Abstract 4305
Background
The EVIDENS study aims to describe clinical characteristics and health-related quality of life (HRQoL) of lung cancer patients treated with nivolumab in real-life in France and to assess its effectiveness and safety.
Methods
EVIDENS is an observational, multicenter, longitudinal cohort study of adult lung cancer patients treated with nivolumab. Survival was assessed using the Kaplan-Meier method and health-related quality of life (HRQoL) was assessed using EQ-5D-3L questionnaire.
Results
A total of 1,462 lung cancer patients were enrolled in the study from Oct 2016 to Nov 2017 in 146 French centers. Previous reports with a 8-month minimum follow-up showed that baseline patient and tumor characteristics from EVIDENS were representative of a standard advanced NSCLC population and that nivolumab was mostly administered as a 2nd line regimen. Median PFS and median OS was 2.8 months (95% CI: 2.6-3.0) and 10 months (95% CI: 9.2-11.0), respectively. Adverse events occurred in 440 patients (31.6%), including 98 patients (7.0%) with grade 3-4 events. Concerning HRQoL, mean change of visual analog score from baseline was statistically significant at 9 and 12 months and minimal important difference was achieved at 12 months for the squamous population. The analysis presented during the congress will include updated effectiveness, safety and HRQoL data as well as subgroups of interest (e.g. brain metastasis, age, prior radiotherapy) with a 17-month minimum follow-up.
Conclusions
TTo date, EVIDENS is the largest prospective observational study of nivolumab in lung cancer patients confirming effectiveness and safety in the real world setting. This updated analysis provides new insights on the experience of nivolumab over a period of longer follow-up and, for the first time, in clinically important subgroups of interest.
Clinical trial identification
NCT03382496.
Editorial acknowledgement
Legal entity responsible for the study
Bristol-Myers Squibb France.
Funding
Bristol-Myers Squibb France.
Disclosure
A. Dixmier: Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy: Novartis; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Amgen; Speaker Bureau / Expert testimony: Lilly. D. Debieuvre: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Chugaï; Honoraria (self), Research grant / Funding (institution): Lilly; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): GSK; Travel / Accommodation / Expenses: Pierre Fabre; Travel / Accommodation / Expenses: Mundipharma. J.B. Auliac: Advisory / Consultancy, Non-remunerated activity/ies: Bristol-Myers Squibb; Advisory / Consultancy: Roche. N. Benoit: Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: AstraZeneca. D. Moro-Sibilot: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: MSD; Advisory / Consultancy: Lilly; Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): AbbVie; Advisory / Consultancy: Takeda. C. Audigier-Valette: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (institution), Advisory / Consultancy: Roche. B. Asselain: Advisory / Consultancy: Bristol-Myers Squibb. P. Lamoureux: Full / Part-time employment: Bristol-Myers Squibb. F. Cotté: Full / Part-time employment: Bristol-Myers Squibb. V. Allan: Full / Part-time employment: Bristol-Myers Squibb. M. Daumont: Full / Part-time employment: Bristol-Myers Squibb. N. Ozan: Full / Part-time employment: Bristol-Myers Squibb. C. Calvet: Full / Part-time employment: Bristol-Myers Squibb. M. Perol: Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Lilly; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: Boehringer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Takeda; Advisory / Consultancy: Clovis. All other authors have declared no conflicts of interest.
Resources from the same session
3345 - Escalation plans and DNACPR discussions in the unwell oncology patient
Presenter: Raghad Elghadi
Session: Poster Display session 1
Resources:
Abstract
4165 - The Relation between the Symptom Burden of Hospitalized Patients with Incurable Cancer and the Quality-of-Life of Their Family Caregivers
Presenter: Eman Tawfik
Session: Poster Display session 1
Resources:
Abstract
1784 - Clinical predictors for analgesic response to radiotherapy in patients with painful bone metastases
Presenter: Ragnhild Habberstad
Session: Poster Display session 1
Resources:
Abstract
5323 - 30-Day Mortality in Palliative Radiotherapy
Presenter: Shing Fung Lee
Session: Poster Display session 1
Resources:
Abstract
3942 - The relationship between Naldemedine administration and the maximum dose of oral opioids
Presenter: Shinya Kajiura
Session: Poster Display session 1
Resources:
Abstract
3698 - Exposure to low energy amplitude modulated radiofrequency electromagnetic fields (EMF) is associated with rapid improvement in quality of life (QoL) status in patients with advanced hepatocellular carcinoma (HCC), using various analyses of EORTC-C30.
Presenter: Elizabeth Santana
Session: Poster Display session 1
Resources:
Abstract
3885 - Olanzapine Combined with 5-HT3 RA Plus Dexamethasone for Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting in High and Moderate Emetogenic Chemotherapy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Presenter: Jian-Guo Zhou
Session: Poster Display session 1
Resources:
Abstract
5700 - Early Palliative care in advanced cancer, is it really effective?
Presenter: Raquel Gómez Bravo
Session: Poster Display session 1
Resources:
Abstract
5924 - Deprescribing Potentially Inappropriate Medication in Cancer Patients
Presenter: Simon Reuter
Session: Poster Display session 1
Resources:
Abstract
5314 - Spirituality and religious coping for Cancer patients and providers: An ‘Almighty’ belief for palliative care
Presenter: Vibhay Pareek
Session: Poster Display session 1
Resources:
Abstract