Combination treatment of copanlisib and gemcitabine in relapsed/refractory PTCL (COSMOS): an open-label phase I/II trial
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Yhim, H.-Y. | - |
dc.contributor.author | Kim, T. | - |
dc.contributor.author | Kim, S.J. | - |
dc.contributor.author | Shin, H.-J. | - |
dc.contributor.author | Koh, Y. | - |
dc.contributor.author | Kim, J.S. | - |
dc.contributor.author | Park, J. | - |
dc.contributor.author | Park, G.S. | - |
dc.contributor.author | Kim, W.S. | - |
dc.contributor.author | Moon, J.H. | - |
dc.contributor.author | Yang, D.-H. | - |
dc.date.available | 2021-04-08T00:40:11Z | - |
dc.date.created | 2021-02-09 | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/80672 | - |
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. © 2020 European Society for Medical Oncology | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER | - |
dc.relation.isPartOf | Annals of Oncology | - |
dc.title | Combination treatment of copanlisib and gemcitabine in relapsed/refractory PTCL (COSMOS): an open-label phase I/II trial | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000629502100016 | - |
dc.identifier.doi | 10.1016/j.annonc.2020.12.009 | - |
dc.identifier.bibliographicCitation | Annals of Oncology, v.32, no.4, pp.552 - 559 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-85100172001 | - |
dc.citation.endPage | 559 | - |
dc.citation.startPage | 552 | - |
dc.citation.title | Annals of Oncology | - |
dc.citation.volume | 32 | - |
dc.citation.number | 4 | - |
dc.contributor.affiliatedAuthor | Park, J. | - |
dc.type.docType | Article in Press | - |
dc.subject.keywordAuthor | copanlisib | - |
dc.subject.keywordAuthor | gemcitabine | - |
dc.subject.keywordAuthor | peripheral T-cell lymphoma | - |
dc.subject.keywordAuthor | phase I/II trial | - |
dc.subject.keywordAuthor | relapsed or refractory | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea(13120)031-750-5114
COPYRIGHT 2020 Gachon University All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.