Clinical assessment of patients with advanced non-small-cell lung cancer eligible for second-line chemotherapy: A prognostic score from individual data of nine randomised trials

Purpose: Knowledge of prognostic factors for advanced non-small-cell lung cancer (NSCLC) patients eligible for second-line treatment is scarce. The aim of this study was to assess the prognostic role of a number of routinely collected clinical variables and to provide a summary index to discriminate patients according to probability of survival. Methods: individual data from nine randomised trials of second-line treatment in advanced NSCLC were analysed. Primary end-point was overall survival (OS). Cox model, stratified by trial, was used for multivariate analyses, and a prognostic index was provided and validated according to an internal/external procedure. Results: Out of 1239 patients, 1197 patients (97%) had complete information. Median OS was 7.4 months. At multivariate analysis, prognosis was significantly influenced by gender (worse in males), performance status (PS), tumour histology (worse in squamous and other histology versus adenocarcinoma), stage (worse in IV versus IIIB), type of previous treatment (worse for patients pretreated with platinum) and response to first-line (worse for patients not obtaining objective response). Prognostic score values ranges from 0 to 14. When three categories were derived, median overall survival values were equal to 11.6, 7.5 and 3.0 months for best (<5), intermediate (5-9) and worst (>9) category, respectively. Conclusion: Prognosis of patients eligible for second-line treatment of advanced NSCLC is significantly conditioned by gender, PS, histology, stage, previous use of platinum and response to first-line. A prognostic score was derived that discriminates well subjects with a relatively more favourable prognosis and those with very short life expectancy. (C) 2009 Elsevier Ltd. All rights reserved.