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...

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Detalles Bibliográficos
Autores: Provencio, M, Campos, B, Guirado, M, Vila, L, Campelo, RG, Dorta, M, Estévez, SV, Ferrández, A, Sala, MA, Ortega, AL, Blasco, A, Insa, A, Areses, MC, Sullivan, I, Lopez, R, Calvo, V, Rodriguez-Abreu, D, Bosch-Barrera, J, Lopez-Martín, A, Marsé, R, Torrado, L, Matskov, K, Giner, J, Bruno, MF, Saugar, ES, Martínez-Toledo, C, Mediavilla, P, Romero, A, Cruz-Bermúdez, A
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p6755
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/6755
https://www.scopus.com/inward/record.uri?eid=2-s2.0-105025689063&doi=10.1038%2Fs41467-025-66097-w&partnerID=40&md5=b33b9d55da8323a85c6534679d96cd90
Access Level:acceso abierto
Palabra clave:atezolizumab
carboplatin
circulating tumor DNA
paclitaxel
antineoplastic agent
durvalumab
monoclonal antibody
chemotherapy
immune system
safety
survival
adult
age
aged
anemia
Article
cancer immunotherapy
chemoimmunotherapy
chemoradiotherapy
clinical article
clinical feature
cohort analysis
disease exacerbation
drug safety
febrile neutropenia
female
follow up
high throughput sequencing
histopathology
human
maintenance therapy
male
multiple cycle treatment
non small cell lung cancer
overall response rate
overall survival
phase 2 clinical trial
pleura effusion
pneumonia
progression free survival
sex
smoking
treatment outcome
cancer staging
clinical trial
drug therapy
immunotherapy
induction chemotherapy
lung tumor
middle aged
mortality
multicenter study
pathology
procedures
therapy
Adult
Aged
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
Carboplatin
Carcinoma, Non-Small-C
Descripción
Sumario: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.

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