Editorial article
Diagnostic role of tumor markers
Papel diagnóstico de los marcadores tumorales
a Unidad de Gestión Clínica de Laboratorio, Área de Gestión Sanitaria de la Serranía de Málaga, Servicio Andaluz de Salud, Ronda, Málaga, Spain
b Dirección Regional para la Seguridad del Paciente, Consejería de Salud, Junta de Andalucía, Sevilla, Spain
c Comisión de Seguridad del Paciente, Sociedad Española de Bioquímica Clínica y Medicina del Laboratorio, Barcelona, Spain
d Asociación Española de Biopatología Médica y Medicina de Laboratorio, Madrid, Spain
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Seguridad del Paciente, Consejería de Salud, Junta de Andalucía, Sevilla, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Comisión de Seguridad del Paciente, Sociedad Española de Bioquímica Clínica y Medicina del Laboratorio, Barcelona, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Asociación Española de Biopatología Médica y Medicina de Laboratorio, Madrid, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Papel diagnóstico de los marcadores tumorales" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Tumor markers might be one of the <span class="elsevierStyleItalic">in vitro</span> diagnostics assays that more expectations raised in their beginning. They were used to define a particular type of tumor, diagnose and establish the degree of spread, raise a prognosis and track some types of tumors. Nonetheless, experience and research have shown over time the need to review the usefulness of these markers, until finding their role depending on the case and type of marker, improving their use and, therefore, favoring the safety of patients.<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">1,2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">When the first tumor markers were discovered in the first half of the 20th century and developed more profusely in the second half of this century, the medical community saw a magnificent opportunity to face one of the diseases with the greatest impact on society. Not only because of the number of deaths it causes, but also because of the burden of this disease on patients, their families, society and the healthcare system.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Basically it was about measuring, through a blood test, certain substances (hormones, proteins, <span class="elsevierStyleItalic">etc.</span>) that would allow “to diagnose” the neoplastic disease. The first advantage was how easy it was to obtain the sample with a simple venipuncture. Moreover, any blood drawing could be used to perform any other laboratory tests. This opportunity could not be missed, becoming a routine test, particularly because over time more and more molecules were appearing with specific profiles related to a particular type of tumor or a specific anatomical region. Thus, alpha-fetoprotein (AFP) was available for germ-cell and hepatic tumors, human chorionic gonadotropin (HCG) for germ-cell tumors and choriocarcinoma, carcinoembryonic antigen (CEA) that guided on gastrointestinal tumors, the various carbohydrate antigens (CA), CA 125 for ovarian cancer, CA 15-3 “suggestive” of breast cancer, CA 19-9 focused on pancreatic cancer and prostate-specific antigen (PSA) related to cancer of prostate, among many others.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The impact of these assays was so important that they were quickly included into the service portfolios of the laboratories, which competed with one another to offer the broadest panel of tumor markers that would allow, in a single act, to alert the clinician on the existence of a neoplastic disease. These tests were even used as “screening” tests, sometimes being requested without clear criteria and, more important, without knowing how to subsequently manage their results.</p><p id="par0025" class="elsevierStylePara elsevierViewall">It is not necessary to explain the impact for a patient to be reported of having a positive “tumor marker”, even knowing that although high levels of a tumor marker might evidence the presence of cancer, this fact alone is not enough for its diagnosis. In addition to the anguish of the finding, we should add the risk associated with the additional tests listed below and the uncertainty regarding the results of these tests, being negative in a very high percentage.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">3</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">While the use of tumor markers has been progressing, the first studies on sensitivity and specificity showed that tumor markers can be high both in the presence of a neoplastic disease and in benign diseases. Moreover, even in the presence of tumors at an early stage, tumor markers can be negative.</p><p id="par0035" class="elsevierStylePara elsevierViewall">This performance, including markers as a routine test, has led to a significant number of unnecessary laboratory tests, prescription of additional studies, mostly bloody, aimed at corroborating or refuting this finding, exposing patients to numerous risks that occasionally have resulted in harming the patient. In radiology, the VOMIT (Victim of Modern Imaging Technology) syndrome has been reported, which means that the prognosis, diagnosis or treatment provided have been wrong due to a wrong indication or a failed interpretation of the radiological tests. Unfortunately, in the world of <span class="elsevierStyleItalic">in vitro</span> diagnostics, despite the consequences that sometimes have led to an inappropriate indication or a failed interpretation of blood tests, a similar syndrome has not been described yet.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">4</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">It was in the year 2000, with the publication of the report “To err is human”, of the Institute of Medicine of USA when the focus was placed on medical performance as a cause of death and adverse events in medical practice.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">5</span></a> Five years later, in our country, the national study on adverse effects linked to hospitalization (ENEA) was launched, trying to reproduce the findings of the American study. Although initially the <span class="elsevierStyleItalic">in vitro</span> and <span class="elsevierStyleItalic">in vivo</span> diagnostic tests did not account for an important percentage, only 2.7% of the total causes were compared against the errors related to medication or surgery, it did draw attention that in almost 90% cases all those errors could be prevented.