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

Published online by Cambridge University Press:  10 May 2006

Yan Fei Deng
Affiliation:
Department of Otorhinolaryngology, the First Clinical Academy of the Medical College of Xiamen University, Xiamen, 361004, People’s Republic of China.
Ping Chen
Affiliation:
Department of Otorhinolaryngology, the First Clinical Academy of the Medical College of Xiamen University, Xiamen, 361004, People’s Republic of China.
Yong Zhi Lin
Affiliation:
The Central Laboratory, the First Clinical Academy of the Medical College of Xiamen University, Xiamen, 361004, People’s Republic of China.
Jia Zhen Le
Affiliation:
Department of Otorhinolaryngology, the First Clinical Academy of the Medical College of Xiamen University, Xiamen, 361004, People’s Republic of China.
Xiao Li Wu
Affiliation:
Department of Otorhinolaryngology, the First Clinical Academy of the Medical College of Xiamen University, Xiamen, 361004, People’s Republic of China.
Ming Qiang Yu
Affiliation:
Department of Otorhinolaryngology, the First Clinical Academy of the Medical College of Xiamen University, Xiamen, 361004, People’s Republic of China.
Pei Yun Zhuang
Affiliation:
Department of Otorhinolaryngology, the First Clinical Academy of the Medical College of Xiamen University, Xiamen, 361004, People’s Republic of China.
Ming Hua Gao
Affiliation:
Department of Otorhinolaryngology, the First Clinical Academy of the Medical College of Xiamen University, Xiamen, 361004, People’s Republic of China.

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.

Type
Research Article
Copyright
© Royal Society of Medicine Press Limited 2003

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