Phase II trial of romidepsin as consolidation therapy after gemcitabine, dexamethasone, and cisplatin in elderly transplant-ineligible patients with relapsed/refractory peripheral T- cell lymphoma

Abstract

Abstract Romidepsin is an important therapeutic option for patients with peripheral T-cell lymphoma (PTCL). However, the timing of romidepsin administration remains controversial. The objective of this study was to characterize the safety and efficacy of romidepsin as consolidation therapy after gemcitabine, dexamethasone, and cisplatin (GDP) therapy (GDPR). This study of patients treated between March 2019 and March 2021 was registered with the Japan Registry of Clinical Trials (registration number: jRCT0000000519). If complete response, partial response, or stable disease was confirmed after 2–4 GDP cycles, romidepsin was administered every 4 weeks until 1 year. The outcomes of patients participating in this prospective study (PTCL-GDPR) who were receiving GDPR between 2000 and 2015 before starting this trial were retrospectively reviewed. Seven patients with relapsed/refractory (R/R) PTCL [T-follicular helper phenotype (n = 1) and angioimmunoblastic T-cell lymphoma (AITL, n = 6)] were included in PTCL-GDPR. The outcomes of eight patients with R/R PTCL not otherwise specified and seven patients with AITL were retrospectively reviewed. After a median follow-up of 34, 63, and 65 months in patients in PTCL-GDPR and the retrospective cohorts with PTCL-NOS and AITL, respectively, the 2-year OS rates were 71%, 100%, and 100%, respectively, and the overall response rates after treatment were 57%, 100%, and 100%, respectively. Common adverse events in patients in PTCL-GDPR included hematological toxicities such as neutropenia, which improved with supportive treatment. There were no treatment-related mortalities. GDPR might be safe and effective in elderly transplant-ineligible patients with R/R PTCL, and further investigation is warranted.