The safety of bendamustine in patients with chronic lymphocytic leukemia or non-Hodgkin lymphoma and concomitant renal impairment: a retrospective electronic medical record database analysis

被引:12
作者
Nordstrom, Beth L. [1 ]
Knopf, Kevin B. [2 ]
Teltsch, Dana Y. [1 ]
Engle, Robert [1 ]
Beygi, Hooman [3 ]
Sterchele, James A. [3 ]
机构
[1] Evidera, Lexington, MA 02420 USA
[2] Calif Pacific Med Ctr, San Francisco, CA USA
[3] Teva Branded Pharmaceut Prod R&D Inc, Frazer, PA USA
关键词
Bendamustine; non-Hodgkin lymphoma; chronic lymphocytic leukemia; renal impairment; retrospective; PREVIOUSLY UNTREATED PATIENTS; PHASE-II MULTICENTER; INDOLENT B-CELL; MULTIPLE-MYELOMA; EFFECTIVE THERAPY; RITUXIMAB; COMBINATION; TRIAL;
D O I
10.3109/10428194.2013.836600
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
This retrospective study compared adverse-event rates in patients with chronic lymphocytic leukemia (CLL) or non-Hodgkin lymphoma (NHL), with and without renal impairment, receiving bendamustine alone or with rituximab. Patients (n = 940) were stratified into a renally impaired group (creatinine clearance [CrCL] < 40 mL/min) and two comparator groups (CrCL >= 40 mL/min and CrCL >= 60 mL/min). Renally impaired patients with NHL had a significantly greater incidence of grade 3-4 thrombocytopenia compared with the CrCL >= 60 mL/min group (hazard ratio [HR], 2.57; p = 0.025). For CLL and NHL together, grade 3-4 increased blood urea nitrogen was significantly higher in the renally impaired group than in the CrCL >= 40 mL/min (HR, 2.36; p = 0.02) and CrCL >= 60 mL/min (HR, 4.46; p = 0.001) groups. Based on these results, monitoring blood counts (including platelets) and renal function would be prudent in the management of patients with renal dysfunction and NHL or CLL who receive bendamustine-based regimens.
引用
收藏
页码:1266 / 1273
页数:8
相关论文
共 25 条
[1]  
[Anonymous], 2009, COMM TERM CRIT ADV E
[2]   Optimal Use of Bendamustine in Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphomas, and Multiple Myeloma: Treatment Recommendations From an International Consensus Panel [J].
Cheson, Bruce D. ;
Wendtner, Clemens-Martin ;
Pieper, Angelika ;
Dreyling, Martin ;
Friedberg, Jonathan ;
Hoelzer, Dieter ;
Moreau, Philippe ;
Gribben, John ;
Knop, Stefan ;
Montillo, Marco ;
Rummel, Mathias .
CLINICAL LYMPHOMA MYELOMA & LEUKEMIA, 2010, 10 (01) :21-27
[3]   Pharmacokinetics and excretion of 14C-bendamustine in patients with relapsed or refractory malignancy [J].
Dubbelman A.-C. ;
Rosing H. ;
Darwish M. ;
D'Andrea D. ;
Bond M. ;
Hellriegel E. ;
Robertson Jr. P. ;
Beijnen J.H. ;
Schellens J.H.M. .
Drugs in R&D, 2013, 13 (1) :17-28
[4]   Metabolite Profiling of Bendamustine in Urine of Cancer Patients after Administration of [14C]Bendamustine [J].
Dubbelman, Anne-Charlotte ;
Jansen, Robert S. ;
Rosing, Hilde ;
Darwish, Mona ;
Hellriegel, Edward ;
Robertson, Philmore, Jr. ;
Schellens, Jan H. M. ;
Beijnen, Jos H. .
DRUG METABOLISM AND DISPOSITION, 2012, 40 (07) :1297-1307
[5]   Bendamustine in Combination With Rituximab for Previously Untreated Patients With Chronic Lymphocytic Leukemia: A Multicenter Phase II Trial of the German Chronic Lymphocytic Leukemia Study Group [J].
Fischer, Kirsten ;
Cramer, Paula ;
Busch, Raymonde ;
Boettcher, Sebastian ;
Bahlo, Jasmin ;
Schubert, Joeerg ;
Pflueger, Karl H. ;
Schott, Silke ;
Goede, Valentin ;
Isfort, Susanne ;
von Tresckow, Julia ;
Fink, Anna-Maria ;
Buehler, Andreas ;
Winkler, Dirk ;
Kreuzer, Karl-Anton ;
Staib, Peter ;
Ritgen, Matthias ;
Kneba, Michael ;
Doehner, Hartmut ;
Eichhorst, Barbara F. ;
Hallek, Michael ;
Stilgenbauer, Stephan ;
Wendtner, Clemens-Martin .
JOURNAL OF CLINICAL ONCOLOGY, 2012, 30 (26) :3209-3216
[6]   Bendamustine Combined With Rituximab in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia: A Multicenter Phase II Trial of the German Chronic Lymphocytic Leukemia Study Group [J].
Fischer, Kirsten ;
Cramer, Paula ;
Busch, Raymonde ;
Stilgenbauer, Stephan ;
Bahlo, Jasmin ;
Schweighofer, Carmen D. ;
Boettcher, Sebastian ;
Staib, Peter ;
Kiehl, Michael ;
Eckart, Michael J. ;
Kranz, Gabriele ;
Goede, Valentin ;
Elter, Thomas ;
Buehler, Andreas ;
Winkler, Dirk ;
Kneba, Michael ;
Doehner, Hartmut ;
Eichhorst, Barbara F. ;
Hallek, Michael ;
Wendtner, Clemens-Martin .
JOURNAL OF CLINICAL ONCOLOGY, 2011, 29 (26) :3559-3566
[7]   Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: Results from a phase II multicenter, single-agent study [J].
Friedberg, Jonathan W. ;
Cohen, Philip ;
Chen, Ling ;
Robinson, K. Sue ;
Forero-Torres, Andres ;
La Casce, Ann S. ;
Fayad, Luis E. ;
Bessudo, Alberto ;
Camacho, Elber S. ;
Williams, Michael E. ;
Van der Jagt, Richard H. ;
Oliver, Jennifer W. ;
Cheson, Bruce D. .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (02) :204-210
[8]  
Hosmer DW, 2008, Applied survival analysis: Regression modeling of time-to-event data, V2nd
[9]  
Jaffe E.S., 2009, American Society of Hematology. Education Program, P523
[10]   Bendamustine Is Effective Therapy in Patients With Rituximab-Refractory, Indolent B-cell Non-Hodgkin Lymphoma Results From a Multicenter Study [J].
Kahl, Brad S. ;
Bartlett, Nancy L. ;
Leonard, John P. ;
Chen, Ling ;
Ganjoo, Kristen ;
Williams, Michael E. ;
Czuczman, Myron S. ;
Robinson, K. Sue ;
Joyce, Robin ;
van der Jagt, Richard H. ;
Cheson, Bruce D. .
CANCER, 2010, 116 (01) :106-114