Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer

Abstract

| Multiple clinical trials have demonstrated that intravesical Bacillus Calmette-Guérin (BCG) treatment reduces recurrences and progression in patients with non-muscle-invasive bladder cancer (NMIBC). However, although BCG has been in use for almost 40 years, this agent is often underutilized and practice patterns of administration vary. This neglect is most likely caused by uncertainties about the optimal use of BCG, including unawareness of optimal treatment schedules and about patient populations that most benefit from BCG treatment. To address this deficit, a focus group of specialized urologic oncologists (urologists, medical oncologists and radiation oncologists) reviewed the current guidelines and clinical evidence, discussed their experiences and formed a consensus regarding the optimal use of BCG in the management of patients with NIMBC. The experts concluded that continuing therapy with 3-week BCG maintenance is superior to induction treatment only and is the single most important factor in improving outcomes in patients with NMIBC. They also concluded that a reliable alternative to radical cystectomy in truly BCG-refractory disease remains the subject of clinical trials. In addition, definitions for common terms of BCG failure, such as BCG-refractory and BCG-intolerant, have been formulated.

Papillary Recurrence of Bladder Cancer at First Evaluation after Induction Bacillus Calmette-Guérin Therapy: Implication for Clinical Trial Design

“…In fact, patients who have papillary disease recurrence at the 3-mo evaluation are often referred to as “BCG refractory,” although some experts have suggested that to be considered truly unresponsive to BCG as the disease should have been treated with at least one additional 3-wk course of BCG [9]. Nonetheless, patients with papillary recurrence after induction BCG at the 3-mo cystoscopic evaluation present a treatment quandary, as well as being a matter of discussion during clinical trial designs in the BCG failure population.…”

What is new in non-muscle-invasive bladder cancer in 2016?

“…[31] BCG there is, once again, the potential for a global shortage with regards to this crucial, lifesaving therapy for bladder cancer. [33] Kamat et al [34] reported the "Expert Consensus Document" that provides a comprehensive review of immunomodulatory therapy with BCG, recommends best practice guidelines to improve overall use and patient outcomes (Table 1). However, the definitions of the terms BCG relapse, BCG-refractory and BCG-intolerant were described in Table 2.…”

“…However, the definitions of the terms BCG relapse, BCG-refractory and BCG-intolerant were described in Table 2. [34] Peer-review: This manuscript was prepared by the invitation of the Editorial Board and its scientific evaluation was carried out by the Editorial Board. …”

Mycobacteria-Derived Agents for the Treatment of Urological and Renal Cancers

“…But even in the case of BCG treatment for NMIBC patients, many issues remain under question: the appropriate schedule to reduce recurrence and progression without increasing adverse events [94][95][96]; the reason why a proportion of patients do not respond to BCG treatment; the detail description of immune mechanism which could permit to predict the response to the treatment; the possibility of using other mycobacteria species that have shown similar or increased effective than BCG but with potential increased safety; etc. In fact, the experience using mycobacteria in BC is permitting novel approaches for improving its efficacy.…”