UNASSIGNED: 7556 Background: Prognostic index for second-line chemotherapy of @entity1149 was previously developed, based on individual @entity1 data (IPD) of 9 randomized trials (Table) (Di Maio et al, Eur J Cancer 2010; 46: 735-743). In this study, we aimed to validate the prognostic score, with the use of an external dataset. METHODS: We analyzed IPD of @entity1 (pts) enrolled in a non-inferiority phase III trial comparing @entity24986 vs. @entity1205 in second-line treatment of advanced @entity1149 . The study showed similar efficacy for both agents. Primary endpoint of this analysis was overall survival (OS). The following variables were considered for survival analysis and score calculation: gender, performance status (PS), extent of disease, @entity5 histotype, type of first-line treatment, response to first-line treatment. Cox model, stratified by treatment arm, was used for multivariate analysis. Individual prognostic scores were derived according to our scoring system, and pts were divided into 3 categories according to the score: <5 (best), 5-9 (intermediate), >9 (worst). RESULTS: All 551 pts enrolled in the trial had complete information for prognostic score calculation. Median OS in all pts was 6.9 months. Median OS was 12.9, 6.9 and 3.8 months for the best, intermediate and worst categories, respectively. Cox model analysis showed a significant effect for intermediate vs. best category comparison (hazard ratio 1.79, 95%CI 1.31 - 2.47, p=0.0003) and for worst vs. best category comparison (hazard ratio 3.25, 95%CI 2.18 - 4.83, p<0.0001). The C-index of the model was high (0.926), indicating a good discrimination according to the proposed risk categories. CONCLUSIONS: Prognostic ability of our score for candidates to second-line treatment in advanced @entity1149 was validated. Subgroups of @entity1 with more vs. less favorable prognosis were identified. Prognostic score could be useful in clinical practice. [Table: see text].

Prognostic score for second-line chemotherapy of advanced @entity1149 ( @entity1149 ): External validation in a phase III trial comparing XXXX with @entity1205 .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity24986 :: ('MESH:C111217', 'Chemical') :: ['vinflunine'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['docetaxel']
@entity24986 :: (MESH:C111217,Chemical) :: ['vinflunine']
