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Clarisse Audigier Valette



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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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  |  Author(s): Clarisse Audigier Valette

      • 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.

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    Mini Oral session II (ID 63)

    • Event: ELCC 2019
    • Type: Mini Oral session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 16:40 - 17:40, Room C
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      116O - Health-related quality of life (HRQoL) of non-small cell lung cancer (NSCLC) patients treated with nivolumab in real-life: The EVIDENS study (ID 271)

      16:40 - 17:40  |  Author(s): Clarisse Audigier Valette

      • Abstract
      • Presentation
      • Slides

      Background

      EVIDENS is an observational, prospective, multicenter cohort study following lung cancer patients initially treated with nivolumab between Oct 2016 and Nov 2017 in 146 French centers. Interim efficacy and safety results were consistent with those from nivolumab clinical trials. This analysis describes temporal changes in HRQoL.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      HRQoL was measured using the EQ-5D-3L, a 3-level version consisting of the 5 dimensions descriptive system (EQ-5D) and the visual analogue scale (VAS; 0–100 [worst–best health]). Outcomes for each dimension were described as the proportion of patients with no change, improvement or deterioration, and the utility index and VAS mean changes from baseline (minimally important difference [MID] = 0.08 and ±7 point change, respectively).

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Overall 1,394 NSCLC patients were followed-up for a median of 11.5 months. Baseline characteristics: median age 66.0 years, 69.2% men, 89.6% current/former smokers, 83.2% PS 0-1, 31.1% squamous (SQ) histology. Baseline completion rates for EQ-5D-3L/VAS were 80.2%/77.0%. At 9 and 12 months (276 and 78 patients at risk, respectively), they were 51.4%/48.9% and 69.2%/66.7%, respectively. The table summarizes HRQoL outcomes. Of note, mean change of VAS from baseline was statistically significant at 9 and 12 months regardless of histology and MID was achieved at 12 months for SQ (+7.6 [2.1 ; 13.1]).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Twelve months after initiating nivolumab, all the 5 dimensions measured by EQ-5D-3L were stable in at least half of NSCLC patients and a clinically meaningful improvement of VAS was observed in the SQ patients.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT03382496.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      Bristol-Myers Squibb.

      213f68309caaa4ccc14d5f99789640ad Funding

      Bristol-Myers Squibb.

      682889d0a1d3b50267a69346a750433d Disclosure

      M. Pérol: Boards: Roche, Genentech, Eli Lilly, Pfizer, Boehringer Ingelheim, Clovis Onco, MSD, BMS, Novartis, Pierre Fabre, Takeda, AZ; Symposia: Eli Lilly, Roche, Pfizer, Amgen, Boehringer Ingelheim, BMS, Takeda, AstraZeneca. A. Dixmier: Advisory board: BMS, Roche, Novartis; Support for congress participation: BMS, Roche, AstraZeneca, Boehringer Ingelheim, MSD, Amgen, Lilly. F. Barlesi: Fees: AstraZeneca, BMS, Boehringer Ingelheim, Clovis Oncology, Eli Lilly Oncology, F. Hoffmann-La Roche Ltd, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda. D. Debieuvre: Consulting: Roche; Honoraria as speaker: AstraZeneca, Chugai, Lilly, Roche, Novartis, Pfizer, MSD, BMS; Grant for research: Roche, AstraZeneca, BMS, Boehringer Ingelheim, Chiesi, Chugai, Janssen, Pfizer, MSD, Novartis, GSK, Sandoz; Advisory boards : Roche, Boehringer Ingelheim, Pfizer, MSD, BMS, Novartis; Support for congress participation: Roche, Boehringer Ingelheim, Novartis, Pierre Fabre, Pfizer, Mundipharma, BMS. C. Raspaud: Fees: Novartis, Boehringer Ingelheim, GSK, Chiesi, BMS, MSD, AstraZeneca, SOSO2, AgirAdom, Lilly. J.B. Auliac: Advisory boards: AstraZeneca, Boehringer Ingelheim, BMS, Roche; Speakers bureau: AstraZeneca, Amgen, BMS, Roche, Lilly, Pfizer, MSD. N. Benoit : Fees: BMS, AstraZeneca. P. Bombaron: Fees: BMS, Novartis, Boehringer Ingelheim, Roche, Amgen. D. Moro-Sibilot: Fees: BMS, MSD, Roche, AstraZeneca, Pfizer, Lilly. B. Asselain: Speakers bureau: BMS. F-E. Cotté, P. Lamoureux, N. Karam, N. Ozan, C. Calvet, B. Bryan, V. Allan: Employee: BMS. C. Audigier Valette: Principal investigator : AstraZeneca, Boehringer Ingelheim, BMS, Novartis, Roche, MSD, Pfizer; Consulting: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, MSD, Pfizer, Roche AbbVie; Speaker: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Pfizer, Roche, MSD, AbbVie.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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