1.Efficacy and safety of induction therapy with first-line chidamide plus chemotherapy and sequential chidamide maintenance therapy for peripheral T-cell lymphoma
Donglu ZHAO ; Ou BAI ; Jun MA
Journal of Leukemia & Lymphoma 2025;34(4):222-229
Objective:To evaluate the efficacy and safety of induction therapy with first-line chidamide plus chemotherapy and sequential chidamide maintenance therapy for peripheral T-cell lymphoma (PTCL) to provide evidence for clinical medication.Methods:The relevant literature in the databases of Cochrane Library, PubMed, EMbase, Web of Science, Chinese Biomedical Database, China National Knowledge Infrastructure Database, Wanfang, and VIP from December 2014 to November 2023 were retrieved. Meta-analysis and comparison were conducted on the objective response rate (ORR), complete remission (CR) rate, progression-free survival (PFS), and overall survival (OS) of patients receiving induction therapy with first-line chidamide plus chemotherapy and sequential chidamide maintenance therapy (chidamide combined with chemotherapy group) and those receiving chemotherapy alone (control group). A systematic descriptive analysis was performed on the occurrence of adverse events.Results:A total of 5 relevant literature on the induction therapy with first-line chidamide plus CHOP/CHOP-like regimens and sequential chidamide maintenance therapy for PTCL was included, including 350 initial-treated PTCL patients. Among them, there were 176 cases in the chidamide combined with chemotherapy group and 174 cases in the control group. The CR rate of the chidamide combined with chemotherapy group was higher than that of the control group [59.6% (90/151) (95% CI: 51.9%-67.5%) vs. 41.6% (62/149) (95% CI: 27.8%-51.7%)], and the difference was statistically significant ( P < 0.01); the ORR of the chidamide combined with chemotherapy group was 83.4% (126/151) (95% CI: 73.3%-94.1%), while the control group was 69.1% (103/149) (95% CI: 58.4%-79.2%), and the difference was not statistically significant ( P = 0.051). The 2-year PFS rate of the chidamide combined with chemotherapy group was higher than that of the control group [60.2% (106/176) (95% CI: 47.1%-74.6%) vs. 31.6% (55/174) (95% CI: 17.8%-45.7%)], and the difference was statistically significant ( P < 0.01); the 2-year OS rate of the chidamide combined with chemotherapy group was higher than that of the control group [83.2% (114/137) (95% CI: 66.8%-100.0%) vs. 53.4% (93/174) (95% CI: 42.1%-67.9%)], and the difference was statistically significant ( P < 0.01). There was no statistically significant difference between the chidamide combined with chemotherapy group and the control group in the incidence of grade 3-4 neutropenia [60.6% (20/33) and 57.6% (19/33)], anemia [17.9% (20/112) and 16.0% (17/106)] and thrombocytopenia [22.3% (25/112) and 22.6% (24/106)] (all P > 0.05); during the maintenance therapy with chidamide, the incidence of grade 3-4 neutropenia, anemia and thrombocytopenia was 28.1% (9/32), 12.5% (4/32) and 15.6% (5/32), respectively; the hematological adverse events mostly occured within 6 weeks of initial administration and were relieved after symptomatic treatment. Conclusions:Compared with only receiving chemotherapy, the first-line combination therapy with chidamide and CHOP/CHOP-like regimens can improve the CR rate of PTCL patients, and the maintenance therapy with chidamide alone after remission can improve PFS and OS and the hematological adverse reactions are tolerable.
2.Progress of treatment strategies for follicular lymphoma
Zhaoxia LI ; Jia LI ; Ou BAI
Journal of Leukemia & Lymphoma 2025;34(10):630-633
Follicular lymphoma (FL) is a group of indolent tumors originating in the lymphohematopoietic system including lymph nodes and lymphoid tissues. The survival of FL has been significantly improved through the continuous development and optimization of novel drugs and therapeutic regimens. This article reviews the research progress of treatment strategies for newly diagnosed and relapsed/refractory FL.
