Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT)
10.3760/cma.j.cn115356-20230516-00113
- VernacularTitle:盐酸米托蒽醌脂质体注射液治疗外周T细胞淋巴瘤有效性和安全性的多中心、非干预性、双向性队列真实世界研究（MOMENT）
- Author:
Huiqiang HUANG
1
;
Zhiming LI
;
Lihong LIU
;
Liang HUANG
;
Jie JIN
;
Hongyan TONG
;
Hui ZHOU
;
Zengjun LI
;
Zhenqian HUANG
;
Wenbin QIAN
;
Kaiyang DING
;
Quande LIN
;
Ming HOU
;
Yunhong HUANG
;
Jingbo WANG
;
Pengcheng HE
;
Xiuhua SUN
;
Xiaobo WANG
;
Zunmin ZHU
;
Yao LIU
;
Jinhai REN
;
Huijing WU
;
Liling ZHANG
;
Hao ZHANG
;
Liangquan GENG
;
Jian GE
;
Ou BAI
;
Liping SU
;
Guangxun GAO
;
Xin LI
;
Yanli YANG
;
Yijian CHEN
;
Aichun LIU
;
Xin WANG
;
Yi WANG
;
Liqun ZOU
;
Xiaobing HUANG
;
Dongping HUANG
;
Shujuan WEN
;
Donglu ZHAO
;
Jun MA
Author Information
1. 中山大学肿瘤防治中心淋巴瘤科，广州 510060
- Keywords:
Lymphoma, T-cell, peripheral;
Mitoxantrone hydrochloride liposome injection;
Treatment outcome;
Safety
- From:
Journal of Leukemia & Lymphoma
2023;32(8):457-464
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.
