Editorial commentary on: “Reduced vs full-dose BCG therapy in bladder cancer: A systematic review and meta-analysis”

Carrion, D.M.; Pradere, B.; Soria, F.; del Giudice, F.; Moschini, M.
doi:10.1016/j.acuroe.2022.09.002
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">We read with great interest the study performed by Verri et al&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> where they performed a systematic review and meta-analysis on a controversial topic&#58; the efficacy and safety of reduced-dose bacilli Calmette-Gu&#233;rin &#40;BCG&#41; instillations for bladder cancer in comparison with the standard full-dose&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Although the standard dosage has been empirically proposed&#44; and can differ among the different strains available &#40;without definitive superiority among available strains&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> BCG remains the standard of care for preventing recurrences&#44; and lowering the risk of progression of high-risk non-muscle invasive bladder cancer &#40;HR-NMIBC&#41; and improving survival outcomes&#46;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Clinicians face two main problems while using BCG therapy&#58; the side effects that may lead to discontinuation and its worldwide shortage&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> Studies have shown that compliance with the entire maintenance therapy with BCG is poor in patients with HR-NMIBC&#44; ranging from 29&#37; to 59&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> On the other hand&#44; a few years ago&#44; Sanofi Pasteur &#40;Lyon&#44; France&#41; discontinued their production of BCG Connaught strain causing a worldwide shortage of BCG&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">To overcome the BCG shortage&#44; it has been suggested to decrease the number and dose of instillations&#46; The recently published NIMBUS trial&#44; a multicentric randomized clinical trial &#40;RCT&#41;&#44; showed that a reduced number of instillations &#40;3 and further 2 instillations at 3&#44; 6&#44; and 12 months&#41; was significantly inferior to the standard schedule &#40;6 instillations for induction and 3 instillations at 3&#44; 6&#44; and 12 months for maintenance&#41; regarding the primary endpoint of time to first recurrence&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Despite the results from this high level of evidence study&#44; results of previously published systematic reviews and meta-analyses were conflictive&#46;<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9&#8211;11</span></a> Although a recent meta-analysis by Choi et al&#46; which included nine RCTs with 1217 patients &#40;from 1992 to 2016&#41; found a higher recurrence rate in the reduced-dose group without difference in progression&#44; cancer-specific survival or overall survival&#44; the authors did not performed any subgroup analysis between the studies including only induction and those including induction and maintenance therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Verri et al&#46; have reviewed the literature up to January 2022&#44; founding 17 studies that met their inclusion criteria &#40;prospective or retrospective comparison studies on oncologic and&#47;or toxicologic outcomes&#41;&#44; from 1992 to 2021&#44; involving a total of 3757 patients&#46; The results of their primary analysis showed that a reduced-dose was associated with a significantly higher recurrence rate &#40;OR&#58; 1&#46;19&#59; 95&#37; CI&#58; 1&#46;03&#8211;1&#46;36&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;02&#41;&#44; although no association was found in progression&#44; metastasis&#44; death from bladder cancer&#44; or death from any cause&#46; The most interesting and innovative part of their results stands in the preplanned subgroup analysis according to the schedule and regimen used &#40;induction only or induction<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>maintenance&#41;&#46; Indeed&#44; they found that the reduced-dose was associated with higher recurrence rates in the studies that evaluated an induction schedule only &#40;OR&#58; 1&#46;70&#59; 95&#37; CI&#58; 1&#46;19&#8211;2&#46;42&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;004&#41;&#44; but found no difference if a maintenance schedule was performed &#40;OR&#58; 1&#46;07&#59; 95&#37; CI&#58; 0&#46;96&#8211;1&#46;29&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;17&#41;&#46; Therefore&#44; these results offer new evidence to consider a potential benefit of reduced-dose regimen as long as a maintenance therapy and a strict follow-up are applied&#46; Nevertheless&#44; some limitations need to be underlined&#44; first the inclusion of prospective and retrospective studies in their analysis may affect the results in the subgroup analysis&#46; Second&#44; we need to keep in mind that proposing a reduced regimen should be offered only in very selective cases&#44; when BCG instillations are well tolerated and only in BCG shortage circumstances as the highest level of evidence remains against its common use&#46; Additionally&#44; genomic changes over the past 40&#8211;50 years have led to several worldwide available sub-strains of BCG&#44; which ultimately may have altered or imbalanced the compared strain&#8217;s potential efficacy&#46; Available evidence is indeed suggesting efficacy and safety of some strains may lead to a more robust immune response earlier on during induction therapy course balanced by some loss of efficacy during maintenance due to a decrease in the immune response over time&#46; By contrast&#44; other strains seem presenting specific long-acting immunogenic proprieties following the induction phase&#44; supporting the idea that it needs a long-term duration therapy to exhibit its proper therapeutic potential&#46;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">12&#44;13</span></a> Future cumulative evidence will indeed need to further explore the relative influence immune response of different BCG strains in association with their dose and schedule administration&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The landscape for newer treatments for high-risk NMIBC&#44; not only to enhance BCG therapy but to be effective when failures and resistances are detected is constantly evolving&#46; Some strategies are enhancing BCG activity inside the bladder with hydrogels&#44; the use of drug delivery carriers such as nanocarriers or liposomes&#44; combining BCG with immune checkpoint inhibitors&#44; and genetically modifying BCG strains that could improve the effectiveness as well as reducing side effects&#46;<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">14&#44;15</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">There is a need to improve our armamentarium for the treatment of HR-NMIBC with effective and safe treatments and the future might be bright with the actual drugs evaluated in enrolling studies&#46; Nevertheless&#44; BCG is the best treatment available and altought the best schedule and regimen remains debated&#44; it could be probably considered to offer a reduce dose when a maintenance therapy can be proposed in selected patients&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p></span>"
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                      "autores" => array:1 [
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