Role of rituximab in first-line treatment of chronic lymphocytic leukemia

Therapeutics and Clinical Risk Management

Volumn 7, Issue 1, 2011, Pages 1-11

  Bryan, Jeffrey ^a   Borthakur, Gautam ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Chlorambucil; Chronic; Elderly; Fludarabine; Leukemia; Lymphocytic; Pentostatin; Rituximab; Tolerability

Indexed keywords

ALEMTUZUMAB; ANTIHISTAMINIC AGENT; BENDAMUSTINE; CHLORAMBUCIL; CYCLOPHOSPHAMIDE; FLUDARABINE; MEPREDNISONE; MITOXANTRONE; PARACETAMOL; PENTOSTATIN; RITUXIMAB;

ANTINEOPLASTIC ACTIVITY; BRONCHOSPASM; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CHRONIC LYMPHATIC LEUKEMIA; CYTOPENIA; DRUG APPROVAL; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; ELDERLY CARE; FATIGUE; FOLLICULAR LYMPHOMA; HEMATOLOGIC DISEASE; HEPATITIS B; HUMAN; HYPERGLYCEMIA; HYPOTENSION; INFECTION; INJECTION SITE REACTION; LARGE CELL LYMPHOMA; LYMPHOCYTOMA; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; REVIEW; SINGLE DRUG DOSE; SINUSITIS; SKIN MANIFESTATION; TREATMENT DURATION; TREATMENT RESPONSE; TUMOR LYSIS SYNDROME;

EID: 79951648917     PISSN: 11766336     EISSN: 1178203X     Source Type: Journal    
DOI: 10.2147/TCRM.S5855     Document Type: Review

References (77)

