Editorial
An aid to a better understanding of the definitions of BCG failure provided by the European Urology Association
Una ayuda a la mejor comprensión de las definiciones de fracaso a la BCG dadas por la asociación Europea de Urologia
J. Huguet Pérez
, O. Rodríguez Faba, J.M. Gaya Sopena, J. Palou Redorta, A. Breda
Corresponding author
Fundació Puigvert, Barcelona, Spain
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Huguet Pérez, O. Rodríguez Faba, J.M. Gaya Sopena, J. Palou Redorta, A. Breda" "autores" => array:5 [ 0 => array:4 [ "nombre" => "J. Huguet" "apellidos" => "Pérez" "email" => array:1 [ 0 => "jhuguet@fundacio-puigvert.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "O. Rodríguez" "apellidos" => "Faba" ] 2 => array:2 [ "nombre" => "J.M." "apellidos" => "Gaya Sopena" ] 3 => array:2 [ "nombre" => "J." "apellidos" => "Palou Redorta" ] 4 => array:2 [ "nombre" => "A." "apellidos" => "Breda" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Fundació Puigvert, Barcelona, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Una ayuda a la mejor comprensión de las definiciones de fracaso a la BCG dadas por la asociación Europea de Urologia" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 864 "Ancho" => 2508 "Tamanyo" => 130342 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0015" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Illustrative scheme of the definitions of BCG failure provided by the EAU.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Bacillus Calmette Guerin (BCG) is the treatment for intermediate and high-risk non-muscle invasive bladder tumors (NMIBT), with a response rate close to 70% in papillary tumors and to 80% in patients with CIS. Some authors have observed that it reduces progression, and it is currently the drug with which new treatments are compared.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1,2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">However, BCG may not be effective in certain cases. Failure to BCG will occur due to 2 situations during or after treatment: progression (development of<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>T2 tumor) or high-grade recurrence.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Progression to invasive tumor occurs in 9.5–21% of high-risk patients treated with BCG.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> It is an undesirable situation because these patients have a much poorer prognosis. Witjes' group was one of the first to observe the poor prognosis of invasive tumors resulting from the progression of a NMIBT (progressive). They compared 89 primary invasive tumors with 74 progressive tumors. In spite of having comparable pathological stages, cancer-specific survival (CSS) at 5 years was 55% for primary tumors and 28% for progressive tumors.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> In another study, the same author analyzed 3088 high-risk NMIBT, most of them treated with BCG, of which 650 (21%) progressed. The survival of patients with progression did not exceed 35%.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> On the same subject, Pietzak compared 254 patients with primary invasive tumors with 43 secondary (progressive) tumors. Secondary tumors had a worse pathologic response to neoadjuvant treatment and worse CSS and overall survival. He also observed that mutations in ERCC2, related to a better response to chemotherapy, were less expressed in secondary tumors.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> We analyzed our series of 95 cystectomies indicated for BCG failure. At that time, the indications were: progression (appearance of ≥T2 tumor), early failure of BCG (3 months) or failure of 2 courses of BCG. In 33 patients (34.7%), cystectomy was performed for progression, and their 5-year CSS was 53%. In 62 patients (65.2%), cystectomy was performed due to the presence of recurrent high-grade NMIBT. In 45 (72.5%) of these 62, the clinical and pathological stage was NMIBT; CSS in this group was 90%. In 17 (27.4%) of the 62, the pathologic stage at cystectomy showed ≥T2 tumor. These tumors were understaged at previous TUR, and many of them had undergone subclinical progression through the prostatic urethra; their 5-year CSS was only 38%.<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6,7</span></a> Therefore, in high-risk NMIBT, we should not wait until progression to perform cystectomy, because the prognosis is significantly worse.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The second situation in which BCG failure is considered is high-grade recurrence during or after BCG. Since its introduction by Morales<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> and FDA approval (1990) for the treatment of NMIBT, the use of BCG became widespread. It was observed to be effective, but it was also seen that there were unresponsive patients. Several authors began to consider that the lack of response to 6 instillations of BCG (1 course) defined patients at higher risk of recurrence and progression.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Over time, the most accepted definition of BCG unresponsive disease was failure to 2 courses of BCG. Responses of more than 35% could be achieved with a second course, but failure to 2 courses implied a risk of progression that exceeded 50%.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> Another strategy used in the management of these patients was that, in cases with high-grade recurrence more than 1<span class="elsevierStyleHsp" style=""></span>year after BCG treatment, they could undergo another course, regardless of the previous ones.<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% of the cases (especially if CIS or tumor in the prostatic urethra was associated).<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> Therefore, early recurrence (at 3 months) after BCG was also considered BCG failure. With the progressive introduction of maintenance, there was a change in the definitions of BCG failure. The authors have shifted from using the number of BCG courses to define failure to using the time in which it occurs. Most authors go on to define BCG failure as the presence of high-grade tumor after 6 months from the start of BCG treatment (corresponding to after induction and 1 maintenance, or after a second induction cycle). The probability of progression of a recurrent high-grade T1 at 6 months after BCG could exceed 57%.<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, but if they persisted at 6<span class="elsevierStyleHsp" style=""></span>m, they were considered BCG failure, with risks of progression of 28% and 25% respectively.<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">14,15</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">From 2015 to the present, the need for consensus on the definition of BCG unresponsive disease has emerged. This is made even more necessary by the development of numerous clinical trials in patients with BCG unresponsive NMIBT. The different urological societies, including the European Association of Urology (EAU), have their own definitions of BCG failure (although all of them are very similar). Since 2018, the EAU Guidelines (which most of us follow) have used a table to define BCG failure.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> Although the table contains a lot of information, it is structured in a way that makes it difficult to understand. We have designed <a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a> in an attempt to better understand the definitions of BCG failure given by the EAU. According to the EAU, unresponsive patients are those who will not benefit from further BCG treatment. They will be divided into (1) refractory: high-grade relapse during BCG treatment, and specifically high grade T1 at 3 and 6 months and Ta and CIS with relapse at 3 and 6 months. (2) Early relapse: high-grade papillary recurrences within the 6 months after completion of maintenance, or CIS within one year after completion of BCG. Late relapse: high-grade recurrences beyond one year after BCG completion. There are authors who believe that refractory BCG and early BCG relapse have the same risk of progression, although there is no evidence to support this. Late BCG relapsing patients have better prognosis than BCG refractory patients, as previously indicated.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">As final comments, we would like to mention that the standardization of the definitions of BCG failure was necessary, and the definitions given by the EAU seem adequate and conservative. Although refractory patients seem to have the worst prognosis, 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.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 864 "Ancho" => 2508 "Tamanyo" => 130342 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0015" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Illustrative scheme of the definitions of BCG failure provided by the EAU.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:16 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Mantainance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "D.L. 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