Low incidence of tumor lysis syndrome in elderly patients with chronic lymphocytic leukemia treated with venetoclax under real-world conditions: results from the prospective observational VeRVe study

被引:0
作者
Schwaner, Ingo [1 ]
Kuhn, Thomas [2 ]
Losem, Christoph [3 ]
Wolff, Thomas [4 ]
Otremba, Burkhard [5 ]
Zaiss, Matthias [6 ]
Huelsenbeck, Johannes [2 ]
Famulla, Kirsten [2 ]
Noesslinger, Thomas [7 ]
Rossi, Davide [8 ,9 ,10 ]
机构
[1] Onkol Schwerpunktpraxis Kurfuerstendamm, Kurfuerstendamm 65, D-10707 Berlin, Germany
[2] AbbVie Deutschland GmbH & Co KG, Hamatol, Wiesbaden, Germany
[3] Rheinlandklinikum Grevenbroich, Grevenbroich, Germany
[4] Onkol Lerchenfeld, Hamburg, Germany
[5] Onkol Praxis Oldenburg, Oldenburg, Germany
[6] Praxis Interdisziplinare Onkol & Hamatol, Freiburg, Germany
[7] Hanusch Krankenhaus Wien, Med Dept Hematol & Oncol 3, Vienna, Austria
[8] Oncol Inst Southern Switzerland IOSI, Clin Hematol, Bellinzona, Switzerland
[9] Inst Oncol Res, Expt Hematol, Bellinzona, Switzerland
[10] Univ Svizzera Italiana, Lugano, Switzerland
关键词
Venetoclax; Chronic lymphocytic leukemia; Tumor lysis syndrome; Real-world evidence; OPEN-LABEL; OBINUTUZUMAB; MULTICENTER; MANAGEMENT; INHIBITOR;
D O I
10.1007/s00277-024-05638-7
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Venetoclax is active in both frontline and relapsed/refractory settings for the treatment of chronic lymphocytic leukemia (CLL). Although the prevalence and severity of tumor lysis syndrome (TLS) are well characterized in clinical trials, laboratory and clinical TLS remain relatively unexplored in real-world clinical practice.In this prospective, real-world observational study, we aimed to determine the incidence and outcomes of TLS in patients with CLL receiving venetoclax outside a clinical trial. The study (VeRVe) was conducted in centers in Austria, Germany, and Switzerland.Two hundred and thirty-nine patients were treated according to local label with at least one dose of venetoclax. Patient demographics, baseline characteristics, and blood chemistry at baseline were documented, and descriptive statistical analyses were conducted.Seventy eight patients (33%) were treated with venetoclax monotherapy, 101 (42%) with venetoclax in combination with rituximab and 60 (25%) with venetoclax in combination with obinutuzumab. In all cases, the TLS risk mitigation strategy adhered to the ramp-up protocol. Median age was 73 years and 66% of patients were male. The majority of patients (75%) had relapsed/refractory CLL, 63/192 (32.8%) patients tested had a del(17p) and 93/134 (69.4%) patients tested had unmutated immunoglobulin heavy chain variable region gene (IGHV). Clinical TLS occurred in 5 patients (2.1%) and laboratory TLS occurred in 15 patients (6.3%). Ten patients received specific treatment, of which 6 were hospitalized. There were no deaths due to a TLS event and venetoclax was well-tolerated. Of the 5 clinical TLS events reported, none were fatal or resulted in renal failure (NCT03342144, registered on Nov 10, 2017).
引用
收藏
页码:2013 / 2020
页数:8
相关论文
共 34 条
[1]  
Al-Sawaf O, 2020, LANCET ONCOL, V21, P1188, DOI 10.1016/S1470-2045(20)30443-5
[2]   Apoptosis inducers in chronic lymphocytic leukemia [J].
Billard, Christian .
ONCOTARGET, 2014, 5 (02) :309-325
[3]   Real-world outcomes following venetoclax therapy in patients with chronic lymphocytic leukemia or Richter syndrome: a FILO study of the French compassionate use cohort [J].
Bouclet, Florian ;
Calleja, Anne ;
Dilhuydy, Marie-Sarah ;
Veronese, Lauren ;
Pereira, Bruno ;
Amorim, Sandy ;
Cymbalista, Florence ;
Herbaux, Charles ;
de Guibert, Sophie ;
Roos-Weil, Damien ;
Hivert, Benedicte ;
Aurran, Therese ;
Dupuis, Jehan ;
Blouet, Anaise ;
Tchernonog, Emmanuelle ;
Laribi, Kamel ;
Dmytruck, Nataliya ;
Morel, Pierre ;
Michallet, Anne-Sophie ;
Dartigeas, Caroline ;
Tournilhac, Olivier ;
Nguyen-Khac, Florence ;
Delmer, Alain ;
Feugier, Pierre ;
Ysebaert, Loic ;
Guieze, Romain .
