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Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer

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Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer

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dc.contributor.author Provencio Pulla, Mariano
dc.contributor.author Nadal, Ernest
dc.contributor.author González Larriba, Jose Luís
dc.contributor.author Martínez Martí, Alex
dc.contributor.author Bernabé, Reyes
dc.contributor.author Bosch Barrera, Joaquim
dc.contributor.author Casal Rubio, Joaquín
dc.contributor.author Calvo, Virginia
dc.contributor.author Insa, Amelia
dc.contributor.author Ponce, Santiago
dc.contributor.author Reguart, Noemí
dc.contributor.author De Castro, Javier
dc.contributor.author Mosquera, Joaquín
dc.contributor.author Cobo, Manuel
dc.contributor.author Aguilar, Andrés
dc.contributor.author López Vivanco, Guillermo
dc.contributor.author Camps, Carlos
dc.contributor.author López Castro, Rafael
dc.contributor.author Morán, Teresa
dc.contributor.author Barneto, Isidoro
dc.contributor.author Rodríguez Abreu, Delvys
dc.contributor.author Serna Blasco, Roberto
dc.contributor.author Benítez, Raquel
dc.contributor.author Aguado de la Rosa, Carlos
dc.contributor.author Palmero, Ramón
dc.contributor.author Hernando Trancho, Florentino
dc.contributor.author Martín López, Javier
dc.contributor.author Cruz Bermúdez, Alberto
dc.contributor.author Massuti, Bartomeu
dc.contributor.author Romero Alfonso, Atocha
dc.date.accessioned 2023-09-06T11:25:50Z
dc.date.available 2023-12-28T05:45:06Z
dc.date.issued 2023
dc.identifier.citation Provencio Pulla, Mariano Nadal, Ernest González Larriba, Jose Luís Martínez Martí, Alex Bernabé, Reyes Bosch Barrera, Joaquim Casal Rubio, Joaquín Calvo, Virginia Insa, Amelia Ponce, Santiago Reguart, Noemí De Castro, Javier Mosquera, Joaquín Cobo, Manuel Aguilar, Andrés López Vivanco, Guillermo Camps, Carlos López Castro, Rafael Morán, Teresa Barneto, Isidoro Rodríguez Abreu, Delvys Serna Blasco, Roberto Benítez, Raquel Aguado de la Rosa, Carlos Palmero, Ramón Hernando Trancho, Florentino Martín López, Javier Cruz Bermúdez, Alberto Massuti, Bartomeu Romero Alfonso, Atocha 2023 Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer New England Journal of Medicine
dc.identifier.uri https://hdl.handle.net/10550/89125
dc.description.abstract BACKGROUND Approximately 20% of patients with non-small-cell lung cancer (NSCLC) receive a diagnosis of stage III disease. There is no current consensus regarding the most appropriate treatment for these patients. METHODS In this open-label, phase 2 trial, we randomly assigned patients with resectable stage IIIA or IIIB NSCLC to receive neoadjuvant nivolumab plus platinum-based chemotherapy (experimental group) or chemotherapy alone (control group), followed by surgery. Patients in the experimental group who had R0 resections received adjuvant treatment with nivolumab for 6 months. The primary end point was a pathological complete response (0% viable tumor in resected lung and lymph nodes). Secondary end points included progression-free survival and overall survival at 24 months and safety. RESULTS A total of 86 patients underwent randomization; 57 were assigned to the experimental group and 29 were assigned to the control group. A pathological complete response occurred in 37% of the patients in the experimental group and in 7% in the control group (relative risk, 5.34; 95% confidence interval [CI], 1.34 to 21.23; P=0.02). Surgery was performed in 93% of the patients in the experimental group and in 69% in the control group (relative risk, 1.35; 95% CI, 1.05 to 1.74). Kaplan-Meier estimates of progression-free survival at 24 months were 67.2% in the experimental group and 40.9% in the control group (hazard ratio for disease progression, disease recurrence, or death, 0.47; 95% CI, 0.25 to 0.88). Kaplan-Meier estimates of overall survival at 24 months were 85.0% in the experimental group and 63.6% in the control group (hazard ratio for death, 0.43; 95% CI, 0.19 to 0.98). Grade 3 or 4 adverse events occurred in 11 patients in the experimental group (19%; some patients had events of both grades) and 3 patients in the control group (10%). CONCLUSIONS In patients with resectable stage IIIA or IIIB NSCLC, perioperative treatment with nivolumab plus chemotherapy resulted in a higher percentage of patients with a pathological complete response and longer survival than chemotherapy alone.
dc.language.iso eng
dc.relation.ispartof New England Journal of Medicine, 2023
dc.subject Càncer
dc.title Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer
dc.type journal article
dc.date.updated 2023-09-06T11:25:50Z
dc.identifier.doi 10.1056/NEJMoa2215530
dc.identifier.idgrec 161070
dc.embargo.terms 6 months
dc.rights.accessRights open access

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