Author of

• 11917

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  P2.21 - Poster Session 2 - Diagnosis and Staging (ID 170)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Prevention & Epidemiology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11925

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    P2.21-008 - Clinical and Epidemiologic Study of ALK Fusion Genes in Lung Cancer Patients in Latin America: challenges and perspectives (ID 3303)

    09:30 - 09:30  |  Author(s): C. Sternberg
    • Abstract

    Background
    Anaplastic Lymphoma kinase (ALK) alterations play a significant role in the pathogenesis of non-small-cell lung cancer (NSCLC), and the ALK pathway has become an important target for novel NSCLC treatment. Despite strong participation in industry-sponsored and recently investigator-initiated multicenter clinical trials, little is known about the prevalence, clinic-pathological parameters and clinical outcomes related to ALK fusion in Latin American (LATAM) NSCLC patients. Preliminary data from previous small studies suggest that the prevalence of other NSCLC driver genes such as EGFR and BRAF may be more frequent in LATAM than in other non-Asian populations. This highlights a clear need for a comprehensive molecular epidemiology investigation in this genetically heterogeneous region.

    Methods
    Collaboration with the Brazilian National Cancer Institute (INCA) and Latin America Oncology Group (LACOG), through a research agreement with Pfizer Inc., was established and 11 sites from 5 different LATAM countries were contacted for participation (Brazil, Mexico, Argentina, Peru and Bolivia). Countries and site selection was based on ethnic, social and cultural characteristics in order to (appropriately) represent the continent’s population. A total of 1,154 patients will be retrospectively enrolled for molecular analysis. Considering that the expected prevalence is no greater than 10%, this sample permits this estimation with a half-width of the 95% confidence interval < 1.7%. Tissue samples will be shipped to INCA (the coordinator center) for central analysis. Clinical data will be collected by local investigators and retrieved by the coordinator center. The primary goal of the study is to estimate the prevalence of ALK fusion gene in LATAM nonsquamous NSCLC patients and build a stable LATAM network for future molecular epidemiology studies. The secondary objective is to perform a comparison of FISH, PCR and IHC methods for ALK fusion gene detection. FISH will be considered the standard method for comparison and performed using the ALK Dual Color Break-Apart probe (Abbott Molecular Inc.). Real time PCR will be performed in collaboration with Fundación Santa Fé, Colombia (probes and primers synthesized at TIB MOLBIO, LLC and designed with Primer 3 software) and IHC performed with Ventana[TM] reagents.

    Results
    The protocol was planned in 2011. Since then, the first LATAM molecular epidemiology network was established with LACOG collaboration, and molecular analysis methodology standardization completed.

    Conclusion
    This trial represents the first cooperative effort for genotype patients in LATAM using sample shipment for central analysis. Enrollment of patients is still pending, waiting for final approval from country regulatory agencies which have different requirements and timeframes for review. Moreover, additional data on tumor specific biomarkers and diagnostic testing across the region may provide a basis to guide future decisions by regulators and treating physicians.