背景:目前霍奇金淋巴瘤(HL)的治疗方案与不良事件的高发生率相关。
目的:本研究旨在比较阿霉素+博来霉素+长春新碱+达卡巴嗪(ABVD)和标准博来霉素+依托泊苷+环磷酰胺+长春新碱+丙卡巴嗪+泼尼松(BEACOPP)化疗治疗晚期HL的疗效和安全性。
方法:这个多中心,随机化,平行,打开,阳性对照非劣效性试验于2016年至2019年进行,包括93名受试者,这些受试者在治疗组(BEACOPP;n=44)和对照组(ABVD;n=49)之间以1:1的比例随机分组.
结果:本试验的主要疗效终点是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%。3级发病率差异显著(P<0.05)(39/44[88.64%]vs.23/49[46.94%])和4级(27/44[61.36%]与8/49[16.94%])治疗组和对照组之间观察到不良事件,分别。然而,这些反应大多是可控的,没有严重的后果,并且在停止治疗后是可逆的。
结论:两种治疗方案的ORR相似,且与大量不良事件相关。ABVD方案比标准BEACOPP方案具有更好的耐受性和安全性。这项研究表明,标准BEACOPP方案可被视为晚期HL患者的治疗选择。
BACKGROUND: The current treatment regimens for Hodgkin\'s lymphoma (HL) are associated with high incidences of adverse events.
OBJECTIVE: 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.
CONCLUSIONS: 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.