Author of

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  P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

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

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    P3.11-017 - Observational post-authorization prospective study to characterize the incidence of EGFR positive mutation (M+) in advanced or metastatic non-small cell lung cancer (aNSCLC) patients (P) and their clinical management in Galicia (NCT01717105): A Galician Lung Cancer Group study (GGCP 048-10) (ID 1695)

    09:30 - 09:30  |  Author(s): L. Fachal
    • Abstract

    Background
    The presence of mutations in the gene encoding the Epidermal Growth Factor Receptor (EGFR) predicts that P with aNSCLC may respond better to Tyrosine Kinase Inhibitors (TKIs). Recently, the Spanish REASON study has reported that the rate of EGFR mutations is 11.6% in Spain; however the mutation rate and the clinical management of aNSCLC carrying EGFR mutations in Galicia are still unknown.

    Methods
    All newly diagnosed aNSCLC P in 9 Galician centers were prospectively included for a 13-month period. P with M+ disease were followed for at least 9 months (m) in order to characterize their clinical management. Mutation testing was performed on available tumor and plasma samples, through a central laboratory using the EGFR RGQ PCR Kit™ (Qiagen). Pre-planned exploratory objectives included comparison of EGFR mutation status between matched baseline tumor and plasma samples.

    Results
    From February 2011 to March 2012, 198P were included in the study. Median age was 65.5 years (range 34-85). 76.3%P were men, 21.7% were never-smokers, 45.5% ex-smokers, and 32.8% current smokers. PS 0-1: 67.1%. 78.3% had non-squamous histology (68.7% adenocarcinoma, 8.1% large-cell carcinoma, 1% adenosquamous carcinoma, and 0.5% non-specified) and 21.7% p had squamous-cell carcinoma. Sample type provided included: 57.6% tissue, 42.4% cytology. Median turnaround time (TAT) was 8 days. Mutation rate in evaluable samples: 13.6% in tumor, tissue or cytology (25P) (11P had exon 19 deletion, 8P L858R mutation, 2P exon 20 insertions and 1P L861Q mutation); 5.9% in plasma. Tumor and plasma EGFR mutation status concordance rate was 90.8%.Plasma test sensitivity was 40%. Mutation rate did not vary by sample type (13.9% tissue, 13.2% cytology). A higher mutation rate was found in never smokers (42.5%), females (38.6%) and adenocarcinoma (19.8%). 23 out of 25 M+ P received first line treatment and 2P only best supportive care. 21P were treated with TKI (Gefitinib), 1P with chemotherapy (CT) (Cisplatin/docetaxel/bevacizumab) and 1P with CT+TKI (Carboplatin+Gefitinib). 20P were evaluated for response. 3P were lost for follow up. At data cut off (31/12/2012), with a median follow up of 9.8m, 14P had partial response (70%), 2 stable disease (10%) and 4P progressive disease (20%). Median progression free survival was 9.7m. 8 out of 20P (40%) received 2[nd] line treatment (7 CT and 1 TKI). 12 out of 25P had died, 3P were lost for follow up and 10P were still alive.

    Conclusion
    Mutation analysis is feasible in clinical practice for aNSCLC patients in Galicia and allows the customization of treatment based on molecular criteria. Despite of the relatively small number of patients in this study, EGFR testing in plasma has a low sensitivity and therefore should not substitute tissue testing although it could be an alternative for those patients without tissue samples.