伊布替尼的暂时停药可减少3-4级感染并实现持久缓解——慢性淋巴细胞白血病患者1b/2期开-关-重复研究的中期分析
Temporary cessation of ibrutinib results in reduced grade 3-4 infections and durable remissions-Interim analysis of an on-off-repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia.
作者信息
Lundin Jeanette, Mulder Tom A, Kättström Magdalena, Wästerlid Tove, Uddevik Anders, Mellstedt Håkan, Heimersson Kia, Hansson Lotta, Palma Marzia, Österborg Anders
机构信息
Department of Oncology-Pathology Karolinska Institutet Stockholm Sweden.
Lymphoma Unit, Department of Hematology Karolinska University Hospital Solna Stockholm Sweden.
出版信息
EJHaem. 2021 Jul 14;2(3):525-529. doi: 10.1002/jha2.261. eCollection 2021 Aug.
Ibrutinib is used continuously in CLL. This phase 1b/2 study interim analysis explored on-off-repeat dosing to reduce toxicity. After 12 months, 16/22 patients (73%) remained in first off-phase irrespective if initial CR/PR or aberration. Grade 3-4 infections were reduced from 55% to 5% during a similarly long off-phase ( < .01). Treg and exhausted T-cells increased ( = .01). Six patients restarted ibrutinib at early progression and remain drug-sensitive. Our interim analysis shows a durable off-phase in most patients, with reduced infections and cost-saving potential. If toxicity-driven permanent cessation of ibrutinib will be affected will be explored in the extended study.
伊布替尼在慢性淋巴细胞白血病（CLL）中持续使用。这项1b/2期研究的中期分析探索了间断重复给药以降低毒性。12个月后，22例患者中有16例（73%）仍处于首次停药阶段，无论初始是否达到完全缓解（CR）/部分缓解（PR）或存在异常。在同样长的停药期内，3-4级感染从55%降至5%（P<0.01）。调节性T细胞（Treg）和耗竭性T细胞增加（P = 0.01）。6例患者在疾病早期进展时重新开始使用伊布替尼，且仍对药物敏感。我们的中期分析显示，大多数患者有持久的停药期，感染减少且有节省成本的潜力。在扩展研究中将探索毒性驱动的伊布替尼永久停药是否会受到影响。
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