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Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study
LW. Kwak, JM. Sancho, SG. Cho, H. Nakazawa, J. Suzumiya, G. Tumyan, JS. Kim, T. Menne, J. Mariz, N. Ilyin, W. Jurczak, A. Lopez Martinez, O. Samoilova, E. Zhavrid, E. Yañez Ruiz, M. Trneny, L. Popplewell, M. Ogura, WS. Kim, SJ. Lee, SH. Kim, KY....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
- MeSH
- biosimilární léčivé přípravky MeSH
- folikulární lymfom * farmakoterapie patologie MeSH
- lidé MeSH
- myší monoklonální protilátky * škodlivé účinky MeSH
- protokoly antitumorózní kombinované chemoterapie MeSH
- rituximab škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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.
Celltrion Inc Incheon 22014 South Korea
Comprehensive Cancer Center Duarte CA 91010
Department of Hematology and Oncology Kasugai Municipal Hospital Aichi 486 8510 Japan
Department of Hematology Hospital Arnau de Vilanova Valencia Comunidad Valenciana 46015 Spain
Department of Hematology Nizhniy Novgorod Region Clinical Hospital Nizhniy Novgorod 603126 Russia
Department of Hematology Shinshu University School of Medicine Nagano 390 8621 Japan
Department of Medicine Charles University 128 08 Czech Republic
Maria Sklodowska Curie National Research Institute of Oncology 331 115 Kraków Poland
Northern Institute for Cancer Care Newcastle University NE7 7DN UK
Citace poskytuje Crossref.org
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