伊布替尼
威尼斯人
医学
套细胞淋巴瘤
内科学
不利影响
无进展生存期
胃肠病学
微小残留病
肿瘤科
淋巴瘤
外科
化疗
骨髓
白血病
慢性淋巴细胞白血病
作者
Sasanka Handunnetti,Mary Ann Anderson,Kate Burbury,P. A. Thompson,Glenda Burke,Mathias Bressel,Juliana L Di Iulio,Rodney J. Hicks,David Westerman,Stephen Lade,Christiane Pott,Rishu Agarwal,Rachel Koldej,David Ritchie,Martin Dreyling,Mark A. Dawson,Sarah‐Jane Dawson,John F. Seymour,Andrew W. Roberts,Constantine S. Tam
出处
期刊:Blood
[American Society of Hematology]
日期:2024-04-25
标识
DOI:10.1182/blood.2023023388
摘要
In the phase-2 clinical trial (AIM) of venetoclax-ibrutinib, 24 patients with mantle cell lymphoma (MCL; 23 with relapsed/refractory [R/R] disease) received ibrutinib 560mg and venetoclax 400mg both once daily. High complete remission (CR) and measurable residual disease negative (MRD-negative) CR rates were previously reported. With median survivor follow-up now exceeding 7 years, we report long-term results. Treatment was initially continuous, with elective treatment interruption (ETI) allowed after protocol amendment for patients in MRD-negative CR. For R/R MCL, the estimated 7-year progression-free survival (PFS) was 30% [95%CI: 14-49] (median 28 months [95%CI: 13-82]) and overall survival was 43% [95%CI: 23-62] (median 32 months [95%CI: 15-NE]). Eight patients in MRD-negative CR entered ETI for a median of 58 months (95%CI, 37-79), with four experiencing disease recurrence. Two of 3 re-attained CR on retreatment. Time-to-treatment-failure (TTF), which excluded progression in ETI for those reattaining response, was 39% overall and 68% at 7-years for responders. Beyond 56 weeks Grade 3 and serious adverse events were uncommon. Newly emergent or increasing cardiovascular toxicity were not observed beyond 56 weeks. We demonstrate long-term durable responses and acceptable toxicity profile of venetoclax-ibrutinib in R/R MCL and show feasibility of treatment interruption while maintaining ongoing disease control. (NCT02471391)
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