2012;6(11):16–21. doi: 10.3941/jrcr.v6i11.1100.
    1. El Hamrouni I., Puttemans T., Dardenne E., Draguet A. Unusual Case of Testicular Tuberculosis. Journal of the Belgian Society of Radiology. 2017;101(1, article 17):1–4. doi: 10.5334/jbr-btr.1142.
    1. Harada H., Seki M., Shinojima H., Miura M., Hirano T., Togashi M. Epididymo-orchitis caused by intravesically instillated bacillus Calmette-Guérin: Genetically proven using a multiplex polymerase chain reaction method. International Journal of Urology. 2006;13(2):183–185. doi: 10.1111/j.1442-2042.2006.01257.x.
    1. Watts M. R., Taylor P. C., Sintchenko V., et al. Implications of isoniazid resistance in mycobacterium bovis bacillus calmette-guerin used for immunotherapy in bladder cancer. Clinical Infectious Diseases. 2011;52(1):86–88. doi: 10.1093/cid/ciq002.
    1. Balasar M., Doğan M., Kandemir A., et al. Investigation of granulomatous prostatitis incidence following intravesical BCG therapy. International Journal of Clinical and Experimental Medicine. 2014;7(6):1554–1557.
    1. Humphrey P. A. BCG Prostatitis. The Journal of Urology. 2012;188(3):961–962. doi: 10.1016/j.juro.2012.06.054.
    1. Matsushima M., Kikuchi E., Akita H., Miyajima A., Oya M., Jinzaki M. Natural course of asymptomatic abnormal prostate findings incidentally detected by CT after intravesical BCG therapy. International Journal of Clinical Oncology. 2017;22(3):554–562. doi: 10.1007/s10147-017-1096-z.
    1. Rais-Bahrami S., Nix J. W., Turkbey B., et al. Clinical and multiparametric MRI signatures of granulomatous prostatitis. Abdominal Radiology. 2017;42(7):1956–1962. doi: 10.1007/s00261-017-1080-0.
    1. Serretta V., Gesolfo C. S., Di Maida F., et al. The clinical value of PSA increase during intravesical adjuvant therapy for nonmuscle-invasive bladder cancer. Urologia Journal. 2016;83(3):145–148. doi: 10.5301/uro.5000189.
    1. Aust T. R., Massey J. A. Tubercular prostatic abscess as a complication of intravesical bacillus Calmette-Guérin immunotherapy. International Journal of Urology. 2005;12(10):920–921. doi: 10.1111/j.1442-2042.2005.01183.x.
    1. Lamm D. L. Efficacy and safety of bacille Calmette-Guérin immunotherapy in superficial bladder cancer. Clinical Infectious Diseases. 2000;31(supplement 3):S86–S90. doi: 10.1086/314064.
    1. Kaneko T., Fujita K., Homma Y. Transient anuria requiring nephrostomy after intravesical bacillus Calmette-Guérin instillations for superficial bladder cancer. International Journal of Urology. 2006;13(3):294–295. doi: 10.1111/j.1442-2042.2006.01283.x.
    1. Al-Qaoud T., Brimo F., Aprikian A. G., Andonian S. BCG-related renal granulomas managed conservatively: a case series. Canadian Tax Journal. 2015;9(3-4):E200–E203. doi: 10.5489/cuaj.2664.
    1. Liaw F., Tan Y. Y., Hendry D. Systemic BCG-osis following intravesical BCG instillation for bladder carcinoma. Clinical Case Reports. 2017;5(10):1569–1572. doi: 10.1002/ccr3.1129.
    1. Rischmann P., Desgrandchamps F., Malavaud B., Chopin D. K. BCG intravesical instillations: Recommendations for side-effects management. European Urology. 2000;37(1):33–36. doi: 10.1159/000052381.
    1. Babjuk M., Burger M., Compérat E., et al. EAU Non-muscle-invasive Bladder Cancer Guidelines. Arnhem, The Netherlands: EAU Guidelines Office; 2018.
    1. Leo E., Molinari A. L., Rossi G., Ferrari S. A., Terzi A., Lorenzi G. Mycotic abdominal aortic aneurysm after adjuvant therapy with bacillus calmette-guérin in patients with urothelial bladder cancer: a rare but misinterpreted complication. Annals of Vascular Surgery. 2015;29(6):1318.e1–1318.e6. doi: 10.1016/j.avsg.2015.01.036.
    1. Coscas R., Arlet J., Belhomme D., Fabiani J., Pouchot J. Multiple mycotic aneurysms due to Mycobacterium bovis after intravesical bacillus Calmette-Guérin therapy. Journal of Vascular Surgery. 2009;50(5):1185–1190. doi: 10.1016/j.jvs.2009.06.004.
