TY  - JOUR
AU  - Schadendorf, Dirk
AU  - Tawbi, Hussein
AU  - Lipson, Evan J.
AU  - Stephen Hodi, F.
AU  - Rutkowski, Piotr
AU  - Gogas, Helen
AU  - Lao, Christopher D.
AU  - Grob, Jean-Jacques
AU  - Moshyk, Andriy
AU  - Lord-Bessen, Jennifer
AU  - Hamilton, Melissa
AU  - Guo, Shien
AU  - Shi, Ling
AU  - Keidel, Sarah
AU  - Long, Georgina V.
TI  - Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial
JO  - European journal of cancer
VL  - 187
SN  - 0014-2964
CY  - Amsterdam [u.a.]
PB  - Elsevier
M1  - DKFZ-2023-01058
SP  - 164 - 173
PY  - 2023
AB  - Background:In the phase II/III RELATIVITY-047 trial, a novel fixed-dose combination (FDC) of nivolumab plus relatlimab (NIVO + RELA; a programmed death-1 and a lymphocyte-activation gene 3 inhibitor, respectively) significantly improved progression-free survival (PFS) versus NIVO in patients with previously untreated unresectable or metastatic melanoma (median follow-up, 13.2 months) with stable health-related quality of life (HRQoL), although grade three or four treatment-related adverse events (TRAEs) were more frequent with the combination. Updated HRQoL results (median follow-up, 19.3 months) are presented.Methods:Patients were randomised to receive intravenous NIVO + RELA (480 mg and 160 mg, respectively) or NIVO (480 mg) every 4 weeks. HRQoL was assessed using the Functional Assessment of Cancer Treatment-Melanoma (FACT-M) and EQ-5D-3L questionnaires at baseline, before dosing at each treatment cycle, and at follow-up (posttreatment) visits.Results:Consistent with the initial analysis, HRQoL remained stable with NIVO + RELA on treatment and was similar to that with NIVO. Mean changes from baseline did not exceed clinically meaningful thresholds. HRQoL results were consistent across instruments and scales/subscales. Despite an increased rate of grade three or four TRAEs with NIVO + RELA versus NIVO, the proportion of patients reporting that they were bothered 'quite a bit' or 'very much' by TRAEs was low and comparable between treatments.Conclusion:Results from the RELATIVITY-047 trial show that the PFS benefit with NIVO + RELA FDC over NIVO was obtained with stable patient-reported HRQoL, supporting NIVO + RELA as a first-line treatment option for patients with advanced melanoma.
LB  - PUB:(DE-HGF)16
DO  - DOI:10.1016/j.ejca.2023.03.014
UR  - https://inrepo02.dkfz.de/record/276328
ER  -