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Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1Positive, Advanced NonSmall-Cell Lung Cancer in the KEYNOTE-010 Study
DC Field | Value | Language |
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dc.contributor.author | Herbst, Roy S. | - |
dc.contributor.author | Garon, Edward B. | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Cho, Byoung Chul | - |
dc.contributor.author | Perez-Gracia, Jose L. | - |
dc.contributor.author | Han, Ji-Youn | - |
dc.contributor.author | Arvis, Catherine Dubos | - |
dc.contributor.author | Majem, Margarita | - |
dc.contributor.author | Forster, Martin D. | - |
dc.contributor.author | Monnet, Isabelle | - |
dc.contributor.author | Novello, Silvia | - |
dc.contributor.author | Szalai, Zsuzsanna | - |
dc.contributor.author | Gubens, Matthew A. | - |
dc.contributor.author | Su, Wu-Chou | - |
dc.contributor.author | Ceresoli, Giovanni Luca | - |
dc.contributor.author | Samkari, Ayman | - |
dc.contributor.author | Jensen, Erin H. | - |
dc.contributor.author | Lubiniecki, Gregory M. | - |
dc.contributor.author | Baas, Paul | - |
dc.date.accessioned | 2021-01-31T08:06:59Z | - |
dc.date.available | 2021-01-31T08:06:59Z | - |
dc.date.created | 2020-06-29 | - |
dc.date.issued | 2020-05 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.38 No.14, pp.1580-1590 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 104417 | - |
dc.identifier.uri | https://hdl.handle.net/10371/171818 | - |
dc.description.abstract | PURPOSE In the KEYNOTE-010 study, pembrolizumab improved overall survival (OS) versus docetaxel in previously treated, programmed death-ligand 1 (PD-L1)expressing advanced nonsmall-cell lung cancer (NSCLC) in patients with a tumor proportion score (TPS) >= 50% and >= 1%. We report KEYNOTE-010 long-term outcomes, including after 35 cycles/2 years or second-course pembrolizumab. METHODS Of 1,033 patients randomly assigned (intention to treat), 690 received up to 35 cycles/2 years of pembrolizumab 2 mg/kg (n = 344) or 10 mg/kg (n = 346) every 3 weeks, and 343 received docetaxel 75 mg/m(2) every 3 weeks. Eligible patients with disease progression after 35 cycles/2 years of pembrolizumab could receive second-course treatment (up to 17 cycles). Pembrolizumab doses were pooled because no between-dose difference was observed at primary analysis. RESULTS Pembrolizumab continued to improve OS over docetaxel in the PD-L1 TPS >= 50% and >= 1% groups (hazard ratio [HR], 0.53; 95% CI, 0.42 to 0.66; P < .00001; and HR, 0.69; 95% CI, 0.60 to 0.80; P < .00001, respectively) after a 42.6-month (range, 35.2-53.2 months) median follow-up. Estimated 36-month OS rates were 34.5% versus 12.7% and 22.9% versus 11.0%, respectively. Grade 3-5 treatment-related adverse events occurred in 16% versus 37% of patients, respectively. Seventy-nine of 690 patients completed 35 cycles/2 years of pembrolizumab; 12-month OS and progression-free survival rates after completing treatment were 98.7% (95% CI, 91.1% to 99.8%) and 72.5% (95% CI, 59.9% to 81.8%), respectively. Seventy-five patients (95%) had objective response (RECIST v1.1, blinded independent central review) and 48 (64%) had ongoing response. Grade 3-5 treatment-related adverse events occurred in 17.7% of patients. Fourteen patients received second-course pembrolizumab: 5 completed 17 cycles, 6 (43%) had partial response, and 5 (36%) had stable disease. CONCLUSION Pembrolizumab provided long-term OS benefit over docetaxel, with manageable safety, durable responses among patients receiving 2 years of treatment, and disease control with second-course treatment, further supporting pembrolizumab for previously treated, PD-L1expressing advanced NSCLC. | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1Positive, Advanced NonSmall-Cell Lung Cancer in the KEYNOTE-010 Study | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1200/JCO.19.02446 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000537768800009 | - |
dc.identifier.scopusid | 2-s2.0-85082774749 | - |
dc.citation.endpage | 1590 | - |
dc.citation.number | 14 | - |
dc.citation.startpage | 1580 | - |
dc.citation.volume | 38 | - |
dc.identifier.sci | 000537768800009 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | PEMBROLIZUMAB | - |
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