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Z. Bortlicek



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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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      P2.11-047 - Sequential treatment with erlotinib and pemetrexed in pretreated patients with lung adenocarcinoma. (ID 3292)

      09:30 - 09:30  |  Author(s): Z. Bortlicek

      • Abstract

      Background
      Erlotinib and pemetrexed are novel agents used for the treatment of patients with advanced-stage NSCLC. Both are frequently used for the treatment of patients after failure of first-line chemotherapy. Sequential treatment strategies have become a very interesting topic in current oncology research. The role of sequential treatment in NSCLC has not been elucidated yet. Thus, we conducted this retrospective study to compare the efficacy of second-line pemetrexed monotherapy followed by third-line erlotinib (P-E) to treatment with the reverse sequence (E-P).

      Methods
      Clinical data of 57 patients with advanced (IIIB/IV) lung adenocarcinoma harboring wild-type epidermal growth factor receptor (EGFR) gene were analysed. 31 patients were treated with P-E and 26 patients with E-P sequence. Genetic testing was performed using PCR direct sequencing. The terminations of PFS and OS, as well as the estimations of survival probabilities, were performed using Kaplan Meier survival curves; all point estimates were accompanied by 95% confidence intervals. The differences in survival were tested using the log-rank test.

      Results
      The median progression-free survival (PFS) for patients treated with the P-E sequence was 3.6 months compared to 7.8 months for patients treated with E-P sequence (p=0.029). The median overall survival (OS) for patients treated with P-E sequence was 7.9 months compared to 26.3 months for patients treated with E-P sequence (p=0.006).

      Conclusion
      The study results proved significant improvement of both PFS and OS for patients treated with the E-P sequence as compared to the P-E sequence. Although the study was limited, its findings could have a great impact on the treatment of advanced-stage NSCLC. Thus, the role of the sequential treatment of NSCLC should be confirmed in a prospective randomised study in the future.

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    P3.06 - Poster Session 3 - Prognostic and Predictive Biomarkers (ID 178)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P3.06-029 - Predictive role of serum tumor markers in NSCLC patients treated with erlotinib (ID 2433)

      09:30 - 09:30  |  Author(s): Z. Bortlicek

      • Abstract

      Background
      Erlotinib is an epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor. Clinical trials proved its efficacy in patients with advanced-stage NSCLC. Although, activating EGFR gene mutations are currently the strongest predictor of erlotinib efficacy, the majority of NSCLC patiens harbor wild-type EGFR gene and moreover there is still a large proportion of patients in whom it is not feasible to acquire an adequate tissue for EGFR mutation analysis. We conducted this retrospective study aiming to prove the predictive role of tumor markers in patients with advanced-stage NSCLC treated with erlotinib.

      Methods
      144 patients with advanced-stage (IIIB, IV) NSCLC were treated with erlotinib (150 mg daily). Pretreatment serum levels of CEA, CYFRA 21-1, NSE and TK were assessed. Comparison of patients’survival (PFS and OS) according to the level of assessed tumor markers was performed using the log-rank test.

      Results
      Median PFS and OS for patients with normal CEA levels was 2.9 and 16.1 vs. 1.9 and 8.6 months in patients with high CEA levels (p = 0.046 and p = 0.116). Median PFS and OS for patients with normal CYFRA 21-1 levels was 3.4 and 23.8 vs. 1.9 and 6.1 months in patients with high CYFRA 21-1 levels (p < 0.01 and p < 0.01). Median PFS and OS for patients with normal NSE levels was 2.1 and 9.8 vs. 1.1 and 3.8 months in patients with high NSE levels (p = 0.051 and p = 0.022). Median PFS and OS for patients with normal TK levels was 2.1 and 23.7 vs. 2.0 and 8.5 months in patients with high TK levels (p = 0.110 and p = 0.037).

      Conclusion
      The study proved that high pretreatment levels of CEA, CYFRA 21-1 and NSE predict low efficacy of erlotinib treatment in patients with advanced-stage NSCLC. Assessment of these tumor markers is a good predictive tool for erlotinib treatment efficacy especially for those patients with unknown EGFR mutation status.

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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): Z. Bortlicek

      • 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.