Safety of chidamide plus rituximab in elderly patients with relapsed or refractory B-cell lymphoma in China: a multicenter, single-arm, phase II study

Xinrui Chen; Huaqing Wang; Xiuhua Sun; Liping Su; Fengting Liu; Ke Zhao; Liye Xu; Shaohua Wu; Teng Song

doi:10.21037/atm-21-6019

Safety of chidamide plus rituximab in elderly patients with relapsed or refractory B-cell lymphoma in China: a multicenter, single-arm, phase II study

Ann Transl Med. 2021 Dec;9(24):1769. doi: 10.21037/atm-21-6019.

Authors

Xinrui Chen^{1

2}, Huaqing Wang^{1

2}, Xiuhua Sun³, Liping Su⁴, Fengting Liu^{1

2}, Ke Zhao^{1

2}, Liye Xu³, Shaohua Wu⁴, Teng Song^{1

2}

Affiliations

¹ Department of Oncology, Tianjin Union Medical Center, Nankai University, Tianjin, China.
² The Institute of Translational Medicine, Tianjin Union Medical Center, Nankai University, Tianjin, China.
³ Department of Oncology, Second Hospital of Dalian Medical University, Dalian, Liaoning, China.
⁴ Department of Hematology, Shanxi Provincial Cancer Hospital, Taiyuan, China.

Abstract

Background: Patients over 65 years old with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) relapse or being refractory to rituximab-associated chemotherapy have limited treatment options. Chidamide has the ability to enhance the sensitivity of rituximab-resistant tumors in vivo has been confirmed. We aimed to assess the activity and safety profile of chidamide plus rituximab in elderly Chinese patients with recurrent or refractory B-cell lymphoma.

Methods: In this prospective, single-arm phase II trial, we enrolled patients from three hospitals in China with histopathological diagnoses of DLBCL and FL who had relapsed or were refractory to previous lines of rituximab-associated chemotherapy. Patients were given chidamide (10 mg on days 1-6 and 8-14) and rituximab (375 mg/m² on day 7). The treatments were repeated every 21 days. The primary endpoint was the objective response rate (ORR). The secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results: Thirteen patients were enrolled and commenced treatment between November 12, 2018, and December 24, 2020. As of March 20, 2021, two patients (15.4%) were still receiving treatment. The median follow-up was 13.4 months. The ORR was 40% for the DLBCL cohort (n=10), and 100% for the FL cohort (n=3). DLBCL patients had a median PFS (mPFS) of 2.6 months (0.9-31.2 months) and a median OS (mOS) of 16.7 months (2.3-13.6 months). Neither mPFS nor mOS was reached in the FL cohort. The most frequent treatment-related adverse events (TRAEs) were leukopenia (38.5%), neutropenia (30.8%), lymphopenia (30.8%), thrombocytopenia (30.8%), fatigue (38.5%), and hyperuricemia (30.8%).

Conclusions: Chidamide plus rituximab is clinically effective with an acceptable toxicity profile in elderly patients over 65 years old with relapsed or refractory DLBCL and FL. Further investigation is ongoing.

Keywords: Diffuse large B-cell lymphoma (DLBCL); follicular lymphoma (FL); histone deacetylase inhibitor (HDACi).