Analytical and clinical evaluation of CYFRA 21-1 by electrochemiluminescent immunoassay in head and neck squamous cell carcinoma

Abstract

This paper attempts to evaluate the clinical usefulness of CYFRA 21-1 as a serum tumour marker in patients with head and neck squamous cell carcinoma (HNSCC). The serum concentration of CYFRA 21-1 was measured utilizing a new electrochemiluminescent immunoassay (ECLIA) in 142 patients with HNSCC before and after treatment, 68 patients with benign tumours of the head and neck, and 50 healthy controls. Serum levels of CYFRA 21-1 in patients with HNSCC were significantly higher than those of benign tumours and healthy controls (p < 0.001). The diagnostic sensitivity and specificity of CYFRA 21-1 for HNSCC were 62 per cent and 100 per cent, respectively. The positive rates of CYFRA 21-1 increased with progression of HNSCC, serum CYFRA 21-1 levels were related to the tumour stage expressed by primary tumour (T) and nodal status (N) (p < 0.001), but not related to patient age, gender, smoking and drinking habit, or histopathological grade (p > 0.05). Post-treatment levels of CYFRA 21-1 in HNSCC decreased significantly (p < 0.001). Among 38 patients with clinical or radiological evidence of a recurrence during follow-up, 78.9 per cent (30 of 38) showed an increase in CYFRA 21-1. The analytical ECLIA performance for serum CYFRA 21-1 provides a new means of clinical assessment for HNSCC. The results of ECLIA suggest that the serum marker CYFRA 21-1 is valuable not only for diagnosis but also for close monitoring of patients with HNSCC.

Analytical and clinical evaluation of CYFRA 21-1 by electrochemiluminescent immunoassay in head and neck squamous cell carcinoma: Author’s reply

“…In conformity with Deng et al, 1 an increase of the Cyfra 21-1 serum concentration in case of disease progression, in terms of residual tumour progression, recurrency, and especially in terms of appearance of distant metastasis has previously been described. Also, a decrease of the Cyfra 21-1-serum concentration after therapy in patients with squamous cell carcinomas of the head and neck has been seen earlier.…”

“…Moreover, we have been investigating the survival rate of our cases studied according to different tumour sites. 1 , sent to all practising doctors in England, included an alert regarding topical medicines containing peanut (arachis) oil. Such products are clearly labelled as containing this re ned ingredient.…”

“…Author's reply Dear Sirs, We thank Dr Kuropkat for the comments on our paper. 1 Up to now, the CYFRA 21-1 serum concentration was measured using a dot-blot assay, IRMA, ELISA, and ECLIA. In our study, we utilized ECLIA.…”

Analytical and clinical evaluation of CYFRA 21-1 by electrochemiluminescent immunoassay in head and neck squamous cell carcinoma

“…This might explain the lack of statistical signi cance in the difference between the Cyfra 21-1 positive and the Cyfra 21-1 negative group, described by Deng et al 1 In conformity with Deng et al, 1 an increase of the Cyfra 21-1 serum concentration in case of disease progression, in terms of residual tumour progression, recurrency, and especially in terms of appearance of distant metastasis has previously been described. Also, a decrease of the Cyfra 21-1-serum concentration after therapy in patients with squamous cell carcinomas of the head and neck has been seen earlier.…”

“…Deng letters to the editorset.al. 1 used a new electrochemiluminescent immunoassay (ECLIA) for Cyfra 21-1 measurements in the serum of patients with squamous cell carcinomas of the head and neck. The advantages, or maybe also disadvantages, of the new ECLIA in contrast to the well accepted ELISA for determination of the Cyfra 21-1 serum concentration are not discussed by the authors, apart from the remark that the sensitivity of ECLIA seems to be slightly higher.…”