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Nicolas Ozan

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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): Nicolas Ozan

      • Abstract
      • Presentation
      • Slides


      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


      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.


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