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">6</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">All this information led healthcare systems to place patient safety as a priority in their political agenda, beginning with a critical reading of the health actions performed in every field, describing human errors and system failures as the cause of these adverse events. This has been complemented by the publication of studies on the inadequate use of these tests and the need for the appropriate indication to ensure a proper and safe practice.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Tumor markers do not escape this need and studies are being conducted in this line, not only analyzing the appropriate indication of said markers, but the implications that their prescription may have in other types of studies.</p><p id="par0055" class="elsevierStylePara elsevierViewall">International, European and national scientific societies have also echoed this trend and have deepened in these indications, laying the foundations for an appropriate and safer use. The European Group on Tumor Markers (EGTM), states in its general guidelines that the usefulness of tumor markers lies in the follow-up of the disease and treatment monitoring, and this is worth mentioning.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">7</span></a> In the same way, the National Cancer Institute (NCI) does not recommend its use as screening tests and reiterates the EGTM recommendations, including some biomarkers in these terms.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">8</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">At a national level and within the scope of <span class="elsevierStyleItalic">in vitro</span> diagnostics, we would like to mention the benchmarking project of the Spanish Association of Medical Biopathology “Intelligent decisions from the Laboratory: choosing wisely not to do”, involving more than 70 laboratories throughout Spain and where one of the recommendations is not using serum tumor markers for population screening. The optimal result is the non-inclusion of these tests in population screening.<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">9</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Within the international literature we should highlight the Japanese Gastric Cancer Working Group review that concludes, after reviewing numerous articles, that the combination of CEA, CA 19-9 and CA 72-4 have shown only their usefulness in tumor recurrence and in the estimation of survival rates, not being valid for tumors in initial stages.<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">10</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">On the other hand, in the systematic review on the role of serum markers in the detection of recurrence of pancreatic cancer, it was determined that, despite the limitations, CA 19-9 is the most used marker to determine survival after surgical resection.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">11</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">The scope of these findings not only redefines the usefulness of the markers, but questions that only one of them be sufficient. In the Cochrane review on CEA levels in the study on colorectal cancer recurrence, it is concluded that this marker alone is not enough.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">12</span></a></p><p id="par0080" class="elsevierStylePara elsevierViewall">Also, in the review on the role of human epididymis protein 4 (HE4) in the follow-up of ovarian cancer, it was estimated that the usefulness of this marker should be limited to the detection of recurrences where its sensitivity has been proven.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">13</span></a></p><p id="par0085" class="elsevierStylePara elsevierViewall">One of the most accepted markers is PSA, also being reviewed. In recent studies it has been concluded that, although this marker can reduce mortality, it is associated with up to a false positive rate of 50%, complications with subsequent biopsy and overdiagnosis. Even though early treatment after a positive screening reduces the risk of metastatic recurrence, its impact on long-term mortality rates has not been conclusive yet.<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">14,15</span></a></p><p id="par0090" class="elsevierStylePara elsevierViewall">It is evident that the role of tumor markers has undergone an evolution over time, in the same way as scientific findings have. Far from the initial hopes placed on these tests, we should make a more thorough reading of their indications and find the real usefulness of these indications to minimize the risks and occurrence of any adverse events. Whether from the perspective of patient safety or the quality of prescription or efficiency, we should be aware of the impact that the prescription of this type of tests can have on a patient. In a highly connected and well-informed society, the meaning of tumor markers is within everyone's reach. A positive result does not mean the existence of a tumor, and a negative result does not exclude it. In the first case, the number of tests required to conclude whether there is or not a neoplastic disease is very important and they involve numerous risks for the patient. However, in the second case, a wrong indication or interpretation of the negative result can lead to a false sense of security and relax the level of alert when monitoring a particular patient, which may lead to a diagnosis omission.</p><p id="par0095" class="elsevierStylePara elsevierViewall">Strategies adopted by some centers to change the name of “tumor markers” to “specific markers” as it has been attempted in some laboratories to reduce the burden of anxiety in the patient does not solve the problem.</p><p id="par0100" class="elsevierStylePara elsevierViewall">An adequate knowledge of the test limitations, their indications, their semiological value and the diagnostic usefulness is the only way to make a safe use of them. There is enough knowledge to obtain the best performance from these tests if we adjust to their indications. Only then we will obtain the best results for the patient.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Mérida de la Torre FJ, Moreno Campoy EE. Papel diagnóstico de los marcadores tumorales. Med Clin (Barc). 2019;152:185–187.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:15 [ 0 => array:3 [ "identificador" => "bib0080" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Fundamentos de seguridad del paciente" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "F.J. Merida" 1 => "E.E. 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