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CHIDAMIDE PLUS CHOP VERSUS CHOP AS FRONTLINE TREATMENT IN PERIPHERAL T CELL LYMPHOMA: A RETROSPECTIVE CASE-CONTROL STUDY
Author(s): ,
Qingqing Cai
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Ning Su
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Yu Fang
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Jinni Wang
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Xiaopeng Tian
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Shuyun Ma
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Jun Cai
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Yuchen Zhang
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Huiqiang Huang
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Zhiming Li
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
He Huang
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
,
Yi Xia
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
Panpan Liu
Affiliations:
Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China;State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou,China
EHA Library. Cai Q. 06/09/21; 325297; EP537
Qingqing Cai
Qingqing Cai
Contributions
Abstract
Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP537

Type: E-Poster Presentation

Session title: Aggressive Non-Hodgkin lymphoma - Clinical

Background
Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of aggressive non-Hodgkin lymphoma. The most common frontline regimen for PTCL is cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like regimens. Several histone deacetylase inhibitors(HDACi) have been approved for relapsed and refractory PTCL patients(pts). Chidamide is a novel and orally active benzamide class of HDACi, which has been approved for treatment of PTCL after failure of at least one prior systemic therapy in China. However, whether the frontline treatment with combination of HDACi andCHOP could benefit PTCL is still controversial.

Aims
To retrospectively evaluate the efficacy and safety of chidamide plus CHOP versus CHOP as the frontline treatment for PTCL.

Methods
Medical records of 408 PTCL pts in Sun Yat-sen University Cancer Center between January 2014 and July 2020 were reviewed. We included newly diagnosed PTCL pts treated with chidamide plus CHOP(C-CHOP) or CHOP alone as frontline treatment. Pts with insufficient clinical data or treated with other regimens were excluded. A total of 22 C-CHOP pts and 22 CHOP-based controls were included after a 1 : 1 ratio case-control matching procedure was conducted, according to International Prognostic Index (IPI). Chidamide was administered at 20 mg, P.O., twice per week. Pts achieving complete response (CR) or partial response (PR) were arranged to chidamide maintenance treatment. Overall response rate(ORR), progression free survival (PFS), overall survival (OS) and adverse events (AEs) were analysed. Baseline clinical characteristics were compared using non-parametric test, χ2 test or Fisher’s exact test. Survival outcomes were assessed with Kaplan-Meier method. All statistical analyses were performed using SPSS v.24.0 software (IBM SPSS Statistics). A P value < 0.05 was considered significant.

Results
Median age of C-CHOP and CHOP group were 54.5 years (range 27-78) and 56.0 years (range 32-86) respectively. After matching, 10 female pts(45.5%) and 11 female pts (50%) were included in C-CHOP and CHOP alone group respectively. 31.8% (7/22) pts and 68.2%(15/22) pts were IPI 0-1 and IPI≥2 respectively in both groups. Baseline clinical characteristics were well balanced between two groups (P>0.05, Table 1). ORR of patients in C-CHOP group versus CHOP group was  86.4% versus 76.3%, with CR rate of 68.2% versus 59.1%(P>0.05). With a median follow-up of 22.3 months (range, 5.3–23.1 months), PFS of patients in C-CHOP group showed a statistically significant improvement versus CHOP group. Median PFS of patients in C-CHOP group versus CHOP group was not reached versus 14.2 ± 5.7 months(P=0.035, Figure 1A). However, no benefit in OS was found when CHOP was combined with chidamide in frontline treatment (not reached versus 53.1, P=0.783, Figure 1B). Most grade 3–4 AEs in C-CHOP or CHOP group were hematological toxicity, including neutropenia (36.4% versus 22.7%), thrombocytopenia (22.7% versus 9.0%) and anemia (22.7% versus 4.5%)(P>0.05).

