Real-World Evidence of Adjuvant Immunotherapy in Resected Stage III and IV Melanoma Patients: CADIM Trial Final Results. Experience from 2 Tertiary Referral Centers. / 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 2centros de tercer nivel.
Actas Dermosifiliogr
; 2024 Sep 11.
Article
en En, Es
| MEDLINE
| ID: mdl-39271008
ABSTRACT
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 ANDMETHOD:
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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Colección:
01-internacional
Base de datos:
MEDLINE
Idioma:
En
/
Es
Revista:
Actas Dermosifiliogr
Año:
2024
Tipo del documento:
Article
Pais de publicación:
España