Por favor, use este identificador para citar o enlazar este Item:http://hdl.handle.net/20.500.12105/20587
Título
Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC.
Autor(es)
Andric, Zoran | Gálffy, Gabriella | Cobo Dols, Manuel | Szima, Barna | Stojanovic, Goran | Petrovic, Marina | Felip, Enriqueta | Vicente Baz, David | Ponce Aix, Santiago | Juan-Vidal, Oscar | Szalai, Zsuzsanna | Losonczy, Gyorgy | Calles Blanco, Antonio | Bernabe, Reyes | García Ledo, Gema | Aguilar Hernández, Andrés | Duecker, Klaus | Zhou, Dongli | Schroeder, Andreas | Guezel, Guelseren | Ciardiello, Fortunato
Fecha de publicación
2023-02
Cita
JTO Clin Res Rep . 2023;4(2):100461
Idioma
Inglés
Tipo de documento
journal article
Resumen
INTRODUCTION
We present the results of a phase 2a trial of first-line avelumab (anti-programmed death-ligand 1 antibody) plus cetuximab (anti-EGFR antibody) in patients with advanced squamous NSCLC.
METHODS
Patients with recurrent or metastatic squamous NSCLC received avelumab 800 mg (d 1 and 8), cetuximab 250 mg/m2 (d 1) and 500 mg/m2 (d 8), cisplatin 75 mg/m2 (d 1), and gemcitabine 1250 mg/m2 (d 1 and 8) for four 3-week cycles, followed by avelumab 800 mg and cetuximab 500 mg/m2 every 2 weeks. The primary end point was the best overall response; the secondary end points were progression-free survival, duration of response, overall survival, and safety. Efficacy analyses were reported from an updated data cutoff.
RESULTS
A total of 43 patients were enrolled. The median follow-up was 6.6 months for the primary analyses and 9.2 months for the efficacy analyses. In the efficacy analyses, 15 patients had a confirmed partial response (objective response rate, 34.9% [95% confidence interval: 21.0%-50.9%]), and the median duration of response was 7.1 months (95% confidence interval: 4.2-12.5 mo). The median progression-free survival and overall survival were 6.1 months and 10.0 months, respectively. In the safety analyses (primary analysis), 38 patients (88.4%) had a treatment-related adverse event, of whom 24 (55.8%) had a grade 3 or higher treatment-related adverse event.
CONCLUSIONS
The combination of avelumab + cetuximab and chemotherapy showed antitumor activity and tolerable safety; however, the ORR was not improved compared with those reported for current standards of care (NCT03717155).
Versión en línea
DOI
Aparece en las colecciones
Ficheros en el ítem
![Acceso Abierto Acceso Abierto](/themes/Mirage2/images/openAccess.png)
- Nombre:
- AvelumabinCombinationWithCetux ...
- Tamaño:
- 989.9Kb
- Formato:
- Descripción:
- Artículo principal
![Acceso Abierto Acceso Abierto](/themes/Mirage2/images/openAccess.png)
- Nombre:
- mmc1.docx
- Tamaño:
- 930.4Kb
- Formato:
- Microsoft Word 2007
- Descripción:
- Supplementary information