Clin Chem Lab Med 2015; 53(3): 485–491 Jaume Trapé*, Maria Sala, Fina Franquesa, Josep M. Ordeig, Josep M. Soler-Bel, Eva Bustamante, Rafael Pérez, Jordi Aligué, Jesús Montesinos, Anna Arnau and Roser Ordeig-Villanueva Clinical utility of determining tumor markers in patients with signs and symptoms of cancer DOI 10.1515/cclm-2014-0410 Received April 13, 2014; accepted September 13, 2014; previously published online October 2, 2014 Abstract Background: Diagnosing patients with signs or symptoms suggestive of cancer is difficult. Serum tumor markers (TM) may be useful, but it is known that a range of pathol- ogies other than cancer can increase their concentrations and so TM data must be interpreted with caution. The aim of this study is to determine the diagnostic accuracy of TMs in patients with signs or symptoms of cancer. Methods: We prospectively studied 234 patients seen at rapid diagnostic units who presented signs or symp- toms suggestive of cancer. Ninety patients had wasting syndrome, 74 had pulmonary symptoms and 70 other presentations. CYFRA21-1, CEA, CA19-9, total bilirubin and creatinine were determined. The final diagnosis was obtained after 6 months’ follow-up. Patients were classi- fied according to the absence (group A) or presence (group B) of abnormal bilirubin or creatinine. Results: Of the 234 patients studied, 103 (44.0%) had tumors diagnosed. Cut-off points for each TM were cal- culated for a specificity of 100%. For the total group, the values were CYFRA21-1, 15 μg/L, CEA, 43.8 μg/L and CA19-9, 7428 KU/L, with an overall sensitivity of 46.6%. For group A (n= 142), the following cut-off points were established: CYFRA21-1, 7.8 μg/L, CEA, 13.8 μg/L and CA19-9, 101 KU/L, obtaining a sensitivity of 68.6%. For group B (n= 92), the values were the same as for the whole group, and a sensi- tivity of 42.4% was achieved. Conclusions: We conclude that TMs can aid diagnosis in these patients with signs or symptoms suggestive of can- cer. Their sensitivity can be improved by using different cut-off points in the presence and absence of renal and hepatic dysfunction. Keywords: cancer; CA19-9; CEA; CYFRA 21-1; diagnostic accuracy; tumor markers. Introduction Analysis of serum tumor markers (TMs) is principally indi- cated in the follow-up of patients with specific types of cancer [1]. In patients with localized tumors the sensitivity of tumor markers tends to be low, but most patients with bulky tumors or metastasis present high TM concentra- tions [2–6]. Many cancer patients do not present specific symp- toms or signs when they consult medical services. In these cases, differential diagnosis with other patholo- gies may require a large number of tests [7]. In addition, in certain underlying conditions, such as liver disease, kidney failure or chronic obstructive pulmonary disease, the tests may be difficult to perform and interpret. In this scenario, the differential diagnosis of cancer is made with diseases other than cancer which may occasionally increase TMs (e.g., pneumonia, diverticulitis, cholelithia- sis, etc.,) or in patients presenting underlying conditions, such as liver disease or kidney failure, which may also present high serum TM concentrations in the absence of tumors [8]. The aim of this study is to assess the clinical utility of TMs in patients with signs or symptoms of cancer and to establish whether the identification of renal and hepatic abnormalities can improve their diagnostic utility. *Corresponding author: Jaume Trapé, Servei de Bioquimica Althaia, Xarxa Assistencial Universitària de Manresa F.P.C/Joan Soler 1-3 08243 Manresa, Catalonia Spain, Phone +34 93 8742112, E-mail: jtrape@althaia.cat Maria Sala and Fina Franquesa: Servei de Bioquímica, Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Spain Josep M. Ordeig, Josep M. Soler-Bel, Eva Bustamante, Rafael Pérez, Jordi Aligué and Roser Ordeig-Villanueva: Servei de Medicina Interna, Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Spain Jesús Montesinos: Servei d’Oncologia, Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Spain Anna Arnau: Unitat de Recerca i Innovació, Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Spain Brought to you by | University of Georgia Libraries Authenticated Download Date | 6/8/15 2:57 PM