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本妥昔单抗维罗昔单抗联合环磷酰胺、表柔比星和泼尼松治疗未经治疗的外周 T 细胞淋巴瘤的短期疗效和安全性:一项真实世界、回顾性研究。

The Short-Term Efficacy and Safety of Brentuximab Vedotin Plus Cyclophosphamide, Epirubicin and Prednisone in Untreated PTCL: A Real-World, Retrospective Study.

机构信息

Department of Hematology, The First Hospital of Jilin University, 3808 Jiefang Rd, Hongqi Street, Chaoyang District, Changchun, 130021, Jilin, China.

Department of Pathology, Duke University Medical Center and Cancer Institute, Durham, NC, USA.

出版信息

Adv Ther. 2022 Jan;39(1):532-543. doi: 10.1007/s12325-021-01943-z. Epub 2021 Nov 19.

Abstract

INTRODUCTION

Brentuximab vedotin (BV) showed high overall remission rates in refractory/relapsed classical Hodgkin's lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). Although the efficacy of BV has been reported in clinical trials, its efficacy as a frontline therapy in real world for patients with CD30 positive subtypes of non-Hodgkin's lymphoma (NHL) such as peripheral T-cell lymphoma with T-follicular helper cell (TFH) phenotype (PTCL, TFH), anaplastic large-cell lymphoma (ALCL) and angioimmunoblastic T-cell lymphoma (AITL) in China has not been well documented.

METHODS

Analysis of a real-world, observational, retrospective case series in patients suffering from AITL, sALCL and peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH) and other types of PTCL treated with BV in frontline treatment was conducted. The patients were given treatment from May 2020 till June 28, 2021. All patients were pathologically diagnosed to have PTCL before treatment and expressed CD30. Patients received BV (1.8 mg/kg) combined with CEP (cyclophosphamide, epirubicin, prednisone acetate every 3 weeks). The primary endpoint was objective response rates (ORR), and secondary endpoints were duration of response and incidence of adverse events (AEs). Exploratory endpoints such as progression-free survival (PFS) are discussed even though after such a short period.

RESULTS

Nineteen patients completed ≥ 1 cycles of BV-CEP treatment (16 cases completed ≥ 4 cycles, 3 cases only completed 1 cycle). Among them, the ORR reached 89.5% [CR 52.7%; partial response (PR) 36.8%]. In the ALCL group, CR reached 100% with the median duration of response of up to 8 months, while in the AITL group, the ORR was 75% and 2 patients had disease progression after treatment with BV + CEP. We also observed that BV-CEP may extend the PFS compared to traditional chemotherapy such as the CHOEP regimen (BV-CEP: not evaluable, CHOEP: 6.5 months), although the median follow-up was only 6.7 months. Adverse events (AEs), including incidence and severity of febrile neutropenia (26% patients in the BV-CEP group and 30% in the CHOEP group), were similar between groups. There was no incidence of AEs leading to treatment withdrawal or death under BV-CEP treatment.

CONCLUSION

BV is a promising treatment in patients with ALCL, AITL and PTCL-TFH in frontline treatment settings.

摘要

简介

Brentuximab vedotin(BV)在难治性/复发性经典霍奇金淋巴瘤(HL)和系统性间变性大细胞淋巴瘤(sALCL)中显示出高总体缓解率。尽管在临床试验中已经报道了 BV 的疗效,但在中国,其作为 CD30 阳性亚型非霍奇金淋巴瘤(NHL)如外周 T 细胞淋巴瘤伴滤泡辅助 T 细胞表型(PTCL,TFH)、间变性大细胞淋巴瘤(ALCL)和血管免疫母细胞性 T 细胞淋巴瘤(AITL)的一线治疗的疗效尚未得到很好的记录。

方法

对 2020 年 5 月至 2021 年 6 月 28 日期间接受 BV 一线治疗的 AITL、sALCL 和外周 T 细胞淋巴瘤伴滤泡辅助 T 细胞表型(PTCL-TFH)和其他类型 PTCL 的患者进行了真实世界、观察性、回顾性病例系列分析。所有患者在治疗前均经病理诊断为 PTCL,且表达 CD30。患者接受 BV(1.8mg/kg)联合 CEP(环磷酰胺、表柔比星、泼尼松龙每 3 周)治疗。主要终点是客观缓解率(ORR),次要终点是缓解持续时间和不良事件(AE)发生率。虽然在这么短的时间内,但仍讨论了探索性终点,如无进展生存期(PFS)。

结果

19 名患者完成了≥1 个周期的 BV-CEP 治疗(16 例完成了≥4 个周期,3 例仅完成了 1 个周期)。其中,ORR 达到 89.5%[完全缓解(CR)52.7%;部分缓解(PR)36.8%]。在 ALCL 组中,CR 达到 100%,反应持续时间中位数可达 8 个月,而在 AITL 组中,ORR 为 75%,2 例患者在接受 BV+CEP 治疗后疾病进展。我们还观察到,与传统化疗(如 CHOEP 方案)相比,BV-CEP 可能延长 PFS(BV-CEP:不可评估,CHOEP:6.5 个月),尽管中位随访时间仅为 6.7 个月。两组间发热性中性粒细胞减少症的发生率和严重程度(BV-CEP 组为 26%,CHOEP 组为 30%)相似。在 BV-CEP 治疗下,没有因 AE 导致治疗中断或死亡的情况。

结论

BV 是 ALCL、AITL 和 PTCL-TFH 患者一线治疗的一种有前途的治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6b4/8799538/5ef390bd8fd9/12325_2021_1943_Fig1_HTML.jpg

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