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D Di ia ag gn no os st ti ic c a an nd d p pr ro og gn no os st ti ic c v va al lu ue e o of f t th he e n ne ew w t tu um mo ou ur r m ma ar rk ke er r C CY YF FR RA A2 21 1--1 1 i in n p pa at ti ie en nt ts s w wi it th h s sq qu ua am mo ou us s c ce el ll l l lu un ng g c ca an nc ce er r Elevated preoperative CYFRA 21-1 levels were identified in 63% of patients with squamous cell type (SqCC), 33% with adenocarcinoma, and 30% with large-cell carcinoma type. The diagnostic specificity of the assay was 96%. Positive CYFRA 21-1 levels were observed in 33% of stage I, 52% of stage II, 76% of stage IIIa and 83% of stage IIIb patients with SqCC type. Statistically significant differences were obtained between stages I and II and between II and IIIa, but not between stages IIIa and IIIb. Recurrence-free survival probability for patients with elevated serum CYFRA 21-1 levels before surgery was 63% (24/38) versus 92% (24/26) for patients with normal serum CYFRA 21-1 levels. However, the difference was not statistically significant when adjusted for the TNM stage (primary tumour, regional lymph node involvement, occurrence of distant metastasis). In 9 of the 10 patients with increased trend for CYFRA 21-1 during follow-up, elevated serum CYFRA 21-1 levels preceded (7) or coincided (2) with the clinical detection of tumour recurrence, providing a predictive value of an increased trend of 90%. In the multivariate analysis, the association of the increase of CYFRA 21-1 level with a higher risk of recurrence was statistically significant.Our results indicate that CYFRA 21-1 may be a useful marker in SqCC. Serial determination of CYFRA 21-1 was consistent with the treatment results and the serum CYFRA 21-1 levels were shown to reflect the disease process during followup. Rising serum CYFRA 21-1 levels in patients after tumour resection were an early indicator of tumour recurrence.

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Summary The CYFRA 21-1 assay is a test that has been developed recently for detection of a cytokeratin 19 fragment in serum. A diagnostic role for CYFRA 21-1 has already been proposed. The question of whether this marker is prognostically significant is important in clarifying the role of CYFRA 21-1 in clinical practice. The aim of this study was to evaluate the prognostic significance of elevated preoperative CYFRA 21-1 levels in patients with resected primary squamous-cell lung cancer (SqCC). Serum levels of CYFRA 21-1 were measured using an immunoradiometric assay (CIS bio) in 91 patients with operable SqCC. Survival and disease-free survival curves related to initial levels of this marker were estimated using the Kaplan-Meier method. In the univariate analysis the log-rank test and the log-rank test for trend were used. In the multivariate analysis the stratified log-rank test and the proportional hazard model were used. Elevated preoperative CYFRA 21-1 levels were identified in 55% of patients with SqCC. The number of patients with elevated levels of this marker increased with TNM stage (P=0.0001). In univariate analysis elevated levels of CYFRA 21-1 were significantly associated with poor overall survival (P<0.00005) and with disease-free survival (P<0.00005). In multivariate analysis elevated levels of this marker were also found to be associated with poor overall and disease-free survival (P=0.01 and P=0.003 respectively). In conclusion, CYFRA 21-1 may be an independent prognostic parameter of survival and tumour relapse in SqCC and may be useful in identifying resected SqCC patients at high risk of treatment failure.

Cytokeratin 19 is particularly abundant in carcinoma of the lung. The CYFRA 21-1 assay has recently been developed for detection of a cytokeratin 19 fragment in serum. In the current study, the prognostic information provided by the CYFRA 21-1 assay in operable nonsmall cell lung cancer (NSCLC) was analysed. Serum levels of CYFRA 21-1 were measured using an immunoradiometric assay (DiaSorin) in 94 patients with operable NSCLC. Survival and disease-free survival curves related to initial levels of this marker were estimated using the Kaplan-Meier method. Elevated preoperative CYFRA 21-1 levels were identified in 42% of patients with NSCLC. The number of patients with elevated levels of this marker increased with tumour node metastasis (TNM) stage (p=0.02). In univariate analysis elevated levels of CYFRA 21-1 were significantly associated with poor overall survival (p<0.001) and with disease-free survival (p<0.001). The results remained significant when the comparisons were adjusted, using the stratified log-rank test, for patient's TNM stage (p<0.001 for both overall and disease-free survival). Elevated preoperative levels of CYFRA 21-1 decreased the probability of survival or surviving without recurrence 15 months or more after the operation. This was confirmed by the results of the multivariate analysis. In conclusion, CYFRA 21-1 may be an independent prognostic parameter of survival and tumour relapse in nonsmall cell lung cancer and may be useful in identifying resected cancer patients at high risk for treatment failure.