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I. Kern



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    P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.11-019 - Treatment strategies in patients with advanced EGFR mutation-positive NSCLC in Central Europe: Findings from the INSIGHT observational study (ID 1640)

      09:30 - 09:30  |  Author(s): I. Kern

      • Abstract

      Background
      The INSIGHT observational study aimed at assessing the management of NSCLC patients with EGFR mutations in clinical practice in 10 centres from 6 Central European countries. As part of this project, the treatment strategies used in these patients have been determined.

      Methods
      Between 15 November 2011 and 31 March 2013, EGFR mutations were determined by one of the established methods in 1009 patients with NSCLC. The systemic treatments of patients with EGFR mutation positive NSCLC were assessed.

      Results
      Comprehensive data on systemic treatment were available for 122 patients with EGFR mutation-positive tumors. Mutations were located in exon 19 (52.5%), exon 21 (38.5%), exon 20 (10.7%), and exon 18 (6.6%). In 8 patients, mutations were present in 2 or 3 exons. Patients with mutation-positive tumors had the following characteristics: median age 66 (range 41-83) years; 58 (48%) males, 64 (52%) females; 51 (42%) never smokers, 51 (42%) former smokers, and 19 (16%) current smokers; performance status at diagnosis ECOG 0, 1, and equal or above 2 in 28 (23%), 60 (49%), 20 (16.5%) of patients; in 14 (11.5%) patients PS was not recorded; adenocarcinomas 98 (80%), adenosquamous 6 (5%), squamous 7 (6%), not otherwise specified 2 (2%) and 9 (7%) patients had other types of carcinoma. A total of 116 patients presented with stage IIIB or IV and received the following first-line therapy: gefitinib in 66 (57%), erlotinib in 4 (3%), chemotherapy in 43 (37%), and chemotherapy plus bevacizumab in 3 (3%) patients, respectively. In 22 (19%) patients EGFR test results were obtained after initiation of first-line therapy and the majority of these patients (n=20) received chemotherapy as first-line therapy. For patients tested before the first-line treatment initiation, median time between the date of test result and initiation of first-line therapy was 16 days. Regardless of the lines of treatment, EGFR-directed tyrosine kinase inhibitors were administered to 90 out of 116 (78%) patients. No major differences in treatment strategies between various countries were observed.

      Conclusion
      The INSIGHT observational study demonstrated that most patients with advanced EGFR mutation-positive NSCLC had been treated with EGFR-directed tyrosine kinase inhibitors either in the first- or second-line setting. This study was supported by Boehringer Ingelheim Regional Center Vienna.

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    P3.18 - Poster Session 3 - Pathology (ID 177)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Pathology
    • Presentations: 1
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      P3.18-005 - EGFR mutation testing methods in clinical practice in Central Europe: findings from the INSIGHT observational study (ID 1639)

      09:30 - 09:30  |  Author(s): I. Kern

      • Abstract

      Background
      The INSIGHT observational study aimed at assessing the management of NSCLC patients with EGFR mutations in clinical practice in Central Europe. As part of this project, pathological findings including molecular testing methods were assessed.

      Methods
      Fourteen Pathology Departments from 6 Central European countries participated. Between 15 November 2011 and 31 March 2013, EGFR mutations were determined by one of the established standard methods in patients with NSCLC.

      Results
      Here we report data on 1009 patients who had been enrolled into the INSIGHT study. These patients consisted of 626 (62%) males and 383 (38%) females, 347 (35%) smokers, 452 (46%) former smokers and 182 (19%) never-smokers. Pathological diagnosis was based on histology (41%), cytology (19%) or both (40%) and revealed the following results: 54% non-mucinous adenocarcinomas, 4% mucinous adenocarcinomas, 21% unspecified adenocarcinomas, 9% NSCLC NOS, 7% squamous cell carcinomas, 2% adenosquamous carcinomas, and 2% others. Tumor material was obtained by bronchoscopy (44%), transthoracic needle biopsy (11%), surgery (19%), or other techniques. Specimens were either from primary tumor (88%), lymph node metastases (2.5%) or distant metastases (9.5%). EGFR mutation testing was done by PCR-RFLP (43%), Roche Cobas EGFR mutation test (26%), Sanger sequencing (18%), high resolution melting followed by sequencing (13%) or another method (11%). EGFR mutations were found in 163 (16%) of the patients. Among patients with mutations, the following mutations were found: 12 (7% of mutation-positive patients) exon 18 mutations, 82 (50%) exon 19 mutations including 63 (39%) deletions, 20 (12%) exon 20 mutations including 3 (2%) T790M, 63 (39%) exon 21 mutations including 45 (28%) L858R. Multiple mutations, both common and uncommon, were found in 12 (7%) of the patients. Mutations were found in 8% of smokers, 14% of former smokers and 43% of never-smokers. Mutations rates varied between centers which most likely reflected different patient selection criteria for EGFR mutation testing.

      Conclusion
      The INSIGHT project demonstrated that EGFR mutation testing by one of the standard tests in patients with NSCLC has been established in participating centers in Central Europe. EGFR mutation distribution is similar to other European and American NSCLC patient populations. This study was supported by Boehringer Ingelheim Regional Center Vienna.