Assay-Abhängigkeit der Calcitonin- Zielbereiche für „biochemisch geheilte“ Patienten mit medullärem Schilddrüsenkarzinom

Summary

Aim: Calcitonin (hCT) is an important diagnostic parameter in medullary thyroid carcinoma (MTC). We determined the variability of the reference ranges of several currently available immunometric assays for „biochemically cured“ MTC patients. Patients, methods: We compared six assays [Nichols ICMA, Biomerica IEMA, Immulite 2000 (Siemens), Calcitonin-IRMA magnum (Medipan), SELco-IRMA (Medipan) and Calcitonin IRMA (Medgenix)] in subgroups of 198 patients with differentiated thyroid cancer (DTC) after total thyroidectomy as a model for curatively treated MTC patients. In addition, hCT was measured after pentagastrin stimulation in 13 DTC patients and 13 patients with MTC. Results: The basal hCT concentrations were below the detection limit of the respective assay in 100% of all thyroidectomized DTC patients for Nichols ICMA (n = 138) and Immulite 2000 (n = 60), in 97% for Biomerica IEMA (n = 57), and in 85% for IRMA magnum (n = 20). However, basal hCT was mostly within the reference range in Selco-IRMA (n = 20) and Medgenix IRMA (n = 76). In all DTC patients and 9/13 MTC patients the pentagastrin stimulated hCT was below the detection limit for the Nichols ICMA and Immulite 2000, all four MTC patients with elevated stimulated hCT developed a recurrence during follow-up. Conclusions: For assays with high monomer specificity (Nichols ICMA, Biomerica IEMA, Immulite 2000, to a lesser degree IRMA magnum) biochemical cure is defined by basal and stimulated calcitonin levels below the detection limit. For assays with low monomer specificity (SELco-IRMA, IRMA Medgenix) calcitonin levels in the reference range of patients without thyroid diseases are consistent with “biochemical cure”.

Zusammenfassung

Ziel: Calcitonin (hCT) ist ein entscheidender diagnostischer Parameter beim medullären Schilddrüsenkarzinom (MTC). Verschiedene immuno metrische Assays wurden untersucht, um Einfluss auf den hCT-Zielbereich für so genannte „biochemisch geheilte“ MTC-Patienten zu prüfen. Patienten, Methodik: Mit sechs Assays [Nichols ICMA, Biomerica IEMA, Immulite 2000 (Siemens), Calcitonin-IRMA magnum (Medipan), SELco-IRMA (Medipan) und Calcitonin IRMA (Medgenix)] haben wir als Modell für kurativ behandelte MTC-Patienten basale hCT-Werte von 198 thyreoid ektomierten Patienten mit differenziertem Schilddrüsenkarzinom (DTC) und Penta gastrintest-stimulierte Werte bei 13 DTC- und 13 kurativ behandelte MTC-Patienten, bestimmt. Ergebnisse: Die basalen hCT-Werte der thyreoidektomierten DTC-Patienten waren beim Nichols ICMA (n = 138) und Immulite 2000 (n = 60) in 100%, Biomerica IEMA (n = 57) in 97%, IRMA magnum (Medipan) (n = 20) in 85% der Fälle unterhalb der Nachweisgrenzen (NWG), beim SELco- IRMA (n = 20) und Medgenix IRMA (n = 76) dagegen überwiegend im Bereich Schilddrüsengesunder. Beim Nichols ICMA und Immulite 2000 lagen die Werte der Pentagastrintests bei 13 DTC-Patienten und 9/13 MTC-Patienten auch im Verlauf unter der NWG. Bei vier MTCPatienten, die (auch bei negativen basalem hCT) eine hCT-Stimulierbarkeit zeigten, ließen sich im späten Verlauf Rezidive nachweisen. Schlussfolgerungen: Bei Assays mit hoher Mono mer-Spezifität (Nichols-ICMA, Biomerica IEMA, Immulite 2000, eingeschränkt IRMA magnum) sind für die Definition „biochemisch geheilte“ MTC-Patienten basale und Penta - gastrin-stimulierte hCT-Werte unter der NWG zu fordern. Bei Assays mit geringerer Monomer- Spezifität (SELco-IRMA, IRMA Medgenix) sind Werte innerhalb der Referenzbereiche Schilddrüsengesunder noch kompatibel mit „biochemischer Heilung“.

Keywords

Calcitonin - tumour marker - medullary thyroid carcinoma - monomer-specific calcitonin assay - pentagastrin test - biochemical cure

Schlüsselwörter

Calcitonin - Tumormarker - medulläres Schild drüsenkarzinom - Monomer-spezifischer Calcitonin-Assay - Pentagastrintest - bio chemische Heilung

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