Induction chemo-immunotherapy followed by chemo-radiotherapy and immunotherapy maintenance in stage III NSCLC (APOLO): a phase 2 trial

Unresectable stage III NSCLC standard treatment is chemo-radiotherapy (CT-RT) followed by immunotherapy (IO) with durvalumab. We investigated adding an induction phase with chemo-immunotherapy (ChIO). APOLO was a multicentre, single-arm, phase 2 trial (NCT04776447). Non-resectable stage IIIA-IIIC NS...

ver descrição completa

Detalhes bibliográficos
Autores: Provencio, Mariano, Campos, Begoña, Guirado, María, Vila, Laia, García Campelo, Rosario, Dorta, Miriam, Vázquez Estévez, Sergio, Ferrández, Asia, Sala, M. Ángeles, Ortega, Ana Laura, Blasco, Ana, Insa, Amelia, Areses, María Carmen, Sullivan, Ivana, Lopez, Rafael, Calvo, Virginia, Rodriguez-Abreu, Delvys, Bosch-Barrera, Joaquim, López-Martín, Ana, Marsé Fabregat, Raquel, Torrado, Laura, Matskov, Kirill, Giner, Júlia, Fernández Bruno, Manuel, Sánchez Saugar, Emilio, Martínez-Toledo, Cristina, Mediavilla, Pilar, Romero, Atocha, Cruz-Bermúdez, Alberto
Tipo de documento: artigo
Data de publicação:2025
País:España
Recursos:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositório:Docusalut
Idioma:inglês
OAI Identifier:oai:docusalut.com:20.500.13003/26489
Acesso em linha:https://hdl.handle.net/20.500.13003/26489
Access Level:Acceso aberto
Palavra-chave:Chemoradiotherapy
Immunotherapy
Adult
Aged
Antibodies, Monoclonal
Antineoplastic Combined Chemotherapy Protocols
Carboplatin
Carcinoma, Non-Small-Cell Lung
Female
Humans
Induction Chemotherapy
Lung Neoplasms
Male
Middle Aged
Neoplasm Staging
Quimioradioterapia
Inmunoterapia
Adulto
Anciano
Anticuerpos Monoclonales
Protocolos de Quimioterapia Combinada Antineoplásica
Carboplatino
Carcinoma de Pulmón de Células no Pequeñas
Femenino
Humanos
Quimioterapia de Inducción
Neoplasias Pulmonares
Masculino
Persona de Mediana Edad
Estadificación de Neoplasias
chemo-immunotherapy
chemo-radiotherapy
immunotherapy maintenance i
age III NSCLC (APOLO)
Descrição
Resumo:Unresectable stage III NSCLC standard treatment is chemo-radiotherapy (CT-RT) followed by immunotherapy (IO) with durvalumab. We investigated adding an induction phase with chemo-immunotherapy (ChIO). APOLO was a multicentre, single-arm, phase 2 trial (NCT04776447). Non-resectable stage IIIA-IIIC NSCLC patients received induction ChIO (atezolizumab + carboplatin + paclitaxel, for 3 cycles), followed by concurrent CT-RT (3 cycles), and IO maintenance (atezolizumab for 16 cycles). Primary objective was 12-month progression-free survival (PFS). Secondary endpoints included 12- and 24-month overall survival (OS), ORR, first-site failure pattern, and safety. Exploratory endpoints included PD-L1, TMB, and ctDNA. 38 patients were enrolled. Median follow-up was 29.6 months (data cutoff, February 2024). PFS was 68.4% (95% CI, 51.1-80.7) at 12 months (statistically significant compared to null hypothesis of 55%) and 50.0% at 24 months; OS was 86.8% and 60.5%, respectively. After induction, 18 (47.4%) had partial response, 14 (36.8%) stable disease, and 5 (13.2%) progressive disease. Overall, 18 patients had disease progression: 8 local (44.4%) and 10 distant (55.6%). Grade ≥3 TRAEs occurred in 11 (28.9%) during induction, 10 (26.3%) during CT-RT, and 2 (5.3%) during maintenance. ChIO induction before CT-RT and IO maintenance showed activity and safety, warranting confirmation in larger studies.

Registros relacionados