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Considerations in Latin America" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "257" "paginaFinal" => "259" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Mario I. Fernández" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Mario I." "apellidos" => "Fernández" "email" => array:1 [ 0 => "mariofernandez@udd.cl" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Departamento de Urología, Facultad de Medicina, Clínica Alemana Universidad del Desarrollo, Santiago, CAU de Grupo de Trabajo de Cáncer de Vejiga, Chile" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Implementación de los nuevos tratamientos para el tumor vesical no músculo invasivo que no responde al tratamiento con BCG. Aspectos a considerar en Latinoamérica" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The management of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) has developed significantly in recent years. After an adequate definition was finally established, numerous studies were published evaluating different therapeutic lines including both intravesical and systemic administration. This led to the approval of some of them by agencies such as the FDA, making them available for use.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In the present issue, a multidisciplinary team summarizes the current scientific evidence on the management of BCG-unresponsive NMIBC, providing consensus-based recommendations using GRADE methodology.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> First, it is emphasized that a tumor should be classified as unresponsive according to the definitions approved by the FDA.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Secondly, radical cystectomy remains the standard treatment and the management should be chosen within the framework of multidisciplinary discussions. Regarding alternative treatments, the implementation of FDA-approved therapies (intravesical Nadofaragene Firadenovec and systemic Pembrolizumab) is strongly recommended, while maintaining consideration of their use based on validation by the respective health authorities. Additionally, patient participation in ongoing clinical trials in this area should be considered in all instances. With respect to trials, the recent recommendations regarding endpoints, inclusion criteria, evaluations and statistical analyses will undoubtedly improve their quality and contribute to having more solid and comparable data.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The epidemiological reality of bladder cancer (BC) in Latin America presents its own characteristics. Beyond the well-known regional socioeconomic differences, there are several factors inherent to the countries in which the main clinical studies have been conducted. In fact, the regions with the lowest BC incidence worldwide correspond to countries with lower Human Development Index, BC being more frequent in industrialized societies. Differences in exposure to environmental carcinogens, especially tobacco use, could explain this. However, we must consider that cancer incidence might be under-reported in less developed nations.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> According to the most updated version of the International Agency for Research on Cancer (IARC) GLOBOCAN estimates, only 5.8% of new BC cases worldwide correspond to Latin America, compared to 52.2% in Europe and North America. This corresponds to incidences of 2.3–4.5/100,000 vs. 11–16.9/100,000 respectively, with the highest incidence in the Southern Cone region of Latin America (Argentina, Brazil, Chile and Uruguay).<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Thus, not being a common neoplasm, BC has hardly been studied and characterized in this region.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> Furthermore, the development of specific clinical guidelines has also been scarce. This situation is undoubtedly worrying, considering that predictions of BC incidence estimate the greatest percentage increases in Latin America and Africa (85%) by 2040.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">With respect to BCG, Latin America also has several special situations that must be considered. A recent epidemiological study revealed a significant association between childhood BCG vaccination with a lower incidence of BC; this adds to the previously mentioned differences in BC risk factors between developed and developing countries. In 2010, 157 countries, including all in Latin America, had a universal TB vaccination policy in place. Conversely, this measure was implemented in most industrialized societies (Europe and North America). The comparison of both groups showed a reduction of up to 37% in the incidence rate of BC, which reproduced similar results for leukemia and lung cancer, and which respond to an antineoplastic effect of BCG that has not yet been well characterized.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Along the same lines, several clinical studies of NMIBC have shown better oncologic outcomes in previously vaccinated patients. A study was conducted in Japan (which maintains vaccination) with the PPD skin test. As an indicator of BCG immunity, this test may be positive in previously exposed individuals, including vaccinated individuals. The study revealed a significantly lower tumor recurrence in patients with a positive PPD skin test (HR 0.23; <span class="elsevierStyleItalic">P</span> < .001).<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> However, it should be noted that vaccine protection decreases over time. Thus, the impact of BCG vaccination during childhood is variable, as BC occurs mainly in older adults, thus forming several decades later. This would explain the absence of differences in clinical outcomes in studies without evaluation of immune status.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The potential enhanced response of Latin American patients to BCG has several implications. We must maximize our efforts to perform adequate treatment to minimize the number of BCG-unresponsive patients. The latter is justified in many ways. Recent series have shown that oncologic outcomes in patients with adequate BCG, according to the FDA definition, are superior to those established by the European Association of Urology (EAU) risk classification.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> A recent study in Latin America with high-risk NMIBC patients receiving adequate BCG confirms this, with a high-grade recurrence rate of only 11.9% at 3 years of follow-up.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Accordingly, there is scope for optimizing BCG administration, and consequently for improving oncologic outcomes through this strategy in Latin America. This is relevant not only from a clinical point of view, but also from an administrative one, considering the high cost of the new agents reviewed in the consensus document, which will obviously have an even greater impact in developing countries.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Logistics related to human resources, among others, must also be considered. One example is the need for specialized staff and pharmacies to prepare chemotherapeutic agents, which are not available in all centers in the region.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> Finally, the incorporation of Medical Oncologists specialized in the management of NMIBC patients is another relevant aspect, which further intensifies the growing need for these physicians in view of the increasing global incidence of cancer.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">To sum up, along with recognizing and incorporating advances in BCG-unresponsive NMIBC, it is still important to apply treatment protocols correctly and according to clinical guidelines during the previous stage. As is so often the case in medicine, it is important to review how and why we are obtaining certain clinical results.</p><span id="sec1045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect1055">Funding</span><p id="par1190" class="elsevierStylePara elsevierViewall">Proyecto Anillo ACT210079, National Agency for Research and Development (ANID), Chile.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec1045" "titulo" => "Funding" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:13 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Documento multidisciplinar de consenso sobre el tratamiento actual del tumor vesical no-músculo invasor que no responde al tratamiento con bacilo Calmette-Guérin" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "F. 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Editorial
Implementation of new treatments for BCG-unresponsive non-muscle-invasive bladder cancer. Considerations in Latin America
Implementación de los nuevos tratamientos para el tumor vesical no músculo invasivo que no responde al tratamiento con BCG. Aspectos a considerar en Latinoamérica
Mario I. Fernández
Departamento de Urología, Facultad de Medicina, Clínica Alemana Universidad del Desarrollo, Santiago, CAU de Grupo de Trabajo de Cáncer de Vejiga, Chile