Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 Therapy

ABSTRACT Background Programmed cell death protein‐1 (PD1) antibodies are currently the standard treatment for resected high‐risk melanoma, yet recurrence rate remains high. Objectives This real‐life observational study aimed to describe the outcomes of patients with resected high‐risk melanoma follo...

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Main Authors: Liza Benzoni, Anaïs Eberhardt, Sarah Milley, Safa Idoudi, Camille Trefcon, Nicolas Romain‐Scelle, Luc Thomas, Stéphane Dalle
Format: Article
Language:English
Published: Wiley 2025-03-01
Series:Cancer Medicine
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Online Access:https://doi.org/10.1002/cam4.70432
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author Liza Benzoni
Anaïs Eberhardt
Sarah Milley
Safa Idoudi
Camille Trefcon
Nicolas Romain‐Scelle
Luc Thomas
Stéphane Dalle
author_facet Liza Benzoni
Anaïs Eberhardt
Sarah Milley
Safa Idoudi
Camille Trefcon
Nicolas Romain‐Scelle
Luc Thomas
Stéphane Dalle
author_sort Liza Benzoni
collection DOAJ
description ABSTRACT Background Programmed cell death protein‐1 (PD1) antibodies are currently the standard treatment for resected high‐risk melanoma, yet recurrence rate remains high. Objectives This real‐life observational study aimed to describe the outcomes of patients with resected high‐risk melanoma following adjuvant anti‐PD1 immunotherapy and identify factors associated with recurrence risk. Materials and Methods A total of 235 patients with resected stage III/IV melanoma treated with adjuvant nivolumab or pembrolizumab were included. Imaging scans and cerebral imaging were performed every 12 weeks to detect recurrences. Adverse events were collected. Univariate and multivariate analyses were performed to identify predictive factors of recurrence. Overall survival (OS) and recurrence‐free survival (RFS) were estimated. Results Among the 235 patients, 103 experienced at least one recurrence (43%); first recurrences were predominantly locoregional (47%). The predictive factor for recurrence identified by multivariate analysis was ulceration (RR 2,03, 95% CI [1,20; 2,86]). RFS was estimated at 75% [70–81] at 12 months and at 64% [58–71] at 24 months. RFS at 12 months was significantly lower in patients with ulcerations (RFS at 83%) compared to those without ulceration (RFS at 66%), p < 0.01. Overall survival (OS) was estimated at 91% [87%–94%] at 12 months and 84% [79%–89%] at 24 months. The OS after a first recurrence was estimated at 69% [60%–80%] at 12 months and decreased to 43% [32%–57%] at 24 months. After a first locoregional recurrence, surgery with a year of adjuvant immunotherapy (40%) was the favoured therapeutic approach. For distant recurrences, clinical trial enrolment was preferred (21%). Double curative immunotherapy was the preferred strategy for cerebral recurrences (30%). Conclusions In this cohort, nearly half of the patients underwent recurrences and RFS at 24 months was 64%. The RFS and OS data were comparable o those reported in the pivotal study Ulceration was the only significant predictive factor for recurrence, associated with decreased RFS at 24 months.
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spelling doaj-art-22dc7b74374648c7bafb980bc40b6d552025-08-20T02:12:19ZengWileyCancer Medicine2045-76342025-03-01146n/an/a10.1002/cam4.70432Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 TherapyLiza Benzoni0Anaïs Eberhardt1Sarah Milley2Safa Idoudi3Camille Trefcon4Nicolas Romain‐Scelle5Luc Thomas6Stéphane Dalle7Service de Dermatologie, Hospices Civils de Lyon Hôpital Lyon Sud Lyon FranceService de Dermatologie, Hospices Civils de Lyon Hôpital Lyon Sud Lyon FranceService de Dermatologie, Hospices Civils de Lyon Hôpital Lyon Sud Lyon FranceService de Dermatologie, Hôpital Saint Louis Paris FranceService de Dermatologie, Hospices Civils de Lyon Hôpital Lyon Sud Lyon FranceService de Biostatistique, Hospices Civils de Lyon Hôpital Lyon Sud Pierre‐Bénite FranceService de Dermatologie, Hospices Civils de Lyon Hôpital Lyon Sud Lyon FranceService de Dermatologie, Hospices Civils de Lyon Hôpital Lyon Sud Lyon FranceABSTRACT Background Programmed cell death protein‐1 (PD1) antibodies are currently the standard treatment for resected high‐risk melanoma, yet recurrence rate remains high. Objectives This real‐life observational study aimed to describe the outcomes of patients with resected high‐risk melanoma following adjuvant anti‐PD1 immunotherapy and identify factors associated with recurrence risk. Materials and Methods A total of 235 patients with resected stage III/IV melanoma treated with adjuvant nivolumab or pembrolizumab were included. Imaging scans and cerebral imaging were performed every 12 weeks to detect recurrences. Adverse events were collected. Univariate and multivariate analyses were performed to identify predictive factors of recurrence. Overall survival (OS) and recurrence‐free survival (RFS) were estimated. Results Among the 235 patients, 103 experienced at least one recurrence (43%); first recurrences were predominantly locoregional (47%). The predictive factor for recurrence identified by multivariate analysis was ulceration (RR 2,03, 95% CI [1,20; 2,86]). RFS was estimated at 75% [70–81] at 12 months and at 64% [58–71] at 24 months. RFS at 12 months was significantly lower in patients with ulcerations (RFS at 83%) compared to those without ulceration (RFS at 66%), p < 0.01. Overall survival (OS) was estimated at 91% [87%–94%] at 12 months and 84% [79%–89%] at 24 months. The OS after a first recurrence was estimated at 69% [60%–80%] at 12 months and decreased to 43% [32%–57%] at 24 months. After a first locoregional recurrence, surgery with a year of adjuvant immunotherapy (40%) was the favoured therapeutic approach. For distant recurrences, clinical trial enrolment was preferred (21%). Double curative immunotherapy was the preferred strategy for cerebral recurrences (30%). Conclusions In this cohort, nearly half of the patients underwent recurrences and RFS at 24 months was 64%. The RFS and OS data were comparable o those reported in the pivotal study Ulceration was the only significant predictive factor for recurrence, associated with decreased RFS at 24 months.https://doi.org/10.1002/cam4.70432adjuvantanti‐PD1 therapyhigh‐risk melanoma
spellingShingle Liza Benzoni
Anaïs Eberhardt
Sarah Milley
Safa Idoudi
Camille Trefcon
Nicolas Romain‐Scelle
Luc Thomas
Stéphane Dalle
Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 Therapy
Cancer Medicine
adjuvant
anti‐PD1 therapy
high‐risk melanoma
title Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 Therapy
title_full Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 Therapy
title_fullStr Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 Therapy
title_full_unstemmed Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 Therapy
title_short Real‐Life Cohort of Patients With Resected High‐Risk Melanoma Treated by Adjuvant Anti‐PD1 Therapy
title_sort real life cohort of patients with resected high risk melanoma treated by adjuvant anti pd1 therapy
topic adjuvant
anti‐PD1 therapy
high‐risk melanoma
url https://doi.org/10.1002/cam4.70432
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