3.Observation on the Therapeutic Effect of Internal and External Application of Osteoking in Treating Knee Osteoarthritis of Cold-Damp Blockage Type
Yixiao XIONG ; Qindai LIU ; Linhan BAI ; Sheng HUA ; Zuyu TANG ; Ke LIU ; Liang OU ; Jianjun KUANG
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(2):298-308
Objective To observe the clinical efficacy of oral use combined with targeted transdermal delivery of Osteoking in treating knee osteoarthritis(KOA)of cold-damp blockage type.Methods A total of 120 patients with KOA of cold-damp blockage type who admitted to Hunan Provincial Hospital of Integrated Traditional Chinese And West Medicine from September 2022 to September 2023 were randomly divided into the control group,oral use group,transdermal delivery group and combination group according to the random number table method,with 30 cases in each group.The control group was treated with Celecoxib Capsule orally,the oral use group was treated with Osteoking orally,the transdermal delivery group was treated with Osteoking by targeted transdermal delivery,and the combination group was treated with oral use combined with targeted transdermal delivery of Osteoking.One course of treatment covered 12 days,and all of the four groups were treated for two continuous courses.Before and after treatment,the scores of traditional Chinese medicine(TCM)syndrome,Visual Analogue Scale(VAS)for pain,Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)for joint function,36-Item Short Form Health Survey(SF-36)for quality of life(QOL),as well as the levels of serum interleukin 1β(IL-1β),interleukin 6(IL-6),and tumor necrosis factor α(TNF-α)were observed in the patients of each group.After treatment,the clinical efficacy and safety of patients in each group were evaluated.Results(1)After two courses of treatment,the total effective rate of the combination group was 96.67%(29/30),which was higher than those of the control group[73.33%(22/30)],oral use group and transdermal delivery group[both being 70.00%(21/30)],and the difference was statistically significant(P<0.05).However,no statistically significant difference of the total effective rate was presented among the control group,oral use group,and transdermal delivery group(P>0.05).(2)After treatment,the scores of TCM syndrome,VAS for pain and WOMAC for joint function in the four groups were decreased compared with those before treatment(P<0.01).The intergroup comparison showed that the scores of TCM syndrome,VAS for pain and WOMAC in the combination group were lower than those in the other three groups(P<0.05),while no statistically significant difference of the scores of TCM syndrome,VAS for pain and WOMAC were presented among the control group,oral use group,and transdermal delivery group(P>0.05).(3)After treatment,the QOL scores of the eight dimensions of SF-36 such as physical functioning(PF),bodily pain(BP),general health(GH),vitality(VT),role-physical(RP),social functioning(SF),role-emotional(RE),and mental health(MH)in the four groups were significantly increased compared with those before treatment(P<0.01).The intergroup comparison showed that the scores of each dimension of SF-36 in the combination group were significantly higher than those in the other three groups(P<0.05),while no statistically significant difference of the dimension score of SF-36 was presented among the control group,oral use group,and transdermal delivery group(P>0.05).(4)After treatment,the levels of serum inflammatory factors of IL-1β,IL-6,and TNF-α in the four groups were decreased compared with those before treatment(P<0.01).The intergroup comparison showed that the decrease of serum levels of inflammatory factors in the combination group were significantly superior to those in the other three groups(P<0.05),and the decrease in the control group and oral use group were all superior to those in the transdermal delivery group(P<0.05),while the difference between the control group and oral use group was not statistically significant(P>0.05).(5)During the trial,no serious adverse reactions were found in the patients of four groups,which is of high safety.Conclusion Oral use combined with targeted transdermal delivery of Osteoking is effective on improving the joint pain,joint function and QOL of patients with KOA of cold-damp blockage type,and can speed up the rehabilitation of patients.Its therapeutic mechanism may be related to the decrease of the expression level of inflammatory factors.
