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Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies
DC Field | Value | Language |
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dc.contributor.author | 정현철 | - |
dc.date.accessioned | 2021-09-29T00:30:03Z | - |
dc.date.available | 2021-09-29T00:30:03Z | - |
dc.date.issued | 2020-10 | - |
dc.identifier.issn | 0020-7136 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/183874 | - |
dc.description.abstract | We present data from patients with advanced biliary tract cancer (BTC) receiving pembrolizumab in the KEYNOTE-158 (NCT02628067; phase 2) and KEYNOTE-028 (NCT02054806; phase 1b) studies. Eligible patients aged ≥18 years from both studies had histologically/cytologically confirmed incurable BTC that progressed after standard treatment regimen(s), measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status 0/1, and no prior immunotherapy. Programmed death ligand 1 (PD-L1)-positive tumors were required for eligibility in KEYNOTE-028 only. Patients received pembrolizumab 200 mg every three weeks (KEYNOTE-158) or 10 mg/kg every two weeks (KEYNOTE-028) for ≤2 years. Primary efficacy endpoint was objective response rate (ORR) by RECIST v1.1. Response assessed by independent central review is reported. KEYNOTE-158 enrolled 104 patients and KEYNOTE-028 enrolled 24 patients. Median (range) follow-up was 7.5 months (0.6-34.3) in KEYNOTE-158 and 5.7 months (0.6-55.4) in KEYNOTE-028. In KEYNOTE-158, ORR was 5.8% (6/104; 95% CI, 2.1%-12.1%); median duration of response (DOR) was not reached (NR) (range, 6.2-26.6+ months). Median (95% CI) OS and PFS were 7.4 (5.5-9.6) and 2.0 (1.9-2.1) months. Among PD-L1-expressers (n = 61) and PD-L1-nonexpressers (n = 34), respectively, ORR was 6.6% (4/61) and 2.9% (1/34). In KEYNOTE-028, ORR was 13.0% (3/23; 95% CI, 2.8%-33.6%); median DOR was NR (range, 21.5-53.2+ months). Median (95% CI) OS and PFS were 5.7 (3.1-9.8) and 1.8 (1.4-3.1) months. Grade 3 to 5 treatment-related adverse events occurred in 13.5% of patients in KEYNOTE-158 (no grade 4; grade 5 renal failure, n = 1) and 16.7% in KEYNOTE-028 (no grade 4/5). In summary, pembrolizumab provides durable antitumor activity in 6% to 13% of patients with advanced BTC, regardless of PD-L1 expression, and has manageable toxicity. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Wiley-Liss | - |
dc.relation.isPartOf | INTERNATIONAL JOURNAL OF CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized / adverse effects* | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized / therapeutic use* | - |
dc.subject.MESH | Antineoplastic Agents, Immunological / adverse effects* | - |
dc.subject.MESH | Antineoplastic Agents, Immunological / therapeutic use* | - |
dc.subject.MESH | B7-H1 Antigen / metabolism | - |
dc.subject.MESH | Biliary Tract Neoplasms / drug therapy* | - |
dc.subject.MESH | Biliary Tract Neoplasms / metabolism | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Response Evaluation Criteria in Solid Tumors | - |
dc.title | Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Sarina A Piha-Paul | - |
dc.contributor.googleauthor | Do-Youn Oh | - |
dc.contributor.googleauthor | Makoto Ueno | - |
dc.contributor.googleauthor | David Malka | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.contributor.googleauthor | Adnan Nagrial | - |
dc.contributor.googleauthor | Robin K Kelley | - |
dc.contributor.googleauthor | Willeke Ros | - |
dc.contributor.googleauthor | Antoine Italiano | - |
dc.contributor.googleauthor | Kazuhiko Nakagawa | - |
dc.contributor.googleauthor | Hope S Rugo | - |
dc.contributor.googleauthor | Filippo de Braud | - |
dc.contributor.googleauthor | Andrea Iolanda Varga | - |
dc.contributor.googleauthor | Aaron Hansen | - |
dc.contributor.googleauthor | Hui Wang | - |
dc.contributor.googleauthor | Suba Krishnan | - |
dc.contributor.googleauthor | Kevin G Norwood | - |
dc.contributor.googleauthor | Toshihiko Doi | - |
dc.identifier.doi | 10.1002/ijc.33013 | - |
dc.contributor.localId | A03773 | - |
dc.relation.journalcode | J01092 | - |
dc.identifier.eissn | 1097-0215 | - |
dc.identifier.pmid | 32359091 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/10.1002/ijc.33013 | - |
dc.subject.keyword | MSI-H | - |
dc.subject.keyword | PD-L1 | - |
dc.subject.keyword | biliary tract cancer | - |
dc.subject.keyword | pembrolizumab | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | 정현철 | - |
dc.citation.volume | 147 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 2190 | - |
dc.citation.endPage | 2198 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL JOURNAL OF CANCER, Vol.147(8) : 2190-2198, 2020-10 | - |
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