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M. Lees



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    P1.06 - Poster Session with Presenters Present (ID 458)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.06-032 - The Humanistic Burden of Advanced Non-Small Cell Lung Cancer Patients in Europe - A Real World Survey (ID 5654)

      14:30 - 15:45  |  Author(s): M. Lees

      • Abstract
      • Slides

      Background:
      Previous publications have demonstrated that advanced Non-Small Cell Lung Cancer (aNSCLC) patients have worse HRQoL compared to the general population. Few publications have focused on the impact of aNSCLC on activities of daily living and the humanistic burden incurred by different groups of aNSCLC patients in the real world setting.

      Methods:
      Data were taken from a multi-center, cross-sectional study of aNSCLC patients conducted in France, Germany and Italy. The study consisted of three components: medical chart review, patient questionnaire and caregiver questionnaire. Overall, 683 consulting patients were recruited via treating physicians. Patients’ health state was quantified using the EuroQoL-5D (EQ-5D-3L - comprising of five domains: mobility, self-care, ability to perform usual activities, pain, anxiety and depression) and the burden on HRQoL quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a 30 item questionnaire yielding five functional scales, three symptom scales, a global health status/QoL scale, and six single items. Analysis was stratified by patients’ line of therapy. Statistical significance was assessed using Mann-Whitney U tests.

      Results:
      Patients’ mean (SD) age was 65.2 (9.7), 68.8% were male and 89.0% had stage IV NSCLC. Over two-thirds (71%) of patients were receiving 1st line advanced therapy, whilst 29% were receiving later lines of therapy. Regarding histology, 74% of patients were non-squamous compared to 26% squamous. The mean EQ-5D-3L index for 2[nd] line or later patients was significantly lower compared to patients on 1[st] line treatment (0.57 vs 0.65; p=0.002). Three domains showed significant decreases: mobility, self-care and ability to perform usual activities. In terms of EORTC scores, patients on later lines of treatment experienced a lower overall global health status (QL2) compared to 1[st] line patients (43.8 vs 50.7; p<0.001). Significant differences were also observed in all other EORTC scales except for diarrhoea.

      Conclusion:
      1[st] line aNSCLC patients have a diminished health state in comparison to the general population (EQ-5D scores 0.65 v 0.78). In addition compared to other cancer sufferers, aNSCLC patients have a worse QoL (QLQ-C-30 QL2 score 48.8 v 61.5 for stage IIIB/IV cancer patients). The real world study shows that both health status and QoL significantly worsen with advancement to later lines of treatment. The results show a high unmet need for more effective 1[st]–line treatments to prevent disease progression while maintaining patient quality of life.

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    P2.03b - Poster Session with Presenters Present (ID 465)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03b-097 - Prognostic Factors for Overall Survival among Patients with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) (ID 4582)

      14:30 - 15:45  |  Author(s): M. Lees

      • Abstract
      • Slides

      Background:
      The LENS (Leading the Evaluation of Non-squamous and Squamous NSCLC) retrospective medical chart review was undertaken to describe characteristics, treatment patterns and outcomes among patients receiving systemic treatment for advanced/metastatic NSCLC in Europe. This analysis reports on prognostic factors associated with overall survival (OS) from start of first line treatment (1L).

      Methods:
      Patients with NSCLC stage IIIb/IV diagnosis between July 2009 and August 2011 were sampled from oncology/pulmonology practices in France, Germany, Italy, and Spain. Patients were followed to their most recent visit (data collected October 2013 to April 2014). Data were extracted from medical charts. Prognostic factors associated with OS from start of 1L were examined through Cox proportional hazard estimation. Independent clinically relevant variables included age, gender, tumor histology, and TNM disease stage. Additionally, variables for presence of metastases, prior administration of mutation (EGFR, ALK, KRAS) tests, surgery, and health insurance type were included. A backwards selection process (model 1) was applied to select the variables from the latter group with a significance level of 0.1. The remaining variables were entered into a second model 2 with all clinically relevant variables regardless of their significance. The final model 3 included all clinically relevant variables plus the significant variables from model 2.

