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M. Pesek



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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-016 - TULUNG registry: Analysis of data from PS 0-1 patients with advanced/metastatic non-squamous NSCLC (adenocarcinoma, large cell carcinoma) treated in second line with pemetrexed (ID 962)

      09:30 - 09:30  |  Author(s): M. Pesek

      • Abstract

      Background
      The TULUNG registry is an independent national non-interventional clinical registry, focused on collection and analysis of epidemiologic and clinical data of non-small cell lung cancer (NSCLC) patients who have been treated with pemetrexed (Alimta®), erlotinib (Tarceva®), gefitinib (Iressa®) and/or bevacizumab (Avastin®) in 10 centers of complex thoracic oncology care in the Czech Republic. The report is based on data analysis of 476 advanced/metastatic non-squamous (adenocarcinoma or large cell carcinoma) NSCLC patients, who had good performance status (PS 0-1), were treated with pemetrexed in the second line of treatment, and whose data were recorded in TULUNG registry as of March 18, 2013.

      Methods
      There were analyzed baseline demographic data, information about treatment aministered and efficacy and safety clinical outcomes of pemetrexed second line treatment in this selected registry patient population, using descriptive statistics.

      Results
      In analyzed group of 476 patients slightly prevailed men (56.9%) over women, median age at start of pemetrexed treatment was 62 years (range 27-81 let). Majority of patiens were current smokers and ex-smokers (41.0% and 32.8% resp.). 95% of tumours had adenocarcinoma histology. Vast majority of analyzed patiens (87.4%) had metastatic disease at start of second line pemetrexed treatment, the rest had stage IIIb. 83.8% of patiens had ECOG PS 1 at start of second line pemetrexed treatment and 87.4% of patiens received pemetrexed in monotherapy. At the moment of analysis, pemetrexed treatment was already terminated in 408 patients out of 476 patients (the most frequent reasons for discontinuation of treatment were disease progression in 56.9% and planned completion of treatment in 28.2%), treatment was at moment of analysis ongoing in 68 patients. Median duration of treatment with pemetrexed was 12.3 weeks (corresponds with 4 cycles). When focusing on the subset of patients with finished pemetrexed treatment, the disease control rate (i.e. CR+PR+SD) was reported in 59.6% of patients, while progressive disease (PD) was reported in 33.3%. For 7,1% of patiens there were missing data on treatment response. Median overall survival was 11.3 months (95% CI 9.6 – 13.0) and median progression-free survival was 3.3 months (95% CI 2.7 – 3.8). 1-year survival rate from start of pemetrexed treatment was 47,5%. Adverse events were reported to registry for 21.8% of pemetrexed treated patiens from analysed population. The most frequent (>5% patients) reported adverse events were neutropenia (9.7%), anemia (6.5%), leukocytopenia (6.1%), and fatigue (6.1%).

      Conclusion
      Reported efficacy and safety outcomes from registry are more favourable than results of published controlled randomized registrational trial. It probably reflects the different methodology of data collection and more prudent approach to patient selection for pemetrexed second line treatment in real clinical practice in the Czech Republic in participating centers. Based on registry data, pemetrexed treatment was in suitable patiens with good PS very well tolerated (78.2% of patiens without reported adverse events in registry) and allowed for reaching disease control in almost 60% of treated patiens, with median OS approaching one year from starting second line therapy.

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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): M. Pesek

      • 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): M. Pesek

      • 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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      P2.11-019 - 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): M. Pesek

      • 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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    P2.24 - Poster Session 2 - Supportive Care (ID 157)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P2.24-032 - Bronchoscopy in the Czech Republic, 2012 (ID 2338)

      09:30 - 09:30  |  Author(s): M. Pesek

      • Abstract

      Background
      The incidence of lung cancer in the Czech Republic has been unacceptably high for decades. It has reached 91/100 000 in men and 31/100 000 in women. Bronchoscopy plays an important role in the diagnostic process. To assess the quality and density of the bronchological net and to determine the current situation in the implementation of bronchoscopy in the Czech Republic we decided to carry out a national survey.

      Methods
      A bronchological questionnaire was sent by e-mail to every pneumologist performing bronchoscopy. With the help of repeated e–mails and additional telephone interviews we achieved a response rate of more than 95%.

