Prognostic and Predictive Biomarkers for Act (Adjuvant Chemotherapy) in Resected Non-Small Cell Lung Cancer (R-Nsclc): Lace-Bio

摘要: ABSTRACT Aim: The precise selection of patients for ACT is critical but there remain no validated molecular tools which are prognostic relapse or predictive benefit from ACT. Methods: LACE-Bio, based on the LACE (Lung Adjuvant Cisplatin Evaluation) meta-analysis project, includes a fully annotated database and tissue bank 4 randomised trials comparing to non-treated control (IALT(1), ANITA(2), NCIC CTG JBR-10 (3) CALGB 9633(4). It contains ∼1500 samples, including frozen (JBR.10). Histochemical/immunohistochemical (HC) biomarkers shown in one trial have significant and/or effect overall survival, were cross-validated 3 other trials; when only trend (T) such effects was observed we performed pooled analysis combining all trials. All statistical analyses conducted by unit at Gustave Roussy. Biomarker assays validation/pooled general group reporting original biomarker results Results: Numerous issues encountered during attempted validation promising assays, method fixation, storage, use TMAs vs. sections, stored fresh reagent/antibody batches. Despite meticulous methodology, majority (other than mutations) could not be confirmed as value. Marker Trial Predictive? Prognostic? Confirmed? ERCC1 IALT Yes No LYMPHOID INFILTRATE MUCIN PROGNOSTIC (DFS) b-TUBULIN JBR10 Trend P27 FASL FAS/FASL BAX Conclusions: Although inexpensive widely available, HC single may misleading require before being implemented. Of particular concern validate, used open LACE-Bio-2 evaluating potential genomic using next-generation sequencing that allow more NSCLC NSCLC. Disclosure: authors declared conflicts interest.