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M. Zemanova



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    O02 - NSCLC - Combined Modality Therapy I (ID 111)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Combined Modality
    • Presentations: 1
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      O02.01 - Geographic differences in the combined-modality treatment of stage III unresectable non-small cell lung cancer: Results from a global phase III trial of tecemotide (L-BLP25) (ID 2712)

      10:30 - 10:40  |  Author(s): M. Zemanova

      • Abstract
      • Presentation
      • Slides

      Background
      Chemo-radiotherapy (chemo/RT) is the standard of care for patients with unresectable stage III non-small cell lung cancer (NSCLC), but little is known about differences in clinical practice between regions of the world. The START trial is a global phase III trial of the MUC1-specific cancer immunotherapy tecemotide (L-BLP25), for which key efficacy and safety results have been reported previously. Here we report regional differences in diagnostic procedures and treatment of stage III NSCLC prior to enrolment in START.

      Methods
      The START trial recruited patients (performance status 0/1) with unresectable stage III NSCLC who had not progressed within 28–84 days of completing ≥2 cycles of platinum-based chemotherapy with concurrent or sequential radiotherapy (≥50 Gy). Baseline characteristics, diagnostic procedures and the initial chemo/RT administered of those recruited were compared between centers in different regions.

      Results
      From Jan 2007 to Nov 2011, 1513 patients were recruited at >250 centers in 33 countries: Western Europe 40.3%, Eastern Europe 26.0%, North America 21.8%, Latin America 5.7%, Asia 3.4%, Australia 2.8%. The majority of patients (92.1%) were Caucasian and median age was 61 years. Overall, 6.3% of patients were never-smokers with little inter-regional variation except for Asia (31.4%). The proportion of current smokers upon entry into the trial was highest in Eastern Europe (36.3%) and lowest in Australia (11.6%). Median tobacco consumption by region ranged from 36.2 (Eastern Europe) to 53.6 (Latin America) pack-years. The proportion of patients considered for the START trial who received concurrent rather than sequential chemo/RT varied widely between regions and was highest in North America and Australia, lower in Western Europe, Latin America and Asia, and lowest in Eastern Europe. There were also substantial variations in the diagnostic procedures between the regions, although pathological confirmation of N-status was infrequent in all regions. Detailed results by region for the time from diagnosis to randomization, duration of chemo- and radiotherapy, and chemotherapy agents used will be presented.

      Proportion of patients (%) with:
      Use of concurrent chemo/RT N-status determined with PET or PET/CT N-status determined with mediastinoscopy
      Australia (n=43) 100 74.4 2.3
      North America (n=330) 92.7 37.9 18.5
      Asia (n=51) 66.7 21.5 2.0
      Latin America (n=86) 65.1 7.0 5.8
      Western Europe (n=609) 67.2 32.2 6.9
      Eastern Europe (n=394) 28.9 7.3 3.6

      Conclusion
      Baseline data from the START trial suggest substantial variations in the management of unresectable stage III NSCLC between different regions of the world. While recruited patients from North American and Australian centers mostly received concurrent chemo/RT in accordance with current recommendations, a substantial proportion of patients in Europe, Latin America and Asia received sequential chemo/RT. More frequent use of concurrent chemo/RT as the recommended standard of care should be made across geographic regions.

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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. Zemanova

      • 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. Zemanova

      • 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): M. Zemanova

      • 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): M. Zemanova

      • 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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    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. Zemanova

      • 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.