An aid to a better understanding of the definitions of BCG failure provided by the European Urology Association

Pérez, J. Huguet; Faba, O. Rodríguez; Gaya Sopena, J.M.; Palou Redorta, J.; Breda, A.
doi:10.1016/j.acuroe.2023.01.008
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Bacillus Calmette Guerin &#40;BCG&#41; is the treatment for intermediate and high-risk non-muscle invasive bladder tumors &#40;NMIBT&#41;&#44; with a response rate close to 70&#37; in papillary tumors and to 80&#37; in patients with CIS&#46; Some authors have observed that it reduces progression&#44; and it is currently the drug with which new treatments are compared&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">However&#44; BCG may not be effective in certain cases&#46; Failure to BCG will occur due to 2 situations during or after treatment&#58; progression &#40;development of<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>T2 tumor&#41; or high-grade recurrence&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Progression to invasive tumor occurs in 9&#46;5&#8211;21&#37; of high-risk patients treated with BCG&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> It is an undesirable situation because these patients have a much poorer prognosis&#46; Witjes&#39; group was one of the first to observe the poor prognosis of invasive tumors resulting from the progression of a NMIBT &#40;progressive&#41;&#46; They compared 89 primary invasive tumors with 74 progressive tumors&#46; In spite of having comparable pathological stages&#44; cancer-specific survival &#40;CSS&#41; at 5 years was 55&#37; for primary tumors and 28&#37; for progressive tumors&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> In another study&#44; the same author analyzed 3088 high-risk NMIBT&#44; most of them treated with BCG&#44; of which 650 &#40;21&#37;&#41; progressed&#46; The survival of patients with progression did not exceed 35&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> On the same subject&#44; Pietzak compared 254 patients with primary invasive tumors with 43 secondary &#40;progressive&#41; tumors&#46; Secondary tumors had a worse pathologic response to neoadjuvant treatment and worse CSS and overall survival&#46; He also observed that mutations in ERCC2&#44; related to a better response to chemotherapy&#44; were less expressed in secondary tumors&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> We analyzed our series of 95 cystectomies indicated for BCG failure&#46; At that time&#44; the indications were&#58; progression &#40;appearance of &#8805;T2 tumor&#41;&#44; early failure of BCG &#40;3 months&#41; or failure of 2 courses of BCG&#46; In 33 patients &#40;34&#46;7&#37;&#41;&#44; cystectomy was performed for progression&#44; and their 5-year CSS was 53&#37;&#46; In 62 patients &#40;65&#46;2&#37;&#41;&#44; cystectomy was performed due to the presence of recurrent high-grade NMIBT&#46; In 45 &#40;72&#46;5&#37;&#41; of these 62&#44; the clinical and pathological stage was NMIBT&#59; CSS in this group was 90&#37;&#46; In 17 &#40;27&#46;4&#37;&#41; of the 62&#44; the pathologic stage at cystectomy showed &#8805;T2 tumor&#46; These tumors were understaged at previous TUR&#44; and many of them had undergone subclinical progression through the prostatic urethra&#59; their 5-year CSS was only 38&#37;&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6&#44;7</span></a> Therefore&#44; in high-risk NMIBT&#44; we should not wait until progression to perform cystectomy&#44; because the prognosis is significantly worse&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The second situation in which BCG failure is considered is high-grade recurrence during or after BCG&#46; Since its introduction by Morales<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> and FDA approval &#40;1990&#41; for the treatment of NMIBT&#44; the use of BCG became widespread&#46; It was observed to be effective&#44; but it was also seen that there were unresponsive patients&#46; Several authors began to consider that the lack of response to 6 instillations of BCG &#40;1 course&#41; defined patients at higher risk of recurrence and progression&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Over time&#44; the most accepted definition of BCG unresponsive disease was failure to 2 courses of BCG&#46; Responses of more than 35&#37; could be achieved with a second course&#44; but failure to 2 courses implied a risk of progression that exceeded 50&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> Another strategy used in the management of these patients was that&#44; in cases with high-grade recurrence more than 1<span class="elsevierStyleHsp" style=""></span>year after BCG treatment&#44; they could undergo another course&#44; regardless of the previous ones&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> Solsona published a conclusive article on the subject indicating that patients with T1 G3 tumors and recurrence at 3 months post BCG could potentially progress in 73&#37; of the cases &#40;especially if CIS or tumor in the prostatic urethra was associated&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> Therefore&#44; early recurrence &#40;at 3 months&#41; after BCG was also considered BCG failure&#46; With the progressive introduction of maintenance&#44; there was a change in the definitions of BCG failure&#46; The authors have shifted from using the number of BCG courses to define failure to using the time in which it occurs&#46; Most authors go on to define BCG failure as the presence of high-grade tumor after 6 months from the start of BCG treatment &#40;corresponding to after induction and 1 maintenance&#44; or after a second induction cycle&#41;&#46; The probability of progression of a recurrent high-grade T1 at 6 months after BCG could exceed 57&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> Numerous authors considered that patients with CIS or high-grade Ta at 3 months could benefit from reinduction&#44; but if they persisted at 6<span class="elsevierStyleHsp" style=""></span>m&#44; they were considered BCG failure&#44; with risks of progression of 28&#37; and 25&#37; respectively&#46;<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">14&#44;15</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">From 2015 to the present&#44; the need for consensus on the definition of BCG unresponsive disease has emerged&#46; This is made even more necessary by the development of numerous clinical trials in patients with BCG unresponsive NMIBT&#46; The different urological societies&#44; including the European Association of Urology &#40;EAU&#41;&#44; have their own definitions of BCG failure &#40;although all of them are very similar&#41;&#46; Since 2018&#44; the EAU Guidelines &#40;which most of us follow&#41; have used a table to define BCG failure&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> Although the table contains a lot of information&#44; it is structured in a way that makes it difficult to understand&#46; We have designed <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a> in an attempt to better understand the definitions of BCG failure given by the EAU&#46; According to the EAU&#44; unresponsive patients are those who will not benefit from further BCG treatment&#46; They will be divided into &#40;1&#41; refractory&#58; high-grade relapse during BCG treatment&#44; and specifically high grade T1 at 3 and 6 months and Ta and CIS with relapse at 3 and 6 months&#46; &#40;2&#41; Early relapse&#58; high-grade papillary recurrences within the 6 months after completion of maintenance&#44; or CIS within one year after completion of BCG&#46; Late relapse&#58; high-grade recurrences beyond one year after BCG completion&#46; There are authors who believe that refractory BCG and early BCG relapse have the same risk of progression&#44; although there is no evidence to support this&#46; Late BCG relapsing patients have better prognosis than BCG refractory patients&#44; as previously indicated&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">As final comments&#44; we would like to mention that the standardization of the definitions of BCG failure was necessary&#44; and the definitions given by the EAU seem adequate and conservative&#46; Although refractory patients seem to have the worst prognosis&#44; we should not be too strict with the definitions of BCG unresponsive disease because on many occasions treatment should be individualized according to the characteristics of the patient and the tumor&#46;</p></span>"
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