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V. Kolek



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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): V. Kolek

      • 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: 2
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      P2.10-010 - Full oral vinorelbine (NVBO) on D1 and D8 with carboplatin (CBDCA) as first line treatment in advanced non-small lung cancer (NSCLC) patients: results of a prospective study in nonrandomized and unselected population of 396 patient (ID 911)

      09:30 - 09:30  |  Author(s): V. Kolek

      • Abstract

      Background
      Lung cancer is the leading cause of cancer mortality in the Czech Republic. Approximately 80%are NSCLC and 65% of patients have advanced disease at the time of diagnosis. Most patients who receive first-line chemotherapy experience disease progression within 3 to 6 months of initiating therapy and the median survival time observed is 8 to 10 months. In this situation, there is a need to find effective therapeutic regimen with an administration as simple as possible and the most favorable toxicity profile. The purpose of this study was to evaluate the activity and feasibility of CBDCA together with full oral vinorelbin (NVBO).

      Methods
      Patients with advanced NSCLC received NVBO 80 mg/m² on D1 and D8 with CBDCA AUC5 on D1 every three weeks. In stage III, chemotherapy was followed by external radiotherapy. 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
      396 patients were treated: 311 men (78,5) and 50 women (21,5%), median age 65 years. ECOG performance status at inclusion was PS 0 in 51 (12,9% patients, PS 1 in 287 (72,7%) and PS 2 in 57 (14,4%) patients. Most patients had stage IIIB 116 (29,3%) and stage IV NSCLC 257 (64,9), only 32 (5,84%) were stage IIIA . Adenocarcinoma was confirmed in 90 patients (22,7%), squamous-cell carcinoma in 238 (60,1%), large-cell carcinoma 11 and other in 57 (17,2%). Complete response was confirmed in 2 (0,5%) patient, partial response in 136 (34,3%), stable disease in 104 (26,3%), 154 (38,9%) patients progressed. The regimen was well tolerated. Median cycles was 4, the dosage of NVBO was without changes in 268 (67,7%) patients, the dosage of NVBO was reduced in 28 (7,1%) and escalated in 77 (19,48%). In 23 (5,8%)of patients was the dosage of NVBO reduced after escalation. Major toxicities (Grade 3-4) were neutropenia in 29%, leucopenia in 20,8%, anemia in 3,3% and thrombocytopenia in 1,8% patients. Febrile neutropenia was observed in 6,1% patients. Gastrointestinal toxicity grade 3-4 was observed in 4,6% patients. The mPFS was 7,4 moths and mOS was 9,92 months by median follow-up 8,5 months. The differences between groups of pts according to PS (0+1 vs. 2) were statistically significant (p < 0,001) better for patiens with PS 0+1. The differences between groups of pts according histology were not statistically significant (p=0,3975).

      Conclusion
      In this group of 396 unselected patients with advanced NSCLC was the treatment with full NVBO and-CBDCA in first line more convenient and well tolerated with evidence of high antitumour activity. This combination was active in all groups patients according histology (mOS was 9,92 and mPFS was 7,4 months). Statistically significant better were the results in patients with PS 0+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): V. Kolek

      • 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

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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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      P2.11-018 - EGFR mutations in NSCLC patients in Central Europe: the INSIGHT observational study (ID 1635)

      09:30 - 09:30  |  Author(s): V. Kolek

      • Abstract

      Background
      Central European countries are among those with the highest incidence rates of lung cancer and most of these cancers are smoking-related. The INSIGHT observational study aimed at assessing prevalence and treatment of patients with EGFR mutations in clinical practice in Central Europe. Here we report on the overall findings of this study.

      Methods
      Patients with NSCLC and tested for EGFR mutations between 15 November 2011 and 31 March 2013 in 14 centers from 6 Central European countries (Austria, Czech Republic, Hungary, Poland, Slovakia, Slovenia) were enrolled. EGFR mutations were determined by sequencing, PCR or other techniques.

      Results
      Here we report data on 1009 NSCLC patients who had been enrolled into the INSIGHT study. The patients had the following characteristics: median age 64 (range 29-93), 62% male, 38% female, 99.9% Caucasians, ECOG performance status 0-1, 2 and 3-4 in 79%, 17% and 4%; 19% never-smokers, 46% former smokers, 35% current smokers; 79% adenocarcinomas, 2% adenosquamous carcinomas, 7% squamous cell carcinomas, 9% NSCLC NOS and 3% others; tumor stages I-II, III and IV in 15.5%, 24% and 60.5% of the patients. EGFR mutations were found in 163 (16%) patients. Patients with mutations had the following characteristics: age median 66 (range 34-89) years, 46% male, 54% female, 47% never-smokers, 38% former smokers, 15% current smokers; performance status was recorded in 153 patients and was 0, 1, 2 and 3 in 30%, 50%, 14% and 6% of the patients. The mutation-positive tumors had the following characteristics: 85% adenocarcinomas, 4% adenosquamous carcinomas, 4% squamous cell carcinomas, 2% NSCLC NOS, and 5% others. Among patients with mutations, exon 18 mutations were seen in 7% of the patients, exon 19 mutations in 50% of the patients including deletions in 39%, exon 20 mutations in 12%, exon 21 mutations in 39% including L858R in 28% of the patients. Detailed data on systemic treatment were available for 122 patients with advanced EGFR mutation-positive NSCLC and most of these patients received EGFR-directed tyrosine kinase inhibitors during the course of their disease.

      Conclusion
      The INSIGHT observational study demonstrated that EGFR mutation testing has been established in the participating centres in Central Europe. The mutation rate of 16% is on the upper limit of the range seen in Western European countries but a potential selection bias for testing of patients with higher likelihood of harboring EGFR mutations cannot be excluded. Systemic treatment in patients with EGFR mutations is similar to treatment patterns observed in other countries. This study was supported by Boehringer Ingelheim Regional Center Vienna.