Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: Multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials

European Journal of Cancer

Volumn 60, Issue , 2016, Pages 154-165

  Gentile, Massimo ^a   Zirlik, Katja ^b   Ciolli, Stefania ^c   Mauro, Francesca R ^d   Di Renzo, Nicola ^e   Mastrullo, Lucia ^e   Angrilli, Francesco ^g   Molica, Stefano ^h   Tripepi, Giovanni ⁱ   Giordano, Annamaria ^j   Di Raimondo, Francesco ^k   Selleri, Carmine ^l   Coscia, Marta ^m   Musso, Maurizio ⁿ   Orsucci, Lorella ^o   Mannina, Donato ^p   Rago, Angela ^q   Giannotta, Angela ^r   Ferrara, Felicetto ^s   Herishanu, Yair ^t   Shvidel, Lev ^u   Tadmor, Tamar ^v   Scortechini, Ilaria ^w   Ilariucci, Fiorella ^x   Murru, Roberta ^y   Guarini, Attilio ^z   Musuraca, Gerardo ^aa   Mineo, Giuseppe ^ab   Vincelli, Iolanda ^ac   Arcari, Annalisa ^ad   Tarantini, Giuseppe ^ae   Caparrotti, Giuseppe ^af   Chiarenza, Annalisa ^k   Levato, Luciano ^g   Villa, Maria Rosaria ^f   De Paolis, Maria Rosaria ^e   Zinzani, Pier Luigi ^ag   Polliack, Aaron ^ah   Morabito, Fortunato ^a   more..

^a Azienda Ospedaliera di Cosenza   (Italy)

^b UNIVERSITY OF FREIBURG   (Germany)

^c UNIVERSITY OF FLORENCE   (Italy)

^d SAPIENZA UNIVERSITY OF ROME   (Italy)

^e VITO FAZZI HOSPITAL   (Italy)

^f San Gennaro Hospital   (Italy)

^g SPIRITO SANTO HOSPITAL   (Italy)

^h PUGLIESE CIACCIO HOSPITAL   (Italy)

ⁱ CNR   (Italy)

^j POLICLINICO   (Italy)

^k UNIVERSITY OF CATANIA   (Italy)

^l UNIVERSITY OF SALERNO   (Italy)

^m UNIVERSITY OF TURIN   (Italy)

ⁿ Bone Marrow Transplantation Unit   (Italy)

^o MOLINETTE HOSPITAL   (Italy)

^p Ospedale Papardo   (Italy)

^q UOC Eatologia Opedale Santa Maria Goretti   (Italy)

^r Ospedale A Perrino   (Italy)

^s CARDARELLI HOSPITAL   (Italy)

^t TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^u KAPLAN MEDICAL CENTER   (Israel)

^v BNAI ZION MEDICAL CENTER   (Israel)

^w OSPEDALI RIUNITI   (Italy)

^x S MARIA NUOVA HOSPITAL   (Italy)

^y Ospedale Oncologico A Businco   (Italy)

^z National Cancer Research Centre   (Italy)

^aa DEPARTMENT OF MEDICAL ONCOLOGY   (Italy)

^ab Ospedale San Vincenzo   (Italy)

^ac Hematology Unit   (Italy)

^ad GUGLIELMO DA SALICETO HOSPITAL   (Italy)

^ae UOC Ematologia Ospedale Dimiccoli Barletta   (Italy)

^af g Moscati Hospital   (Italy)

^ag UNIVERSITY OF BOLOGNA   (Italy)

^ah HEBREW UNIVERSITY OF JERUSALEM   (Israel)

more..

