罗米地辛对老年外周T细胞淋巴瘤患者有效且耐受性良好：两项II期试验分析

Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials.

作者信息

Shustov Andrei, Coiffier Bertrand, Horwitz Steven, Sokol Lubomir, Pro Barbara, Wolfson Julie, Balser Barbara, Eisch Robin, Popplewell Leslie, Prince H Miles, Allen Steven L, Piekarz Richard, Bates Susan

机构信息

a Department of Hematology , University of Washington Medical Center , Seattle , WA , USA.

b Department of Hematology , Hospices Civils de Lyon , Lyon , France.

出版信息

Leuk Lymphoma. 2017 Oct;58(10):2335-2341. doi: 10.1080/10428194.2017.1295143. Epub 2017 Mar 7.

DOI:10.1080/10428194.2017.1295143

PMID:28264616

Abstract

UNLABELLED

Peripheral T-cell lymphomas (PTCLs) are a rare group of lymphoid neoplasms with high relapse rates after initial therapy and poor prognosis. Most patients are aged ≥60 years and are often not candidates for aggressive salvage therapies. Romidepsin, a potent class I histone deacetylase inhibitor, has shown significant single-agent activity in relapsed/refractory PTCL. We evaluated the efficacy and tolerability of romidepsin in elderly patients in this setting. Ninety-five patients aged ≥60 years were identified from 2 prospective phase 2 registration trials of romidepsin, and comparative analyses were performed with younger patients from these trials. Response rates, progression-free survival, and overall survival were not statistically different for younger vs older patients. The toxicity profile in older and younger patients was similar in both trials. Romidepsin demonstrated similar efficacy and tolerability in younger and older patients and presents an attractive treatment option for relapsed/refractory PTCL regardless of age.

TRIAL REGISTRATION

Clinicaltrials.gov identifiers: NCT00426764, NCT00007345.

摘要

未标注

外周T细胞淋巴瘤（PTCL）是一组罕见的淋巴瘤，初始治疗后复发率高，预后差。大多数患者年龄≥60岁，通常不适合进行积极的挽救治疗。罗米地辛是一种有效的I类组蛋白脱乙酰酶抑制剂，在复发/难治性PTCL中显示出显著的单药活性。我们评估了罗米地辛在老年患者中的疗效和耐受性。从两项罗米地辛的前瞻性2期注册试验中确定了95例年龄≥60岁的患者，并与这些试验中的年轻患者进行了比较分析。年轻患者与老年患者的缓解率、无进展生存期和总生存期无统计学差异。两项试验中老年患者和年轻患者的毒性特征相似。罗米地辛在年轻和老年患者中显示出相似的疗效和耐受性，无论年龄大小，都是复发/难治性PTCL的一个有吸引力的治疗选择。