Huntington Scott F, Rhodes Joanna M, Manzoor Beenish S, Jawaid Dureshahwar, Puckett Justin T, Emechebe Nnadozie, Ravelo Arliene, Kamal-Bahl Sachin, Marx Steven E, Doshi Jalpa A
Yale University, New Haven, CT.
Rutgers University, New Brunswick, NJ.
JCO Oncol Pract. 2025 Aug;21(8):1124-1133. doi: 10.1200/OP.24.00220. Epub 2024 Dec 20.
Venetoclax and Bruton's tyrosine kinase inhibitors (BTKis) are key treatment options for patients with chronic lymphocytic leukemia (CLL) in the frontline setting. This study characterized postdiscontinuation treatment patterns and hospitalization of frontline venetoclax and BTKis in a national sample of older adults with CLL.
We identified 1,770 Medicare beneficiaries 66 years and older with CLL initiating venetoclax with obinutuzumab (VEN-O, n = 193) or BTKi treatment (n = 1,577) in the frontline setting between June 01, 2019, and June 30, 2020. Discontinuation was defined as a consecutive 90-day gap in treatment at any point over an 18-month follow-up. BTKi patients were expected to receive treatment continuously; VEN-O patients were expected to complete 11 months of treatment (12 cycles × 28 days = 336 days). The rates of subsequent CLL treatment and all-cause/CLL-related hospitalization were assessed.
Over an 18-month follow-up, 102 (52.8%) VEN-O patients discontinued after completing the fixed-duration period; 597 (37.9%) BTKi and 57 (29.5%) VEN-O patients discontinued treatment prematurely. The median time to discontinuation was 11.9 months (VEN-O) and 4.0 months (BTKi patients), respectively. Few patients (n < 11) who discontinued VEN-O initiated another CLL treatment over a median postdiscontinuation follow-up period of 6.1 months. By contrast, 39.0% of discontinuers in the BTKi group had evidence of subsequent CLL treatment over a median 13.8-month postdiscontinuation follow-up period. Post-BTKi regimens included BCL-2 (35.6%), subsequent BTKi (31.8%), chemotherapy (14.6%), anti-CD20 monotherapy (9.9%), and other (8.2%). The rate of postdiscontinuation all-cause and CLL-related hospitalization per 100 patient-months was 2.0 and 1.5 for the VEN-O group and 3.3 and 2.9 for the BTKi group, respectively.
In this real-world study, early discontinuation was more common in patients initiating a BTKi in contrast to VEN-O. Patients who initiated a BTKi also had high rates of subsequent treatment and hospitalization.
维奈克拉和布鲁顿酪氨酸激酶抑制剂（BTKis）是一线慢性淋巴细胞白血病（CLL）患者的关键治疗选择。本研究对全国范围内老年CLL患者一线使用维奈克拉和BTKis治疗停药后的治疗模式和住院情况进行了特征分析。
我们确定了1770名66岁及以上的医疗保险受益人，他们在2019年6月1日至2020年6月30日期间一线开始使用维奈克拉联合奥妥珠单抗（VEN-O，n = 193）或BTKi治疗（n = 1577）。停药定义为在18个月的随访期间任何时间连续90天无治疗。BTKi患者预计持续接受治疗；VEN-O患者预计完成11个月的治疗（12个周期×28天 = 336天）。评估后续CLL治疗率和全因/与CLL相关的住院率。
在18个月的随访中，102名（52.8%）VEN-O患者在完成固定疗程后停药；597名（37.9%）BTKi患者和57名（29.5%）VEN-O患者过早停药。停药的中位时间分别为11.9个月（VEN-O）和4.0个月（BTKi患者）。在中位停药后6.1个月的随访期内，很少有（n < 11）停用VEN-O的患者开始另一种CLL治疗。相比之下，在中位停药后13.8个月的随访期内，BTKi组39.0%的停药患者有后续CLL治疗的证据。BTKi治疗后的方案包括BCL-2（35.6%）、后续BTKi（31.8%）、化疗（14.6%）、抗CD20单药治疗（9.9%）和其他（8.2%）。VEN-O组每100患者月的停药后全因和与CLL相关的住院率分别为2.0和1.5，BTKi组分别为3.3和2.9。
在这项真实世界研究中，与VEN-O相比，开始使用BTKi的患者早期停药更为常见。开始使用BTKi的患者后续治疗和住院率也较高。
