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标准 BEACOPP 方案与 ABVD 方案治疗晚期霍奇金淋巴瘤的疗效和安全性。

Efficacy and safety of standard BEACOPP regimen versus ABVD regimen for treatment of advanced Hodgkin's lymphoma.

机构信息

Department of Hematology, Beijing Cancer Hospital, Beijing, China.

Department of Hematology, West China Hospital, Sichuan University, Chengdou, China.

出版信息

J Cancer Res Ther. 2024 Aug 1;20(4):1258-1264. doi: 10.4103/jcrt.jcrt_511_23. Epub 2024 Aug 29.

Abstract

INTRODUCTION

The current treatment regimens for Hodgkin's lymphoma (HL) are associated with high incidences of adverse events.

PURPOSE

This study aimed to compare the efficacy and safety of doxorubicin + bleomycin + vincristine + dacarbazine (ABVD) and standard bleomycin + etoposide + doxorubicin + cyclophosphamide + vincristine + procarbazine + prednisone (BEACOPP) chemotherapy in the treatment of advanced stage HL.

METHODS

This multicenter, randomized, parallel, open, positive control noninferiority trial was conducted from 2016 to 2019 and comprised 93 subjects who were randomized in a 1:1 ratio between the treatment (BEACOPP; n = 44) and control (ABVD; n = 49) groups.

RESULTS

The primary efficacy endpoint of this trial was the objective response rate (ORR) after eight cycles of chemotherapy, which was 100.00% (36/36) in the treatment group and 95.74% (45/49) in the control group. The incidence of adverse reactions was 100% in both groups. Significant differences (P < 0.05) in the incidences of grade 3 (39/44 [88.64%] vs. 23/49 [46.94%]) and grade 4 (27/44 [61.36%] vs. 8/49 [16.94%]) adverse events were observed between the treatment and control groups, respectively. However, most of these reactions were manageable, with no serious consequences, and were reversible after discontinuation of the treatment.

CONCLUSION

Both regimens had a similar ORR and were associated with a high number of adverse events. The ABVD regimen was better tolerated and safer than the standard BEACOPP regimen. This study indicates that the standard BEACOPP regimen may be considered as a treatment option for patients with advanced HL.

摘要

简介

目前霍奇金淋巴瘤(HL)的治疗方案与较高的不良反应发生率相关。

目的

本研究旨在比较多柔比星+博来霉素+长春新碱+达卡巴嗪(ABVD)与标准博来霉素+依托泊苷+多柔比星+环磷酰胺+长春新碱+丙卡巴肼+泼尼松(BEACOPP)化疗治疗晚期 HL 的疗效和安全性。

方法

这是一项多中心、随机、平行、开放、阳性对照非劣效性试验,于 2016 年至 2019 年进行,共纳入 93 例患者,按 1:1 比例随机分为治疗(BEACOPP;n=44)和对照(ABVD;n=49)组。

结果

本试验的主要疗效终点为 8 个周期化疗后的客观缓解率(ORR),治疗组为 100.00%(36/36),对照组为 95.74%(45/49)。两组不良反应发生率均为 100.00%。治疗组和对照组的 3 级(39/44[88.64%] vs. 23/49[46.94%])和 4 级(27/44[61.36%] vs. 8/49[16.94%])不良事件发生率差异有统计学意义(P<0.05)。但这些反应大多是可管理的,没有严重后果,停药后可逆转。

结论

两种方案的 ORR 相似,且不良反应发生率较高。ABVD 方案的耐受性和安全性优于标准 BEACOPP 方案。本研究表明,标准 BEACOPP 方案可作为晚期 HL 患者的治疗选择之一。

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