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Article: Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer

TitleDurvalumab after chemoradiotherapy in stage III non–small-cell lung cancer
Authors
Issue Date2017
Citation
New England Journal of Medicine, 2017, v. 377, n. 20, p. 1919-1929 How to Cite?
AbstractBACKGROUND: 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<0.001); the 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month progression-free survival rate was 44.2% versus 27.0%. The response rate was higher with durvalumab than with placebo (28.4% vs. 16.0%; P<0.001), and the median duration of response was longer (72.8% vs. 46.8% of the patients had an ongoing response at 18 months). The median time to death or distant metastasis was longer with durvalumab than with placebo (23.2 months vs. 14.6 months; P<0.001). Grade 3 or 4 adverse events occurred in 29.9% of the patients who received durvalumab and 26.1% of those who received placebo; the most common adverse event of grade 3 or 4 was pneumonia (4.4% and 3.8%, respectively). A total of 15.4% of patients in the durvalumab group and 9.8% of those in the placebo group discontinued the study drug because of adverse events. CONCLUSIONS: Progression-free survival was significantly longer with durvalumab than with placebo. The secondary end points also favored durvalumab, and safety was similar between the groups.
Persistent Identifierhttp://hdl.handle.net/10722/326473
ISSN
2023 Impact Factor: 96.2
2023 SCImago Journal Rankings: 20.544
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorAntonia, S. J.-
dc.contributor.authorVillegas, A.-
dc.contributor.authorDaniel, D.-
dc.contributor.authorVicente, D.-
dc.contributor.authorMurakami, S.-
dc.contributor.authorHui, R.-
dc.contributor.authorYokoi, T.-
dc.contributor.authorChiappori, A.-
dc.contributor.authorLee, K. H.-
dc.contributor.authorDe Wit, M.-
dc.contributor.authorCho, B. C.-
dc.contributor.authorBourhaba, M.-
dc.contributor.authorQuantin, X.-
dc.contributor.authorTokito, T.-
dc.contributor.authorMekhail, T.-
dc.contributor.authorPlanchard, D.-
dc.contributor.authorKim, Y. C.-
dc.contributor.authorKarapetis, C. S.-
dc.contributor.authorHiret, S.-
dc.contributor.authorOstoros, G.-
dc.contributor.authorKubota, K.-
dc.contributor.authorGray, J. E.-
dc.contributor.authorPaz-Ares, L.-
dc.contributor.authorDe Castro Carpeño, J.-
dc.contributor.authorWadsworth, C.-
dc.contributor.authorMelillo, G.-
dc.contributor.authorJiang, H.-
dc.contributor.authorHuang, Y.-
dc.contributor.authorDennis, P. A.-
dc.contributor.authorÖzgüroğlu, M.-
dc.date.accessioned2023-03-10T02:19:32Z-
dc.date.available2023-03-10T02:19:32Z-
dc.date.issued2017-
dc.identifier.citationNew England Journal of Medicine, 2017, v. 377, n. 20, p. 1919-1929-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/326473-
dc.description.abstractBACKGROUND: 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<0.001); the 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month progression-free survival rate was 44.2% versus 27.0%. The response rate was higher with durvalumab than with placebo (28.4% vs. 16.0%; P<0.001), and the median duration of response was longer (72.8% vs. 46.8% of the patients had an ongoing response at 18 months). The median time to death or distant metastasis was longer with durvalumab than with placebo (23.2 months vs. 14.6 months; P<0.001). Grade 3 or 4 adverse events occurred in 29.9% of the patients who received durvalumab and 26.1% of those who received placebo; the most common adverse event of grade 3 or 4 was pneumonia (4.4% and 3.8%, respectively). A total of 15.4% of patients in the durvalumab group and 9.8% of those in the placebo group discontinued the study drug because of adverse events. CONCLUSIONS: Progression-free survival was significantly longer with durvalumab than with placebo. The secondary end points also favored durvalumab, and safety was similar between the groups.-
dc.languageeng-
dc.relation.ispartofNew England Journal of Medicine-
dc.titleDurvalumab after chemoradiotherapy in stage III non–small-cell lung cancer-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1056/NEJMoa1709937-
dc.identifier.pmid28885881-
dc.identifier.scopuseid_2-s2.0-85032655147-
dc.identifier.volume377-
dc.identifier.issue20-
dc.identifier.spage1919-
dc.identifier.epage1929-
dc.identifier.eissn1533-4406-
dc.identifier.isiWOS:000415228800005-

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