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Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC)
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2021-09-29T02:09:29Z | - |
dc.date.available | 2021-09-29T02:09:29Z | - |
dc.date.issued | 2021-07 | - |
dc.identifier.issn | 1525-7304 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/184742 | - |
dc.description.abstract | Background: The phase 3 MYSTIC study of durvalumab ± tremelimumab versus chemotherapy in metastatic non-small-cell lung cancer (NSCLC) patients with tumor cell (TC) programmed cell death ligand 1 (PD-L1) expression ≥ 25% did not meet its primary endpoints. We report patient-reported outcomes (PROs). Patients and methods: Treatment-naïve patients were randomized (1:1:1) to durvalumab, durvalumab + tremelimumab, or chemotherapy. PROs were assessed in patients with PD-L1 TC ≥ 25% using EORTC Quality of Life Questionnaire (QLQ)-C30/LC13. Changes from baseline (12 months) for prespecified PRO endpoints of interest were analyzed by mixed model for repeated measures (MMRM) and time to deterioration (TTD) by stratified log-rank tests. Results: There were no between-arm differences in baseline PROs (N = 488). Between-arm differences in MMRM-adjusted mean changes from baseline favored at least one of the durvalumab-containing arms versus chemotherapy (nominal P < .01) for C30 fatigue: durvalumab (-9.5; 99% confidence interval [CI], -17.0 to -2.0), durvalumab + tremelimumab (-11.7; 99% CI, -19.4 to -4.1); and for C30 appetite loss: durvalumab (-11.9; 99% CI, -21.1 to -2.7). TTD was longer with at least one of the durvalumab-containing arms versus chemotherapy (nominal P < .01) for global health status/quality of life: durvalumab (hazard ratio [HR] = 0.7; 95% CI, 0.5-1.0), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-1.0); and for physical functioning: durvalumab (HR = 0.6; 95% CI, 0.4-0.8), durvalumab + tremelimumab (HR = 0.6; 95% CI, 0.5-0.9) (both C30); as well as for the key symptoms of dyspnea: durvalumab (HR = 0.6; 95% CI, 0.5-0.9), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-1.0) (both LC13); fatigue: durvalumab + tremelimumab (HR = 0.6; 95% CI, 0.4-0.8); and appetite loss: durvalumab (HR = 0.5; 95% CI, 0.4-0.7), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-0.9) (both C30). Conclusion: Durvalumab ± tremelimumab versus chemotherapy reduced symptom burden and improved TTD of PROs, suggesting it had no detrimental effects on quality of life in metastatic NSCLC patients. Trial registration: ClinicalTrials.gov NCT02453282 NCT02453282. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | CLINICAL LUNG CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC) | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Edward B Garon | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Niels Reinmuth | - |
dc.contributor.googleauthor | Ki Hyeong Lee | - |
dc.contributor.googleauthor | Alexander Luft | - |
dc.contributor.googleauthor | Myung-Ju Ahn | - |
dc.contributor.googleauthor | Gilles Robinet | - |
dc.contributor.googleauthor | Sylvestre Le Moulec | - |
dc.contributor.googleauthor | Ronald Natale | - |
dc.contributor.googleauthor | Jeffrey Schneider | - |
dc.contributor.googleauthor | Frances A Shepherd | - |
dc.contributor.googleauthor | Marina Chiara Garassino | - |
dc.contributor.googleauthor | Sarayut Lucien Geater | - |
dc.contributor.googleauthor | Zsolt Papai Szekely | - |
dc.contributor.googleauthor | Tran Van Ngoc | - |
dc.contributor.googleauthor | Feng Liu | - |
dc.contributor.googleauthor | Urban Scheuring | - |
dc.contributor.googleauthor | Nikunj Patel | - |
dc.contributor.googleauthor | Solange Peters | - |
dc.contributor.googleauthor | Naiyer A Rizvi | - |
dc.identifier.doi | 10.1016/j.cllc.2021.02.010 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J03603 | - |
dc.identifier.eissn | 1938-0690 | - |
dc.identifier.pmid | 33775558 | - |
dc.subject.keyword | Functioning | - |
dc.subject.keyword | Health status | - |
dc.subject.keyword | Immunotherapy | - |
dc.subject.keyword | Quality of life | - |
dc.subject.keyword | Symptoms | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 22 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 301 | - |
dc.citation.endPage | 312.e8 | - |
dc.identifier.bibliographicCitation | CLINICAL LUNG CANCER, Vol.22(4) : 301-312.e8, 2021-07 | - |
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