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Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer
Mariano Provencio1, Ernest Nadal1, José L González-Larriba1
1From Hospital Universitario Puerta de Hierro-Majadahonda (M.P., V.C., R.S.-B., J.M.-L., A.C.-B., A.R.), Hospital Universitario Clínico San Carlos (J.L.G.-L., C.A.R., F.H.-T.), Hospital Universitario 12 de Octubre (S.P.), Hospital Universitario La Paz (J.C.), and the Genetic and Molecular Epidemiology Group, Spanish National Cancer Research Center (R. Benítez), Madrid, Institut Català d'Oncologia, L'Hospitalet de Llobregat (E.N., R.P.), Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebrón (A.M.-M.), the Medical Oncology Department Hospital Clinic and Translational Genomics and Targeted Therapies in Solid Tumors, Institut de Investigacions Biomèdiques (N.R.), and Instituto Oncológico Dr. Rosell, Dexeus University Hospital (A.A.), Barcelona, Hospital Universitario Virgen del Rocio, Seville (R. Bernabé), Institut Català d'Oncologia, Hospital Universitari Dr. Josep Trueta, Girona (J.B.-B.), Complejo Hospitalario Universitario de Vigo, Pontevedra (J.C.-R.), Fundación Instituto de Investigación Sanitaria, Hospital Clínico Universitario de Valencia (A.I.), and Hospital General Universitario de Valencia, Universidad de Valencia and Centro de Investigación Biomédica en Red Cáncer (C.C.), Valencia, Complejo Hospitalario Universitario A Coruña, A Coruña (J.M.), the Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, Instituto de Investigación Biomédica de Málaga, Málaga (M.C.), Hospital Universitario Cruces, Barakaldo (G.L.V.), Hospital Clínico Universitario de Valladolid, Valladolid (R.L.-C.), the Medical Oncology Department, Catalan Institute of Oncology, Badalona-Germans Trias i Pujol Hospital, Badalona Applied Research Group in Oncology, Fundació Institut de Investigado de Ciences de la Salut Germans Trias i Pujol, Department of Medicine, Universitat Autònoma de Barcelona, Campus Can Ruti, Badalona (T.M.), Hospital Universitario Reina Sofia, Córdoba (I.B.), Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria (D.R.-A.), and Hospital Universitario Dr. Balmis Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante, Alicante (B.M.) - all in Spain.
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. (Funded by Bristol Myers Squibb and others; NADIM II ClinicalTrials.gov number, NCT03838159; EudraCT number, 2018-004515-45.).
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