BACKGROUND: The frequent recurrence of early-stage @entity1149 ( @entity1149 ) is generally attributable to metastatic disease undetected at complete resection. Management of such @entity1 depends on prognostic staging to identify the individuals most likely to have @entity66 . We aimed to develop and validate a practical, reliable assay that improves risk stratification compared with conventional staging. METHODS: A 14-gene expression assay that uses quantitative PCR, runs on @entity406 -fixed paraffin-embedded tissue samples, and differentiates @entity1 with heterogeneous statistical prognoses was developed in a cohort of 361 @entity1 with non-squamous @entity1149 resected at the University of California, San Francisco. The assay was then independently validated by the Kaiser Permanente Division of Research in a masked cohort of 433 @entity1 with stage I non-squamous @entity1149 resected at Kaiser Permanente Northern California hospitals, and on a cohort of 1006 @entity1 with stage I-III non-squamous @entity1149 resected in several leading Chinese @entity5 centres that are part of the China Clinical Trials Consortium (CCTC). FINDINGS: Kaplan-Meier analysis of the Kaiser validation cohort showed 5 year overall survival of 71  4% (95% CI 60  5-80  0) in low-risk, 58  3% (48  9-66  6) in intermediate-risk, and 49  2% (42  2-55  8) in high-risk @entity1 (p(trend)=0  0003). Similar analysis of the CCTC cohort indicated 5 year overall survivals of 74  1% (66  0-80  6) in low-risk, 57  4% (48  3-65  5) in intermediate-risk, and 44  6% (40  2-48  9) in high-risk @entity1 (p(trend)<0  0001). Multivariate analysis in both cohorts indicated that no standard clinical risk factors could account for, or provide, the prognostic information derived from @entity5 gene expression. The assay improved prognostic accuracy beyond National @entity5 Network criteria for stage I high-risk @entity5 (p<0  0001), and differentiated low-risk, intermediate-risk, and high-risk @entity1 within all disease stages. INTERPRETATION: Our practical, quantitative-PCR-based assay reliably identified @entity1 with early-stage non-squamous @entity1149 at high risk for mortality after surgical resection. FUNDING: UCSF Thoracic Oncology Laboratory and Pinpoint Genomics.

A practical molecular assay to predict survival in resected non-squamous, XXXX : development and international validation studies.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity66 :: ('MESH:D004194', 'Disease') :: ['occult disease'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer', 'tumours', 'Comprehensive Cancer', 'tumour'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small-cell lung cancer'] @entity406 :: ('MESH:D005557', 'Chemical') :: ['formalin']
@entity1149 :: (MESH:D002289,Disease) :: ['non-small-cell lung cancer']
