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

Ningjing Lin, Chuan He, Qingyuan Zhang, Xiaonan Hong, Lihong Liu, Shune Yang, Hang Su, Xiaoyi Li, Xiangrong Dai, Yujie Li, Jun Zhu
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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.

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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对比。
简介:目前治疗霍奇金淋巴瘤(HL)的方案不良反应发生率较高: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)和标准博来霉素+依托泊苷+多柔比星+环磷酰胺+长春新碱+丙卡巴嗪+泼尼松(BEACOPP)化疗治疗晚期霍奇金淋巴瘤的疗效和安全性:这项多中心、随机、平行、开放、阳性对照的非劣效性试验于2016年至2019年进行,93名受试者按1:1的比例随机分为治疗组(BEACOPP;n=44)和对照组(ABVD;n=49):该试验的主要疗效终点是八个化疗周期后的客观反应率(ORR),治疗组为100.00%(36/36),对照组为95.74%(45/49)。两组的不良反应发生率均为100%。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%])不良反应发生率分别有显著差异(P < 0.05)。然而,这些不良反应大多是可控的,没有严重后果,并且在停止治疗后是可逆的:结论:两种方案的ORR相似,但不良反应较多。ABVD方案比标准BEACOPP方案更耐受、更安全。这项研究表明,标准BEACOPP方案可作为晚期HL患者的一种治疗选择。
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