CYFRA 21-1 in non-small cell lung cancer-standardisation and application during diagnosis

Pavićević, Radomir and Bubanović, Gordana and Franjević, Ana and Stančić-Rokotov, Dinko and Samaržija, Miroslav (2008) CYFRA 21-1 in non-small cell lung cancer-standardisation and application during diagnosis. Collegium Antropologicum, 32 (2). pp. 485-498. ISSN 0350-6134

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Abstract

There is no ideal tumour marker at present. The clinical application of CYFRA 21-1 is possible once a thorough standardisation process is carried out. Standardisation is achieved by determining the reference range in asymptomatic population, benign and malignant lung diseases, and benign and malignant diseases of other organs. Furthermore, it depends on knowledge of research population characteristics, patient medical histories and individual diagnostic procedure results, the size of research target samples and the clinically defined control groups. The cut-off level of CYFRA 21-1 for non-small cell lung cancer (NSCLC) is 1.72 ng/mL in the Croatian population. It is based on the clinically applicable sensitivity of 78% and specificity of 95% in benign lung diseases. The cut-off value is verified by clinical findings. For clinicians the level of CYFRA 21-1 is an early sign of NSCLC in relation to all the benign lung diseases and all the benign diseases of other organs, of which it was confirmed that they can influence the above level, provided that NSCLC is verified using standard diagnostic methods. The level of CYFRA 21-1 is also influenced by the time of sampling in relation to other diagnostic invasive procedures. The marker is clinically applicable if clinical findings verify it; otherwise, it is useless. This research has involved 343 healthy persons, 474 patients with a benign disease and 4440 patients with a malignant disease, 2453 of whom suffer from NSCLC. The sensitivity of CYFRA 21-1 in NSCLC is 78%, in squamous cell lung cancer (SQC) 84.6%, in adenocarcinomas (AD) 74.3% and in large cell lung cancer (LCC) 75.3%. The level of CYFRA 21-1 differs significantly between healthy persons, benign and malignant diseases (p<10(-3)). There are differences between the three histological types of NSCLC (p<10(-6)) and according to T and N (p<10(-3)). The level of CYFRA 21-1 prompts clinicians to repeat the clinical procedure during diagnosis, and helps to detect the disease earlier and implement treatment in NSCLC. We have achieved high concordance between marker findings and clinical diagnostic.

Abstract in Croatian

Za sada nema idealnog tumorskog markera. Klinička primjena CYFRA 21-1 moguća je nakon temeljito provedenog postupka standardizacije koju čini određivanje referentnog raspona u asimptomatskoj populaciji, benignim i malignim bolestima pluća, te benignim i malignim bolestima drugih organa. Ovaj postupak ovisi o poznavanju karakteristika istraživane populacije, anamnestičkih podataka i nalaza dijagnostičkih postupaka kod svakog pacijenta, veličini ciljano odabranog uzorka i klinički definiranih kontrolnih grupa. Referentna razina (engl. cut-off) CYFRA 21-1 kod karcinoma nemalih stanica pluća (NSCLC) u Hrvatskoj populaciji iznosi 1,72 ng/ml. Bazira se na klinički primjenjivoj senzitivnosti 78% i specifičnosti 95% kod benignih bolesti pluća. Vrijednost referentne razine je potvrđena u kliničkim nalazima. Razina CYFRA 21-1 ranije ukazuje kliničaru na NSCLC u odnosu na sve benigne bolesti pluća i drugih organa za koje smo utvrdili da mogu utjecati na razinu, ukoliko se potvrdi standardnim dijagnostičkim metodama. Na CYFRA 21-1 utječe i vrijeme uzimanja uzoraka u odnosu na druge dijagnostičke invazivne postupke. Klinički primjenjiv marker ima potvrdu u kliničkim nalazima, inače je beskoristan. U ovom radu su obuhvaćene 343 zdrave osobe te pacijenti s 474 benigne bolesti i 4.440 malignoma od čega je 2.453 NSCLC. Senzitivnost CYFRA 21-1 kod NSCLC je 78%, u karcinomu skvamoznih stanica pluća 84,6 %, adenokarcinomu pluća 74,3 % i karcinomu velikih stanica pluća 75,3 %. Razina CYFRA 21-1 se značajno razlikuje između zdravih, benignih i malignih bolesti (p<10–3). Razlike postoje između tri histološka tipa NSCLC (p<10–6) te T i N između histoloških tipova (p<10–3). CYFRA 21-1 upućuje kliničare da ponavljanim postupcima u doba dijagnoze ranije detektiraju bolest i započnu liječenje pacijenata s NSCLC. Naši nalazi markera su u visokom podudaranju s dijagnostikom.

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