PMID- 37835517 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231031 IS - 2072-6694 (Print) IS - 2072-6694 (Electronic) IS - 2072-6694 (Linking) VI - 15 IP - 19 DP - 2023 Sep 30 TI - Real-World Effectiveness, Safety, and Health-Related Quality of Life in Patients Receiving Adjuvant Nivolumab for Melanoma in Belgium and Luxembourg: Results of PRESERV MEL. LID - 10.3390/cancers15194823 [doi] LID - 4823 AB - BACKGROUND: Nivolumab, an anti-programmed cell death 1 immuno-oncology therapy, is approved as an adjuvant treatment for patients with completely resected stage III or stage IV melanoma. PRESERV MEL (Prospective and REtrospective Study of nivolumab thERapy in adjuVant MELanoma) is a real-world observational study evaluating the effectiveness and safety of adjuvant nivolumab in patients with completely resected stage III or stage IV melanoma in clinical practice in Belgium and Luxembourg. METHODS: Patients were enrolled prospectively and retrospectively during a 2-year period (January 2019-January 2021), and will be followed for 5 years. The results reported here are for the second interim analysis (cutoff date 31 December 2021). The index date was the date of first administration of adjuvant nivolumab. Patients received nivolumab for up to 12 months per label. Outcomes included relapse-free survival (RFS), adverse events (AEs)/treatment-related AEs (TRAEs), and health-related quality of life (HRQoL; assessed in prospectively enrolled patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Melanoma (FACT-M), and EQ-5D-3L instruments). HRQoL was evaluated at group level (mean change in scores from baseline based on minimally important differences) and individual patient level (percentage of patients with clinically important scores based on threshold of clinical importance). Outcomes were analyzed descriptively. RESULTS: The study enrolled 152 patients (125 prospective, 27 retrospective) at 15 hospitals in Belgium and Luxembourg. Minimum potential follow-up at time of analysis was 11.4 months. Median age was 60 years (range 29-85), and 53% of patients were male. At 12 and 18 months, the RFS rates were 74.7% (95% confidence interval (CI): 66.9-80.9) and 68.4% (95% CI: 60.0-75.5), respectively. Median RFS was not reached. Grade 3 or 4 TRAEs were reported in 14% of patients. AEs led to treatment discontinuation in 23% of patients. Deaths occurred in 3% of patients and were not related to treatment. Questionnaire completion rates for HRQoL were high at baseline (90-94%) and at 24 months (78-81%). In the group-level analysis for HRQoL, mean changes in scores from baseline remained stable and did not exceed prespecified thresholds for minimally important differences during and after treatment, except for a clinically meaningful improvement in FACT-M surgery subscale scores. In the individual patient-level analysis for EORTC QLQ-C30 subscales, the percentages of patients who reported clinically relevant scores for fatigue and cognitive impairment increased during treatment (at 9 months) compared with baseline. After treatment cessation (at 18 months), the percentage of patients who reported clinically relevant scores for fatigue decreased. However, the percentages of patients who reported clinically relevant scores for emotional, cognitive, and social impairment increased at 18 months compared with during treatment. Most patients with emotional impairment at 9 and 18 months did not experience disease recurrence (91% and 89%, respectively). CONCLUSIONS: These results confirm the real-world effectiveness and safety of nivolumab as an adjuvant treatment for patients with completely resected stage III or stage IV melanoma. Cancer-specific, disease-specific, and generic HRQoL were maintained during and after treatment. The percentage of patients reporting emotional and cognitive impairment increased after treatment cessation, emphasizing the need for further investigation and tailored supportive care in these patients. FAU - Rogiers, Anne AU - Rogiers A AUID- ORCID: 0000-0003-3716-2559 AD - Departement of Psychiatry, Centre Hospitalier Universitaire Brugmann, 1020 Brussels, Belgium. AD - Department of Medical