      Results:

      Significant Prognostic Factors for OS from Start of 1L (p<.05) in Final Multivariable Model
      Variable (Reference) Level Hazard Ratio (95%CI) P-Value
      Age Category at first diagnosis (<65 ) >79 2.6 (1.9-3.7) <.0001
      Country (Germany) Spain 1.6 (1.2-2.0) <.0001
      TNM disease stage (IIIB) IV 1.6 (1.2-2.1) <.0001
      ECOG Score (0) 1 2+ 1.5 (1.2-1.9) 2.8 (2.1-3.7) <.0001 <.0001
      Smoking (Never) Current Former 2.3 (1.7-3.2) 1.6 (1.2-2.1) <.0001 .005
      Malignant Pleural Effusion (No) Yes 1.3 (1.0-1.5) .037
      Any Mutation Testing Conducted (No) Yes 0.74 (0.6-0.91) .004
      EGFR+ Mutation Test (Negative, Not Tested, Inconclusive) Yes 0.75 (0.6-0.97) .027
      Surgery (No) Yes 0.36 (0.2-0.6) <.0001
      The analysis included data from 736 1L patients from 168 sites in the four countries, who were followed for a mean of 1.7 years (range: 22 days – 4.6 years) until the most recent visit (28.9%) or death (71.1%).

      Conclusion:
      This rich multi-country clinical dataset provides insight into real world patient clinical, demographic, and treatment characteristics prognostic for OS. The results indicate survival worsened for patients who were older, with higher ECOG scores, TNM stage IV, and smokers. Prior surgery and EGFR testing were associated with improved survival. OS was not associated with insurance plan type.

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    P3.02a - Poster Session with Presenters Present (ID 470)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02a-033 - The Humanistic Burden Associated with Caring for Advanced NSCLC Patients in Europe - A Real World Survey of Caregivers (ID 5665)

      14:30 - 15:45  |  Author(s): M. Lees

      • Abstract
      • Slides

      Background:
      While the financial aspects of the burden on caregivers for patients with advanced Non-Small Cell Lung Cancer (aNSCLC) have been estimated, limited published information exists on the humanistic burden incurred by these caregivers.

      Methods:
      Data were taken from a multi-center, cross-sectional study of aNSCLC patients and their caregivers conducted in France, Germany and Italy. The study consisted of three components: medical chart review, patient questionnaire and caregiver questionnaire. Overall, 683 consulting patients and 277 accompanying informal caregivers were recruited via treating physicians. The impact on health related quality of life was measured using the EuroQoL-5D (EQ-5D-3L) while caregiver burden was quantified using the Zarit Burden Interview (ZBI), which consists of 22 items, each rated 0-4. ZBI scores were grouped into: little/no burden (0-20), mild/moderate (21-40), moderate/severe (41-60) and severe burden (61-88). Scores of 24+ were assumed to identify caregivers at risk of depression. Analysis, conducted on 277 matched patient and caregiver forms, was stratified by country and by patients’ line of therapy. Statistical significance was assessed using Mann-Whitney U tests.

      Results:
      Caregivers’ mean (SD) age was 55.2 (13.0) years; 78.6% were female and 62.3% were the patient’s partner/spouse. Patients’ mean (SD) age was 66.2 (9.7); 73.6% were male and 91.0% had Stage IV NSCLC. Over two-thirds (70.4%) of patients were receiving 1[st] line advanced therapy, while 29.6% were receiving later lines of therapy. The mean (SD) EQ-5D-3L index for caregivers was 0.87 (0.19). Differences in EQ-5D-3L were observed between carers of 1[st] line patients and later line patients (0.89 v 0.83 p=0.003). The mean ZBI score for caregivers was 32.1 (15.6); A quarter (24.0%) of caregivers had little/no burden, 44.6% mild/moderate, 28.8% moderate/severe and 2.6% severe burden; 69.7% of caregivers were identified as at risk of depression. Differences in ZBI were observed between carers of 1[st] line patients and later line patients (30.9 v 34.9 p=0.099).

      Conclusion:
      Comparing these results with other published ZBI data, the burden suffered by aNSCLC patient caregivers appears to be higher than other conditions studied in Europe, namely , Parkinson’s disease (25.8) another study conducted across advanced cancer (18.5). Caregivers for aNSCLC patients suffer significant humanistic burden in addition to the overall burden faced by patients and is likely to result in additional costs. When assessing the impact of a treatment, the potential to improve the impact on caregivers should also be included.

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