Nivolumab (nivo) in recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN): real-world effectiveness, quality of life (QoL) of patients and their caregivers in France (ProNiHN study)
dc.rights.license | open | en_US |
dc.contributor.author | LE TOURNEAU, C. | |
dc.contributor.author | EVEN, C. | |
dc.contributor.author | SALAS, S. | |
dc.contributor.author | POINTREAU, Y. | |
dc.contributor.author | CERUSE, P. | |
dc.contributor.author | BABIN, E. | |
dc.contributor.author | FAYETTE, J. | |
hal.structure.identifier | Bordeaux population health [BPH] | |
dc.contributor.author | RONDEAU, Virginie
ORCID: 0000-0001-7109-4831 IDREF: 16662988X | |
dc.contributor.author | GRUMBERG, V. | |
dc.contributor.author | COTTE, F. E. | |
dc.contributor.author | GOVART, A. | |
dc.contributor.author | BAUMSTARCK, K. | |
dc.contributor.author | GUIGAY, J. | |
dc.date.accessioned | 2024-01-22T13:19:10Z | |
dc.date.available | 2024-01-22T13:19:10Z | |
dc.date.issued | 2023-10 | |
dc.date.conference | 2023-10-20 | |
dc.identifier.issn | 0923-7534 | en_US |
dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/187377 | |
dc.description.abstractEn | Background ProNiHN is a prospective, observational, and multicenter study of patients (pts) with R/M SCCHN treated with nivo after progressing on or after platinum-based therapy. We report here the effectiveness and QoL for pts and their caregivers (cg). Methods Based on a minimum follow-up of 17-months (mo), progression-free survival (PFS) and overall survival (OS) were estimated with Kaplan-Meier method. QoL changes of pts were measured with 3 questionnaires (FACT-H&N & EQ-5D-3L&VAS) between inclusion (incl) and week-6, mo-3, 6, 12 and 18. QoL and needs of cg were estimated with CarGOQoL and SCNS-P&C-F questionnaires at incl and at 6 mo. Results Among 487 patients, median PFS and OS were 3.3 mo and 9.3 mo, respectively. OS rates were 64% at 6 mo, 40% at 12 mo and 28% at 18 mo. The number of pts completing FACT-H&N was 354 at incl and decreased to 39 at 18 mo. QoL of overall population tended to be stable or improved over time (Table). Same trend was observed for EQ-5D-3L&VAS. For pts (n=121) who completed FACT-H&N both at incl and 6 mo, overall total score significantly decreased (mean: -4.7; p=0.003), in particular for pts who stopped nivo within the 6 mo (-8.8; p<0.001) whereas it remained stable (0.0; p=0.986) for pts still on nivo. No significant difference was observed for pts (n=64) between incl and 12 mo (-2.4; p=0.291). 292 pts mentioned a cg, mostly spouse (71.4%). Among them, 48 cg completed CarGOQoL at incl and 6 mo. Psychological well-being improved over time (43.8 vs. 52.0; p=0.027) while relationship with healthcare decreased (62.0 vs. 53.1; p=0.045). FACT-H&N and CarGOQoL results were correlated at incl (0.226, p=0.003) and at 6 mo (0.362; p=0.006). Conclusions Nivo showed similar effectiveness and QoL in the real-world as in pivotal trial. QoL of pts tended to be stabilized over time, especially for patients still treated with nivolumab at 6 mo. QoL of cg and pts seems to be correlated. | |
dc.language.iso | EN | en_US |
dc.title.en | Nivolumab (nivo) in recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN): real-world effectiveness, quality of life (QoL) of patients and their caregivers in France (ProNiHN study) | |
dc.type | Communication dans un congrès | en_US |
dc.identifier.doi | 10.1016/j.annonc.2023.09.2082 | en_US |
dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
bordeaux.page | S590-S590 | en_US |
bordeaux.volume | 34 | en_US |
bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
bordeaux.issue | supplement 2 | en_US |
bordeaux.institution | Université de Bordeaux | en_US |
bordeaux.institution | INSERM | en_US |
bordeaux.conference.title | ESMO Congress 2023 | en_US |
bordeaux.country | es | en_US |
bordeaux.title.proceeding | Abstract Book of the ESMO Congress 2023 | en_US |
bordeaux.team | BIOSTAT_BPH | en_US |
bordeaux.conference.city | Madrid | en_US |
bordeaux.identifier.funderID | Bristol-Myers Squibb | en_US |
hal.identifier | hal-04409859 | |
hal.version | 1 | |
hal.date.transferred | 2024-01-22T13:19:13Z | |
hal.invited | oui | en_US |
hal.proceedings | oui | en_US |
hal.conference.organizer | European Society for Medical Oncology | en_US |
hal.conference.end | 2023-10-24 | |
hal.popular | non | en_US |
hal.audience | Internationale | en_US |
hal.export | true | |
dc.rights.cc | Pas de Licence CC | en_US |
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