Abstract
Purpose: Peripheral T-cell lymphomas (PTCLs) represent a diverse group of non-Hodgkin lymphomas with a poor prognosis and no accepted standard of care for patients with relapsed or refractory disease. This study evaluated the efficacy and tolerability of belinostat, a novel histone deacetylase inhibitor, as a single agent in relapsed or refractory PTCL. Patients and Methods: Patients with confirmed PTCL who experienced progression after ≥ one prior therapy received belinostat 1,000 mg/m2 as daily 30-minute infusions on days 1 to 5 every 21 days. Central assessment of response used International Working Group criteria. Primary end point was overall response rate. Secondary end points included duration of response (DoR) and progression-free and overall survival. Results: A total of 129 patients were enrolled, with a median of two prior systemic therapies. Overall response rate in the 120 evaluable patients was 25.8% (31 of 120), including 13 complete (10.8%) and 18 partial responses (15%). Median DoR by International Working Group criteria was 13.6 months, with the longest ongoing patient at ≥ 36 months. Median progression-free and overall survival were 1.6 and 7.9 months, respectively. Twelve of the enrolled patients underwent stem-cell transplantation after belinostat monotherapy. The most common grade 3 to 4 adverse events were anemia (10.8%), thrombocytopenia (7%), dyspnea (6.2%), and neutropenia (6.2%). Conclusion: Monotherapy with belinostat produced complete and durable responses with manageable toxicity in patients with relapsed or refractory PTCL across the major subtypes, irrespective of number or type of prior therapies. These results have led to US Food and Drug Administration approval of belinostat for this indication.
| Original language | English |
|---|---|
| Pages (from-to) | 2492-2499 |
| Number of pages | 8 |
| Journal | Journal of Clinical Oncology |
| Volume | 33 |
| Issue number | 23 |
| DOIs | |
| Publication status | Published - aug. 10 2015 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
- Medicine(all)
Cite this
Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma : Results of the pivotal phase II BELIEF (CLN-19) study. / O'Connor, Owen A.; Horwitz, Steven; Masszi, T.; Van Hoof, Achiel; Brown, Peter; Doorduijn, Jeannette; Hess, Georg; Jurczak, Wojciech; Knoblauch, Poul; Chawla, Shanta; Bhat, Gajanan; Choi, Mi Rim; Walewski, Jan; Savage, Kerry; Foss, Francine; Allen, Lee F.; Shustov, Andrei.
In: Journal of Clinical Oncology, Vol. 33, No. 23, 10.08.2015, p. 2492-2499.Research output: Article
}
TY - JOUR
T1 - Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma
T2 - Results of the pivotal phase II BELIEF (CLN-19) study
AU - O'Connor, Owen A.
AU - Horwitz, Steven
AU - Masszi, T.
AU - Van Hoof, Achiel
AU - Brown, Peter
AU - Doorduijn, Jeannette
AU - Hess, Georg
AU - Jurczak, Wojciech
AU - Knoblauch, Poul
AU - Chawla, Shanta
AU - Bhat, Gajanan
AU - Choi, Mi Rim
AU - Walewski, Jan
AU - Savage, Kerry
AU - Foss, Francine
AU - Allen, Lee F.
AU - Shustov, Andrei
PY - 2015/8/10
Y1 - 2015/8/10
N2 - Purpose: Peripheral T-cell lymphomas (PTCLs) represent a diverse group of non-Hodgkin lymphomas with a poor prognosis and no accepted standard of care for patients with relapsed or refractory disease. This study evaluated the efficacy and tolerability of belinostat, a novel histone deacetylase inhibitor, as a single agent in relapsed or refractory PTCL. Patients and Methods: Patients with confirmed PTCL who experienced progression after ≥ one prior therapy received belinostat 1,000 mg/m2 as daily 30-minute infusions on days 1 to 5 every 21 days. Central assessment of response used International Working Group criteria. Primary end point was overall response rate. Secondary end points included duration of response (DoR) and progression-free and overall survival. Results: A total of 129 patients were enrolled, with a median of two prior systemic therapies. Overall response rate in the 120 evaluable patients was 25.8% (31 of 120), including 13 complete (10.8%) and 18 partial responses (15%). Median DoR by International Working Group criteria was 13.6 months, with the longest ongoing patient at ≥ 36 months. Median progression-free and overall survival were 1.6 and 7.9 months, respectively. Twelve of the enrolled patients underwent stem-cell transplantation after belinostat monotherapy. The most common grade 3 to 4 adverse events were anemia (10.8%), thrombocytopenia (7%), dyspnea (6.2%), and neutropenia (6.2%). Conclusion: Monotherapy with belinostat produced complete and durable responses with manageable toxicity in patients with relapsed or refractory PTCL across the major subtypes, irrespective of number or type of prior therapies. These results have led to US Food and Drug Administration approval of belinostat for this indication.
AB - Purpose: Peripheral T-cell lymphomas (PTCLs) represent a diverse group of non-Hodgkin lymphomas with a poor prognosis and no accepted standard of care for patients with relapsed or refractory disease. This study evaluated the efficacy and tolerability of belinostat, a novel histone deacetylase inhibitor, as a single agent in relapsed or refractory PTCL. Patients and Methods: Patients with confirmed PTCL who experienced progression after ≥ one prior therapy received belinostat 1,000 mg/m2 as daily 30-minute infusions on days 1 to 5 every 21 days. Central assessment of response used International Working Group criteria. Primary end point was overall response rate. Secondary end points included duration of response (DoR) and progression-free and overall survival. Results: A total of 129 patients were enrolled, with a median of two prior systemic therapies. Overall response rate in the 120 evaluable patients was 25.8% (31 of 120), including 13 complete (10.8%) and 18 partial responses (15%). Median DoR by International Working Group criteria was 13.6 months, with the longest ongoing patient at ≥ 36 months. Median progression-free and overall survival were 1.6 and 7.9 months, respectively. Twelve of the enrolled patients underwent stem-cell transplantation after belinostat monotherapy. The most common grade 3 to 4 adverse events were anemia (10.8%), thrombocytopenia (7%), dyspnea (6.2%), and neutropenia (6.2%). Conclusion: Monotherapy with belinostat produced complete and durable responses with manageable toxicity in patients with relapsed or refractory PTCL across the major subtypes, irrespective of number or type of prior therapies. These results have led to US Food and Drug Administration approval of belinostat for this indication.
UR - http://www.scopus.com/inward/record.url?scp=84940562761&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84940562761&partnerID=8YFLogxK
U2 - 10.1200/JCO.2014.59.2782
DO - 10.1200/JCO.2014.59.2782
M3 - Article
C2 - 26101246
AN - SCOPUS:84940562761
VL - 33
SP - 2492
EP - 2499
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 23
ER -