Author keywords

Bendamustine; Chronic lymphocytic leukaemia; Rituximab; Therapy

Indexed keywords

BENDAMUSTINE; CREATININE; GRANULOCYTE COLONY STIMULATING FACTOR; IMMUNOGLOBULIN HEAVY CHAIN; RITUXIMAB; SULFAMETHOXAZOLE; TRIMETHOPRIM; ANTINEOPLASTIC AGENT;

ADULT; AGED; ALLERGIC REACTION; ANTIBIOTIC PROPHYLAXIS; ARTICLE; AUTOIMMUNE HEMOLYTIC ANEMIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL PRACTICE; COHORT ANALYSIS; CREATININE CLEARANCE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; FOLLOW UP; GENE MUTATION; HUMAN; LEUKEMIA REMISSION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PNEUMOCYSTOSIS; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; RATING SCALE; RETROSPECTIVE STUDY; THROMBOCYTOPENIA; TREATMENT RESPONSE; CLINICAL TRIAL; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MULTICENTER STUDY; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENDAMUSTINE HYDROCHLORIDE; FEMALE; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; RITUXIMAB; TREATMENT OUTCOME;

EID: 84964478073     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2016.03.069     Document Type: Article

References (31)

1. M.J. Keating, S. O'Brien, M. Albitar, and et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia J Clin Oncol 23 2005 4079 4088
2. W. Wierda, S. O'Brien, S. Wen, and et al. Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia J Clin Oncol 23 2005 4070 4078
3. T. Robak, A. Dmoszynska, P. Solal-Celigny, and et al. Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia J Clin Oncol 28 2010 1756 1765
4. M. Hallek, K. Fischer, G. Fingerle-Rowson, and et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial Lancet 376 2010 1164 1174
5. M. Gentile, A.G. Recchia, C. Mazzone, and et al. An old drug with a new future: bendamustine in multiple myeloma Expert Opin Pharmacother 14 2013 2263 2280
6. W.U. Knauf, T. Lissichkov, A. Aldaoud, and et al. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia J Clin Oncol 27 2009 4378 4384
7. K. Fischer, P. Cramer, R. Busch, and et al. 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 Clin Oncol 29 2011 3559 3566
8. E. Iannitto, F. Morabito, S. Mancuso, and et al. Bendamustine with or without rituximab in the treatment of relapsed chronic lymphocytic leukaemia: an Italian retrospective study Br J Haematol 153 2011 351 357
9. F. Zaja, M. Mian, S. Volpetti, and et al. Bendamustine in chronic lymphocytic leukemia: outcome according to different clinical and biological prognostic factors in the everyday clinical practice Am J Hematol 88 2013 955 960
10. K. Fischer, P. Cramer, R. Busch, and et al. 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 Clin Oncol 30 2012 3209 3216
11. B. Eichhorst, A.M. Fink, R. Busch, and et al. Frontline chemoimmunotherapy with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) shows superior efficacy in comparison to bendamustine (B) and rituximab (BR) in previously untreated and physically fit patients (pts) with advanced chronic lymphocytic leukemia (CLL): final analysis of an International, Randomized Study of the German CLL Study Group (GCLLSG) (CLL10 Study) Blood (ASH Annual Meeting) 124 2014 abstr 19
12. M. Hallek, B.D. Cheson, D. Catovsky, and et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the international workshop on chronic lymphocytic leukemia updating the National Cancer Institute-working group 1996 guidelines Blood 111 2008 5446 5456
13. F. Morabito, G. Cutrona, M. Gentile, and et al. Definition of progression risk based on combinations of cellular and molecular markers in patients with Binet stage A chronic lymphocytic leukaemia Br J Haematol 146 2009 44 53
14. H. Dohner, S. Stilgenbauer, A. Benner, and et al. Genomic aberrations and survival in chronic lymphocytic leukemia N Engl J Med 343 2000 1910 1916
