1. ¹Department of Thoracic Oncology, Faculty of Medicine – Assistance Publique Hôpitaux de Marseille, Fédération des Maladies Respiratoires, Hôpital Sainte-Marguerite, 270, Bd de Sainte-Marguerite, 13274 Marseille Cedex 09, France
2. ²Department of Thoracic Surgery, Faculty of Medicine – Assistance Publique Hôpitaux de Marseille, Hôpital Sainte-Marguerite, 13274 Marseille Cedex 09, France
3. ³Département d'Information Médicale, Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone, 13385 Marseille Cedex 5, France

Correspondence: Dr F Barlési, E-mail: fabrice.barlesi@mail.ap-hm.fr

Received 9 August 2004; Revised 14 October 2004; Accepted 15 October 2004; Published online 14 December 2004.

Abstract

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) as gefitinib emerged as an accepted treatment in second- or third-line setting in NSCLC. However, clinical surrogate markers of EGFR-TKI activity in NSCLC patients remain to be identified and we studied the prognostic value of CYFRA 21-1 in this setting. Serum samples from 53 patients with NSCLC receiving gefitinib after failure of at least a platinum-containing regimen were prospectively collected from January 2002 to December 2003. Multivariate analysis demonstrated an independent negative impact on survival for a level of CYFRA 21-1 higher than 3.5 ng ml^-1 (HR=2.45, 95% CI 1.13–5.29; P=0.02). In conclusion, CYFRA 21-1 is a tool available to predict the survival of NSCLC patients receiving gefitinib as third-line therapy in an independent manner. In case of a CYFRA 21-1 level higher than 3.5 ng ml^-1, treatment with gefitinib needs further evaluation giving its relative poor effect on survival.