Janssen Scientific Affairs, LLC, Horsham, PA, USA.
Analysis Group, Inc, Montréal, Canada.
Curr Med Res Opin. 2023 Sep;39(9):1227-1235. doi: 10.1080/03007995.2023.2243815. Epub 2023 Aug 21.
To evaluate the time to discontinuation (TTD) and baseline characteristics among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) treated with first-line (1L) venetoclax + obinutuzumab (VO) in the United States.
A nationwide electronic health record-derived database was used to select adults with CLL/SLL initiating a 1L venetoclax-based regimen between April 11, 2016-July 31, 2020. Study measures included TTD (defined as >120-day treatment gap or switching therapy) and baseline characteristics by discontinuation status.
A total of 113 patients receiving 1L VO on/before July 31, 2020 were eligible for analysis (mean age: 65.9 years; 31.9% women). During the first 60 days post-treatment initiation, 3.5% had tumor lysis syndrome (TLS). The proportion of patients using corticosteroids, anti-hyperuricemics, and anti-emetics was higher during the first 60 days post-treatment initiation (100.0%, 78.8%, and 52.2%, respectively) than the period from day 61 onward (67.0%, 45.5%, and 33.9%, respectively). Mean (median) duration of active treatment was 11.6 (12.1) months; 16.8% discontinued treatment before completing 12 cycles, 68.1% completed ≥12 cycles (among which 29.9% completed ≥15 cycles), and 15.0% who did not discontinue treatment were censored before completing 12 cycles. Kaplan-Meier analysis showed that median TTD was 13.8 months. Relative to those completing ≥12 cycles, patients discontinuing treatment before completing the prescribed 12 cycles were older (70.4 vs. 65.1 years) and had poorer renal function (36.8% vs. 13.0% with creatinine clearance <60 mL/min).
A small proportion of CLL/SLL patients who were older and had poorer baseline renal function discontinued 1L VO prior to completing 12 treatment cycles. Additionally, treatment utilization, including medications related to TLS mitigation and management, was more intense during the initiation phase of VO. Further research with longer follow-up to assess long-term outcomes of VO treatment after early discontinuation is warranted.
评估美国接受一线（1L）维奈托克联合奥滨尤妥珠单抗（VO）治疗的慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者的停药时间（TTD）和基线特征。
使用全国性的电子病历数据库，筛选 2016 年 4 月 11 日至 2020 年 7 月 31 日期间开始使用 1L 维奈托克为基础的治疗方案的 CLL/SLL 成年患者。研究措施包括根据停药状态的 TTD（定义为>120 天的治疗间隔或转换治疗）和基线特征。
共有 113 名患者于 2020 年 7 月 31 日前接受 1L VO 治疗，符合分析条件（平均年龄：65.9 岁；31.9%为女性）。在治疗开始后的头 60 天，有 3.5%的患者发生肿瘤溶解综合征（TLS）。在治疗开始后的头 60 天内，使用皮质类固醇、降尿酸药和止吐药的患者比例较高（分别为 100.0%、78.8%和 52.2%），而在第 61 天及以后，使用这三种药物的患者比例分别为 67.0%、45.5%和 33.9%（分别）。平均（中位数）治疗持续时间为 11.6（12.1）个月；16.8%的患者在完成 12 个周期前停药，68.1%的患者完成了≥12 个周期（其中 29.9%的患者完成了≥15 个周期），15.0%未停药的患者在完成 12 个周期前被删失。Kaplan-Meier 分析显示，中位 TTD 为 13.8 个月。与完成 12 个周期的患者相比，在完成规定的 12 个周期前停药的患者年龄较大（70.4 岁 vs. 65.1 岁），且肾功能较差（36.8% vs. 13.0%的患者肌酐清除率<60ml/min）。
少数年龄较大、基线肾功能较差的 CLL/SLL 患者在完成 12 个治疗周期前停止了 1L VO 治疗。此外，在 VO 治疗开始阶段，治疗的使用，包括与 TLS 缓解和管理相关的药物，更为集中。需要进行更长时间的随访，以进一步研究 VO 治疗早期停药后的长期结局。
