已切除的 III 期和 IV 期黑色素瘤患者接受辅助免疫疗法的实际证据：CADIM 试验最终结果。来自两家三级转诊中心的经验。

IF 3.8 Q1 DERMATOLOGY

Actas dermo-sifiliograficas Pub Date : 2025-03-01 DOI:10.1016/j.ad.2024.07.021

M. Morellá Fernández , J. Balsalobre Yago , J. Martínez García , M. Peláez Gutiérrez , A. López Muñoz , A.I. Silvestre Ballesta , B. Sánchez Lafuente , I. Martínez Martín , P. Cerezuela Fuentes

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引用次数: 0

摘要

简介临床试验验证了在切除的III期和IV期黑色素瘤患者中使用nivolumab和pembrolizumab作为无复发生存期（RFS）的辅助疗法。目前，真实世界患者的证据还很有限：CADIM试验（黑色素瘤患者辅助免疫疗法的特征）从2018年2月至2022年12月共招募了81名接受nivolumab或pembrolizumab辅助治疗的III期和IV期黑色素瘤切除患者：III期患者的分期率为81.5%（n = 71），15名患者（18.5%）为切除的IV期。在III期患者中，38例为IIIC期（46.9%）。中位随访时间为22.8个月，意向治疗（ITT）人群1年的RFS为84%，2年的RFS为81.5%。总生存率（OS）为1年99%，2年91.4%。12.3%的患者出现了3-4级治疗相关不良事件：这项研究显示了切除的III期和IV期黑色素瘤患者接受抗PD-1辅助治疗的结果，并最终证实了临床试验所描述的安全性和有效性。将临床试验数据与真实世界的证据进行比较，对于更加实用、可靠和方便地使用这些药物是非常必要的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Evidencia en la práctica clínica del tratamiento adyuvante con inmunoterapia en pacientes con melanoma en estadios III y IV resecados: resultados finales del estudio CADIM. Experiencia de 2 centros de tercer nivel

Introduction

Clinical trials have validated the use of nivolumab and pembrolizumab as adjuvant therapies regarding relapse-free survival in patients with resected stage III and IV melanoma. Evidence in real-world patients is currently limited.

Material and method

The CADIM trial (Characterization of adjuvant immunotherapy in melanoma patients) recruited a total of 81 patients with resected stage III and IV melanoma on nivolumab or pembrolizumab as adjuvant therapy from February 2018 through December 2022.

Results

The stage distribution rate was 81.5% (n = 71) for stage III, while 15 patients (18.5%) had resected stage IV. Among stage III patients, 38 were stage IIIC (46.9%). With a median follow-up of 22.8 months, the relapse-free survival in the intention-to-treat population was 84% at one year and 81.5% at 2 years. The overall survival rate was 99% at one year and 91.4% at 2 years. Grade 3-4 treatment-related adverse events were reported in 12.3% of the patients.

Conclusions

This study shows the results of resected stage III and IV melanoma patients on adjuvant therapy with anti-PD-1, and eventually confirmed the safety and efficacy profile described by clinical trials. Comparing clinical trial data with real-world evidence is necessary for a more practical, reliable, and accessible use of these drugs.

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来源期刊

Actas dermo-sifiliograficas DERMATOLOGY-

CiteScore

1.90

自引率

9.40%

发文量

473

审稿时长

56 weeks

期刊介绍： Actas Dermo-Sifiliográficas, publicación Oficial de la Academia Española de Dermatología y Venereología, es una revista de prestigio consolidado. Creada en 1909, es la revista mensual más antigua editada en España.En 2006 entró en Medline, y hoy resulta imprescindible para estar al día sobre la dermatología española y mundial.