Virginia Cancer Specialists, US Oncology Research, Johns Hopkins Medicine, Fairfax, VA.
RTI Health Solutions, Research Triangle Park, NC.
Clin Lymphoma Myeloma Leuk. 2022 Mar;22(3):158-168. doi: 10.1016/j.clml.2021.09.001. Epub 2021 Sep 22.
Loncastuximab tesirine has shown antitumor activity with an acceptable toxicity profile in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were relapsed or refractory after ≥2 prior therapies, including activity in patients with high-risk disease characteristics. This analysis examined health-related quality of life (HRQoL), symptoms, and tolerability in patients receiving loncastuximab tesirine for relapsed or refractory DLBCL.
The single-arm, open-label phase II LOTIS-2 study (ADCT-402-201; NCT03589469) enrolled 145 patients aged ≥18 years. Patients received loncastuximab tesirine as a 30-minute intravenous infusion on day 1 of each 3-week treatment cycle. Patient-reported outcomes were measured using EQ-5D and FACT-Lym at baseline, day 1 of each cycle, and the end-of-treatment visit.
During the course of treatment, EQ VAS overall health score was improved over time. The adjusted improvement was 0.65 per cycle (95% CI, 0.26-1.04; P = .001), and the adjusted mean change from baseline score was 5.00 (95% CI, 1.75-8.25; P = .003) at cycle 9, day 1. FACT-Lym total scores remained stable during treatment. More patients reported improvement compared to baseline in pain, lumps/swelling, and losing weight for a majority of visits. More than 60% of patients reported being "not at all" or "a little bit" bothered by treatment side effects for all treatment visits. Findings in elderly patients were similar to the population as whole.
The findings on HRQoL, symptoms, and tolerability further support the clinical use of loncastuximab tesirine for the treatment of relapsed or refractory DLBCL.
This work was funded by ADC Therapeutics SA. Authors affiliated with ADC Therapeutics SA participated in designing the study; in collecting, analyzing, and interpreting the data; in writing the report; and in the decision to submit the article for publication.
Loncastuximab tesirine 在复发或难治性弥漫性大 B 细胞淋巴瘤(DLBCL)患者中显示出抗肿瘤活性,这些患者在接受≥2 种先前治疗后复发或难治,包括高危疾病特征患者。这项分析检查了接受 loncastuximab tesirine 治疗的复发或难治性 DLBCL 患者的健康相关生活质量(HRQoL)、症状和耐受性。
这项单臂、开放标签的 II 期 LOTIS-2 研究(ADCT-402-201;NCT03589469)纳入了 145 名年龄≥18 岁的患者。患者在每个 3 周治疗周期的第 1 天接受 30 分钟静脉输注 loncastuximab tesirine。使用 EQ-5D 和 FACT-Lym 在基线、每个周期的第 1 天和治疗结束时测量患者报告的结果。
在治疗过程中,EQ VAS 总体健康评分随时间改善。每个周期的调整改善为 0.65(95%CI,0.26-1.04;P=.001),从基线评分的调整平均变化为 5.00(95%CI,1.75-8.25;P=.003)在第 9 个周期的第 1 天。在治疗期间,FACT-Lym 总评分保持稳定。与大多数就诊时相比,更多患者报告疼痛、肿块/肿胀和体重减轻有所改善。超过 60%的患者报告在所有治疗就诊时,治疗副作用“一点也不”或“有点”困扰。老年患者的发现与整个人群相似。
HRQoL、症状和耐受性的发现进一步支持 loncastuximab tesirine 治疗复发或难治性 DLBCL 的临床应用。
这项工作由 ADC Therapeutics SA 资助。与 ADC Therapeutics SA 有关联的作者参与了研究的设计;数据的收集、分析和解释;报告的撰写;以及决定提交文章供发表。