Overall Survival and Biomarker Analysis of Neoadjuvant Nivolumab Plus Chemotherapy in Operable Stage IIIA Non–Small-Cell Lung Cancer (NADIM phase II trial)
| Autor: | Mariano Provencio, Roberto Serna-Blasco, Ernest Nadal, Amelia Insa, M. Rosario García-Campelo, Joaquín Casal Rubio, Manuel Dómine, Margarita Majem, Delvys Rodríguez-Abreu, Alex Martínez-Martí, Javier De Castro Carpeño, Manuel Cobo, Guillermo López Vivanco, Edel Del Barco, Reyes Bernabé Caro, Nuria Viñolas, Isidoro Barneto Aranda, Santiago Viteri, Eva Pereira, Ana Royuela, Virginia Calvo, Javier Martín-López, Francisco García-García, Marta Casarrubios, Fernando Franco, Estela Sánchez-Herrero, Bartomeu Massuti, Alberto Cruz-Bermúdez, Atocha Romero |
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| Přispěvatelé: | Institut Català de la Salut, [Provencio M, Serna-Blasco R] Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain. [Nadal E] Institut Català d’Oncologia, L’Hospitalet De Llobregat, Barcelona, Spain. [Insa A] Fundación INCLIVA, Hospital Clínico Universitario de Valencia, Valencia, Spain. [García-Campelo MR] Hospital Universitario A Coruña, A Coruña, Spain. [Casal Rubio J] Hospital Universitario de Vigo, Pontevedra, Spain. [Martínez-Martí A] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Rok vydání: | 2022 |
| Předmět: |
Cancer Research
Lung Neoplasms terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma Bronchogenic::Carcinoma Non-Small-Cell Lung [DISEASES] neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas [ENFERMEDADES] Other subheadings::Other subheadings::/drug therapy [Other subheadings] Quimioteràpia combinada Neoadjuvant Therapy Therapeutics::Combined Modality Therapy::Neoadjuvant Therapy [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] Nivolumab Oncology Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Humans terapéutica::tratamiento combinado::tratamiento neoadyuvante [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Pulmons - Càncer - Tractament Biomarkers |
| Zdroj: | JOURNAL OF CLINICAL ONCOLOGY r-CIPF. Repositorio Institucional Producción Científica del Centro de Investigación Principe Felipe (CIPF) Universitat Rovira i virgili (URV) Journal of clinical oncology : official journal of the American Society of Clinical Oncology r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA instname Scientia |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.21.02660 |
| Popis: | PURPOSE 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. METHODS 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. RESULTS 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). CONCLUSION 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. |
| Databáze: | OpenAIRE |
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