Editorial
¿Is CRPC definition still valid in the new era of antiandrogens for mHSPC treatment?
¿Sigue siendo válida la definición del CPRC en la nueva era de los antiandrógenos para el tratamiento del CPHSm?
A.V. Ojeda-Claro
, M.J. Ledo-Cepero, J.L. Álvarez-Ossorio
Corresponding author
Unidad de Uro-Oncología, Hospital Universitario Puerta del Mar, Cádiz, Spain
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"tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "543" "paginaFinal" => "545" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "A.V. Ojeda-Claro, M.J. Ledo-Cepero, J.L. Álvarez-Ossorio" "autores" => array:3 [ 0 => array:4 [ "nombre" => "A.V." "apellidos" => "Ojeda-Claro" "email" => array:2 [ 0 => "anavictoriaojeda.1@gmail.com" 1 => "anav.ojeda.sspa@juntadeandalucia.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "M.J." "apellidos" => "Ledo-Cepero" ] 2 => array:2 [ "nombre" => "J.L." "apellidos" => "Álvarez-Ossorio" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Unidad de Uro-Oncología, Hospital Universitario Puerta del Mar, Cádiz, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "¿Sigue siendo válida la definición del CPRC en la nueva era de los antiandrógenos para el tratamiento del CPHSm?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In recent years, systemic treatment for patients with metastatic hormone-sensitive prostate cancer (mHSPC) has changed considerably, after the publication of different phase 3 clinical trials that have shown an increase in overall survival (OS) and a longer time to castration-resistant prostate cancer (CRPC)<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–5</span></a> when adding androgen receptor (AR) inhibitors (apalutamide or enzalutamide) as well as the CYP 17 inhibitor abiraterone, to androgen deprivation therapy (ADT) in an earlier phase of the disease. Therefore, in our daily clinical practice, we are set in a new era full of changes and uncertainty regarding how to assess the progression to CRPC of patients with mHSPC who are under treatment with the new AR axis targets, and when to switch to second-line therapy.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In this regard, in the recently published European guidelines on prostate cancer,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> CRPC is defined as follows:</p><p id="par0015" class="elsevierStylePara elsevierViewall">Castrate serum testosterone <50 ng/dL or 1.7 nmol/L plus either:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">1</span><p id="par0020" class="elsevierStylePara elsevierViewall">Biochemical progression: Three consecutive rises in PSA at least one week apart resulting in two 50% increases over the nadir, and a PSA > 2 ng/mL</p></li></ul></p><p id="par0025" class="elsevierStylePara elsevierViewall">or<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">2</span><p id="par0030" class="elsevierStylePara elsevierViewall">Radiological progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using RECIST (Response Evaluation Criteria in Solid Tumours). Symptomatic progression alone must be questioned and subject to further investigation. It is not sufficient to diagnose CRPC.</p></li></ul></p><p id="par0035" class="elsevierStylePara elsevierViewall">However, the biochemical criterion of CRPC definition was intended for those patients with mHSPC receiving exclusive treatment with ADT. In this respect, the study protocol of the 5 pivotal trials<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–5</span></a> after which apalutamide, abiraterone and enzalutamide were authorised for mHSPC therapy, indicated that treatment should be maintained until the occurrence of radiological progression, without considering a rising PSA alone as a determining factor of progression disease and therefore, of change to a second-line treatment. In fact, in three of the previously mentioned studies,<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–3</span></a> the main endpoint was radiological progression-free survival (rPFS).</p><p id="par0040" class="elsevierStylePara elsevierViewall">These pivotal clinical trials, which contributed to the new antiandrogens approval, followed the Prostate Cancer Clinical Trials Working Group 2 (PCWG2)<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> guidelines, whose recommendations included not to stop systemic treatments in patients with mCRPC who only presented biochemical progression, or if only a single metastatic lesion had progressed on imaging tests, always the patients kept a good performance status and the therapy was well-tolerated. Subsequently, PCWG3<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> encouraged individualizing each case and assessing whether the progression was significant enough to discontinue a well-tolerated treatment, thus defining the concept of "no longer clinically benefiting”. This concept was based on the time and the specific reason to change the regimen, keeping in mind the objective for which the therapy was started (quality of life, survival, etc). Concluding in this way, that treatment must be continued if serum PSA progression or radiological progression was slow and the symptoms related to the disease, which were present at the beginning of the therapy, remained controlled. According to the above, the recently published Spanish Association of Urology (AEU) consensus on mHSPC<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> concludes that systemic treatment should not be discontinued due only to a rising serum PSA, as long as the therapy provides a clinical benefit to the patient.