Background. It is known that cytokeratin 19 is particularly abundant in carcinoma of the lung. Methods. A sandwich enzyme‐linked immunosorbent assay called CYFRA 21‐1 was, therefore, developed to detect soluble cytokeratin 19 fragments in serum using two specific monoclonal antibodies (Ks 19.1 and BM 19.21). The authors investigated the clinical significance of this new marker compared with the established markers carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCC), neuron‐specific enolase (NSE), carbohydrate antigen (CA) 19–9, CA 125, CA 15–3, CA 72–4, alpha‐fetoprotein, and prostate‐specific antigen in a pilot study on 1741 serum samples from patients with various benign and malignant diseases. Results. Postulating a specificity of 95% versus benign diseases of the lung, the diagnostic sensitivity of CYFRA 21‐1 in lung cancer (independent of histologic type) at primary diagnosis was superior (47%) to CEA (27%), SCC (15%), and NSE (16%). Especially in squamous cell carcinomas of the lung, the true‐positive test results were much higher for CYFRA 21‐1 (60%) than for CEA (18%) or SCC (31%). Conclusions. In small cell lung carcinomas, NSE was confirmed as the marker of first choice. For all of the other solid tumors investigated, CYFRA 21‐1 showed no better profile of specificity and sensitivity than the established markers.
Summary:Recently CYFRA 21-1, a new tumour marker measuring a fragment of cytokeratin 19, was introduced (1,2) and proved to be suitable for the follow-up care and monitoring of the therapy of non-small cell lung carcinomas, especially squamous cell carcinomas of the lung (3, 4). Besides CYFRA 21-1, there are two other tumour markers available, called tissue polypeptide antigen (TPA) and tissue polypeptide specific antigen (TPS), which also measure different cytokeratins in serum. In a retrospective study we investigated the clinical significance of these 3 cytokeratin markers in lung cancer compared with carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCC) and neuron-specific enolase (NSE). We investigated the sera of 50 healthy persons, 273 patients with various benign diseases and 218 patients with histologically proven lung cancer. In a first step the specificity versus benign diseases of the lung was established for all the markers, and was fixed at 95%. Then the single and combined sensitivities were calculated. CYFRA 21-1 proved to possess the highest sensitivity in lung cancer in general (61%), in non-small cell lung carcinomas (64%), in squamous cell carcinomas (79%), in adenocarcinomas (54%) and in large cell carcinomas (65%). In small cell lung carcinomas, neuron-specific enolase proved again to be the marker of first choice (55%). Combined determinations proved clearly increased sensitivity only for large cell carcinomas (CYFRA 21-1 + TPA: 77%) and for small cell lung carcinomas (CYFRA 21-1 + NSE: 62%). From our investigations it was evident that TPA detects at least partly the same substance as CYFRA 21-1 (the sensitivities compared with the markers TPS, CEA, SCC and NSE were rather high, but not as high as for CYFRA 21-1), whereas the TPS assay measures a completely different clinical chemical analyte (lowest number of true positive test results over the whole investigation). These findings correspond cleary to the very recent results of the comparison of CYFRA 21-1, TPA and TPS by immunoblotting (5). Introduction_ ,, , ^.r-r-,^ * ~ * Recently a new tumour marker, called CYFRA 21-1, In many industrialized countries, lung cancer is the was described for the detection of cytokeratin 19-inost common cancer in men and is climbing quickly fragments in serum (1, 2). Cytokeratins and other toward the same incidence in women. Clinical chem-intermediate filaments of the cell like vimentin and ical methods for the support of adequate follow up desmin have become well known since the developcare and the control of efficiency of therapy are avail-ment of monoclonal antibodies in histopathology for able only for small cell lung carcinomas, and they the differentiation and classification of physiological consist of the determination of neuron specific enolase and pathological tissues (8, 9). The expression of a (6, 7).single cytokeratin or a combination of certain cyto-
In a retrospective study we compared the usefulness of the tumour marker CA 72-4 with the established marker CA 125 II (both EIA on Cobas-Core, Hoffmann LaRoche, Basel Switzerland) at the time of primary diagnosis of ovarian carcinoma (n = 123) in order to discriminate between ovarian carcinomas of different histological type. We compared their diagnostic value, behaviour in follow-up care and evaluated possible combinations. Fixing specificity at 95% vs. benign gynaecological diseases (n = 37) as the clinically relevant reference group, we found cut-off values of 160 U/mL for CA 125 II and 3.0 U/mL for CA 72-4. On the basis of this specificity, we found comparable sensitivity for CA 125 II and CA 72-4 for all kinds of ovarian carcinoma at the time of primary diagnosis. With regard to histology, we found best sensitivity for CA 125 II in serous ovarian cancer and for CA 72-4 in mucinous ovarian cancer. Additional sensitivities were found in ovarian carcinoma in general but little in serous ones. No additive sensitivity was found in mucinous ovarian carcinomas with CA 72-4 as leading marker. In follow-up care, CA 72-4 was the leading marker in I I cases and CA I25 II in 16, while in one case both markers were negative. In 6 cases the change of values reflecting clinical follow-up-care was within the so-called reference range. According to our results, at the time of primary diagnosis because of lack of histological findings the combined determination of CA I25 II and CA 72-4 can be recommended. In follow-up care and control of efficacy of therapy the preoperative positive or leading marker is generally sufficient. The determination of both markers in follow-up care is indicated only if they both are negative at primary diagnosis and until one of them becomes clearly positive.0 1996 Wiley-Liss, Inc.
Recently CYFRA 21-1, a new tumor marker measuring a fragment of cytokeratin 19, was introduced and proved to be suitable for therapy monitoring and follow-up of non-small cell lung carcinomas (NSCLC), in particular squamous cell carcinomas. Besides CYFRA 21-1 there are two other tumor markers, tissue polypeptide antigen (TPA) and tissue polypeptide-specific antigen (TPS), which also measure various cytokeratins in serum. In a retrospective study we investigated the clinical significance of these three cytokeratin markers in lung cancer and in carcinoma of the urinary bladder. For this purpose we investigated the sera of 50 healthy persons, 273 patients with various benign diseases, 218 patients with histologically proven lung cancer and 88 patients with carcinoma of the urinary bladder. In a first step the specificity was established for the different reference groups and the cutoff values were fixed at a specificity of 95%. In lung cancer the single and combined sensitivities were calculated versus benign lung diseases (n = 58) as reference group. With single determinations CYFRA 21-1 proved to have the highest sensitivity in lung cancer in general (61%), in non-small cell lung carcinomas (64%), in squamous cell carcinomas (79%), in adenocarcinomas (54%) and in large cell carcinomas (65%). In small cell lung carcinomas (SCLC) NSE was confirmed to be the marker of choice (55%). With combined determinations a clear increase in sensitivity could only be reached in large cell carcinomas (CYFRA 21-1 + TPA: 77%) and in small cell carcinomas (CYFRA 21-1 + NSE: 62%).(ABSTRACT TRUNCATED AT 250 WORDS)
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