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Z. Povolna



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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-013 - Gefitinib for the first-line treatment of NSCLC patients with EGFR mutations in exons 19 or 21: analysis of 74 patients from Czech Republic (ID 1231)

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

      • Abstract

      Background
      Gefitinib (Iressa®) is a potent oral non-cytotoxic anthraquinone. It is the active and selective EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitor). In the Czech Republic NSCLC patients with EGFR activated mutations were treated with gefitinib in first line from 2/2011 in 10 institutions. This study evaluates treatment outcomes in 74 NSCLC with EGFR activated mutations in exons 19 and/or 21 treated between 2/2011 and 3/2013.

      Methods
      Patients with advanced NSCLC and with EGFR activated mutations in exons 19 and/or 21 were treated with gefitinib in first line between 2/2011 and 3/2013. Retrospective analyses were carried out to assess the effectiveness of treatment and to evaluate the safety of targeted therapy.This study evaluates treatment outcomes in 74 patients. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). Response was assessed by imaging techniques after 4-6 weeks of treatment and was confirmed one month later by chest X-ray and/or CT scanning. The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test.

      Results
      Out of 74 treated patients, 46 had EGFR mutations in exon 19 and 28 had EGFR mutations in exon 21. 53 patients (71.6%) were woman, 21 patients (28.4%) were man. At the time of treatment initiation with gefitinib, the following characteristics were recorded. The median age of patients was 67 years. 9 patients (12.1%) were smokers, 19 patients (25.7%) were former smokers, 46 patients (62.2%) were non-smokers; performance status (PS) was 0 in 16 patients (21.6%), 1 in 49 patients (66.2%) and 2 in 9 patients (12.2%); adenocarcinoma was confirmed in 67 patients (90.5%); most of the patients were in stage IV (64 patients, 86.5%). As on the date of data analysis (18 March 2013), treatment was terminated in 32 patients (43.2%). The median duration of treatment was 19.0 weeks (mean 24.7). Among patients in which treatment was terminated, complete response was not achieved in a single case; partial response was achieved in 10 patients (31.3%), stable disease in 10 patients (31.3%), progressive disease in 7 patients (21.9%) and treatment response was not evaluated in 5 patients (15.6%). Adverse effects during treatment with gefitinib were reported in 23 patients (31.1%). Median progression-free survival from gefitinib treatment initiation is 8.1 months (95% CI: 6.9; 9.3). Median overall survival (OS) was not reached.

      Conclusion
      In a group of 74 patients with advanced NSCLC and with activated mutations who were treated with gefitinib in first line, the therapy was well tolerated, median progression-free survival from gefitinib treatment initiation is 8.1 months (95% CI: 6.9; 9.3) and median overall survival (OS) was not reached.

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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-011 - Pemetrexed in combination with cisplatin in the first-line treatment of non-squamous NSCLC: Czech experience with 233 patients (ID 1228)

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

      • Abstract

      Background
      Pemetrexed in combination with cisplatin in the first-line treatment of advanced non-squamous NSCLC (non-smal-cell lung cancer) has been administered in the Czech Republic since 10/2010. The purpose of this study was to evaluate the activity and feasibility of pemetrexed in first-line treatment of NSCLC in combination with cisplatin.

      Methods
      Patients with advanced non-squamous NSCLC were treated with pemetrexed in first line and in combination with cisplatin between 10/2012 and 03/2013 in 12 institutions. Retrospective analyses were carried out to assess the effectiveness of treatment and applied regimens, and to evaluate the safety of targeted therapy. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). Response was assessed by imaging techniques after 4-6 weeks of treatment and was confirmed one month later by chest X-ray and/or CT scanning. The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test.

      Results
      Out of 233 treated patients, 125 were men (53.6%) and 108 were women (46.4%). At the time of treatment initiation with pemetrexed, the following characteristics were recorded. The median age of patients was 61 years. 97 patients (41.6%) were smokers, 72 patients (30.9%) were former smokers, 64 patients (27.5%) were non-smokers. Performance status (PS) was 0 in 53 patients (22.7%), 1 in 172 patients (73.8%) and 2 in 8 patients (3.4%). Adenocarcinoma) was confirmed in 226 patients (97.0%), large-cell carcinoma was reported in 7 patients (3.0%). Most of the patients were diagnosed in stage IV (186 patients, 80.2%) and treatment of most patients was also initiated in stage IV (84.5%). As on the date of data analysis (18 March 2013), treatment was terminated in 185 patients (79.4%), and the median duration of treatment in these patients was 12.1 weeks. Adverse effects during treatment with pemetrexed were reported in 73 patients (31.3%). Complete response was achieved in 4 patients (1.7%), partial response in 58 patients (24.9%), stable disease in 79 patients (33.9%) and progressive disease in 38 patients (16.3%); treatment response was not evaluated in 54 patients (23.2%). Median overall survival (OS) starting from treatment initiation with pemetrexed was 11.6 months (95% CI: 7.0; 16.3). Median progression-free survival (PFS) starting from treatment initiation with pemetrexed was 4.2 months (95% CI: 3.4; 5.1).

      Conclusion
      In a group of 233 patients with advanced non-squamous NSCLC who were treated with pemetrexed in first line and in combination with cisplatin, the therapy was well tolerated: termination of treatment due to adverse events was reported only in 3.8% of patients. Median overall was 11.6 months, median progression-free survival was 4.2 months