1. National Cancer Institute. Surveillance epidemiology and end results stat facts sheets. cancer: chronic lymphocytic leukemia. Available from: http://seer.cancer.gov/statfacts/html/clyl.html. Accessed 2010 Jul 01.
2. Dighiero G, Maloum K, Desablens B, et al. Chlorambucil in indolent chronic lymphocytic leukemia. French Cooperative Group on Chronic Lymphocytic Leukemia. N Engl J Med. 1998;338(21):1506-1514.
3. Maddocks KJ, Lin TS. Update in the management of chronic lymphocytic leukemia. J Hematol Oncol. 2009;2(29):1-8.
4. Han T, Ezdinli EZ, Shimaoka K, Desai DV. Chlorambucil vs combined chlorambucil-corticosteroid therapy in chronic lymphocytic leukemia. Cancer. 1973;31(3):502-508.
5. Binder M, Otto F, Mertelsmann R, Veelken H, Trepel M. The epitope recognized by rituximab. Blood. 2006;108(6):1975-1978.
6. Reff ME, Carner K, Chambers KS, et al. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood. 1994;83(2):435.
7. Maloney DG, Smith B, Appelbaum FR. The anti-tumor effect of monoclonal anti-CD20 antibody therapy includes direct anti-proliferative activity and induction of apoptosis in CD20 positive non- Hodgkin's lymphoma cell lines [abstract]. Blood. 1996;88:637.
8. Johnson P, Glennie M. The mechanisms of action of rituximab in the elimination of tumor cells. Semin Oncol. 2003;30(1 Suppl 2):3-8.
9. Riley JK, Sliwkowski MX. CD20: a gene in search of a function. Semin Oncol. 2000;27(6 Suppl 12):17-24.
10. Maloney DG, Liles TM, Czerwinski DK, et al. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood. 1994;84(8):2457-2466.
11. McLaughlin P, Grillo-López AJ, Link BK, et al. Rituximab chimeric anti- CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998;16(8):2825-2833.
12. Maloney DG, Grillo-Lopez AJ, White CA, et al. IDEC-C2B8 (Rituximab) anti-CD20 antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood. 1997;90(6):2188-2195.
13. Nguyen DT, Amess JA, Doughty H, Hendry L, Diamond LW. IDECC2B8 anti-CD20 (rituximab) immunotherapy in patients with low-grade non-Hodgkin's lymphoma and lymphoproliferative disorders: evaluation of response on 48 patients. Eur J Haematol. 1999;62(2):76-82.
14. Almasri NM, Duque RE, Iturraspe J, Everett E, Braylan RC. Reduced expression of CD20 antigen as a characteristic marker for chronic lymphocytic leukemia. Am J Hematol. 1192;40(4):259-263.
15. Keating MJ, O'Brien S. High-dose rituximab therapy in chronic lymphocytic leukemia. Semin Oncol. 2000;27(6 Suppl 12):86-90.
16. O'Brien SM, Kantarjian H, Thomas DA, et al. Rituximab doseescalation trial in chronic lymphocytic leukemia. J Clin Oncol. 2001;19(8):2165-2170.
17. Byrd JC, Murphy T, Howard RS, et al. Rituximab using a thrice weekly dosing schedule in B-cell chronic lymphocytic leukemia and small lymphocytic lymphoma demonstrates clinical activity and acceptable toxicity. J Clin Oncol. 2001;19(8):2153-2164.
18. Thomas DA, O'Brien S, Giles FJ, et al. Single agent rituxan in early stage chronic lymphocytic leukemia (CLL) [abstract]. Blood. 2001;98:1533.
19. Hainsworth JD, Litchy S, Barton JH, et al. Single-agent rituximab as firstline and maintenance treatment for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma: a phase II trial of the Minnie Pearl Cancer Research Network. J Clin Oncol. 2003;21(9):1746-1751.
20. Rai KR, Peterson BL, Appelbaum FR, et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med. 2000;343(24):1750-1757.
21. Johnson S, Smith AG, Loffler H, et al; for The French Cooperative Group on CLL. Multicentre prospective randomised trial of fludarabine versus cyclophosphamide, doxorubicin, and prednisone (CAP) for treatment of advanced-stage chronic lymphocytic leukaemia. Lancet. 1996;347(9013):1432-1438.
22. Keating MJ, O'Brien S, Lerner S, et al. Long-term follow-up of patients with chronic lymphocytic leukemia (CLL) receiving fludarabine regimens as initial therapy. Blood. 1998;92(4):1165-1171.
23. Leporrier M, Chevret S, Cazin B, et al. Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients. Blood. 2001;98(8):2319-2325.
24. Alas S, Emmanouilides C, Bonavida B. Inhibition of interleukin 10 by rituximab results in down-regulation of bcl-2 and sensitization of B-cell non-Hodgkin's lymphoma to apoptosis. Clin Cancer Res. 2001;7(3):709-723.
25. di Gaetano N, Xiao Y, Erba E, et al. Synergism between fludarabine and rituximab revealed in a follicular lymphoma cell line resistant to the cytotoxic activity of either drug alone. Br J Haematol. 2001;114(4): 800-809.
26. Schulz H, Klein SK, Rehwald U, et al. Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia. Blood. 2002;100(9):3115-3120.
27. Byrd JC, Peterson BL, Morrison VA, et al. Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB9712). Blood. 2003;101(1):6-14.
28. Woyach JA, Ruppert AS, Heerema NA, et al. Treatment with fludarabine and rituximab produces extended overall survival (OS) and progressionfree survival (PFS) in chronic lymphocytic leukemia (CLL) without increased risk of second malignancy: long-term follow up of CALGB study 9712 [abstract]. Blood. 2009;114(22):539.
29. Byrd JC, Rai K, Peterson BL, et al. Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011. Blood. 2005;105(1):49-53.
30. Catovsky D, Richards S, Matutes E, et al; for UK National Cancer Research Institute (NCRI) Haematological Oncology Clinical Studies Group; NCRI Chronic Lymphocytic Leukaemia Working Group. Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial. Lancet. 2007;370(9583):230-239.
31. Eichhorst BF, Busch R, Hopfinger G, et al; for German CLL Study Group. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2006;107(3):885-891.
32. Flinn IW, Neuberg DS, Grever MR, et al. Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997. J Clin Oncol. 2007;25(7):793-798.
33. Keating MJ, O'Brien S, Albitar M, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol. 2005;23(18):4079-4088.
34. Tam CS, O'Brien S, Wierda W, et al. Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia. Blood. 2008;112(4):975-980.
