Abstract

BackgroundUrothelial bladder carcinoma accounts for around 3.9% cases of all the male cancers in India. Non-muscle-invasive bladder carcinoma (NMIBC) is predominant group which constitute approximately three fourth of the urothelial bladder cancer. Intravesical BCG immunotherapy is the corner stone of today’s NMIBC management. However, as with any other therapy it has its own complications and its interruption due to these adverse effects is a major cause of suboptimal efficacy. The aim of this study was to assess the complications of intravesical BCG therapy and their management in NMIBC patients.MethodsThis was a retrospective descriptive study conducted between October 2016 and November 2019; a backward review of 149 patients with diagnosis of NMIBC that undergone intravesicle BCG therapy was performed. Patient’s demographical, clinical, diagnostic and procedural data regarding bladder tumour, BCG therapy, its complications and management were collected and analysed.ResultsTotal 149 patients were analysed, comprising 116 males and 33 females. The mean age was of 57.2 ± 6.7 years. Total 85.23% were primary and 14.76% were recurrent tumours. Total 96 patients (64.42%) completed the planned course, while 53 (35.57%) interrupted. The reasons for BCG interruption includes adverse effects (15.4%), progression of disease (6.7%), disease refractory to BCG (4.6%) and disease recurrence during BCG (3.3%). Most of the adverse events occurred in first 6 months and most interruptions occurred after the induction period. Cystitis was the most common observed adverse effect seen in 39.6% patients. Frequency, urgency, haematuria were common presentation. Radical cystectomy was the most common (16.10%) further treatment with patients whose treatment was interrupted.ConclusionBCG is an indispensable therapy available for NMIBC, but it is associated with array of adverse effects and complications, which are the main reasons for poor compliance to BCG therapy. Although BCG-related complications can affect any organ in the body, potentially life-threatening systemic BCG-related infections are encountered in only < 5% of patients. There are some difficulties in diagnosis of the BCG complications because acid-fast staining, culture and PCR test are not always positive; tissue biopsies should be indicated sometimes to evaluate histopathology and presence of M. bovis. A persistently monitored multidisciplinary approach with high index of suspicion and prompt anti-TB therapy can help to derive the maximum benefits while keeping the complications at check.

Highlights

  • Urothelial bladder carcinoma accounts for around 3.9% cases of all the male cancers in India

  • Intravesical Bacille Calmette–Guerin (BCG) is effective in decreasing the risk of progression and recurrence [7, 8]

  • Lamm et al [11] had reported the incidence of such renal granulomas at a rate of 0.1% (2 cases out of 2602), whereas we found these at a higher proportion (2.6%) which may be attributed to Indian set up as well as to the fact that the previous study was almost 25 years back

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Summary

Introduction

Urothelial bladder carcinoma accounts for around 3.9% cases of all the male cancers in India. Nonmuscle-invasive bladder carcinoma (NMIBC) is predominant group which constitute approximately three fourth of the urothelial bladder cancer. The aim of this study was to assess the complications of intravesical BCG therapy and their management in NMIBC patients. Non-muscle-invasive bladder carcinoma (NMIBC) constitutes around 75% of newlydiagnosed urothelial bladder cancer and has a significant progression and high recurrence rate [3]. TURBT alone treatment is not sufficient because of high recurrence rate (50–70%) and high progression rate (10% and 20%) of NMIBC over a period of 5 years [5, 6]. Intravesical BCG is effective in decreasing the risk of progression and recurrence [7, 8]

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