      Results
      In 2012 there were 56 centers performing bronchoscopy in adults and 9 in children in the Czech Republic. The bronchological units of adult clinics employed 169 bronchologists using 231 fiberscopes, out of which 88 were video bronchoscopes and 79 rigid bronchoscopes. Altogether 30 354 bronchoscopies were performed in adults. General anesthesia was used in 2 146 cases, the rest was carried out under local anesthesia. The total number also includes 1767 bronchoscopies performed using rigid instrumentation. Cytological examination of the material obtained during bronchoscopy was carried out by a pathologist (Department of Clinical Pathology) at 34 centers, by a pneumologist trained in cytology at 13 centers and by both the pathologist and the pneumologist at 9 centers. Interventional bronchoscopic procedures (laser, electrocautery, stenting, brachytherapy, cryocautery and the introduction of endobronchial valves) were used in 17 departments. Altogether the above mentioned procedures were performed 654 times during one year. All 9 children's bronchological departments employed 12 bronchoscopists, using a total number of 29 fiberscopes, out of which 17 were video bronchoscopes. Seven pediatric bronchoscopy centers also used rigid instrumentation. The total number of pediatric bronchoscopies performed in 2012 was 682, the majority of them (621) under general anesthesia. Out of all bronchoscopies, the rigid bronchoscopy was performed in 32 cases. At five centers cytology examination was performed by a pathologist, at 3 centers by a pneumologist trained in cytology and at one center by both specialists together. Further analysis of the specialized bronchological procedures (endobronchial ultrasound, autofluorescence), including a comparison with previous surveys will be given in the lecture or on the poster.

      Conclusion
      The level of bronchological service offered in the Czech Republic is comparable with the most developed countries and serves a prompt and exact diagnostics of patients with respiratory disorders including lung cancer. "Supported by Projects (Ministry of Health) of conceptual development of research organization 00064203 (FN Motol, Prague, Czech Republic)".

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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
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      P3.11-009 - Tulung registry: data analysis of patients with non-squamous NSCLC (adenocarcinoma, large cell carcinoma) and PS 0-1 treated with erlotinib in second line setting (ID 971)

      09:30 - 09:30  |  Author(s): M. Pesek

      • Abstract

      Background
      We conducted a systematic review of data from patients reported in the TULUNG registry (data cut-off 18-Mar-13). The TULUNG registry prospectively collects data from all NSCLC patients treated by erlotinib in the Czech Republic.

      Methods
      Our analysis was performed on a subgroup of patients with non-squamous NSCLC (adenocarcinoma or large-cell carcinoma) with good performance status (PS 0-1), treated with erloninib in a second-line setting.

      Results
      521 of 2365 patients reported in the the TULUNG registry met the above-mentioned criteria. Of 521 patients analyzed, 51,2% were female; the median age at erlotinib treatment initiation was 64 years (range 29-88). The majority of patients were smokers and ex-smokers (34.4% and 34.0% respectively) and 93.1% of tumours were adenocarcinomas by histology. 86.1% patients were at the metastatic stage at the initiation of second-line erlotinib treatment, 12.8% of patients were in stage IIIb and only 1.1% of patients in stage IIIa. The majority of patients (87.7%) was in PS 1 at the initiation of second-line erlotinib treatment. From 521 of all analyzed patients, erlotinib therapy was terminated in 410 (78.7%) patients at data cut-off (the most frequent reasons for termination were disease progression, in 74.6% and death in 11.5% of patients) and treatment was ongoing in 111 (21.3%) patients. In 410 of patients with terminated treatment, the median duration of treatment was 3.0 months (95% CI 0.7 – 16.9), ORR assessment showed CR in 0.7%, PR in 8.3% and SD in 54.6% of patients. Median progression free survival was 4.0 months (95% CI 3.5 – 4.5), median overall survival 11.8 months (95% CI 9.6 – 14.0). 1-year survival from erlotinib treatment initiation was 49.4%. Adverse events were reported in 42.8% of patients, the most frequently reported adverse events (in >5% of patients) were skin toxicity (35.3%) and diarrhea (13.6%). Grade ≥3 adverse events were reported in 10.5% of patients, G≥3 skin toxicity 7.5% and G≥3 diarrhea in 1.3% of patients.

      Conclusion
      Erlotinib therapy of advanced metastatic adenocarcinoma or large cell carcinoma in a second-line setting was very well tolerated in eligible patients with PS 0-1; only 3.4% of patients had to discontinue erlotinib therapy due to adverse effects. In patients with completed erlotinib therapy 63.6% disease control rate was reached with a median survival of approximately 1 year from initiation of second-line erlotinib therapy.