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B. Kadlec



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    P2.11 - Poster Session/ Palliative and Supportive Care (ID 230)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Palliative and Supportive Care
    • Presentations: 1
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      P2.11-010 - Predictors of Thromboembolic Events in Patients with Lung Cancer (ID 671)

      09:30 - 09:30  |  Author(s): B. Kadlec

      • Abstract
      • Slides

      Background:
      Patients with lung cancer experience elevated risk of venous thromboembolism Prothrombotic factors in lung cancer include the ability of tumour cells to produce and secrete procoagulant substances and inflammatory cytokines, and the physical interaction between tumour cell and blood. Other mechanisms of thrombus promotion in malignancy include surgery, metastatic disease and use of chemotherapeutic drugs in combination with novel targeted drugs, such as antiangiogenic agents. Cancer patients with thrombosis have a shorter life expectancy than cancer patients without this complication. The occurrence of VTE worsens the quality of life and may delay, interrupt, or completely halt the cancer therapy.

      Methods:
      Patients diagnosed with primary lung cancer were followed up between 2006-2010. We recorded demographic data, histology and clinical stage, basic laboratory values of blood and coagulation, frequent and significant comorbidities, and details of initial cancer treatment. In patients with advanced, unresectable or metastatic lung cancer, these parameters were evaluated before the first cycle of chemotherapy or targeted therapy. Thromboembolic events were being detected by standard diagnostic procedure; if detected, the risk of VTE was automatically considered to be high. Statistical analysis included standard descriptive statistics; absolute and relative frequency of each category for categorical variables, median and 5% -95% percentile in the case of continuous variables. Analysis of categorical variables was supplemented with an analysis of frequency tables.

      Results:
      A total of 950 patients were enrolled, of whom 600 were men and 350 women. The median age of all patients was 64 years. Squamous cell carcinoma was the most frequent histological subtype (27.3%), followed by adenocarcinoma (23.8%), small cell carcinoma (18.4%) and non-small cell NOS. Hypertension was the most frequent comorbidity (39.6%),followed by COPD (38.2%), diabetes mellitus (19.4%), cerebrovascular disease 9.6%, and heart failure (7.7%). Ninety-one thromboembolic events were registered in the entire group (9.6%), of which 80 (87.9%) were severe and 11(12.1%) less severe. In the group of patients with thromboembolic disease, platelet counts were significantly increased at the time of diagnosis of lung cancer – 368 x10[9] (191.0 to 540.0). Among comorbidites, heart failure was associated with an increased risk of VTE – OR 13.48 (7.80 to 23.28), followed by cerebrovascular disease – OR 3.17 (1.78 to 5.64), atrial fibrillation – OR 2.96 (1.50 to 5.83), and obesity – OR 2.40 (1.26 to 4.58). Among laboratory parameters, platelet counts above 330,5x109 were associated with the occurrence of severe VTE – OR 3.66 (2.25 to 5.96).

      Conclusion:
      The incidence of serious thromboembolic events (8.4%) in our group of lung cancer patients was high, especially in patients with adenocarcinoma, advanced-stage disease, and in patiens on cancer treatment. In patients with thromboembolic disease, significantly higher median platelet counts were observed at the time of cancer diagnosis. In patients treated with chemotherapy, most thromboembolic events were observed shortly after the treatment starts and the majority of thromboembolic events occurred within 6 months after the initiation of chemotherapy. These results justify prophylactic treatment in most patients with advanced or metastatic disease, adenocarcinoma, patients receiving radiotherapy or chemotherapy, and in presence of some associated disorders.

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-008 - Gefitinib in Front-Line Treatment of 161 Caucasian Patients with NSCLC of the Czech Republic (ID 424)

      09:30 - 09:30  |  Author(s): B. Kadlec

      • Abstract
      • Slides

      Background:
      Gefitinib is a potent oral non-cytotoxic, active and selective epidermal growth factor receptor tyrosine kinase inhibitor. This study evaluates treatment outcomes in 161 NSCLC patients from Czech Republic according to activated mutations located in exons 19 and 21.

      Methods:
      Data treated patients with gefitinib are collected in the TULUNG registry, which is a common project of the Czech Pneumological Society, Czech Oncological Society, and Institute Biostatistics and Analyses Masaryk University Brno. NSCLC patients with EGFR activated mutations were treated in first line between 02/2010 and 12/2014 in 10 institutions. Retrospective analyses were carried out to assess the effectiveness and safety of gefitinib treatment according to activated mutations located in exons 19 and 21. The analysed outcomes include following: treatment response rate, median Overall Survival (mOS), median Progression Free Survival (mPFS) and occurrence of types adverse events.

      Results:
      Out of 161 treated patients, 105 (70 female, 35 male) had EGFR mutations in exon 19, and 56 (39 female, 17 male) had EGFR mutations in exon 21. Median age was 66 years in the group with mutations in exon 19 and 69 years in the group with mutations in exon 21. There was no statistically significant difference in sex (p=0.727) and in age (p=0.204). No statistically significant difference was observed in the representation in smoking (p=0.354). There was statistically borderline significant difference in adenocarcinoma proportion (p=0.045). In the group with mutations in exon 19 were 96% patients with adenocarcinoma and in the group with mutations in exon 21 were 85% patients with adenocarcinoma. Between these two groups, there was no statistically significant difference according to performance status (p=0.547); no statistically significant difference according to disease control (CR+PR+SD) (p=0.479); no statistically significant difference according the response to the treatment (CR + PR) (p=0.052). There was no statistically significant difference in mOS (p=0.390). In the group of patients with mutations located in exon 19, the overall survival was 22.7 months (CI 95%: 17.7; 27.8), in the group with mutations in exon 21, overall survival was 16.3 months (CI 95%: 10.8; 21.8). There was no statistically significant difference (p=0.202) in mPFS; in the group of patients with mutations in exon 19 it was 11,0 months (CI 95%:9.1; 12.8) and in the group with mutations in exon 21 it was 9.4 months (CI 95% 6.6; 12.2). SimiIar numbers of adverse effects were observed in either group (35.2% and 35.7%). Almost 70% of patients with mutations in exon 19 and almost 60% of patients with mutations in exon 21 are still alive or were lost to follow up. These patients are censored to the date of last update.

      Conclusion:
      In both groups of patients, the treatment was very safe. Median PFS and median OS were satisfactory without statistically significant differences between the two groups; however, a better trend was observed in the group of patients with mutations in exon 19. Consequently survival estimates shows great variability and longer potential follow up is needed to confirm these results.

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