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C. Chouaid



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    OA16 - Improving the Quality of Lung Cancer Care - Patients Perspective (ID 399)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Patient Support and Advocacy Groups
    • Presentations: 1
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      OA16.05 - Socioeconomic Determinants of Late Diagnosis of Lung Cancer in France: A Nationwide Study (the TERRITOIRE Study) (ID 4840)

      16:45 - 16:55  |  Author(s): C. Chouaid

      • Abstract
      • Presentation
      • Slides

      Background:
      Socioeconomic disparities in survival of patients with lung cancer have been identified in many countries. The aim of this study was to examine determinants of late diagnosis of lung cancer in France.

      Methods:
      All patients with a first diagnosis of lung cancer in 2011 in the National hospitals databases were included. Information on gender, age, presence of metastasis at diagnosis and any significant chronic comorbidities (hypertension, diabetes mellitus, renal insufficiency, and other chronic lung diseases) was retrieved. Based on municipality of residence, patients were classified by population density, social deprivation, access to general practitioners and pulmonologists.

      Results:
      We identified 41,015 patients newly diagnosed for lung cancer in French hospitals. Mean age at diagnosis was 66.4 (±11.9) years and 72% patients were men. 53% (N=21,613) patients were metastatic at the time of diagnosis. This rate was higher for patients in public compared to private hospitals (56.1% vs 42.9%, p<0.0001) and in community compared to university hospitals (60.2% vs 49.6%, p<0.0001). Multivariate analysis found that metastases at the time of diagnosis were significantly associated with a younger age (55 years or less, OR: 1.22 [95%CI:1.16–1.29]; p<0.0001), a low access to pulmonologists (OR: 1.13 [95%CI:1.04–1.23]; p=0.004), a rural or semi-rural dwelling (OR: 1.07 [95%CI:1.02–1.13]; p=0.004) and deprived areas (OR: 1.06 [95%CI:1.01–1.11]; p=0.01). Of the 8,413 patients (20%) who were initially admitted through emergency room (ER) 68.1% had metastatic tumors. Multivariate analysis showed significantly higher rate of admission through ER at diagnosis in patients from most deprived areas (OR: 1.44 [95%CI:1.37–1.52]; p0.0001), rural or semi-rural (OR: 1.25 [95%CI:1.19–1.32]; p<0.0001), with a low access to pulmonologists and general practitioners (OR: 1.24 [95%CI:1.17–1.30]; p<0.0001 and 1.15 [95%CI:1.08–1.23]; p<0.0001, respectively). Gender (male) and presence of comorbidities were also significant determinants of metastatic disease and admission through ER at diagnosis.

      Conclusion:
      A majority of French patients with lung cancer were initially metastatic at the time of diagnosis and 1 out of 5 were diagnosed following admission through ER. Residential socioeconomic indicators and access to general practitioners and pulmonologists were significantly associated with these indicators of poor outcome.

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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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      P1.06-044 - Costs of Adverse Events (AE) Associated with Cancer Therapies in Non-Small Cell Lung Cancer (NSCLC) in France (ID 5970)

      14:30 - 14:30  |  Author(s): C. Chouaid

      • Abstract

      Background:
      AE associated with existing and future treatments in NSCLC are frequent and should be accounted for in health economic models. In addition to utility decrements, appropriate costing of AE management is needed. In the case of NSCLC which affects 45 200 patients per year in France, published data are scarce and not always complete. It was therefore thought of importance to assess resource use and costs associated with AEs.

      Methods:
      When looking at the grade 3 or 4 AEs appearing for at least 1% of patients in the clinical trials for erlotinib (TITAN, LUX-LUNG 8), ramucirumab plus docetaxel (REVEL), docetaxel and pembrolizumab (KEYNOTE 010), a list of 20 grade 3 and 4 AE was identified as relevant for Health Economic analysis. Among them, 7 did not have cost data available in the literature. Three French oncology experts were consulted. A questionnaire was sent before the meeting with the experts, asking for, according to the grade, insight on resource use (hospitalisation, follow-up visits, diagnosis exams, treatments). Results were discussed during the meeting in order to reach a consensus. Direct medical cost per AE, expressed in 2016 Euros, was then calculated from a national health insurance perspective based on public and private weighted tariffs and 2014 PMSI database.