35. Hallek M, Fingerle-Rowson G, Fink AM, et al. First-Line treatment with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) improves overall survival (OS) in previously untreated patients (pts) with advanced chronic lymphocytic leukemia (CLL): results of a randomized phase III trial on behalf of an International Group of Investigators and the German CLL Study Group [abstract]. Blood. 2009;114(22):535.
36. O'Brien S, Wierda WG, Faderl S, et al. FCR-3 as frontline therapy for patients with chronic lymphocytic leukemia (CLL). [abstract]. Blood. 2005;106(11):2117.
37. Foon KA, Boyiadzis M, Land SR, et al. Chemoimmunotherapy with low-dose fludarabine and cyclophosphamide and high dose rituximab in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol. 2009;27(4):498-503.
38. Kay NE, Geyer SM, Call TG, et al. Combination chemoimmunotherapy with pentostatin, cyclophosphamide, and rituximab shows significant clinical activity with low accompanying toxicity in previously untreated B chronic lymphocytic leukemia. Blood. 2007;109(2): 405-411.
39. Kay NE, Wu W, Kabat B, et al. Pentostatin and rituximab therapy for previously untreated patients with B-Cell chronic lymphocytic leukemia. Cancer. 2010;116(9):2180-2187.
40. Bosch F, Abrisqueta P, Villamor N, et al. Rituximab, fludarabine, cyclophosphamide, and mitoxantrone: a new, highly active chemoimmunotherapy regimen for chronic lymphocytic leukemia. J Clin Oncol. 2009 Sep 20;27(27):4578-4584.
41. Bosch F, Ferrer A, Villamor N, et al. Fludarabine, cyclophosphamide, and mitoxantrone as initial therapy of chronic lymphocytic leukemia: High response rate and disease eradication. Clin Cancer Res. 2008;14(1):155-161.
42. Bellosillo B, Villamor N, Colomer D, et al. In vitro evaluation of fludarabine in combination with cyclophosphamide and/or mitoxantrone in B-cell chronic lymphocytic leukemia. Blood. 1999;94(8): 2836-2843.
43. Bellosillo B, Colomer D, Pons G, Gil J, et al. Mitoxantrone, a topoisomerase II inhibitor, induces apoptosis of B- chronic lymphocytic leukaemia cells. Br J Haematol. 1998;100(1):142-146.
44. Bosch F, Ferrer A, Lopez-Guillermo A, et al. Fludarabine, cyclophosphamide and mitoxantrone in the treatment of resistant or relapsed chronic lymphocytic leukaemia. Br J Haematol. 2002;119(4): 976-984.
45. Hendry L, Bowen A, Matutes E, Swansbury J, Catovsky D. Fludarabine, cyclophosphamide and mitoxantrone in relapsed or refractory chronic lymphocytic leukemia and low grade non-Hodgkin's lymphoma. Leuk Lymphoma. 2004;45(5):945-950.
46. Cheson BD, Bennett JM, Grever M, et al. for National Cancer Institute- sponsored Working Group guidelines for chronic lymphocytic leukemia: Revised guidelines for diagnosis and treatment. Blood. 1996;87(12):4990-4997.
47. Faderl S, Wierda W, O'Brien S, Ferrajoli A, Lerner S, Keating MJ. Fludarabine, cyclophosphamide, mitoxantrone plus rituximab (FCM-R) in frontline CLL, 70 Years. Leuk Res. 2010;34(3):284-288.
48. Kath R, Blumenstengel K, Fricke HJ, et al. Bendamustine monotherapy in advanced and refractory chronic lymphocytic leukemia. J Cancer Res Clin Oncol. 2001;127(1):48-54.
49. Aivado M, Becker K, Neise M, et al. Bendamustine is an efficient and well-tolerated option in the palliation of pretreated B-cell chronic lymphocytic leukemias [abstract]. Proc Am Soc Clin Oncol. 2001;20:306.
50. Chow KU, Sommerlad WD, Boehrer S, et al. Anti-CD20 antibody (IDEC-C2B8, rituximab) enhances efficacy of cytotoxic drugs on neoplastic lymphocytes in vitro: role of cytokines, complement, and caspases. Haematologica. 2002;87(1):33-43.
51. Fischer K, et al. Bendamustine in combination with rituximab (BR) for patients with relapsed chronic lymphocytic leukemia (CLL). A multicentre phase II trial of the German CLL Study Group (GCLLSG) [abstract]. Blood. 2008;112(11):330.
52. Fischer K, et al. Bendamustine combined with rituximab (BR) in firstline therapy of advanced CLL: a multicenter phase II trial of the German CLL Study Group (GCLLSG) [abstract]. Blood. 2009;114(22):205.
53. National Institutes of Health. Fludarabine, cyclophosphamide, and rituximab or bendamustine and rituximab in treating patients with previously untreated B-cell chronic lymphocytic leukemia. Available from: http://clinicaltrials.gov/ct2/show/NCT00769522?termfbendamustineuandafludarabine&rankf3. Accessed 2010 Jul 07.
54. Wierda WG, O'Brien S, Ferrajoli A, et al. Combined cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR), an active frontline regimen for high-risk patients with CLL [abstract]. Blood. 2007;110(11):628.
55. Parikh SA, Keating M, O'Brien S, et al. Frontline combined chemoimmunotherapy with fludarabine, cyclophosphamide, alemtuzumab and rituximab (CFAR) in high-risk chronic lymphocytic leukemia [abstract]. Blood. 2009;114(22):208.
56. Osterborg A, Dyer MJ, Bunjes D, et al; for European Study Group of Campath-1H Treatment in Chronic Lymphocytic Leukemia. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. J Clin Oncol. 1997;15(4):1567-1574.
57. Keating MJ, Flinn I, Jain V, et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002;99(10):3554-3561.
58. Osterborg A, Fassas AS, Anagnostopoulos A, Dyer MJ, Catovsky D, Mellstedt H. Humanized CD52 monoclonal antibody Campath-1H as first-line treatment in chronic lymphocytic leukaemia. Br J Haematol. 1996;93(1):151-153.
59. Hillmen P, Skotnicki AB, Robak T, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007;25(35):5616-5623.
60. Lozanski G, Heerema NA, Flinn IW, et al. Alemtuzumab is an effective therapy for chronic lymphocytic leukemia with p53 mutations and deletions. Blood. 2004;103(9):3278-3281.
61. Osuji NC, Del Giudice I, Matutes E, Wotherspoon AC, Dearden C, Catovsky D. The efficacy of alemtuzumab for refractory chronic lymphocytic leukemia in relation to cytogenetic abnormalities of p53. Haematologica. 2005;90(10):1435-1436.
62. Zent CS, Call TG, Shanafelt TD, et al. Early treatment of high-risk chronic lymphocytic leukemia with alemtuzumab and rituximab. