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Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma
DC Field | Value | Language |
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dc.contributor.author | 신상준 | - |
dc.date.accessioned | 2022-09-14T01:16:19Z | - |
dc.date.available | 2022-09-14T01:16:19Z | - |
dc.date.issued | 2021-03 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190371 | - |
dc.description.abstract | Purpose: Programmed death 1 (PD-1) pathway inhibitors have not been prospectively evaluated in patients with non-clear cell renal cell carcinoma (nccRCC). The phase II KEYNOTE-427 study (cohort B) was conducted to assess the efficacy and safety of single-agent pembrolizumab, a PD-1 inhibitor, in advanced nccRCC. Methods: Patients with histologically confirmed, measurable (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) nccRCC and no prior systemic therapy received pembrolizumab 200 mg intravenously once every 3 weeks for ≤ 24 months. The primary end point was objective response rate (ORR) per RECIST v1.1. Results: Among enrolled patients (N = 165), 71.5% had confirmed papillary, 12.7% had chromophobe, and 15.8% had unclassified RCC histology. Most patients (67.9%) had intermediate or poor International Metastatic RCC Database Consortium risk status and tumors with programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 1 (61.8%). The median time from enrollment to database cutoff was 31.5 months (range, 22.7-38.8). In all patients, the ORR was 26.7%. The median duration of response was 29.0 months; 59.7% of responses lasted ≥ 12 months. The ORR by CPS ≥ 1 and CPS < 1 status was 35.3% and 12.1%, respectively. The ORR by histology was 28.8% for papillary, 9.5% for chromophobe, and 30.8% for unclassified. Overall, the median progression-free survival was 4.2 months (95% CI, 2.9 to 5.6); the 24-month rate was 18.6%. The median overall survival was 28.9 months (95% CI, 24.3 months to not reached); the 24-month rate was 58.4%. Overall, 69.7% of patients reported treatment-related adverse events, most commonly pruritus (20.0%) and hypothyroidism (14.5%). Two deaths were treatment related (pneumonitis and cardiac arrest). Conclusion: First-line pembrolizumab monotherapy showed promising antitumor activity in nccRCC. The safety profile was similar to that observed in other tumor types. Trial registration: ClinicalTrials.gov NCT02853344. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
dc.rights | CC 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, Humanized / therapeutic use* | - |
dc.subject.MESH | Antineoplastic Agents, Immunological / therapeutic use* | - |
dc.subject.MESH | Carcinoma, Renal Cell / drug therapy* | - |
dc.subject.MESH | Carcinoma, Renal Cell / pathology | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Follow-Up Studies | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | International Agencies | - |
dc.subject.MESH | Kidney Neoplasms / drug therapy* | - |
dc.subject.MESH | Kidney Neoplasms / pathology | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Prognosis | - |
dc.subject.MESH | Survival Rate | - |
dc.subject.MESH | Young Adult | - |
dc.title | Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | David F McDermott | - |
dc.contributor.googleauthor | Jae-Lyun Lee | - |
dc.contributor.googleauthor | Marek Ziobro | - |
dc.contributor.googleauthor | Cristina Suarez | - |
dc.contributor.googleauthor | Przemyslaw Langiewicz | - |
dc.contributor.googleauthor | Vsevolod Borisovich Matveev | - |
dc.contributor.googleauthor | Pawel Wiechno | - |
dc.contributor.googleauthor | Rustem Airatovich Gafanov | - |
dc.contributor.googleauthor | Piotr Tomczak | - |
dc.contributor.googleauthor | Frederic Pouliot | - |
dc.contributor.googleauthor | Frede Donskov | - |
dc.contributor.googleauthor | Boris Yakovlevich Alekseev | - |
dc.contributor.googleauthor | Sang Joon Shin | - |
dc.contributor.googleauthor | Georg A Bjarnason | - |
dc.contributor.googleauthor | Daniel Castellano | - |
dc.contributor.googleauthor | Rachel Kloss Silverman | - |
dc.contributor.googleauthor | Rodolfo F Perini | - |
dc.contributor.googleauthor | Charles Schloss | - |
dc.contributor.googleauthor | Michael B Atkins | - |
dc.identifier.doi | 10.1200/JCO.20.02365 | - |
dc.contributor.localId | A02105 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 33529058 | - |
dc.contributor.alternativeName | Shin, Sang Joon | - |
dc.contributor.affiliatedAuthor | 신상준 | - |
dc.citation.volume | 39 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 1029 | - |
dc.citation.endPage | 1039 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.39(9) : 1029-1039, 2021-03 | - |
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