      Results:
      The mean AE cost was €206 for thrombocytopenia, €263 for ocular toxic effect, €2,332 for arthralgia, €3,282 for venous thromboembolism, €3,732 for pulmonary bleeding, €5,176 for dehydration, €5,751 for pneumonia, infiltration or pneumonitis. Hospitalization costs corresponded to 46% to 100% of total AE cost. These AE costs were consistent with the costs of other grade ¾ AEs previously published for NSCLC therapies.

      Conclusion:
      Among seven grade 3 and 4 AEs seen, four appear to have an important economic impact, with a management cost of at least €3,000 per event.

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    P2.06 - Poster Session with Presenters Present (ID 467)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
    • Presentations: 1
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      P2.06-024 - Tedopi vs Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Advanced NSCLC Patients in a Phase 3, Randomized Trial: ATALANTE-1 (ID 5329)

      14:30 - 14:30  |  Author(s): C. Chouaid

      • Abstract

      Background:
      HLA-A2 is expressed in 40 to 50% of NSCLC patients. TEDOPI is a combination of neoepitopes that generates cytotoxic T lymphocytes responses. It consists of nine HLA-A2 supertype binding epitopes covering five tumor-associated antigens overexpressed in advanced NSCLC and the universal helper pan-DR epitope. In a phase II trial (NCT00104780, Barve et al. JCO 2008), TEDOPI showed a promising median overall survival of 17.3 months with a manageable safety profile in pre-treated HLA-A2 positive patients with advanced NSCLC. ATALANTE-1 (NCT02654587) is a randomized, open-label, phase 3 study comparing the efficacy and safety of TEDOPI with standard treatment in HLA-A2 positive patients with advanced NSCLC, as second- or third-line therapy.

      Methods:
      Section not applicable

      Results:
      Trial design: Patients with advanced NSCLC without EGFR-sensitizing mutations or ALK rearrangements, with progressive disease to first-line platinum-based chemotherapy or second-line immune checkpoint inhibitors (IC) are eligible if they have HLA-A2 positivity and ECOG PS 0-1. Treated and asymptomatic brain metastases are allowed. Patients are randomized 1:1 to receive 1 ml TEDOPI subcutaneously Q3W for 6 cycles, then every two months for the reminder of the year and finally every three months or standard treatment with: 75 mg/m[2] docetaxel Q3W or 500 mg/m[2] pemetrexed Q3W (in non-squamous histology and pemetrexed-naïve patients). In both arms, treatment continues until progression, intolerable toxicity, consent withdrawal, or investigator decision. In TEDOPI arm, treatment may continue beyond initial radiographic disease progression in case of clinical benefit. Randomisation is stratified by histology (squamous vs. non-squamous), initial response to first-line chemotherapy (partial or complete response vs. stabilization or progression), and previous treatment with IC (yes vs. no). Tumor assessment is performed every 6 weeks and adverse events are collected throughout the study and for 60 days and 90 days thereafter and graded per NCI CTCAE v4.0. Archival biopsies samples are required for assessing PD-L1 status (IHC22C3 pharmDx from Dako). Primary endpoint is overall survival; and secondary are progression free survival based on RECIST 1.1 criteria, objective response rate, disease control rate, duration of response, and quality of life measured by QLQ-C30 and QLQ-LC13 global scores. This is a superiority study with a hazard ratio of 0.7391, two-sided alpha 5% and power 80%, after 356 events are observed over 500 patients. The first patient was enrolled on 25th January 2016. Enrolment is ongoing in Europe and the US. Clinical trial identification: NCT02654587 Legal entity responsible for the study & Funding: OSE Immunotherapeutics, France

      Conclusion:
      Section not applicable

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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-004 - NSCLC Patients Harboring ALK Translocation: Clinical Characteristics and Management in Real World Setting. EXPLORE GFPC 02-14 (ID 5043)

      14:30 - 14:30  |  Author(s): C. Chouaid

      • Abstract

      Background:
      ALK (Anaplastic Lymphoma Kinase) translocation is a rare oncogenic driver in NSCLC (Non Small Cell Lung Cancer) (3 to 5%) and few data are published on the management of these patients outside patients included in clinical trial. objective:to investigate clinical characteristics and management of these patients in real world setting.

