Cited 38 times in
Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study
DC Field | Value | Language |
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dc.contributor.author | 김진석 | - |
dc.date.accessioned | 2022-09-14T01:13:50Z | - |
dc.date.available | 2022-09-14T01:13:50Z | - |
dc.date.issued | 2021-02 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190356 | - |
dc.description.abstract | Background: Natural killer/T-cell lymphoma (NKTCL) is a disease with limited treatment options and poor outcomes. Daratumumab monotherapy demonstrated clinical activity in a single-patient case report. We present data from the primary analysis of a phase 2 study of daratumumab monotherapy in relapsed or refractory (R/R) NKTCL. Methods: This phase 2 study with Simon's two-stage design evaluated daratumumab in patients with histologically confirmed extranodal NKTCL, nasal type, per WHO classification that was refractory to or relapsed after ≥ 1 line of chemotherapy, who were not candidates for other treatment modalities. All patients received daratumumab 16 mg/kg intravenously once weekly for Cycles 1 and 2, every other week for Cycles 3 through 6, and every 4 weeks thereafter until progression or unacceptable toxicity; all cycles were 28 days. The primary end point was objective response rate (ORR) based on blinded independent central review per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin Lymphoma (Lugano classification). Results: In total, 32 Asian patients received daratumumab. The ORR was 25.0% (95% confidence interval [CI] 11.5-43.4); all 8 responders had a partial response; and the median duration of response was 55.0 days (95% CI 29-339). At 10.2 months of median follow-up, median progression-free survival (PFS) was 53.0 days (95% CI 43-106); the 4-month PFS rate was 13.0%. Median overall survival (OS) was 141.0 days (95% CI 94-438); the 6-month OS rate was 42.9%. Nineteen (59.4%) patients had grade 3/4 treatment-emergent adverse events (TEAEs); the most common was thrombocytopenia (25.0%; n = 8). TEAEs leading to death occurred in 4 patients (death, respiratory failure, septic shock, and pneumonia); all were unrelated to daratumumab. Conclusions: In patients with R/R NKTCL, daratumumab monotherapy was well tolerated with no new safety concerns and achieved an ORR of 25.0%. However, no patients achieved complete response, and duration of response was short. Trial registration ClinicalTrials.gov, NCT02927925. Registered 7 October 2016. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Biomed Central | - |
dc.relation.isPartOf | JOURNAL OF HEMATOLOGY & ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antibodies, Monoclonal / therapeutic use* | - |
dc.subject.MESH | Antineoplastic Agents, Immunological / therapeutic use* | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lymphoma, Extranodal NK-T-Cell / drug therapy* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Recurrence, Local / drug therapy* | - |
dc.subject.MESH | Progression-Free Survival | - |
dc.title | Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Huiqiang Huang | - |
dc.contributor.googleauthor | Jun Zhu | - |
dc.contributor.googleauthor | Ming Yao | - |
dc.contributor.googleauthor | Tae Min Kim | - |
dc.contributor.googleauthor | Dok Hyun Yoon | - |
dc.contributor.googleauthor | Seok-Goo Cho | - |
dc.contributor.googleauthor | Hyeon Seok Eom | - |
dc.contributor.googleauthor | Soon Thye Lim | - |
dc.contributor.googleauthor | Su-Peng Yeh | - |
dc.contributor.googleauthor | Yuqin Song | - |
dc.contributor.googleauthor | Yok Lam Kwong | - |
dc.contributor.googleauthor | Jin Seok Kim | - |
dc.contributor.googleauthor | Jie Jin | - |
dc.contributor.googleauthor | Yuankai Shi | - |
dc.contributor.googleauthor | HyeJin Kim | - |
dc.contributor.googleauthor | Min Qing | - |
dc.contributor.googleauthor | Tianyuan Zhou | - |
dc.contributor.googleauthor | Grace Gao | - |
dc.contributor.googleauthor | Zongqi Dong | - |
dc.contributor.googleauthor | Ming Qi | - |
dc.contributor.googleauthor | Won Seog Kim | - |
dc.identifier.doi | 10.1186/s13045-020-01020-y | - |
dc.contributor.localId | A01017 | - |
dc.relation.journalcode | J01439 | - |
dc.identifier.eissn | 1756-8722 | - |
dc.identifier.pmid | 33588922 | - |
dc.subject.keyword | CD38 | - |
dc.subject.keyword | Daratumumab | - |
dc.subject.keyword | NK/T-cell lymphoma | - |
dc.contributor.alternativeName | Kim, Jin Seok | - |
dc.contributor.affiliatedAuthor | 김진석 | - |
dc.citation.volume | 14 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 25 | - |
dc.identifier.bibliographicCitation | JOURNAL OF HEMATOLOGY & ONCOLOGY, Vol.14(1) : 25, 2021-02 | - |
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