Four-year follow-up of a single arm, phase II clinical trial of ibrutinib with rituximab (IR) in patients with relapsed/refractory mantle cell lymphoma (MCL)

被引:62
作者
Jain, Preetesh [1 ]
Romaguera, Jorge [1 ]
Srour, Samer A. [1 ]
Lee, Hun J. [1 ]
Hagemeister, Frederick [1 ]
Westin, Jason [1 ]
Fayad, Luis [1 ]
Samaniego, Felipe [1 ]
Badillo, Maria [1 ]
Zhang, Liang [1 ]
Nastoupil, Lorreta [1 ]
Kanagal-Shamanna, Rashmi [2 ]
Fowler, Nathan [1 ]
Wang, Michael L. [1 ]
机构
[1] Univ Texas MD Anderson Canc Ctr, Dept Lymphoma & Myeloma, Houston, TX 77030 USA
[2] Univ Texas MD Anderson Canc Ctr, Dept Hematopathol, Houston, TX 77030 USA
关键词
ibrutinib; MCL; rituximab; mantle cell lymphoma; BTK; INVESTIGATORS CHOICE; AGENT IBRUTINIB; OPEN-LABEL; LENALIDOMIDE; TEMSIROLIMUS; MULTICENTER; BORTEZOMIB; STRATEGIES; OUTCOMES;
D O I
10.1111/bjh.15411
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Ibrutinib has shown significant activity in patients with relapsed or refractory mantle cell lymphoma (RR-MCL). We report the long-term outcome and safety profile of a single-centre, single arm, open-label, phase 2 study of RR-MCL treated with IR. Overall, the median follow-up time was 47months (range 1-52months), median duration on treatment was 16months (range 1-53months) and median number of treatment cycles was 17 (range 1-56). Twenty-nine patients (58%) achieved complete remission and of these, 12 patients continue on study. Thirty-eight patients discontinued treatment, 14 due to disease progression (2 transformed). Patients with blastoid morphology, high risk MCL International Prognostic Index score and high Ki67% had inferior survival. The commonest grade 1-2 toxicities were fatigue, diarrhoea, nausea, arthralgias and myalgias. None had long term toxicities. Median progression-free survival was 43months. Eighteen patients (36%) died (14 deaths were MCL-related). The median overall survival has not been reached. Treatment with IR can provide durable remissions in a subset of patients with RR-MCL, especially those with low Ki67%. The possible benefit of adding other therapies in combination with IR in RR-MCL is under exploration.
引用
收藏
页码:404 / 411
页数:8
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