4.Application of poly-D-lysine in assisting suspension cells transfection and colony formation experiments
Jia LI ; Jianpeng ZHOU ; Ou BAI
Journal of Leukemia & Lymphoma 2024;33(9):528-533
Objective:To investigate the application of poly-D-lysine (PDL) in assisting suspension cells transfection and colony formation experiments.Methods:The human-derived diffuse large B-cell lymphoma (DLBCL) cell line SU-DHL-4 was selected. The cytotoxicity of different concentrations (0.01, 0.1, 1.0, 10.0 mg/ml) of PDL solution on SU-DHL-4 cells was assessed by using the CCK-8 assay, and cell viability was calculated. SU-DHL-4 cells with normal morphology in logarithmic growth phase were seeded into 96-well plates coated and uncoated with PDL. Cells were then infected with viral suspensions at a multiplicity of infection (MOI) of 50 or 100, and cell morphology was observed. A stable SU-DHL-4 cell model transfected with the luciferase gene was constructed by using lentiviral infection method. The infected SU-DHL-4 cells were divided into the control group (infected with control virus fluid) and the experimental group (infected with virus fluid carrying luciferase gene). The transfected cells were continuously cultured in RPMI 1640 complete medium containing puromycin. A dual-luciferase gene reporter assay kit was used to detect fluorescence intensity. Colony formation experiments with suspension cells were conducted by using PDL-coated dishes. The cells were cultured in RPMI 1640 complete medium containing 0.1% dimethyl sulfoxide (DMSO) (the control group), 0.1 μmol/L etoposide (group A), and 0.2 μmol/L etoposide (group B), and colony formation was observed and colony formation rate was calculated.Results:After 48 h of seeding SU-DHL-4 cells into 96-well plates coated with 0.01, 0.1, 1.0, and 10.0 mg/ml PDL, cell viability was (98.1±1.6)%, (97.1±0.7)%, (91.7±1.5)%, and (83.3±2.0)%, respectively, compared to (100.0±2.7)% in the control group (not adding PDL solution). There were no statistically significant differences between 0.01 and 0.1 mg/ml PDL-coated groups and the control group (both P > 0.05); there were statistically significant differences between 1.0 and 10.0 mg/ml PDL-coated groups and the control group (both P < 0.001). There were statistically significant differences between 1.0 mg/ml and 10.0 mg/ml PDL-coated groups ( t = 5.80, P = 0.004). Therefore, 0.1 mg/ml PDL-coated dishes, which showed no obvious toxicity to SU-DHL-4 cell growth, were used in subsequent experiments. SU-DHL-4 cells seeded in uncoated dishes grew in suspension, while SU-DHL-4 cells seeded in 0.1 mg/ml PDL-coated dishes adhered to the dish bottom and exhibited a monolayer growth pattern. SU-DHL-4 cells seeded in uncoated 96-well plates and infected with viral suspensions at MOI 50 or 100 failed to transfect. However, when SU-DHL-4 cells were seeded in PDL-coated 96-well plates, the originally suspended cells adhered to the dish bottom and exhibited a monolayer growth pattern, and gentle shaking did not dislodge the cells, which maintained intact and smooth cell membrane structures. After puromycin selection, the fluorescence intensity of SU-DHL-4 cells in the experimental group was 106 times that of cells in the control group (26 903±248 vs. 252±11, t = 186.10, P < 0.001), indicating successful transfection. Compared to the control group, colony formation was reduced and smaller in group A, and nearly no colony formation was observed in group B. The colony formation rates in the control group, group A, and group B were (100±6)%, (48±5)%, and 0, respectively, and the differences were statistically significant between groups A and the control group, between group B and the control group ( t = 11.13 for group A, t = 28.53 for group B, both P < 0.001). Conclusions:PDL-coated dishes at a concentration of 0.1 mg/ml can increase the transfection efficiency of suspension cells and assist in colony formation experiments with suspension cells.
5.Influencing of preoperative total bilirubin on perioperative complications of hepatolithiasis receiving liver resection
Xia OU ; Yule LUO ; Zhipeng LIU ; Haisu DAI ; Yi GONG ; Ying WU ; Yan JIANG ; Jie BAI ; Shuo JIN ; Zhiyu CHEN
Chinese Journal of Digestive Surgery 2024;23(8):1087-1092
Objective:To investigate the influencing of preoperative total bilirubin (TBil) on perioperative complications of hepatolithiasis receiving liver resection.Methods:The retrospective cohort study was conducted. The clinical data of 300 patients with hepatolithiasis who were admitted to 2 medical centers from January 2010 to January 2022 were collected. There were 115 males and 185 females, aged (54±13)years. Measurement data with normal distribution were represented as Mean± SD, and the independent sample t test was used for comparison between groups. Measurement data with skewed distribution were represented as M( Q1, Q3), and the Mann-Whitney U test was used for comparison between groups. Count data were expressed as absolute numbers, and the chi-square test was used for comparison between groups. Variables with P<0.10 in the univariate analysis were included