Cited 15 times in
Combination treatment of copanlisib and gemcitabine in relapsed/refractory PTCL (COSMOS): an open-label phase I/II trial
DC Field | Value | Language |
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dc.contributor.author | 김진석 | - |
dc.date.accessioned | 2022-09-14T01:19:05Z | - |
dc.date.available | 2022-09-14T01:19:05Z | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190393 | - |
dc.description.abstract | Background: Current treatment options for peripheral T-cell lymphomas (PTCLs) in the relapsed/refractory setting are limited and demonstrate modest response rates with rare achievement of complete response (CR). Patients and methods: This phase I/II study (NCT03052933) investigated the safety and efficacy of copanlisib, a phosphatidylinositol 3-kinase-α/-δ inhibitor, in combination with gemcitabine in 28 patients with relapsed/refractory PTCL. Patients received escalating doses of intravenous copanlisib on days 1, 8, and 15, administered concomitantly with fixed-dose gemcitabine (1000 mg/m2 on days 1 and 8) in 28-day cycles. Results: Dose-limiting toxicity was not observed in the dose-escalation phase and 60 mg copanlisib was selected for phase II evaluation. Twenty-five patients were enrolled in phase II of the study. Frequent grade ≥3 adverse events (AEs) included transient hyperglycemia (57%), neutropenia (45%), thrombocytopenia, (37%), and transient hypertension (19%). However, AEs were manageable, and none were fatal. The overall response rate was 72% with a CR rate of 32%. Median duration of response was 8.2 months, progression-free survival was 6.9 months, and median overall survival was not reached. Combination treatment produced a greater CR rate in patients with angioimmunoblastic T-cell lymphoma than those with PTCL-not otherwise specified (55.6% versus 15.4%, respectively, P = 0.074) and progression-free survival was significantly longer (13.0 versus 5.1 months, respectively, P = 0.024). In an exploratory gene mutation analysis of 24 tumor samples, TSC2 mutation was present in 25% of patients and occurred exclusively in responders. Conclusion: The combination of copanlisib and gemcitabine is a safe and effective treatment option in relapsed/refractory PTCLs and represents an important new option for therapy in this rare group of patients. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Oxford University Press | - |
dc.relation.isPartOf | ANNALS OF ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Deoxycytidine / analogs & derivatives | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lymphoma, T-Cell, Peripheral* | - |
dc.subject.MESH | Neoplasm Recurrence, Local / drug therapy | - |
dc.subject.MESH | Pyrimidines | - |
dc.subject.MESH | Quinazolines | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Combination treatment of copanlisib and gemcitabine in relapsed/refractory PTCL (COSMOS): an open-label phase I/II trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | H-Y Yhim | - |
dc.contributor.googleauthor | T Kim | - |
dc.contributor.googleauthor | S J Kim | - |
dc.contributor.googleauthor | H-J Shin | - |
dc.contributor.googleauthor | Y Koh | - |
dc.contributor.googleauthor | J S Kim | - |
dc.contributor.googleauthor | J Park | - |
dc.contributor.googleauthor | G S Park | - |
dc.contributor.googleauthor | W S Kim | - |
dc.contributor.googleauthor | J H Moon | - |
dc.contributor.googleauthor | D-H Yang | - |
dc.identifier.doi | 10.1016/j.annonc.2020.12.009 | - |
dc.contributor.localId | A01017 | - |
dc.relation.journalcode | J00171 | - |
dc.identifier.eissn | 1569-8041 | - |
dc.identifier.pmid | 33352201 | - |
dc.subject.keyword | copanlisib | - |
dc.subject.keyword | gemcitabine | - |
dc.subject.keyword | peripheral T-cell lymphoma | - |
dc.subject.keyword | phase I/II trial | - |
dc.subject.keyword | relapsed or refractory | - |
dc.contributor.alternativeName | Kim, Jin Seok | - |
dc.contributor.affiliatedAuthor | 김진석 | - |
dc.citation.volume | 32 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 552 | - |
dc.citation.endPage | 559 | - |
dc.identifier.bibliographicCitation | ANNALS OF ONCOLOGY, Vol.32(4) : 552-559, 2021-04 | - |
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