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Until now, the clinical experience and guidelines for switching to second-line treatment with these new molecules were current only in the CRPC framework. However, in the mCSPC setting, we cannot continue using the same progression criteria as when patients were only treated with ADT, since various studies recognize that serum PSA as a tumor marker in this phase may have limitations<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10,11</span></a> and exist the possibility of a rising PSA without clinical progression in up to 22.1% of patients<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> so that treatments that are still effective could be prematurely interrupted. Alan H. Bryce et al., demonstrated a longer OS in patients with mCSPC in whom progression was exclusively biochemical [OS of 43.5 months (95% CI: 38.7–49.1) vs. 29.5 (95% CI: 24.3–37.9) months]. For this reason, the associated use of different parameters such as the PSA Doubling-time (PSADT) could be useful in decision-making,<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> to establish a closer follow-up in patients with fast PSA progression.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Focusing on the second progression criterion of the current CRPC definition (radiological progression criteria), pivotal clinical trials have been designed with conventional imaging tests, however, new-generation imaging (NGI) tests could detect metastases from the diagnosis of biochemical recurrence after radical prostatectomy, in up to 9% of cases.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> Fendler et al.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> proved that PSMA PET detected metastases in 55% of patients with CRPC, initially classified as non-metastatic (CRPC M0) by conventional imagen study; This fact affects the robustness of the second criterion of the current definition of CRPC, which is based on the diagnosis of radiological progression with conventional imaging tests.</p><p id="par0055" class="elsevierStylePara elsevierViewall">On the other hand, according to the protocol "Rationalization of the use of PET imaging in prostate cancer" recently published by the Andalusian Association of Urology (AAU), the Andalusian Society of Cancerology (SAC) and the Andalusian Society of Nuclear Medicine (SAMN),<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> patients diagnosed as metastatic through NGI, should have a follow-up of the potential progression of the metastatic stage through PET/CT, using if possible the same biological ligand and the same radiotracer, also describing in enunciated protocol possible new radiological progression criteria through the performance of these tests.</p><p id="par0060" class="elsevierStylePara elsevierViewall">The above highlights the need to establish new progression criteria, concerning the administration of much more powerful therapies than androgen deprivation therapy alone at an earlier stage of the disease, individualizing each case and not discontinuing the treatment by a slow rise in PSA, if a clinical benefit is obtained. On one hand, it is extremely important to review the biochemical progression criterion and establish guidelines to perform a closer patient control that helps to detect radiographic progression, instead of switching prematurely to a second line. On the other hand, we must encourage NGI use in the hormone-sensitive follow-up setting, favouring an earlier metastasis detection than conventional techniques. However, the use of NGI for the diagnosis and follow-up of patients with mHSPC is available in a minority of centres, so until NGI is extended, diagnosis and follow-up with conventional examinations could be a good clinical practice, even if the initial diagnosis came from NGI, the follow-up could be guided by conventional imaging.</p><p id="par0065" class="elsevierStylePara elsevierViewall">In conclusion, as the current definition of CRPC has become obsolete in its two points,</p><p id="par0070" class="elsevierStylePara elsevierViewall">new multicenter studies are needed on the progression criteria from the mHSPC stage to the CRPC stage in patients under treatment with the new AR axis target, as well as new protocols endorsed by scientific societies and expert committees, that help in the approach and current management of patients, individualizing each case in our daily clinical practice.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:15 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN Study" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "K.N. 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