Bladder Epicheck® for surveillance in high-risk non-muscle-invasive bladder cancer: Initial experience and follow-up proposal

Caño Velasco, J.; Polanco Pujol, L.; Moreno Cortés, J.C.; Lafuente Puentedura, A.; Hernández Fernández, C.
doi:10.1016/j.acuroe.2023.06.011
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Bladder cancer is the 7th most common cancer in men worldwide and the 10th if we consider both sexes&#44; with an incidence rate &#40;per 100&#44;000 person&#47;years&#41; of 9&#46;5 for men and 2&#46;4 for women&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> The recurrence rate of non-muscle-invasive bladder cancer &#40;NMIBC&#41; ranges between 60&#37;&#8211;70&#37;&#44; thus requiring a close follow-up&#44; especially in high-risk cases &#40;HR-NMIBC&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">At the European level&#44; the cost of bladder cancer was estimated at 4&#46;9 billion euros in 2012&#44; with healthcare expenditure accounting for nearly 60&#37; of this value&#44; which represents approximately 7000 euros per prevalent case and around 5&#37; of the total healthcare costs for cancer&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> North American studies have estimated a total expenditure in the management of each NMIBC case of between 96&#44;000 and 230&#44;000 dollars&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The current clinical practice guidelines of the European Association of Urology &#40;EAU&#41;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> recommend&#44; although with a weak strength&#44; that the surveillance of patients with HR-NMIBC includes urine cytology and cystoscopy every 3 months for the first 2 years after the initial TURB&#44; every six months until the fifth year and yearly thereafter&#46; Regular &#40;yearly&#41; upper tract imaging &#40;computed tomography-intravenous urography &#91;CT-IVU&#93; or IVU&#41; is also recommended&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Repeated cystoscopies during follow-up not only entail high healthcare costs but also have a negative impact on the quality of life &#40;QoL&#41; of patients due to the invasive nature of the test&#46; Nearly 50&#37; of patients who undergo cystoscopy experience pain during the procedure&#44; with urinary urgency&#44; hematuria&#44; and the need for subsequent antibiotic therapy as undesirable side effects that occur with certain frequency&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">In recent years&#44; we are witnessing the progressive development of different urinary biomarkers which are useful in the diagnosis and surveillance of bladder cancer<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> &#40;Cx-Bladder&#44;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> ADX-Bladder&#8482;&#44;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Xpert Bladder&#174;&#44;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> Bladder Epicheck&#174;&#44;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> Uromonitor&#174;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a>&#41;&#46; We must remember that the ideal biomarker&#44; besides being cost-effective&#44; should have a high sensitivity &#40;Se&#41; and specificity &#40;Sp&#41;&#44; as well as a fast and easy interpretation&#46; On the other hand&#44; considering that its main objective is to reduce the number of unnecessary cystoscopies&#44; it should predominantly have a high negative predictive value &#40;NPV&#41;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Today&#44; their application in routine clinical practice is not consolidated&#46; However&#44; current EAU clinical guidelines<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;12</span></a> suggest that they might be used to replace and&#47;or postpone cystoscopy as they may identify HG recurrences occurring in low&#47;intermediate risk NMIBC&#46; This is due to their high S and NPV in HG disease&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The studies performed in HR-NMIBC<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13&#8211;15</span></a> using Bladder Epicheck&#174; show promising results despite their limited sample sizes&#46; Bladder EpiCheck&#174; &#40;Nucleix Ltd&#46;&#44; distributed by Palex Medical&#41; is based on identification of DNA methylation changes associated with BC in a panel of 15 genomic biomarkers&#46; Spontaneously voided urine samples undergo centrifugation for DNA extraction&#44; which is digested using a methylation-sensitive restriction enzyme that cleaves DNA at recognition sequences if it is unmethylated&#44; while leaving methylated sequences intact&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> Subsequently&#44; it is amplified via real-time PCR and a numerical value called EpiScore&#8482; is obtained&#46; Episcore above 60 is considered positive for urothelial carcinoma&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Since its introduction as an ancillary test in our center&#44; a tertiary public hospital in the Community of Madrid&#44; we have carried out an analysis of its Sensitivity &#40;Se&#41;&#44; Specificity &#40;Sp&#41;&#44; positive predictive value &#40;PPV&#41; and negative predictive value &#40;NPV&#41;&#44; by comparing it with cystoscopy&#44; which is the gold standard in the follow-up of HR-NMIBC&#46; For this purpose&#44; a prospective analysis of 98 HR-NMIBC patients according to EAU 2020 criteria &#40;T1 or HG&#47;G3 tumors or carcinoma in situ &#40;CIS&#41; or low-grade Ta &#40;LG&#41; multiple&#44; recurrent and larger than 3<span class="elsevierStyleHsp" style=""></span>cm tumors&#41; followed in our center between June 2021 and February 2023 by white light cystoscopy&#44; urine cytology and Bladder Epicheck&#174; has been carried out&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">The median age of our series was 69 &#40;IQR 65&#8211;75&#41; years&#44; with 80&#46;6&#37; being male&#46; Of note&#44; 87&#46;7&#37; received intravesical instillations after TURB &#40;83&#46;6&#37; BCG and 4&#46;1&#37; mitomycin C&#41;&#46; Of the series&#44; 62&#46;2&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>61&#41; were T1 &#40;81&#46;9&#37;HG and 18&#46;1&#37;LG&#41;&#59; 34&#46;7&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>34&#41; Ta &#40;85&#46;3&#37;HG and 14&#46;7&#37;LG&#41;&#59; and only 3&#46;1&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>3&#41; presented CIS&#46; There were 15 positive Bladder Epicheck&#174; results&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Urothelial bladder cancer recurrence was confirmed in 8 patients &#40;8&#46;1&#37;&#41;&#44; of whom 6 underwent TURB of the bladder tumor &#40;83&#46;3&#37;TaLG and 16&#46;7&#37;T1HG&#41; and 2 are under active surveillance after the diagnosis of TaLG confirmed by biopsy with cold forceps&#46; These two patients had negative cytology and a tumor size of less than 1<span class="elsevierStyleHsp" style=""></span>cm&#46; There was no recurrence in the upper urinary tract&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Overall&#44; we obtained Se values of 87&#46;5&#37;&#44; Sp of 91&#46;1&#37;&#44; PPV of 46&#46;7&#37;&#44; and NPV of 98&#46;8&#37; for Bladder Epicheck&#174; in the follow-up of HR-NMIBC in our series&#46; However&#44; the low sample size and the small number of recurrence events identified are the main limiting factors of our analysis&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">With the results obtained&#44; supported by the high NPV and by relevant published literature&#44; we have developed an alternative surveillance protocol that could be considered in the follow-up of HR-NMIBC &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0065" class="elsevierStylePara elsevierViewall">To ensure oncological safety&#44; the first check-up &#8211; 3 months after diagnosis &#8211; requires a cystoscopy&#44; preferably using PDD&#44; NBI or IMAGE1 S&#8482;&#44;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> if available&#46; Subsequently&#44; the performance of cystoscopy and Bladder Epicheck&#174; will be alternated&#46; Using imaging tests when cystoscopy is not performed&#44; could provide a higher Se&#44; thus coinciding the annual URO-CT with the urinary biomarker check-up&#46; The performance of urinary cytology in all stages of surveillance could be controversial&#46; However&#44; given its low cost&#44; its adequate Se for HG&#44; its non-invasive nature&#44; and the dogma of its performance at the present time in the follow-up of HR-NMIBC&#44; we believe that it can be maintained in the surveillance schedule as it does not deteriorate the patient&#8217;s QoL&#46; This strategy would allow us to reduce the number of cystoscopies in HR-NMIBC to 50&#37; with respect to the current EAU surveillance schedule&#44; and this would probably have a positive impact on the economic and QoL spheres of our patients&#46; However&#44; we must not overlook the patient&#8217;s oncologic safety&#46; Recently&#44; an estimated delay in the detection of recurrence of 1&#46;3 months has been established for patients with HR-NMIBC when applying a surveillance schedule similar to ours&#44; in which cystoscopy and Bladder Epicheck&#174;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> are alternated in the same time frame&#46; However&#44; would a 40-day delay in diagnosis have clinical impact on our patients&#63;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Further prospective and multicenter studies&#44; the improvement of current ones&#44; and the development of new urinary biomarkers will provide us with information to optimize their use and application in the follow-up of NMIBC&#46; In our opinion&#44; the greatest impact&#44; both in QoL and economic terms&#44; will be produced when Bladder Epicheck&#174; is applied to HR-NMIBC&#44; as recently indicated by the group of Hekman et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> which has reduced by up to 9&#37; their social and healthcare expenditures in this group of patients&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0075" class="elsevierStylePara elsevierViewall">None&#46;</p></span></span>"
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