    1. Leeman M., Burgers P., Brehm V., van Brussel J. P. Psoas abscess after bacille Calmette-Guérin instillations causing iliac artery contained rupture. Journal of Vascular Surgery. 2017;66(4):1236–1238. doi: 10.1016/j.jvs.2017.02.038.
    1. Lee C. J., Davila D., Dua A., et al. Disseminated mycotic aneurysms following intravesical bacillus calmette–guérin therapy for bladder cancer: case discussion and systematic treatment algorithm. Annals of Vascular Surgery. 2017;39:284.e5–284.e10. doi: 10.1016/j.avsg.2016.05.120.
    1. Colmenero J. D., Sanjuan-Jimenez R., Ramos B., Morata P. Miliary pulmonary tuberculosis following intravesical BCG therapy: case report and literature review. Diagnostic Microbiology and Infectious Disease. 2012;74(1):70–72. doi: 10.1016/j.diagmicrobio.2012.05.026.
    1. Calleris G., Marra G., Corcione S., et al. Miliary pulmonary infection after BCG intravesical instillation: A rare, misdiagnosed and mistreated complication. Le Infezioni in Medicina. 2017;25(4):366–370.
    1. Moussa M., Abou Chakra M. Granulomatous hepatitis caused by Bacillus Calmette-Guerin (BCG) infection after BCG bladder instillation: A case report. Urology Case Reports. 2018;20:3–4. doi: 10.1016/j.eucr.2018.05.012.
    1. Miranda S., Vernet M., Héron F., Vittecoq O., Levesque H., Marie I. Arthrites réactionnelles secondaires à la BCG-thérapie. Deux observations et revue de la littérature. La Revue de Médecine Interne. 2010;31(8):558–561. doi: 10.1016/j.revmed.2010.01.010.
    1. Tinazzi E., Ficarra V., Simeoni S., Artibani W., Lunardi C. Reactive arthritis following BCG immunotherapy for urinary bladder carcinoma: A systematic review. Rheumatology International. 2006;26(6):481–488. doi: 10.1007/s00296-005-0059-2.
    1. Bernini L., Manzini C. U., Giuggioli D., Sebastiani M., Ferri C. Reactive arthritis induced by intravesical BCG therapy for bladder cancer: our clinical experience and systematic review of the literature. Autoimmunity Reviews. 2013;12(12):1150–1159. doi: 10.1016/j.autrev.2013.06.017.
    1. Ikeuchi R., Sunada T., Yoshikawa T., et al. Reactive arthritis during the second course of intravesical BCG therapy requiring administration of methotrexate: a case report. Hinyokika Kiyo. 2017;63(8):329–332.
    1. E C., Mackel S. M., Huhta T., Riesenburger R., Weller S. J. Mycobacterial osteomyelitis of the spine following intravesical BCG therapy for bladder cancer. Cureus. 2016;8(3)e545
    1. Kusakabe T., Endo K., Nakamura I., et al. Bacille Calmette-Guérin (BCG) spondylitis with adjacent mycotic aortic aneurysm after intravesical BCG therapy: a case report and literature review. BMC Infectious Diseases. 2018;18(1):p. 290. doi: 10.1186/s12879-018-3205-7.
    1. Białecki J., Nowak-Misiak M., Rąpała K., Marczyński W., Suchodolski G., Truszczyńska A. Spinal tuberculosis with severe neurological symptoms as a complication of intravesical BCG therapy for carcinoma of the bladder. Neurologia i Neurochirurgia Polska. 2016;50(2):131–138. doi: 10.1016/j.pjnns.2015.12.003.
    1. Shedid D., Obaid S., Rahme R., Weil A., Gendron C. Mycobacterium bovis spondylodiscitis after intravesical Bacillus Calmette-Guérin therapy. Surgical Neurology International. 2011;2(1):p. 162. doi: 10.4103/2152-7806.89879.
    1. Rajasekaran S., Soundararajan D. C., Shetty A. P., Kanna R. M. Spinal tuberculosis: current concepts. Global Spine Journal. 2018;8(supplement 4):96S–108S. doi: 10.1177/2192568218769053.
    1. Golub V., Malhotra P., Patel S. Mycobacterial brain tuberculomas due to Bacille Calmette-Guérin intravesical chemotherapy for bladder cancer: A case report and literature review. Canadian Journal of Infectious Diseases & Medical Microbiology. 2011;22(3):104–106. doi: 10.1155/2011/869286.