15. T.J. Hamblin, Z. Davis, A. Gardiner, and et al. Unmutated Ig V(H) genes are associated with a more aggressive form of chronic lymphocytic leukemia Blood 94 1999 1848 1854
16. R.N. Damle, T. Wasil, F. Fais, and et al. Ig V gene mutation status and CD38 expression as novel prognostic indicators in chronic lymphocytic leukemia Blood 94 1999 1840 1847
17. A.S. Michallet, M. Aktan, A. Schuh, and et al. Rituximab in combination with bendamustine or chlorambucil for the treatment of chronic lymphocytic leukaemia: primary results from the randomised phase IIIb MABLE study Leuk Lymphoma (XVI International Workshop on CLL) 2015 Suppl. 1: abstr 178
18. L. Laurenti, I. Innocenti, F. Autore, and et al. Bendamustine in combination with rituximab for elderly patients with previously untreated B-cell chronic lymphocytic leukemia: a retrospective analysis of real-life practice in Italian hematology departments Leuk Res 39 2015 1066 1070
19. P. Michel, J.L. Quenon, A.M. de Sarasqueta, and et al. Comparison of three methods for estimating rates of adverse events and rates of preventable adverse events in acute care hospitals Br Med J 328 2004 199 202
20. E. Bouvet, C. Borel, L. Oberic, and et al. Impact of dose intensity on outcome of fludarabine, cyclophosphamide, and rituximab regimen given in the first-line therapy for chronic lymphocytic leukemia Haematologica 98 2013 65 70
21. Y. Herishanu, N. Goldschmidt, O. Bairey, and et al. Efficacy and safety of front-line therapy with fludarabine-cyclophosphamide-rituximab regimen for chronic lymphocytic leukemia outside clinical trials: the Israeli CLL study group experience Haematologica 100 2015 662 669
22. D. Rossi, L. Terzi-di-Bergamo, L. De Paoli, and et al. Molecular prediction of durable remission after first-line fludarabine-cyclophosphamide-rituximab in chronic lymphocytic leukemia Blood 126 2015 1921 1924
23. F. Morabito, M. Gentile, J.F. Seymour, and A. Polliack Ibrutinib, idelalisib and obinutuzumab for the treatment of patients with chronic lymphocytic leukemia: three new arrows aiming at the target Leuk Lymphoma 56 2015 3250 3256
24. J. von Tresckow, P. Cramer, J. Bahlo, and et al. CLL2-BIG - a novel treatment regimen of bendamustine followed by GA101 and ibrutinib followed by ibrutinib and GA101 maintenance in patients with chronic lymphocytic leukemia (CLL): interim results of a phase II-trial Blood (ASH Annual Meeting) 126 2015 4151
25. Efficacy and safety of idelalisib in combination with bendamustine and rituximab in subjects with previously untreated chronic lymphocytic leukemia. Available from: https://clinicaltrials.gov/ct2/show/NCT01980888.
26. Sequential regimen of bendamustine-debulking followed by ABT-199 and GA101-induction and -maintenance in CLL (CLL2-BAG). Available from: https://clinicaltrials.gov/ct2/show/NCT02401503.
27. A. Chanan-Khan, P. Cramer, F. Demirkan, and et al. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study Lancet Oncol 17 2016 200 211
28. A.D. Zelenetz, T. Robak, B. Coiffier, and et al. Idelalisib plus bendamustine and rituximab (BR) is superior to br alone in patients with relapsed/refractory chronic lymphocytic leukemia: results of a phase 3 randomized double-blind placebo-controlled study Blood (ASH Annual Meeting) 126 2015 abs LBA-5
29. V. Goede, K. Fischer, R. Busch, and et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions N Engl J Med 370 2014 1101 1110
30. P. Hillmen, T. Robak, A. Janssens, and et al. Chlorambucil plus ofatumumab verses chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial Lancet 85 2015 1873 1883
31. A. Quinquenel, C. Willekens, J. Dupuis, and et al. Bendamustine and rituximab combination in the management of chronic lymphocytic leukemia-associated autoimmune hemolytic anemia: a multicentric retrospective study of the French CLL intergroup (GCFLLC/MW and GOELAMS) Am J Hematol 90 2015 204 207