TY - JOUR
T1 - Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma
T2 - prolonged stable disease provides clinical benefits for patients in the pivotal trial
AU - Foss, Francine
AU - Horwitz, Steven
AU - Pro, Barbara
AU - Prince, H. Miles
AU - Sokol, Lubomir
AU - Balser, Barbara
AU - Wolfson, Julie
AU - Coiffier, Bertrand
N1 - Funding Information:
This study was supported by the research funding from Celgene Corporation. The authors take full responsibility for the content of this manuscript but thank Stacey Rose, PhD and William Ho, PhD (MediTech Media), for providing medical editorial assistance during the preparation of this manuscript. Financial support for medical editorial assistance was provided by Celgene Corporation.
Publisher Copyright:
© 2016 Foss et al.
PY - 2016/3/10
Y1 - 2016/3/10
N2 - Background: Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD). Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130), including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD. Methods: Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m2 romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months. Results: Of the 32 patients (25 %) with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment). The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m2 on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated. Conclusions: We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses. Trial registration: NCT00426764.
AB - Background: Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD). Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130), including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD. Methods: Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m2 romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months. Results: Of the 32 patients (25 %) with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment). The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m2 on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated. Conclusions: We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses. Trial registration: NCT00426764.
KW - Peripheral T cell lymphoma
KW - Romidepsin
KW - Stable disease
UR - http://www.scopus.com/inward/record.url?scp=84960853949&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84960853949&partnerID=8YFLogxK
U2 - 10.1186/s13045-016-0243-8
DO - 10.1186/s13045-016-0243-8
M3 - Article
C2 - 26965915
AN - SCOPUS:84960853949
SN - 1756-8722
VL - 9
JO - Journal of Hematology and Oncology
JF - Journal of Hematology and Oncology
IS - 1
M1 - 243
ER -