into the multivariate analysis. Univariate analysis was conducted using the Logistic regression model,and multivariate analysis was conducted using the Logistic stepwise regression model with backward Wald method. Continuous variables were converted into categorical variables based on commonly reported cutoff values when conducting Logistic regression analysis. Results:(1) Comparison of clinical data of patients with different preoperative TBil. Of 300 patients with hepatolithiasis, there were 252 cases with low level of preoperative TBil as 14.4(11.1,19.7)μmol/L, and there were 48 cases with high level of preoperative TBil as 44.0(31.3,59.8)μmol/L. Of the pati-ents with low level of preoperative TBil, neutrophils percentage was 62%±10%, cases with intra-operative blood transfusion was 29, and cases undergoing anatomical liver resection was 166. Of the patients with high level of preoperative TBil, neutrophils percentage was 70%±11%, cases with intraoperative blood transfusion was 22, and cases undergoing anatomical liver resection was 15. There were significant differences in cases classified as>grade 2 of ASA classification, neutrophils percentage, cases with intraoperative blood transfusion and cases undergoing anatomical liver resection between patients with low and high level of preoperative TBil ( t=5.182, χ2=33.669, 18.775, P<0.05). (2) Comparison of perioperative complications of patients with different preoperative TBil. Of the 252 patients with low level of TBil, there were 151 cases with complications including 35 cases of serious complications, there was 1 case with postoperative liver failure, the duration of postoperative hospital stay was 13.0(10.0,16.0)days. Of the 48 patients with high level of TBil, there were 32 cases with complications including 17 cases of serious complications, there were 6 cases with postoperative liver failure, the duration of postoperative hospital stay was 14.0(10.0,18.8)days. There were significant differences in cases with serious complications and cases with postoperative liver failure between patients with low and high level of preoperative TBil ( χ2=13.041, 20.879, P<0.05). (3) Analysis of factors influencing postoperative serious complications in patients undergoing liver resection. Results of multivariate analysis showed that age, body mass index (BMI), preoperative TBil and volume of intraoperative blood loss were independent factors influencing postoperative serious complications in patients undergoing liver resection for hepatolithiasis ( odds ratio=3.852, 2.358, 2.935, 5.135, 95% confidence interval as 1.478?9.979, 1.110?5.009, 1.398?6.158, 2.088?12.626, P<0.05). Conclusions:Patients with high level of preoperative TBil have a significantly increased risk of postoperative serious complications and liver failure who receive liver resection for hepatolithiasis. Age, preoperative BMI, TBil and volume of intraoperative blood loss are independent factors influencing postoperative serious complications in patients undergoing liver resection for hepatolithiasis.
6.Mechanism of GLI1 mediated macrophages polarization in hypoxic pulmonary hypertension
Xiangrui ZHU ; Jian MEI ; Zhaosi WANG ; Langlin OU ; Lixin ZHANG ; Xiaoying WANG ; Siyu HE ; Jun'e BAI ; Xiaoyu GUAN ; Hao YUAN ; Cui MA
Chinese Journal of Immunology 2024;40(5):1016-1022
Objective:To explore effect of Glioma-associated oncogene family zinc finger 1(GLI1)on hypoxia induced trans-formation of NR8383 to M1 phenotype and development of pulmonary hypertension(PH).Methods:Fifteen adult male Wistar rats were randomly divided into control group,hypoxia PH model group and hypoxic PH with GANT61 treatment group,with 5 rats in each group.PH related indexes of rats were detected by small animal ultrasound and right cardiac catheter experiment to determine effect of GLI1 specific inhibitor GANT61 on progression of PH.Pulmonary arterial thickness was measured by HE staining.α-SMA and M1 polarization markers TNF-α and IL-1β expressions were determined by immunohistochemistry.M1 polarization markers CD86 and TNF-α expressions were determined by immunofluorescence.GLI1 expression and NF-κB protein were detected by Western blot.mRNA expressions of iNOS,CD86,TNF-α,IL-1β and IL-12 were detected by qRT-PCR.CHIP-PCR verified that GLI1 regulates NF-κB promoter activity.IL-12 content was detected by ELISA.Rat pulmonary artery smooth muscle cells proliferation was detected by CCK-8.Results:GLI1 inhibitor GANT61 could alleviate symptoms of PH in hypoxic rats(P<0.05).Compared with hypoxic group,inhibition of GLI1 reduced expressions of TNF-α and IL-1β in rat lung tissue(P<0.05).In cell experiments,hypoxia induced M1 polarization of NR8383 by up-regulating GLI1 to activate NF-κB pathway,GLI1 overexpression increased expressions of iNOS,CD86,TNF-α,IL-1β and IL-12 in M1 macrophages(P<0.05).NR8383 culture supernatants could stimulate pulmonary artery smooth muscle cell proliferation(P<0.05)and contribute to development of PH.Conclusion:Hypoxia activates NF-κB pathway by up-regulating GLI1 to induce M1 polarization of macrophages contributes to development of PH.
