Patients with RR DLBCL who have received ≥ 2 lines of therapy have limited treatment options and an expected overall survival (OS) of < 6 months. The SADAL study evaluated single-agent oral selinexor in patients with RR DLBCL and demonstrated an overall response rate (ORR) of 29.1% with median duration of response (DOR) of 9.3 months. The analyses described here evaluated a number of subpopulations in order to understand how response correlates with survival outcomes in order to identify patients who could most optimally benefit from selinexor treatment. Median age was 67 years; 44.8% of patients were ≥ 70 years of age. The median OS was 9.0 months (95% CI 6.2, 13.7) at a median follow-up of 14.8 months. The median OS was not reached in patients with a CR or PR, while patients who did not respond have a median OS of 4.9 months (p < 0.0001). Patients < 70 years had an OS of 11.1 months compared with 7.8 months in patients ≥ 70 years. Among patients with or without prior ASCT, the median OS was 10.9 and 7.8 months, respectively. Among patients with disease refractory to the most recent DLBCL treatment regimen, the median OS was 7.0 months compared with 11.1 months for disease not refractory to the most recent treatment. In a patient population in which survival is expected to be < 6 months, treatment with single-agent oral selinexor was associated with a median survival of 9 months. Increased median OS observed in patients responding to selinexor was consistent across subgroups regardless of age, prior ASCT therapy, or refractory status. Randomized studies of selinexor in combination with a variety of other anti-DLBCL agents are planned. This trial was registered at ClinicalTrials.gov (NCT02227251) on August 28, 2014. https://clinicaltrials.gov/ct2/show/NCT02227251 .

中文翻译：

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SADAL 研究中使用单药 selinexor 治疗的复发/难治性弥漫性大 B 细胞淋巴瘤患者的生存率

已接受 ≥ 2 线治疗的 RR DLBCL 患者的治疗选择有限，预期总生存期 (OS) < 6 个月。SADAL 研究在 RR DLBCL 患者中评估了单药口服 selinexor，显示总缓解率 (ORR) 为 29.1%，中位缓解持续时间 (DOR) 为 9.3 个月。此处描述的分析评估了许多亚群，以了解反应如何与生存结果相关，从而确定最能从 selinexor 治疗中受益的患者。中位年龄为 67 岁；44.8% 的患者年龄≥ 70 岁。中位 OS 为 9.0 个月（95% CI 6.2, 13.7），中位随访时间为 14.8 个月。CR 或 PR 患者的中位 OS 未达到，而无反应患者的中位 OS 为 4.9 个月（p < 0.0001）。< 70 岁患者的 OS 为 11.1 个月，而 ≥ 70 岁患者的 OS 为 7.8 个月。在有或没有既往 ASCT 的患者中，中位 OS 分别为 10.9 和 7.8 个月。在对最新 DLBCL 治疗方案无效的疾病患者中，中位 OS 为 7.0 个月，而对最新治疗无效的疾病的中位 OS 为 11.1 个月。在预计生存期 < 6 个月的患者群体中，单药口服 selinexor 治疗与 9 个月的中位生存期相关。无论年龄、既往 ASCT 治疗或难治状态如何，在对 selinexor 有反应的患者中观察到的中位 OS 增加在各亚组中是一致的。计划对 selinexor 与多种其他抗 DLBCL 药物联合进行随机研究。