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Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2018-07-20T11:57:42Z | - |
dc.date.available | 2018-07-20T11:57:42Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/161556 | - |
dc.description.abstract | 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<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. (Funded by AstraZeneca; PACIFIC ClinicalTrials.gov number, NCT02125461 .). | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Antibodies, Monoclonal/adverse effects | - |
dc.subject.MESH | Antibodies, Monoclonal/therapeutic use | - |
dc.subject.MESH | Antineoplastic Agents/adverse effects | - |
dc.subject.MESH | Antineoplastic Agents/therapeutic use | - |
dc.subject.MESH | B7-H1 Antigen/antagonists & inhibitors | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung/mortality | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung/secondary | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung/therapy | - |
dc.subject.MESH | Chemoradiotherapy | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Intention to Treat Analysis | - |
dc.subject.MESH | Kaplan-Meier Estimate | - |
dc.subject.MESH | Lung Neoplasms/mortality | - |
dc.subject.MESH | Lung Neoplasms/pathology | - |
dc.subject.MESH | Lung Neoplasms/therapy | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Staging | - |
dc.title | Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | S.J. Antonia | - |
dc.contributor.googleauthor | A. Villegas | - |
dc.contributor.googleauthor | D. Daniel | - |
dc.contributor.googleauthor | D. Vicente | - |
dc.contributor.googleauthor | S. Murakami | - |
dc.contributor.googleauthor | R. Hui | - |
dc.contributor.googleauthor | T. Yokoi | - |
dc.contributor.googleauthor | A. Chiappori | - |
dc.contributor.googleauthor | K.H. Lee | - |
dc.contributor.googleauthor | M. de Wit | - |
dc.contributor.googleauthor | B.C. Cho, M. Bourhaba | - |
dc.contributor.googleauthor | X. Quantin | - |
dc.contributor.googleauthor | T. Tokito | - |
dc.contributor.googleauthor | T. Mekhail | - |
dc.contributor.googleauthor | D. Planchard | - |
dc.contributor.googleauthor | Y.-C. Kim | - |
dc.contributor.googleauthor | C.S. Karapetis | - |
dc.contributor.googleauthor | S. Hiret | - |
dc.contributor.googleauthor | G. Ostoros | - |
dc.contributor.googleauthor | K. Kubota | - |
dc.contributor.googleauthor | J.E. Gray | - |
dc.contributor.googleauthor | L. Paz‑Ares | - |
dc.contributor.googleauthor | J. de Castro Carpeño | - |
dc.contributor.googleauthor | C. Wadsworth | - |
dc.contributor.googleauthor | G. Melillo | - |
dc.contributor.googleauthor | H. Jiang | - |
dc.contributor.googleauthor | Y. Huang | - |
dc.contributor.googleauthor | P.A. Dennis | - |
dc.contributor.googleauthor | M. Özgüroğlu | - |
dc.identifier.doi | 10.1056/NEJMoa1709937 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 28885881 | - |
dc.identifier.url | https://www.nejm.org/doi/10.1056/NEJMoa1709937 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | Cho, Byoung Chul | - |
dc.citation.volume | 377 | - |
dc.citation.number | 20 | - |
dc.citation.startPage | 1919 | - |
dc.citation.endPage | 1929 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.377(20) : 1919-1929, 2017 | - |
dc.identifier.rimsid | 61585 | - |
dc.type.rims | ART | - |
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