دورية أكاديمية
Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma
العنوان: | Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma |
---|---|
المؤلفون: | Patrick B. Johnston, Amanda F. Cashen, Petros G. Nikolinakos, Anne W. Beaven, Stefan Klaus Barta, Gajanan Bhat, Steven J. Hasal, Sven De Vos, Yasuhiro Oki, Changchun Deng, Francine M. Foss |
المصدر: | Experimental Hematology & Oncology, Vol 10, Iss 1, Pp 1-11 (2021) |
بيانات النشر: | BMC, 2021. |
سنة النشر: | 2021 |
المجموعة: | LCC:Diseases of the blood and blood-forming organs LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
مصطلحات موضوعية: | Peripheral T-cell lymphoma (PTCL), Histone deacetylase inhibitor (HDACi), Belinostat, CHOP, Diseases of the blood and blood-forming organs, RC633-647.5, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
الوصف: | Abstract Background Belinostat is a histone deacetylase inhibitor approved for relapsed refractory peripheral T-cell lymphoma (PTCL). The primary objective of this study was to determine the maximum tolerated dose (MTD) of belinostat combined with CHOP (Bel-CHOP). Secondary objectives included safety/tolerability, overall response rate (ORR), and belinostat pharmacokinetics (PK). Methods Patients were ≥ 18 years with histologically confirmed, previously untreated PTCL. Patients received belinostat (1000 mg/m2 once daily) + standard CHOP for 6 cycles with varying schedules using a 3 + 3 design in Part A. Part B enrolled patients at MTD dose. Results Twenty-three patients were treated. One patient experienced DLT (Grade 3 non-hematologic toxicity) on Day 1–3 schedule, resulting in escalation to Day 1–5 schedule (n = 3). No DLTs were observed and Day 1–5 schedule with 1000 mg/m2 was declared as MTD. Twelve additional patients were enrolled in Part B using MTD. Median relative dose intensity was 98%. All patients experienced adverse events (AEs), including nausea (78%), fatigue (61%), and vomiting (57%). Serious AEs occurred in 43%, with febrile neutropenia (17%) and pyrexia (13%). Overall ORR was 86% with 71% reported CR at MTD. Belinostat PK parameters were similar to single-agent. Conclusions Bel-CHOP was well tolerated and MTD in CHOP combination was the same dose and schedule as single agent dosing. Trial Registration: ClinicalTrials.gov Identifier: NCT01839097. |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 2162-3619 |
Relation: | https://doaj.org/toc/2162-3619 |
DOI: | 10.1186/s40164-021-00203-8 |
URL الوصول: | https://doaj.org/article/af527152ded04cb9a0629860f5f6b4cf |
رقم الأكسشن: | edsdoj.f527152ded04cb9a0629860f5f6b4cf |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 21623619 |
---|---|
DOI: | 10.1186/s40164-021-00203-8 |