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P. Theodore



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    P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      P3.04-089 - Prospective Use of Prognostic Molecular Assay Identifies Patients at Risk for Recurrence and Changes Clinical Management in Early-Stage NSCLC (ID 1497)

      09:30 - 09:30  |  Author(s): P. Theodore

      • Abstract
      • Slides

      Background:
      Adjuvant chemotherapy recommendations depend on identification of early-stage non-small-cell lung cancer (NSCLC) patients at high-risk of recurrence. Current National Comprehensive Cancer Network (NCCN) guidelines use certain clinicopathologic features to make this recommendation for stage Ib-IIa patients. An internationally validated, 14-gene expression assay has been shown retrospectively to better stratify mortality risk in non-squamous NSCLC than conventional staging.

      Methods:
      Following up on a previously reported cohort of 52 patients, prospective molecular risk-stratification by the 14-gene test was performed in 66 patients with a mean follow up of 20.7 ±14.1 months. Disease-free survival and lung cancer mortality rates were compared between high- and low-risk patients by both molecular risk-stratification and NCCN “high-risk” characteristics.

      Results:
      Patients with low-, intermediate-, and high-risk based on molecular testing had recurrence rates of 4%, 8%, and 28% (p=.031, Fisher’s exact test) and lung cancer mortalities of 0%, 0%, and 16% (p=.039), respectively. Molecular high-risk was associated with shorter disease-free survival (p=.043, Kaplan-Meier log-rank). Molecular risk assessment was discordant from NCCN “high-risk” features in 15 of 25 stage Ib-IIa patients (60%). NCCN criteria failed to significantly predict either recurrence or mortality with recurrence rates of 8% and 23% (p=.077, Fisher’s exact test) and lung cancer related mortality of 3% and 12% (p=.165) among patients with NCCN low- and high-risk features respectively. Molecular high-risk scores changed adjuvant chemotherapy recommendations in 3 of 10 (30%) patients who otherwise did not meet NCCN criteria for adjuvant chemotherapy.

      Conclusion:
      This study demonstrates that prospective application of a 14-gene prognostic assay significantly predicts differences in disease-free survival. This prognostic information differs from NCCN high-risk clinicopathologic features and has clinical utility in better informing adjuvant chemotherapy recommendations.

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