7.Ameliorative effects of Schisandrol A in Suhuang antitussive capsule on post-infectious cough
Nan WU ; Zi-Yu BAI ; Yong-Yu OU ; Tong-Lian DI ; Zi-Yao ZHAO ; Hong JIANG ; Zhi-Hao ZHANG ; Ning-Hua TAN
Chinese Traditional Patent Medicine 2024;46(8):2562-2571
AIM To investigate the ameliorative effects of Schisandrol A(Sol A)in Suhuang antitussive capsule on post-infectious cough(PIC).METHODS The in vivo mouse PIC model was established by intratracheal instillation of lipopolysaccharide(LPS)combined with cigarette smoke exposure.The mice were randomly divided into the control group,the model group,the Suhuang antitussive capsule group(14 g/kg),the montelukast sodium positive control group(3 mg/kg),and low and high dose Sol A groups(10,30 mg/kg).The in vitro PIC model was established by stimulating human bronchial epithelial cells(BEAS-2B)with LPS.The cells were divided into the control group,the model group,the Suhuang antitussive capsule group(10 μg/mL)and low and high dose Sol A groups(3,10 μmol/L).HE and Masson staining were used to detect the pathological changes of the lung and bronchial tissues.ELISA was used to detect the levels of IL-1β,IL-6,TNF-α,ROS,MDA,SOD and GSH in the lung tissues.RT-qPCR was used to detect the IL-1β,IL-6 and TNF-α mRNA expressions in BEAS-2B cells.And Western blot was applied to detect the protein expressions of p-PI3K,p-Akt,NOX4,SIRT1,p-ERK,Fibronectin,E-cadherin,Vimentin and α-SMA in mouse lung tissue and BEAS-2B cells.RESULTS Compared with the model group,the groups intervened with Sol A or Suhuang antitussive capsule displayed prolonged cough latency(P<0.01);reduced cough frequency(P<0.01);relieved pulmonary inflammatory cell infiltration and collagen deposition in PIC mice;decreased pulmonary levels of IL-1β,IL-6,TNF-α,ROS,MDA and protein expressions of Fibronectin,Vimentin,α-SMA,p-ERK,p-PI3K,p-Akt,and NOX4(P<0.05,P<0.01);increased pulmonary levels of SOD and GSH and protein expressions of E-cadherin and SIRT1(P<0.05,P<0.01);decreased ROS level,IL-1β,IL-6,TNF-α mRNA expressions and p-ERK,p-PI3K,p-Akt,NOX4 protein expressions in vitro(P<0.05,P<0.01);and increased SIRT1 protein expression in vitro as well(P<0.01).CONCLUSION Being the main antitussive component of Suhuang antitussive capsule upon the PIC model,Sol A inhibits the inflammation via SIRT1/ERK signaling pathway and relieve the oxidative stress via PI3K/Akt/NOX4 signaling pathway.
8.Ameliorative effects of praeruptorin A from Suhuang antitussive capsules on cough variant asthma
Zi-Yao ZHAO ; Hong JIANG ; Yong-Yu OU ; Xiao-Yuan CHEN ; Nan WU ; Zi-Yu BAI ; Zhi-Hao ZHANG ; Ning-Hua TAN
Chinese Traditional Patent Medicine 2024;46(9):2904-2914
AIM To explore the effects of praeruptorin A from Suhuang antitussive capsules on cough variant asthma(CVA).METHODS The rats were randomly divided into the normal group,the model group,the dexamethasone group(0.5 mg/kg),the Suhuang antitussive capsules group(7 g/kg)and the low,medium and high dose praeruptorin A groups(15,30 and 60 mg/kg).The rat model of CVA was established by intraperitoneal injection of sensitizer(1 mg/mL ovalbumin and 10 mg/mL aluminum hydroxide)and aerosol inhalation of 1%ovalbumin followed by the corresponding dosing of drugs by gavage initiated on the 14th day.Another 14 days later,the rats had their pathological pulmonary changes observed by HE,Masson and PAS stainings;their number of inflammatory cells in bronchoalveolar lavage fluid(BALF)detected by hematology analyzer;and their levels of IL-4,IL-5,IL-13 and MUC5AC in BALF detected by ELISA.The RAW264.7 cell inflammatory model induced by lipopolysaccharide(LPS)was treated with 4,8,16 μmol/L praeruptorin A or 0.25 mg/mL Suhuang antitussive capsules,respectively.And the cells had their NO level detected by Griess method,and their ROS expression observed using fluorescence microscopy.The detections of the pulmonary and cellular mRNA expressions of IL-6,IL-1β,COX-2,iNOS and PPAR-γ by RT-qPCR;and the protein expressions of p-P65,P65,p-IκBα,IκBα,NLRP3,caspase-1(p20)and IL-1β by Western blot were conducted in both the cells and the rats.RESULTS The in vivo result showed that praeruptorin A reduced the cough frequency(P<0.01);prolonged the cough latency(P<0.05,P<0.01);reduced