ANNALS OF HEMATOLOGY, 2021, 100 (04) :987-993
[4]   Tumour lysis syndrome: new therapeutic strategies and classification [J].
Cairo, MS ;
Bishop, M .
BRITISH JOURNAL OF HAEMATOLOGY, 2004, 127 (01) :3-11
[5]   Tumor Lysis Syndrome in Chronic Lymphocytic Leukemia with Novel Targeted Agents [J].
Cheson, Bruce D. ;
Enschede, Sari Heitner ;
Cerri, Elisa ;
Desai, Monali ;
Potluri, Jalaja ;
Lamanna, Nicole ;
Tam, Constantine .
ONCOLOGIST, 2017, 22 (11) :1283-1291
[6]   The Bcl-2 family: roles in cell survival and oncogenesis [J].
Cory, S ;
Huang, DCS ;
Adams, JM .
ONCOGENE, 2003, 22 (53) :8590-8607
[7]   BH3 profiling identifies three distinct classes of apoptotic blocks to predict response to ABT-737 and conventional chemotherapeutic agents [J].
Deng, Jing ;
Carlson, Nicole ;
Takeyama, Kunihiko ;
Dal Cin, Paola ;
Shipp, Margaret ;
Letai, Anthony .
CANCER CELL, 2007, 12 (02) :171-185
[8]   Efficacy and Safety of Treatment Venetoclax Monotherapy or Combined with Rituximab in Patients with Relapsed/ Refractory Chronic Lymphocytic Leukemia (CLL) in the Real-World Setting in Spain: An Update of the Venares Study [J].
Ferra, Christelle ;
Terol, Maria Jose ;
Marquet Palomanes, Juan ;
Ramirez Payer, Angel ;
Moreno, Carol ;
Osorio, Santiago ;
De la Cruz, Fatima ;
Garcia-Marco, Jose A. ;
Ortiz, Macarena ;
Rios Herranz, Eduardo ;
Magnano, Laura ;
Iraheta, Sandra ;
Manuel Puerta, Jose ;
de la Serna, Javier ;
Smucler, Alicia ;
Maria Arguinano, Jose ;
Loscertales, Javier ;
Muina, Begona ;
Fernandez, Ruben ;
Garcia, Tomas ;
Marquez, Jose A. ;
Muntanola Prat, Ana ;
Perez Persona, Ernesto ;
Yanez, Lucrecia ;
Perez-Encinas, Manuel ;
Gonzalez Diaz, Marcos ;
Caballero, Gonzalo ;
Angeles Andreu, Maria ;
Andreu, Rafael ;
Ruiz-Zorrilla, Ana ;
Moreno, Diana ;
Baltasar, Patricia .
BLOOD, 2022, 140 :9908-9910
[9]   Venetoclax ramp-up strategies for chronic lymphocytic leukaemia in the United Kingdom: a real world multicentre retrospective study [J].
Figueroa-Mora, Rocio ;
Rampotas, Alexandros ;
Halperin, Daniel ;
Worth, Tina ;
Vidler, Jennifer ;
Melotti, Dario ;
Ferguson, Paul ;
Elmusharaf, Nagah ;
Preston, Gavin ;
Furtado, Michelle ;
Dungarwalla, Moez ;
Gohill, Satyen ;
Patten, Piers ;
Kennedy, Ben ;
Eyre, Toby A. ;
Schuh, Anna ;
Fox, Christopher P. ;
Munir, Tahla ;
Martinez-Calle, Nicolas .
BRITISH JOURNAL OF HAEMATOLOGY, 2023, 202 (01) :48-53
[10]   Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions [J].
Fischer, K. ;
Al-Sawaf, O. ;
Bahlo, J. ;
Fink, A. -M. ;
Tandon, M. ;
Dixon, M. ;
Robrecht, S. ;
Warburton, S. ;
Humphrey, K. ;
Samoylova, O. ;
Liberati, A. M. ;
Pinilla-Ibarz, J. ;
Opat, S. ;
Sivcheva, L. ;
Du, K. Le ;
Fogliatto, L. M. ;
Niemann, C. U. ;
Weinkove, R. ;
Robinson, S. ;
Kipps, T. J. ;
Boettcher, S. ;
Tausch, E. ;
Humerickhouse, R. ;
Eichhorst, B. ;
Wendtner, C. -M. ;
Langerak, A. W. ;
Kreuzer, K. -A. ;
Ritgen, M. ;
Goede, V. ;
Stilgenbauer, S. ;
Mobasher, M. ;
Hallek, M. .
NEW ENGLAND JOURNAL OF MEDICINE, 2019, 380 (23) :2225-2236