Managing the adverse events of intravesical bacillus Calmette–Guérin therapy

Abstract

This paper provides recommendations on the management of complications arising from intravesical treatment with bacillus Calmette–Guérin (BCG) for nonmuscle-invasive bladder tumors. There is minimal recommendations currently available as randomized trials on the side effects of intravesical BCG are lacking and severe complications are usually described in case reports only. All physicians giving intravesical BCG should be aware of the possible complications that could arise and how to treat these. The incidence of bladder irritation, general malaise, and fever is very high, while severe complications remain rare. Approximately 8% of patients have to stop treatment because of these complications. BCG infections and reactions can occur anywhere in the body, and may happen straight away or even several months or years after BCG treatment, making early diagnosis difficult. Additionally, correct diagnosis is hampered by the uncertain appearance of BCG in tissue and body fluid. An essential step in the management complications arising from BCG is written information for both the family doctor and the patient on the possible adverse events and their management. Recent data demonstrated that none of the earlier advocated methods to prevent BCG toxicity are valid: lowering the dose, tuberculostatic drugs, or oxybutynin. Severe complications are treated with three or four tuberculostatics over 3–12 months, depending on the severity of the situation. Corticosteroids are an essential therapy in BCG septicemia. Nonsteroidal anti-inflammatory drugs and corticosteroids can manage efficiently the immunological complications.

Mycobacteria Bovis osteomyelitis following intravesical BCG for bladder cancer

“…In one report of 2600 patients treated with intravesical BCG, 27%-95% had symptoms of irritative lower urinary tract symptoms (LUTS), 2.9% with fever, 1.0% with hematuria and 0.4% with severe disseminated BCG sepsis [10] . In another study of 1316 patients, the reported BCG-induced cystitis was 35% and bacterial infection 23.3%, with frequency in 23.6%, and macroscopic hematuria in 22.6% [11] . The most frequent systemic side effects were general malaise in 15.5% and fever in 8.1% [11] .…”

“…In another study of 1316 patients, the reported BCG-induced cystitis was 35% and bacterial infection 23.3%, with frequency in 23.6%, and macroscopic hematuria in 22.6% [11] . The most frequent systemic side effects were general malaise in 15.5% and fever in 8.1% [11] . BCG sepsis was observed in four patients (0.3%) [11] .…”

“…The most frequent systemic side effects were general malaise in 15.5% and fever in 8.1% [11] . BCG sepsis was observed in four patients (0.3%) [11] .…”

Disseminated Mycobacterium Bovis Infection Complicating Intravesical BCG Instillation for the Treatment of Superficial Transitional Cell Carcinoma of the Bladder

“…Currently, due to the lack of randomized trials on the side effects of intravesical BCG, minimal recommendations are available, and severe complications are usually described in case reports only. 12 The suggested first-line treatment is the combination of isoniazid, rifampicin, and ethambutol. M. bovis is intrinsically resistant to pyrazinamide, and low-level isoniazid resistance has been described in some strains.…”

Breast abscess due to Bacillus Calmette-Guérin

“…While it is usually well tolerated, local and systemic complications could occur (Liberek et al, 2006). Although these events are still uncommon, its varied range of clinical presentations and severity presents a challenge for the physicians, as they could occur even years after instillation (Decaestecker and Oosterlinck, 2015).…”