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Nicolas Girard



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    Boehringer Ingelheim - Industry Satellite Symposium (ID 27)

    • Event: ELCC 2019
    • Type: Industry Satellite symposium
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 18:00 - 19:00, Room A
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      Prolonging the chemotherapy-free period in EGFRM+ NSCLC (ID 627)

      18:00 - 19:00  |  Presenting Author(s): Nicolas Girard

      • Abstract

      Abstract not provided

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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      101TiP - PACIFIC-R: First real-world study of patients with unresectable, stage III NSCLC treated with durvalumab after chemoradiotherapy (ID 236)

      12:30 - 13:00  |  Presenting Author(s): Nicolas Girard

      • Abstract

      Background

      Approximately 30% of patients (pts) with non-small-cell lung cancer (NSCLC) are diagnosed with Stage III disease, which is often unresectable. Historically, the standard of care (SoC) has been platinum-based chemoradiotherapy (CRT), but outcomes have been poor. Durvalumab is a selective high-affinity, human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. In the phase 3 PACIFIC trial of durvalumab versus placebo in pts with unresectable, Stage III NSCLC without progression after concurrent CRT (cCRT), both primary endpoints progression-free survival (PFS) and overall survival (OS) were met and significantly improved with durvalumab (HR for PFS, 0.52; 95% CI 0.42–0.65; P < 0.001; HR for OS, 0.68; 99.73% CI 0.47–0.997; P = 0.0025) with similar safety between treatments (Antonia et al, NEJM 2017; 2018). Based on these findings, the PACIFIC regimen (durvalumab following CRT) is becoming the SoC. PACIFIC-Real World (PACIFIC-R) will assess if durvalumab treatment after cCRT shows similar efficacy and safety in a large, real-world population.

      a9ded1e5ce5d75814730bb4caaf49419 Trial design

      PACIFIC-R is an international, observational study that will enroll ∼1200 NSCLC pts who have received durvalumab as part of early access programs (EAPs) between Sept 2017 and Dec 2018. In the EAP, eligible pts are adults with histologically or cytologically documented unresectable, Stage III NSCLC, regardless of tumor PD-L1 expression, who have not progressed after definitive CRT. Pts received durvalumab (10 mg/kg intravenously) every two weeks. Pts will be enrolled in the PACIFIC-R study after discontinuation of the EAP in participating countries. Data will be abstracted from pts’ medical records at several time points within the 5 year study period. Primary endpoints are PFS (investigator assessed) and OS. Secondary endpoints include PFS and OS in pt subgroups; time to distant metastases; sites of disease progression; adverse events of special interest leading to treatment interruption, discontinuation or medical intervention; and descriptive analyses of demographic and clinical characteristics of pts treated with durvalumab in a real-world setting. Recruitment for this study is ongoing.

      d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification

      NCT03798535.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by James King of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      AstraZeneca AB.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca AB.

      682889d0a1d3b50267a69346a750433d Disclosure

      N. Girard: Personal fees: AstraZeneca, MSD, BMS, Roche, during the conduct of the study. F. Mornex, D.C. Christoph, R. Fietkau, J. Field, P. Garrido Lopez: Conflict of Interests not immediately avaliable, will be following up with congress directly to provide as soon as possible. A.R. Filippi: Personal fees: AstraZeneca during the conduct of the study. McDonald: Personal fees: AstraZeneca, Elekta; Research grants: MSD, outside the conduct of the study. S. Peters: Personal fees: AbbVie, Amgen, AZ, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F Hoffman-LaRoche, Foundation Medicine, Illumina, Janssen, Merck, Merrimack, Novartis, PharmaMar, Pfizer, Regeneron, Sanofi. A.B. Klein, M. Licour: Employment, stock: AstraZeneca outside the conduct of the study. M.C. Garassino: Personal fees: MSD, BMS, AstraZeneca, Roche, outside the conduct of the study.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      90P - Real-world treatment patterns, clinical practice and outcomes for locally advanced, non resectable, non-small cell lung cancer from the French ESME Lung database (ID 525)

      12:30 - 13:00  |  Presenting Author(s): Nicolas Girard

      • Abstract

      Background

      Approximately 30% of patients (pts) with non-small-cell lung cancer (NSCLC) are diagnosed with locally advanced disease, which is often unresectable. The historical standard of care (SoC) has been platinum-based chemoradiotherapy (CRT), based on data from clinical trials conducted in selected populations. As immunotherapy is being integrated in the treatment strategy, real-world evidence aiming at understanding the current management of those patients is missing.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      This study is an analysis of the Epidemio-Strategy and Medical Economics (ESME) Lung Data Platform, a multi-center real-life database using a retrospective data collection process. This database compiles data from patient’s Electronic medical records (EMR), inpatient hospitalisation records and Pharmacy records. 8514 pts from 20 centres with lung cancer treated between January 1st, 2015 and December 31st, 2016, were included.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      822 pts with unresectable locally advanced NSCLC - 69% male, median age 65y, 61% ECOG PS0-1, 60% non-squamous histology - were included in the analysis. Treatment was initiated in 736 pts (analysis population): 39% concurrent CRT (cCRT), 17% sequential CRT (sCRT), 26% chemotherapy (CT) alone, 16% radiotherapy (RT) alone and 2% other therapy. For cCRT, 95% of pts received induction chemotherapy before the concurrent phase, based on taxanes (32% of pts), vinorelbine (42% of pts), or pemetrexed (16% of pts); 35% of patients received consolidation chemotherapy. For sCRT, preferred platinum doublet chemotherapy regimens were based on taxanes (39% of pts), vinorelbine (26% of pts), or pemetrexed (17% of pts). Radiotherapy was delivered to a total dose of 60-66 Gy for 84% (cCRT) and 71% (sCRT). After a median follow-up of 17 months, progression rate was 62%; progression occurred in the thorax, the brain, or at other sites in 42%, 19% and 38% of pts, respectively. Median PFS was 8.0 months (m) for the analysis population, 9.3 m (cCRT) and 11.6 m (sCRT). 24-month OS rate was 51%, 60%, and 52%, respectively.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Real world data support the use of CRT in locally advanced NSCLC, with similar outcomes than in landmark clinical trials.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      UNICANCER.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca.

      682889d0a1d3b50267a69346a750433d Disclosure

      N. Girard: Fees for attending scientific meetings, speaking, organizing research or consulting: AstraZeneca, Boehringer Ingelheim, Roche, SBMS, MSD, Lilly, Novartis, Pfizer, Amgen. M. Pérol, R. Gervais: Symposium, advisory board: AstraZeneca. C. Audigier Valette: Consultancy, Advisory board membership: AstraZeneca, Pierre Fabre. C. Chouaid: Fees for attending scientific meetings, speaking, organizing research or consulting: AstraZeneca, Boehringer Ingelheim, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Bayer, Pfizer, Takeda, Amgen. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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    Pfizer Oncology - Industry Satellite Symposium (ID 37)

    • Event: ELCC 2019
    • Type: Industry Satellite symposium
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/12/2019, 13:00 - 14:00, Room C
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      How can we make balanced treatment decisions for our EGFR+ patients? (ID 658)

      13:00 - 14:00  |  Presenting Author(s): Nicolas Girard

      • Abstract

      Abstract not provided

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    Should sequencing of ALK inhibitors be molecularly-guided? (ID 51)

    • Event: ELCC 2019
    • Type: Controversy session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/12/2019, 17:45 - 18:45, Room A
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      No (ID 125)

      17:45 - 18:45  |  Presenting Author(s): Nicolas Girard

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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