the number of eosinophils and neutrophils in BALF(P<0.05,P<0.01);decreased the levels of IL-4,IL-5,IL-13 and MUC5AC in BALF and the pulmonary mRNA expressions of IL-6,IL-1β,COX-2 and iNOS(P<0.05,P<0.01);and decreased the phosphorylation of P65 and IκBα protein and NLRP3,caspase-1(p20)and IL-1β protein expressions(P<0.05,P<0.01)as well.The in vitro result showed that praeruptorin A inhibited the release of LPS-induced NO and reduce the ROS level(P<0.01);decreased the mRNA expressions of IL-1β,COX-2 and iNOS(P<0.05,P<0.01);increased PPAR-γ mRNA expression(P<0.05),and decreased the phosphorylation of P65 and IκBα protein and the expression of NLRP3 protein(P<0.05,P<0.01).CONCLUSION Praeruptorin A,one of the main antitussive components of Suhuang antitussive capsules,may improve CVA because of its anti-inflammatory and antitussive role by inhibiting the activation of NF-κB signaling pathway and reducing the expression of NLRP3 inflammatory corpuscles.
9.Clinical treatment analysis of newly treated peripheral T-cell lymphoma
Xianying YIN ; Wei GUO ; Xingtong WANG ; Ou BAI
Journal of Leukemia & Lymphoma 2023;32(4):221-225
Objective:To investigate the treatment methods of peripheral T-cell lymphoma (PTCL).Methods:The clinical data of 251 newly treated PTCL patients in the First Hospital of Jilin University from August 2011 to October 2021 were retrospectively analyzed, from which 168 patients were intercepted from February 2015 (the first targeted drug of PTCL, chidamide, was launched in China) to October 2021, among which 20 patients received chemotherapy combined with brentuximab vedotin (BV, BV group), 37 patients received chemotherapy combined with chidamide (chidamide group), and 111 patients received non-targeted therapy (non-targeted therapy group); all patients received ≥2 courses of treatment. Ten patients received autologous peripheral blood hematopoietic stem cell transplantation, with non-transplanted patients in the same period as controls. The clinical efficacy and prognosis of patients with different treatment methods were analyzed. Kaplan-Meier method was used for survival analysis and log-rank test was performed.Results:Of all 251 patients with PTCL, 26.7% (67/251) received targeted therapy in combination with chemotherapy. In the chidamide group, the efficacy could be evaluated in 36 cases, with an overall response rate (ORR) of 91.7% (33/36); in the non-targeted therapy group, the efficacy could be evaluated in 88 cases, with an ORR of 71.6% (63/88); in the BV group, 20 cases were evaluable, with an ORR of 75.0% (15/20). The difference in ORR between the non-targeted therapy group and the chidamide group was statistically significant ( χ2 = 5.89, P = 0.015), and the difference in ORR between the non-targeted therapy group and the BV group was not statistically significant ( χ2 = 0.09, P = 0.759). The 1-year progression-free survival (PFS) rates were 79.9%, 88.2% and 64.2%, and the 1-year overall survival (OS) rates were 85.7%, 89.7% and 70.1% in the chidamide, BV and non-targeted therapy groups, respectively; the PFS and OS in the chidamide and BV groups were better than those in the non-targeted therapy group (all P < 0.05), and the adverse effects were mostly tolerable. Among patients treated with chemotherapy combined with BV, the ORR of patients with CD30 expression rate <60% and ≥60% were 54.5% (6/11) and 100.0% (9/9), and the difference was statistically significant ( P = 0.038). In the 10 hematopoietic stem cell transplanted patients and 50 non-transplanted patients, 1-year PFS rates were 87.5% and 59.5%, 1-year OS rates were 90.0% and 67.1%, and the differences were not statistically significant (both P > 0.05). Conclusions:Chemotherapy-based combination therapy is the main treatment methods for PTCL, and chemotherapy combined with chidamide or BV targeted therapy and hematopoietic stem cell transplantation can improve the long-term survival of PTCL patients.
10.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)
Huiqiang HUANG ; 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
Journal of Leukemia & Lymphoma 2023;32(8):457-464
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.

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