西达本胺联合阿扎胞苷治疗复发/难治性血管免疫母细胞性T细胞 淋巴瘤的前瞻性临床研究.

Objective To investigate the efficacy and safety of chidamide combined with azacitidine in treating relapsed/refractory angioimmunoblastic T⁃cell lymphoma (AITL). Methods The study was a single⁃center prospective clinical trial at Peking Union Medical College. The eligible patients were pathologically confirmed with AITL and met the criteria for relapsed/ refractory lymphoma. Treat⁃ ment included subcutaneous injection of azactidine azacitidine (100 m/d for 7 d) combined with oral chidamide (20 mg/d twice weekly) in a 4 weeks cycle. Results A total of 7 patients were enrolled from March 2021 to August 2022. The median age of disease onset was 53 (range 45-75) years and the median line of previous treatment was 2 (range 1-4) line. After treatment, complete remission (CR) was achieved in 2 cases and partial remission in 3 cases. The objective response rate was 71.4% and the CR rate was 28.6%. As of August 2022, the median follow⁃up time was 14 months (range 4-17 months). 6 patients survived and 1 patient died, and the median progres⁃ sion⁃free survival (PFS), duration of response, and overall survival (OS) of the whole group were not reached. The 1⁃year PFS and OS rates were 51.4% and 100.0%, respectively. Treatment ⁃ related adverse events were mainly hematological toxicity. The incidence of grade 3-4 neutropenia and thrombocytopenia were 28.6% (2/7) and 14.3% (1/7), respectively. Conclusions Azacitidine combined with chidamide has a high remission rate and safety profile in treating relapsed/refractory AITL, and dual epigenetic regulating drugs may serve as a second⁃line treatment option for patients with AITL. [ABSTRACT FROM AUTHOR]