Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer
| Autor: | Antonia, S.J., Villegas, A., Daniel, D., Vicente, D., Murakami, S., Hui, R., Yokoi, T., Chiappori, A., Lee, K.H., Wit, M. de, Cho, B.C., Bourhaba, M., Quantin, X., Tokito, T., Mekhail, T., Planchard, D., Kim, Y.C., Karapetis, C.S., Hiret, S., Ostoros, G., Kubota, K., Gray, J.E., Paz-Ares, L., Castro Carpeno, J. de, Wadsworth, C., Melillo, G., Jiang, H., Huang, Y., Dennis, P.A., Ozguroglu, M., Heuvel, M. van den |
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| Přispěvatelé: | Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CRLCC Val d'Aurelle - Paul Lamarque, Institut Gustave Roussy (IGR), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER |
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Oncology Adult Male medicine.medical_specialty Durvalumab Lung Neoplasms medicine.medical_treatment Phases of clinical research Antineoplastic Agents [SDV.CAN]Life Sciences [q-bio]/Cancer Kaplan-Meier Estimate Rare cancers Radboud Institute for Molecular Life Sciences [Radboudumc 9] Placebo B7-H1 Antigen Disease-Free Survival Antibodies 03 medical and health sciences 0302 clinical medicine Internal medicine Carcinoma Non-Small-Cell Lung Monoclonal medicine 80 and over Humans Lung cancer Non-Small-Cell Lung Aged Neoplasm Staging Aged 80 and over Chemotherapy business.industry Carcinoma Antibodies Monoclonal General Medicine Chemoradiotherapy Middle Aged medicine.disease Interim analysis Intention to Treat Analysis Radiation therapy 030104 developmental biology 030220 oncology & carcinogenesis Female business [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Zdroj: | The New England Journal of Medicine, 377, 1919-1929 New England Journal of Medicine New England Journal of Medicine, Massachusetts Medical Society, 2017, 377 (20), pp.1919-1929. ⟨10.1056/NEJMoa1709937⟩ The New England Journal of Medicine, 377, 20, pp. 1919-1929 |
| ISSN: | 0028-4793 1533-4406 |
| DOI: | 10.1056/nejmoa1709937 |
| Popis: | Item does not contain fulltext BACKGROUND: Most patients with locally advanced, unresectable, non-small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy). This phase 3 study compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy. METHODS: We randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months. The study drug was administered 1 to 42 days after the patients had received chemoradiotherapy. The coprimary end points were progression-free survival (as assessed by means of blinded independent central review) and overall survival (unplanned for the interim analysis). Secondary end points included 12-month and 18-month progression-free survival rates, the objective response rate, the duration of response, the time to death or distant metastasis, and safety. RESULTS: Of 713 patients who underwent randomization, 709 received consolidation therapy (473 received durvalumab and 236 received placebo). The median progression-free survival from randomization was 16.8 months (95% confidence interval [CI], 13.0 to 18.1) with durvalumab versus 5.6 months (95% CI, 4.6 to 7.8) with placebo (stratified hazard ratio for disease progression or death, 0.52; 95% CI, 0.42 to 0.65; P |
| Databáze: | OpenAIRE |
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