Safety and efficacy of Temsirolimus in combination with Bendamustine and Rituximab in relapsed mantle cell and follicular lymphoma

被引：29

作者：

Hess, G. ^{[1
]}

Keller, U. ^{[2
]}

Scholz, C. W. ^{[3
]}

Witzens-Harig, M. ^{[4
]}

Atta, J. ^{[5
]}

Buske, C. ^{[6
,7
]}

Kirschey, S. ^{[1
]}

Ruckes, C. ^{[8
]}

Medler, C. ^{[8
]}

van Oordt, C. ^{[1
]}

Klapper, W. ^{[9
]}

Theobald, M. ^{[1
]}

Dreyling, M. ^{[10
]}

机构：

[1] Johannes Gutenberg Univ Mainz, Univ Med Ctr, Dept Internal Med 3, Haematol,Oncol,Pneumol, D-55131 Mainz, Germany

[2] Tech Univ Munich, Dept Med 3, D-80290 Munich, Germany

[3] Charite, Sch Berlin, Dept Hematol Oncol, Berlin, Germany

[4] Heidelberg Univ, Dept Internal Med 5, Heidelberg, Germany

[5] Goethe Univ Frankfurt, Dept Internal Med 2, Ctr Internal Med, D-60054 Frankfurt, Germany

[6] Univ Hosp, Inst Expt Canc Res, Ulm, Germany

[7] Univ Hosp, Dept Internal Med 3, Ulm, Germany

[8] Johannes Gutenberg Univ Mainz, Univ Med Ctr, Interdisciplinary Ctr Clin Trials IZKS, D-55131 Mainz, Germany

[9] Univ Kiel, Div Hematophathol, Kiel, Germany

[10] Univ Munich, Dept Internal Med 3, Munich, Germany

来源：

LEUKEMIA | 2015年 / 29卷 / 08期

关键词：

NON-HODGKINS-LYMPHOMA; MULTICENTER PHASE-II; SINGLE-AGENT TEMSIROLIMUS; STUDY-GROUP GLSG; B-CELL; PLUS RITUXIMAB; CLINICAL-TRIAL; LENALIDOMIDE; INDOLENT; DEXAMETHASONE;

D O I：

10.1038/leu.2015.60

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

In this phase I/II study, we explored the combination of Temsirolimus with Bendamustine and Rituximab (BeRT) in patients with r/r follicular lymphoma (FL) or mantle cell lymphoma (MCL). Patients with 1-3 prior therapies received Bendamustine (90 mg/m(2), day 1+2) and Rituximab (375 mg/m(2), day 1) with Temsirolimus in doses from 25 to 75 mg added on day 1, 8, 15 of a 28-day cycle. Fifteen (11 MCL, 4 FL) patients were included in the phase I. Median age was 73 years and median pretreatment number was 2. No formal dose-limiting toxicity was observed. Dominant non-hematological side effects were fatigue in 11 (73%), nausea in 9 (60%), mucositis in 7 (47%) and vomiting in 6 patients (40%). Cough, diarrhea, pyrexia and rash were observed in five patients (33%) each. Grade 3/4 events included leukopenia in 6 (40%), neutropenia in 4 (27%) and thrombocytopenia in 2 patients (13%). An objective response was observed in 14/15 patients (93%), including 5 complete response (33%; all MCL). After a median follow-up of 19 months, 67% of patients are without signs of progression. Temsirolimus can be safely added to BR with promising preliminary activity. Recruitment in phase II is ongoing.

引用

页码：1695 / 1701

页数：7

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