Complications of intravesical BCG therapy in non-muscle invasive bladder cancer: our tertiary care centre experience

Abstract

Background Urothelial 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. Methods This 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. Results Total 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. Conclusion BCG 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.

Quality of Life, Efficacy, and Safety of Sequential Intravesical Gemcitabine + Docetaxel versus BCG for Non-Muscle Invasive Urinary Bladder Cancer: A Pilot Study

“…Around 40% of the Indian population is infected with tuberculosis and almost whole of the population is immunized with BCG [27]. This preexisting exposure to BCG may cause accelerated response against tumor cells and increased local inflammation.…”

Secondary Haemophagocytic Lymphohistiocytosis Syndrome (HLH) After Intravesical Instillation of Bacillus Calmette-Guérin (BCG): A Case Report and Review of the Literature

“…The BCG mechanism of action as an immunotherapeutic agent is not fully elucidated, though it is thought that it activates local immune response leading to the death of tumour cells, with high efficacy and good tolerance [ 1 ] . Adverse reactions are not rare, but tend to be local and usually self-limiting, concerning fever, malaise and bladder irritation due to cystitis [ 2 ] . Serious adverse reactions with systemic symptoms – a condition that is often called BCGitis–are far less common, accounting for less than 5% of all cases.…”

Bacillus Calmette-Guérin pneumonitis after intravesical instillation: Report of two cases and a review of the literature

“…Among sites of systemic infection, lung involvement is the most common 24,44 . Granulomatous hepatitis has also been repeatedly reported 10,12,33 , while the involvement of other organs like musculoskeletal system, aorta or other large vessels is even more rare and reported only anecdotally 15,16,44,45 . Cases involving both the lungs and the liver have been documented 32 .…”