Cited 6 times in
Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study
DC Field | Value | Language |
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dc.contributor.author | 김진석 | - |
dc.date.accessioned | 2022-12-22T01:27:28Z | - |
dc.date.available | 2022-12-22T01:27:28Z | - |
dc.date.issued | 2022-02 | - |
dc.identifier.issn | 2152-2650 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/191228 | - |
dc.description.abstract | Introduction: This double-blind, parallel-group, active-controlled phase III trial (NCT02260804) assessed CT-P10 and rituximab safety and efficacy in patients with previously untreated low-tumor-burden follicular lymphoma (LTBFL), including after a single switch from rituximab to CT-P10. Patients and methods: LTBFL patients were randomized (1:1) to receive CT-P10 or rituximab (375 mg/m2 intravenously; day 1 of 4 7-day cycles). Patients achieving disease control entered a 2-year maintenance period. CT-P10 or rituximab were administered every 8 weeks (6 cycles) in year 1; all patients could receive CT-P10 (every 8 weeks; 6 cycles) in year 2. Secondary endpoints (reported here) were overall response rate (ORR) during the study period, progression-free survival (PFS), time to progression (TTP), and overall survival (OS). Safety and immunogenicity were evaluated. Results: Between November 9, 2015 and January 4, 2018, 258 patients were randomized (130 for CT-P10; 128 for rituximab). ORR was similar between groups over the study period (CT-P10: 88%; rituximab: 87%). After 29.2 months' median follow-up, median PFS, TTP, and OS were not estimable; 24-month Kaplan-Meier estimates suggested similarity between groups. Overall, 114 (CT-P10: 88%), and 104 (rituximab: 81%) patients experienced treatment-emergent adverse events. The single switch was well tolerated. Conclusion: These updated data support therapeutic similarity of CT-P10 and rituximab and support the use of CT-P10 monotherapy for previously untreated LTBFL. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | CLINICAL LYMPHOMA MYELOMA & LEUKEMIA | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal, Murine-Derived* / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols | - |
dc.subject.MESH | Biosimilar Pharmaceuticals | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lymphoma, Follicular* / drug therapy | - |
dc.subject.MESH | Lymphoma, Follicular* / pathology | - |
dc.subject.MESH | Rituximab / adverse effects | - |
dc.title | Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Larry W Kwak | - |
dc.contributor.googleauthor | Juan-Manuel Sancho | - |
dc.contributor.googleauthor | Seok-Goo Cho | - |
dc.contributor.googleauthor | Hideyuki Nakazawa | - |
dc.contributor.googleauthor | Junji Suzumiya | - |
dc.contributor.googleauthor | Gayane Tumyan | - |
dc.contributor.googleauthor | Jin Seok Kim | - |
dc.contributor.googleauthor | Tobias Menne | - |
dc.contributor.googleauthor | José Mariz | - |
dc.contributor.googleauthor | Nikolai Ilyin | - |
dc.contributor.googleauthor | Wojciech Jurczak | - |
dc.contributor.googleauthor | Aurelio Lopez Martinez | - |
dc.contributor.googleauthor | Olga Samoilova | - |
dc.contributor.googleauthor | Edvard Zhavrid | - |
dc.contributor.googleauthor | Eduardo Yañez Ruiz | - |
dc.contributor.googleauthor | Marek Trneny | - |
dc.contributor.googleauthor | Leslie Popplewell | - |
dc.contributor.googleauthor | Michinori Ogura | - |
dc.contributor.googleauthor | Won-Seog Kim | - |
dc.contributor.googleauthor | Sang Joon Lee | - |
dc.contributor.googleauthor | Sung Hyun Kim | - |
dc.contributor.googleauthor | Keum Young Ahn | - |
dc.contributor.googleauthor | Christian Buske | - |
dc.identifier.doi | 10.1016/j.clml.2021.08.005 | - |
dc.contributor.localId | A01017 | - |
dc.relation.journalcode | J04262 | - |
dc.identifier.eissn | 2152-2669 | - |
dc.identifier.pmid | 34686445 | - |
dc.subject.keyword | Biosimilar | - |
dc.subject.keyword | Single switch | - |
dc.subject.keyword | Therapeutic similarity | - |
dc.subject.keyword | Time-to-event data | - |
dc.contributor.alternativeName | Kim, Jin Seok | - |
dc.contributor.affiliatedAuthor | 김진석 | - |
dc.citation.volume | 22 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 89 | - |
dc.citation.endPage | 97 | - |
dc.identifier.bibliographicCitation | CLINICAL LYMPHOMA MYELOMA & LEUKEMIA, Vol.22(2) : 89-97, 2022-02 | - |
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