Conclusion
Our preliminary data suggests that the addition of chidamide 20mg twice per week to frontline CHOP regimen is effective and well-tolerated in PTCL. Although chidamide plus CHOP may prolong PFS in PTCL, no benefit in OS and ORR were observed. The hematological toxicity of chidamide plus CHOP should be cautioned. The combination of chidamide and CHOP as frontline treatment for PTCL deserves further extended clinical trial.

Keyword(s): CHOP, HDAC inhibitor, Peripheral T-cell lymphoma

Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP537

Type: E-Poster Presentation

Session title: Aggressive Non-Hodgkin lymphoma - Clinical

Background
Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of aggressive non-Hodgkin lymphoma. The most common frontline regimen for PTCL is cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like regimens. Several histone deacetylase inhibitors(HDACi) have been approved for relapsed and refractory PTCL patients(pts). Chidamide is a novel and orally active benzamide class of HDACi, which has been approved for treatment of PTCL after failure of at least one prior systemic therapy in China. However, whether the frontline treatment with combination of HDACi andCHOP could benefit PTCL is still controversial.

Aims
To retrospectively evaluate the efficacy and safety of chidamide plus CHOP versus CHOP as the frontline treatment for PTCL.

Methods
Medical records of 408 PTCL pts in Sun Yat-sen University Cancer Center between January 2014 and July 2020 were reviewed. We included newly diagnosed PTCL pts treated with chidamide plus CHOP(C-CHOP) or CHOP alone as frontline treatment. Pts with insufficient clinical data or treated with other regimens were excluded. A total of 22 C-CHOP pts and 22 CHOP-based controls were included after a 1 : 1 ratio case-control matching procedure was conducted, according to International Prognostic Index (IPI). Chidamide was administered at 20 mg, P.O., twice per week. Pts achieving complete response (CR) or partial response (PR) were arranged to chidamide maintenance treatment. Overall response rate(ORR), progression free survival (PFS), overall survival (OS) and adverse events (AEs) were analysed. Baseline clinical characteristics were compared using non-parametric test, χ2 test or Fisher’s exact test. Survival outcomes were assessed with Kaplan-Meier method. All statistical analyses were performed using SPSS v.24.0 software (IBM SPSS Statistics). A P value < 0.05 was considered significant.

Results
Median age of C-CHOP and CHOP group were 54.5 years (range 27-78) and 56.0 years (range 32-86) respectively. After matching, 10 female pts(45.5%) and 11 female pts (50%) were included in C-CHOP and CHOP alone group respectively. 31.8% (7/22) pts and 68.2%(15/22) pts were IPI 0-1 and IPI≥2 respectively in both groups. Baseline clinical characteristics were well balanced between two groups (P>0.05, Table 1). ORR of patients in C-CHOP group versus CHOP group was  86.4% versus 76.3%, with CR rate of 68.2% versus 59.1%(P>0.05). With a median follow-up of 22.3 months (range, 5.3–23.1 months), PFS of patients in C-CHOP group showed a statistically significant improvement versus CHOP group. Median PFS of patients in C-CHOP group versus CHOP group was not reached versus 14.2 ± 5.7 months(P=0.035, Figure 1A). However, no benefit in OS was found when CHOP was combined with chidamide in frontline treatment (not reached versus 53.1, P=0.783, Figure 1B). Most grade 3–4 AEs in C-CHOP or CHOP group were hematological toxicity, including neutropenia (36.4% versus 22.7%), thrombocytopenia (22.7% versus 9.0%) and anemia (22.7% versus 4.5%)(P>0.05).

Conclusion
Our preliminary data suggests that the addition of chidamide 20mg twice per week to frontline CHOP regimen is effective and well-tolerated in PTCL. Although chidamide plus CHOP may prolong PFS in PTCL, no benefit in OS and ORR were observed. The hematological toxicity of chidamide plus CHOP should be cautioned. The combination of chidamide and CHOP as frontline treatment for PTCL deserves further extended clinical trial.

Keyword(s): CHOP, HDAC inhibitor, Peripheral T-cell lymphoma

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