背景:这项研究的目的是分析现实世界中H101在中国恶性胸腔积液和腹水(MPE/MA)患者中的有效性和安全性。
方法:这个多中心,观察,真实世界研究招募了在2020年1月至2022年6月期间接受含H101治疗的恶性肿瘤引起的MPE/MA患者.通过总体缓解率(ORR)评估有效性,根据不良事件(AE)评估安全性。根据肿瘤类型分组的患者进行亚组分析,MPE和MA的数量,和H101的剂量。
结果:共纳入643例符合条件的患者,467人接受H101单药治疗,176人接受H101联合化疗.总患者的ORR为60.3%,其中388例PR。在H101单药治疗组中,282年MPE或MA下降(60.4%,PR)患者,176(37.7%,NC)患者MPE或MA体积无变化,和9个(1.9%,PD)患者显示增加,产生60.4%的ORR(282/467)。联合治疗组的ORR为60.2%(106/176),有106例公关,69例NC和1例PD。基于肿瘤类型的亚组分析,MPE和MA的体积,H101的剂量都显示出高ORR,大约60%。与含H101的方案相关的主要不良事件是发热,恶心和呕吐。两组均未发生严重AE。
结论:在真实世界的临床环境中初步观察到H101对MPE/MA的令人鼓舞的临床益处和可控的毒性,表明含H101的方案是可靠的,安全,可行,为这种疾病的治疗提供了一种新颖有效的选择。
The aim of this
study was to analyze the effectiveness and safety of H101 in Chinese patients with malignant pleural effusion and ascites (MPE/MA) in the real world.
This multicenter, observational, real-world
study recruited patients with MPE/MA caused by malignant tumor receiving H101-containing treatment between January 2020 and June 2022. Effectiveness was evaluated by overall remission rate (ORR), and safety was evaluated based on adverse events (AEs). Subgroup analysis was performed on patients grouped according to tumor type, the volume of MPE and MA, and dosage of H101.
A total of 643 eligible patients were enrolled, and 467 received H101 monotherapy and 176 received H101 combined with chemotherapy. The ORR of total patients was60.3% with 388 case of PR. In the H101 monotherapy group, the decrease of MPE or MA was achieved in 282 (60.4%, PR) patients, 176 (37.7%, NC) patients showed no change in volume of MPE or MA, and nine (1.9%, PD) patients showed an increase, yielding an ORR of 60.4% (282/467). The ORR for the combination therapy group was 60.2% (106/176), with 106 cases of PR, 69 cases of NC and one case of PD. Subgroup analyses based on tumor type, volume of MPE and MA, and dosage of H101 all showed high ORR, approximately 60%. The main AEs associated with H101-containing regimens were fever, nausea and vomiting. No serious AEs occurred in both groups.
Encouraging clinical benefits and manageable toxicity of H101 against MPE/MA were preliminarily observed in the real-world clinical setting, indicating that the H101-containing regimen is reliable, safe, and feasible, providing a novel and effective option for the treatment of this disease.