938P - 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)

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).

Table: 938P

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.

Clinical trial identification

NCT04050761.

Editorial acknowledgement

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

C. Le Tourneau: Financial Interests, Personal, Advisory Board: BMS, MSD, Merck Serono, Nanobiotix, Roche, Rakuten, Seattle Genetics, GSK, Celgene, ALX Oncology, Exscientia. C. Even: Financial Interests, Personal, Advisory Board: BMS, MSD, Innate Pharma, Merck Serono; Financial Interests, Institutional, Advisory Board: F Star Therapeutics, Novartis, Elevar; Financial Interests, Institutional, Invited Speaker: BMS, BMS, AstraZeneca, ISA pharmaceutics, MSD, Debiopharma, Ayala, Novartis, Gilead, sanofi. Y. Pointreau: Financial Interests, Personal, Invited Speaker, consultancy: BMS, MSD, Merck. J. Fayette: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, Elevar, Hookipa, Innate Pharma, Iteos, Merck Serono, MSD, Roche, Seagens; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca. F. Cotté: Financial Interests, Personal, Full or part-time Employment, na: Bristol Myers Squibb. A. Govart: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. K. Baumstarck: Financial Interests, Personal, Research Grant: Bristol Myers Squibb. J. Guigay: Financial Interests, Personal, Advisory Board: Merck SD, BMS, Merck Serono, Nanobiotix; Financial Interests, Institutional, Invited Speaker: Merck, BMS. All other authors have declared no conflicts of interest.