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J. Roubec



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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): J. Roubec

      • 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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    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): J. Roubec

      • 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): J. Roubec

      • 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.