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Y.A. Ragulin



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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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      P3.11-039 - Exploration of patient health status as measured by the generic preference-based questionnaire EQ-5D alongside the START trial of tecemotide (L-BLP25) in non-small cell lung cancer (ID 2744)

      09:30 - 09:30  |  Author(s): Y.A. Ragulin

      • Abstract

      Background
      Tecemotide (L-BLP25) is a mucin 1 (MUC1) antigen-specific cancer immunotherapy investigated in patients not progressing after primary chemo-radiotherapy for stage III non-small cell lung cancer (NSCLC) in the phase III START study. The objective of this analysis was to explore patients’ health status alongside the study.

      Methods
      From January 2007 to November 2011, 1513 patients with unresectable stage III NSCLC that did not progress after chemo-radiotherapy (platinum-based chemotherapy and ≥50 Gy) were randomized (2:1; double-blind) to tecemotide (806 μg lipopeptide) or placebo SC weekly x 8 then Q6 weeks until disease progression or withdrawal. The analysis population (n=1239) was defined prospectively to account for a clinical hold of the study. The impact on patient health status was assessed as an exploratory endpoint using the EuroQoL 5 Dimensions (EQ-5D), a widely used generic preference-based questionnaire covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). EQ-5D index score can be calculated for which perfect health is given a value of 1 and death a value of 0. EQ-5D was collected at baseline, weeks 2, 5 and 8 and then every 6 weeks until end of treatment (EOT) visit (i.e. at time of disease progression), the EOT visit and every 12 weeks afterwards. Analysis of covariance (ANCOVA) was carried out to explore the change of EQ-5D index score over time in the overall population for patients on treatment. The change of EQ-5D to EOT visit was also estimated. Change of EQ-5D index score was explored using all data (i.e. collected both before and after EOT visit) using a linear growth curve model, with random intercept and slope, considering time as a continuous variable.

      Results
      EQ-5D compliance rates (percentage of patients still in the study who completed the questionnaire) were consistently above 85% for all visits of the treatment period in both treatment arms. Mean baseline EQ-5D score was 0.79 (sd=0.19) for both tecemotide and placebo arms. The results from ANCOVA on the overall population did not show any significant difference between the two arms during the treatment phase. Change in the EQ-5D index score from baseline to EOT visit was –0.102 (95%CI: –0.134, –0.071) for tecemotide and –0.136 (95%CI: –0.177, –0.095) for placebo. The linear growth model including the EQ-5D assessments before and after EOT showed that the EQ-5D index score decreased significantly over time in both treatment arms, but that the decrease was slightly slower in the tecemotide than in the placebo arm: –0.0076 per month in tecemotide patients vs. –0.01 in placebo (p=0.0498).

      Conclusion
      During treatment, there was no statistical difference in health status with tecemotide vs. placebo. This supports the good tolerability profile of tecemotide, with a lack of significant toxicity as compared to placebo. Disease progression was associated with a notable deterioration of patient health status, regardless of the treatment. Considering data from both before and after disease progression, patients’ health status appeared to worsen slightly over time, at a slower rate for patients treated with tecemotide.

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    P3.21 - Poster Session 3 - Diagnosis and Staging (ID 171)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P3.21-002 - Lung-EPICLIN: analysis of <em>EGFR</em> mutations and associated clinico-pathological parameters in patients with NSCLC in Russian Federation (ID 1409)

      09:30 - 09:30  |  Author(s): Y.A. Ragulin

      • Abstract

      Background
      Lung cancer is a major cause of mortality in Russia: 51,364 deaths in 2008, 18.0% of all cancer-related deaths (GLOBOCAN). Mutations in the EGFR gene are known to predict for sensitivity to EGFR tyrosine kinase inhibitors in patients with advanced non-small-cell lung cancer (NSCLC). Clinico-pathological characteristics associated with a higher prevalence of EGFR mutations are: adenocarcinoma histology, East Asian origin, non-smoking history, and female gender. This study aimed to document the characteristics, clinical management and outcomes of Russian patients with NSCLC, and to investigate associations between EGFR mutations and clinico-pathological parameters.

      Methods
      A non-interventional, prospective cohort study (ClinTrials ID: NCT01069835) carried out in a representative selection of hospitals in order to assess lung cancer management in countries throughout European and Asian parts of Russia. Patients with confirmed NSCLC attending participating centres for the first time between 1 February 2010 and 31 March 2011 were enrolled and followed-up according to routine practice for a minimum of 12 months or until death.

      Results
      A total of 838 patients were enrolled at 33 sites across the Russian Federation. Baseline characteristics were: mean age, 58.7 (SD ±8.5) years; male, 78.4%; European, 98.0%; Russian, 79.6%; Tatar, 3.8%; Ukrainian, 3.1%; Byelorussian, 1.3%; current smokers, 49.4%; never-smokers, 26.5%; ECOG performance status (PS) 1, 65.6%; disease stage IV, 25.4%; stage III, 37.8%; stage I/II, 36.7%. Metastases were found in 38.1% of patients; the most common metastatic sites included: respiratory system, 70.2%; pleura, 17.2%; bone, 11.9%; liver, 10.3%. EGFR mutations were detected in 85/838 (10.1%) patients (84/821 [10.2%] European patients and 1/15 [6.7%] Asian patients), who were mostly women, 69.4%; <70 years old, 85.9%; never smokers, 71.8%; PS 1, 59.3%; adenocarcinoma, 58.8%. EGFR mutation rates by histological type were: squamous-cell carcinoma (SCC), 18/455 (4.0%); adenocarcinoma, 50/260 (19.2%); adenocarcinoma bronchioloalveolar, 11/54 (20.4%); large-cell carcinoma, 2/24 (8.3%); adenosquamous carcinoma, 2/19 (10.5%); other histology, 2/26 (7.7%). Logistic regression analysis of EGFR mutations; statistically significant odds ratios: male vs female, 0.086 (p<0.0001); any smoking history vs no smoking history, 0.110 (p<0.0001); non-SCC vs SCC, 5.365 (p<0.0001); increase in age (10 years), 1.391 (p=0.0227). Platinum-containing doublets were the most commonly used chemotherapy at first (83.5%) and second line (51.0%). In patients who received first- and second-line chemotherapy, objective response rate, disease progression rate and median progression-free survival (PFS) were, respectively, 16.1% and 3.6%, 63.8% and 76.8%, 35.0 weeks and 19.4 weeks. Median PFS (weeks) after first-line chemotherapy by histology and EGFR mutation status was: SCC, 36.3; non-SCC, 34.0; EGFR mutation positive, 36.9; EGFR mutation negative, 34.3.

      Conclusion
      In this cohort, the proportion of patients with EGFR mutation-positive NSCLC was similar to other studies of NSCLC in Caucasian populations. EGFR mutation status was significantly associated with female gender and non-smoking history, in-line with previous studies of Asian and Caucasian patients with advanced NSCLC. This study contributes to a better understanding of prognostic and predictive factors of NSCLC, which will enable optimal treatment selection in future clinical practice.