      Methods:
      inclusion of patients with a diagnosis of NSCLC harboring ALK translocations between January 2012 and December 2014, collection of demographic and clinical characteristics, risk factors, Progression free survival (PFS), Overall Survival (OS), mode of progression and therapeutic management

      Results:
      132 patients recruited in 31 centers: 67(51%) men; age: 60.1 ± 14,5 years; PS 0/1 at diagnosis: 89%; non smokers:79%, adenocarcinoma: 93%; Stage at diagnosis 4/3/2-1:74%/19%/7%: co-mutations EGFR n=2, BRAF n=2, KRAS = 1, HER2 = 1. Outcomes of stage IV (n=97): first line treatment: chemotherapy: 75%, Best supportive care (BSC): 1 %, anti ALK: 24 %; response rate, disease control rate (DCR) and PFS to first line treatment: 42 %,64% and 7.5 months (CI 5.9 ;9.5), second line treatment (n=60): chemotherapy: 25%, anti BRAF 72%, BSC 3 %; response rate, DCR and PFS to second line treatment: 43.4%,70% and 4,7 months (CI 4.0; 8.1); 2 years-OS: 56.7% (CI 45.5 ;70.4), mediane OS was not reach.

      Conclusion:
      In this real world analysis, the majority of NSCLC patients with ALK translocation were non smokers,adenocarcinoma and appears to have a better survival to NSCLC pts without oncogenic driver. Clinical trial information: Supported by an academic grant from Lilly, Astra Zeneca, boehringer ingelheim

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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02b-127 - NSCLC Patients Harboring HER2 Mutation: Clinical Characteristics and Management in Real World Setting. EXPLORE GFPC 02-14 (ID 4629)

      14:30 - 14:30  |  Author(s): C. Chouaid

      • Abstract

      Background:
      HER 2 (Human epidermal growth factor 2) mutation (exon-20 insertion) is a rare oncogenic driver in Non Small Cell Lung Cancer (NSCLC) (1%) and few data are published on the management of these patients outside patients included in clinical trial. Objective: to investigate clinical characteristics and management of these patients in real world setting

      Methods:
      multicentric inclusion of pts with a diagnosis of NSCLC harboring HER 2 mutations between January 2012 and December 2014, collection of demographic and clinical characteristics, risk factors, Progression free survival (PFS), Overall Survival (OS), mode of progression and therapeutic management

      Results:
      30 patients recruited in 17 centers: 20 (66,6%) female; age: 65,2 ± 12,1 years; PS 0/1 at diagnosis: 92,5 %; current/former smokers: 0/8(27,6%); adenocarcinoma: 93,3%; Stage at diagnosis 4-3/2-1: 93.1%/6,9%: co-mutations ALK n=1, RET n=1. Two-years overall survival (OS) 44,0% [CI :27,1 ; 71,5%] (early stage : 2-years OS : 100%). Management and Outcomes of stage IV (n=22): 82% received a first line platin based doublets With an overall response rate (ORR) and Progression Free Survival (PFS) of 61,5%, and 6.7 months (CI 5.6 ;19.0); 55% received a . second line treatment with an ORR and PFS of 36,4% and 3,4 months (CI 1,8;12,7); Two-years-OS was 27,2 %(CI:11,7;63,2%) and median OS survival 10,7 months (CI not research). .

      Conclusion:
      In this real world analysis, the majority of NSCLC patients with HER2 mutation were women, nonsmokers, adenocarcinoma and appears to have a same survival that NSCLC patients without oncogenic driver. Clinical trial information: Supported by an academic grant from Lilly, Astra Zeneca, boehringer ingelheim