Oncology, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium. AD - Faculty of Medicine and Pharmacy Vrije Universiteit Brussel, 1050 Brussels, Belgium. FAU - Willemot, Laurence AU - Willemot L AD - Bristol Myers Squibb, 1420 Braine L'Alleud, Belgium. FAU - McDonald, Laura AU - McDonald L AD - Bristol Myers Squibb, Uxbridge UB8 1DH, UK. FAU - Van Campenhout, Hilde AU - Van Campenhout H AD - Bristol Myers Squibb, 1420 Braine L'Alleud, Belgium. FAU - Berchem, Guy AU - Berchem G AUID- ORCID: 0000-0003-0157-2257 AD - Centre Hospitalier de Luxembourg, University of Luxembourg, 1210 Luxembourg, Luxembourg. FAU - Jacobs, Celine AU - Jacobs C AUID- ORCID: 0000-0001-5286-3519 AD - Medical Oncology, Universitair Ziekenhuis Gent, 9000 Gent, Belgium. FAU - Blockx, Nathalie AU - Blockx N AD - Ziekenhuis Netwerk Antwerpen Middelheim, 2020 Antwerp, Belgium. FAU - Rorive, Andree AU - Rorive A AD - Centre Hospitalier Universitaire de Liege Sart-Tilman, 4000 Liege, Belgium. FAU - Neyns, Bart AU - Neyns B AUID- ORCID: 0000-0003-0658-5903 AD - Department of Medical Oncology, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium. AD - Faculty of Medicine and Pharmacy Vrije Universiteit Brussel, 1050 Brussels, Belgium. LA - eng GR - N/A/Bristol Myers Squibb/ PT - Journal Article DEP - 20230930 PL - Switzerland TA - Cancers (Basel) JT - Cancers JID - 101526829 PMC - PMC10572061 OTO - NOTNLM OT - adjuvant treatment OT - effectiveness OT - health-related quality of life OT - melanoma OT - nivolumab OT - real-world OT - safety COIS- Anne Rogiers reports support for the submitted work from Bristol Myers Squibb and having received consultancy fees from Bristol Myers Squibb, Janssen Pharmaceuticals, and Merck Sharp & Dohme. Laurence Willemot reports support for the submitted work from Bristol Myers Squibb and being an employee of and having stock ownership in Bristol Myers Squibb. Laura McDonald reports support for the submitted work from Bristol Myers Squibb and being an employee of Bristol Myers Squibb. Hilde Van Campenhout reports support for the submitted work from Bristol Myers Squibb and being an employee of and having stock ownership in Bristol Myers Squibb. Guy Berchem reports support for the submitted work from Bristol Myers Squibb, having received consulting fees and honoraria from Amgen, Bristol Myers Squibb, and Roche, support for attending meetings and/or travel from Roche, and support for participation on a data safety monitoring board or advisory board for Amgen and Bristol Myers Squibb. Celine Jacobs reports support for the submitted work from Bristol Myers Squibb, receiving payment or honoraria from Bristol Myers Squibb, and support for attending meetings and/or travel from Roche and PharmaMar. Nathalie Blockx reports support for the submitted work and for attending meetings and/or travel from Bristol Myers Squibb. Andree Rorive reports support for the submitted work from Bristol Myers Squibb, payment or honoraria from Bristol Myers Squibb and Novartis, and support for attending meetings and/or travel from Bristol Myers Squibb, Merck Sharp & Dohme, and Novartis. Bart Neyns reports support for the submitted work from Bristol Myers Squibb, grants or contracts to his institution from Bristol Myers Squibb and Novartis, consulting fees to his institution from Pierre Fabre, payment or honoraria to his institution from Bristol Myers Squibb, Merck Sharp & Dohme, and Pierre Fabre, support to his institution for attending meetings and/or travel from Merck Sharp & Dohme, and support to his institution for participation on a data safety monitoring board or advisory board from Merck Sharp & Dohme, Novartis, and Pierre-Fabre. EDAT- 2023/10/14 10:46 MHDA- 2023/10/14 10:47 PMCR- 2023/09/30 CRDT- 2023/10/14 01:12 PHST- 2023/06/30 00:00 [received] PHST- 2023/09/20 00:00 [revised] PHST- 2023/09/25 00:00 [accepted] PHST- 2023/10/14 10:47 [medline] PHST- 2023/10/14 10:46 [pubmed] PHST- 2023/10/14 01:12 [entrez] PHST- 2023/09/30 00:00 [pmc-release] AID - cancers15194823 [pii] AID - cancers-15-04823 [pii] AID - 10.3390/cancers15194823 [doi] PST - epublish SO - Cancers (Basel). 2023 Sep 30;15(19):4823. doi: 10.3390/cancers15194823.