    1. Sheron M. W., Holt S. L., Ingram C. W. Mycobacterium bovis cerebellar abscess following treatment with bacillus Calmette-Guérin. Journal of Pharmacy Practice. 2016;30(3):378–380. doi: 10.1177/0897190016636533.
    1. Vadboncoeur J., Olivier S., Soualhine H., Labbé A., Bélair M. Endophthalmitis in a patient treated with bacillus calmette-guérin immunotherapy. Retinal Cases & Brief Reports. 2018;12(4):326–330. doi: 10.1097/ICB.0000000000000493.
    1. Misra S., Gupta A., Symes A., Duncan J. Haemophagocytic syndrome after intravesical bacille Calmette–Guérin instillation. Scandinavian Journal of Urology. 2014;48(3):328–330. doi: 10.3109/21681805.2013.836724.
    1. Ramos-Casals M., Brito-Zerón P., López-Guillermo A., Khamashta M. A., Bosch X. Adult haemophagocytic syndrome. The Lancet. 2014;383(9927):1503–1516. doi: 10.1016/s0140-6736(13)61048-x.
    1. Herr H. W., Dalbagni G. Intravesical bacille Calmette-Guérin (BCG) in immunologically compromised patients with bladder cancer. BJU International. 2013;111(6):984–987. doi: 10.1111/j.1464-410X.2012.11778.x.
    1. Ziegler J., Ho J., Gibson I. W., et al. Disseminated Mycobacterium bovis infection post-kidney transplant following remote intravesical BCG therapy for bladder cancer. Transplant Infectious Disease. 2018;20(5) doi: 10.1111/tid.12931.e12931
    1. Bijl M., Agmon-Levin N., Dayer J., Israeli E., Gatto M., Shoenfeld Y. Vaccination of patients with auto-immune inflammatory rheumatic diseases requires careful benefit-risk assessment. Autoimmunity Reviews. 2012;11(8):572–576. doi: 10.1016/j.autrev.2011.10.015.
    1. Morel J., Czitrom S. G., Mallick A., Sellam J., Sibilia J. Vaccinations in adults with chronic inflammatory joint disease: Immunization schedule and recommendations for patients taking synthetic or biological disease-modifying antirheumatic drugs. Joint Bone Spine. 2016;83(2):135–141. doi: 10.1016/j.jbspin.2015.08.008.
    1. Heiner J. G., Terris M. K. Effect of advanced age on the development of complications from intravesical bacillus Calmette-Guérin therapy. Urologic Oncology: Seminars and Original Investigations. 2008;26(2):137–140. doi: 10.1016/j.urolonc.2007.04.005.
    1. Racioppi M., Di Gianfrancesco L., Ragonese M., Palermo G., Sacco E., Bassi P. The challenges of Bacillus of Calmette-Guerin (BCG) therapy for high risk non muscle invasive bladder cancer treatment in older patients. Journal of Geriatric Oncology. 2018;9(5):507–512. doi: 10.1016/j.jgo.2018.03.020.
    1. Lenis A. T., Asanad K., Blaibel M., Donin N. M., Chamie K. Association between metabolic syndrome and recurrence of nonmuscle invasive bladder cancer following bacillus calmette-guérin treatment. Urology Practice. 2018;5(2):132–138. doi: 10.1016/j.urpr.2017.02.012.
    1. Martínez-Piñeiro J. A., Flores N., Isorna S., et al. Long-term follow-up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette-Guérin with a reduced dose of 27 mg in superficial bladder cancer. BJU International. 2002;89(7):671–680. doi: 10.1046/j.1464-410X.2002.02722.x.
    1. Al Khalifa M., Elfving P., Månsson W., et al. The effect of isoniazid on BCG-induced toxicity in patients with superficial bladder cancer. European Urology. 2000;37(1):26–30. doi: 10.1159/000052379.
    1. van der Meijden A. P. M., Brausi M., Zambon V. Intravesical instillation of epirubicin, bacillus Calmette-Guerin and bacillus Calmette-Guerin plus isoniazid for intermediate and high risk TA, T1 papillary carcinoma of the bladder: a European Organization for Research and Treatment of Cancer Genito-Urinary Group randomized phase III trial. The Journal of Urology. 2001;166(2):476–481. doi: 10.1016/S0022-5347(05)65966-6.
    1. Damiano R., De Sio M., Quarto G., et al. Short-term administration of prulifloxacin in patients with nonmuscle-invasive bladder cancer: an effective option for the prevention of bacillus Calmette-Guérin-induced toxicity? BJU International. 2009;104(5):633–639. doi: 10.1111/j.1464-410X.2009.08469.x.

Source: PubMed

Подписаться