¿Is CRPC definition still valid in the new era of antiandrogens for mHSPC treatment?

Ojeda-Claro, A.V.; Ledo-Cepero, M.J.; Álvarez-Ossorio, J.L.
doi:10.1016/j.acuroe.2023.04.012
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In recent years&#44; systemic treatment for patients with metastatic hormone-sensitive prostate cancer &#40;mHSPC&#41; has changed considerably&#44; after the publication of different phase 3 clinical trials that have shown an increase in overall survival &#40;OS&#41; and a longer time to castration-resistant prostate cancer &#40;CRPC&#41;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#8211;5</span></a> when adding androgen receptor &#40;AR&#41; inhibitors &#40;apalutamide or enzalutamide&#41; as well as the CYP 17 inhibitor abiraterone&#44; to androgen deprivation therapy &#40;ADT&#41; in an earlier phase of the disease&#46; Therefore&#44; in our daily clinical practice&#44; 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&#44; and when to switch to second-line therapy&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">In this regard&#44; in the recently published European guidelines on prostate cancer&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> CRPC is defined as follows&#58;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Castrate serum testosterone &#60;50&#8239;ng&#47;dL or 1&#46;7&#8239;nmol&#47;L plus either&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">1</span><p id="par0020" class="elsevierStylePara elsevierViewall">Biochemical progression&#58; Three consecutive rises in PSA at least one week apart resulting in two 50&#37; increases over the nadir&#44; and a PSA&#8239;&#62;&#8239;2&#8239;ng&#47;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&#58; The appearance of new lesions&#58; either two or more new bone lesions on bone scan or a soft tissue lesion using RECIST &#40;Response Evaluation Criteria in Solid Tumours&#41;&#46; Symptomatic progression alone must be questioned and subject to further investigation&#46; It is not sufficient to diagnose CRPC&#46;</p></li></ul></p><p id="par0035" class="elsevierStylePara elsevierViewall">However&#44; the biochemical criterion of CRPC definition was intended for those patients with mHSPC receiving exclusive treatment with ADT&#46; In this respect&#44; the study protocol of the 5 pivotal trials<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#8211;5</span></a> after which apalutamide&#44; abiraterone and enzalutamide were authorised for mHSPC therapy&#44; indicated that treatment should be maintained until the occurrence of radiological progression&#44; without considering a rising PSA alone as a determining factor of progression disease and therefore&#44; of change to a second-line treatment&#46; In fact&#44; in three of the previously mentioned studies&#44;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#8211;3</span></a> the main endpoint was radiological progression-free survival &#40;rPFS&#41;&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">These pivotal clinical trials&#44; which contributed to the new antiandrogens approval&#44; followed the Prostate Cancer Clinical Trials Working Group 2 &#40;PCWG2&#41;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> guidelines&#44; whose recommendations included not to stop systemic treatments in patients with mCRPC who only presented biochemical progression&#44; or if only a single metastatic lesion had progressed on imaging tests&#44; always the patients kept a good performance status and the therapy was well-tolerated&#46; Subsequently&#44; 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&#44; thus defining the concept of &#34;no longer clinically benefiting&#8221;&#46; This concept was based on the time and the specific reason to change the regimen&#44; keeping in mind the objective for which the therapy was started &#40;quality of life&#44; survival&#44; etc&#41;&#46; Concluding in this way&#44; that treatment must be continued if serum PSA progression or radiological progression was slow and the symptoms related to the disease&#44; which were present at the beginning of the therapy&#44; remained controlled&#46; According to the above&#44; the recently published Spanish Association of Urology &#40;AEU&#41; 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&#44; as long as the therapy provides a clinical benefit to the patient&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Until now&#44; the clinical experience and guidelines for switching to second-line treatment with these new molecules were current only in the CRPC framework&#46; However&#44; in the mCSPC setting&#44; we cannot continue using the same progression criteria as when patients were only treated with ADT&#44; 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&#44;11</span></a> and exist the possibility of a rising PSA without clinical progression in up to 22&#46;1&#37; of patients<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> so that treatments that are still effective could be prematurely interrupted&#46; Alan H&#46; Bryce et al&#46;&#44; demonstrated a longer OS in patients with mCSPC in whom progression was exclusively biochemical &#91;OS of 43&#46;5 months &#40;95&#37; CI&#58; 38&#46;7&#8211;49&#46;1&#41; vs&#46; 29&#46;5 &#40;95&#37; CI&#58; 24&#46;3&#8211;37&#46;9&#41; months&#93;&#46; For this reason&#44; the associated use of different parameters such as the PSA Doubling-time &#40;PSADT&#41; could be useful in decision-making&#44;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> to establish a closer follow-up in patients with fast PSA progression&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Focusing on the second progression criterion of the current CRPC definition &#40;radiological progression criteria&#41;&#44; pivotal clinical trials have been designed with conventional imaging tests&#44; however&#44; new-generation imaging &#40;NGI&#41; tests could detect metastases from the diagnosis of biochemical recurrence after radical prostatectomy&#44; in up to 9&#37; of cases&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> Fendler et al&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> proved that PSMA PET detected metastases in 55&#37; of patients with CRPC&#44; initially classified as non-metastatic &#40;CRPC M0&#41; by conventional imagen study&#59; This fact affects the robustness of the second criterion of the current definition of CRPC&#44; which is based on the diagnosis of radiological progression with conventional imaging tests&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">On the other hand&#44; according to the protocol &#34;Rationalization of the use of PET imaging in prostate cancer&#34; recently published by the Andalusian Association of Urology &#40;AAU&#41;&#44; the Andalusian Society of Cancerology &#40;SAC&#41; and the Andalusian Society of Nuclear Medicine &#40;SAMN&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> patients diagnosed as metastatic through NGI&#44; should have a follow-up of the potential progression of the metastatic stage through PET&#47;CT&#44; using if possible the same biological ligand and the same radiotracer&#44; also describing in enunciated protocol possible new radiological progression criteria through the performance of these tests&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">The above highlights the need to establish new progression criteria&#44; concerning the administration of much more powerful therapies than androgen deprivation therapy alone at an earlier stage of the disease&#44; individualizing each case and not discontinuing the treatment by a slow rise in PSA&#44; if a clinical benefit is obtained&#46; On one hand&#44; 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&#44; instead of switching prematurely to a second line&#46; On the other hand&#44; we must encourage NGI use in the hormone-sensitive follow-up setting&#44; favouring an earlier metastasis detection than conventional techniques&#46; However&#44; the use of NGI for the diagnosis and follow-up of patients with mHSPC is available in a minority of centres&#44; so until NGI is extended&#44; diagnosis and follow-up with conventional examinations could be a good clinical practice&#44; even if the initial diagnosis came from NGI&#44; the follow-up could be guided by conventional imaging&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">In conclusion&#44; as the current definition of CRPC has become obsolete in its two points&#44;</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&#44; as well as new protocols endorsed by scientific societies and expert committees&#44; that help in the approach and current management of patients&#44; individualizing each case in our daily clinical practice&#46;</p></span>"
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