RT Journal Article
T1 Overall Survival and Biomarker Analysis of Neoadjuvant Nivolumab Plus Chemotherapy in Operable Stage IIIA Non-Small-Cell Lung Cancer (NADIM phase II trial).
A1 Provencio, Mariano
A1 Serna-Blasco, Roberto
A1 Nadal, Ernest
A1 Insa, Amelia
A1 García-Campelo, M Rosario
A1 Casal Rubio, Joaquín
A1 Dómine, Manuel
A1 Majem, Margarita
A1 Rodríguez-Abreu, Delvys
A1 Martínez-Martí, Alex
A1 De Castro Carpeño, Javier
A1 Cobo, Manuel
A1 López Vivanco, Guillermo
A1 Del Barco, Edel
A1 Bernabé Caro, Reyes
A1 Viñolas, Nuria
A1 Barneto Aranda, Isidoro
A1 Viteri, Santiago
A1 Pereira, Eva
A1 Royuela, Ana
A1 Calvo, Virginia
A1 Martín-López, Javier
A1 García-García, Francisco
A1 Casarrubios, Marta
A1 Franco, Fernando
A1 Sánchez-Herrero, Estela
A1 Massuti, Bartomeu
A1 Cruz-Bermúdez, Alberto
A1 Romero, Atocha
AB Neoadjuvant chemotherapy plus nivolumab has been shown to be effective in resectable non-small-cell lung cancer (NSCLC) in the NADIM trial (ClinicalTrials.gov identifier: NCT03081689). The 3-year overall survival (OS) and circulating tumor DNA (ctDNA) analysis have not been reported. This was an open-label, multicenter, single-arm, phase II trial in which patients with stage IIIA NSCLC, who were deemed to be surgically resectable, were treated with neoadjuvant paclitaxel (200 mg/m2 once a day) and carboplatin (area under curve 6) plus nivolumab (360 mg) once on day 1 of each 21-day cycle, for three cycles, followed by adjuvant nivolumab monotherapy for 1 year (240 mg once every 2 weeks for 4 months, followed by 480 mg once every 4 weeks for 8 months). The 3-year OS and ctDNA analysis were secondary objectives of the trial. OS at 36 months was 81.9% (95% CI, 66.8 to 90.6) in the intention-to-treat population, rising to 91.0% (95% CI, 74.2 to 97.0) in the per-protocol population. Neither tumor mutation burden nor programmed cell death ligand-1 staining was predictive of survival. Conversely, low pretreatment levels of ctDNA were significantly associated with improved progression-free survival and OS (hazard ratio [HR], 0.20; 95% CI, 0.06 to 0.63, and HR, 0.07; 95% CI, 0.01 to 0.39, respectively). Clinical responses according to RECIST v1.1 criteria did not predict survival outcomes. However, undetectable ctDNA levels after neoadjuvant treatment were significantly associated with progression-free survival and OS (HR, 0.26; 95% CI, 0.07 to 0.93, and HR, 0.04; 95% CI, 0.00 to 0.55, respectively). The C-index to predict OS for ctDNA levels after neoadjuvant treatment (0.82) was superior to that of RECIST criteria (0.72). The efficacy of neoadjuvant chemotherapy plus nivolumab in resectable NSCLC is supported by 3-year OS. ctDNA levels were significantly associated with OS and outperformed radiologic assessments in the prediction of survival.
YR 2022
FD 2022-05-16
LK http://hdl.handle.net/10668/20389
UL http://hdl.handle.net/10668/20389
LA en
DS RISalud
RD Apr 7, 2025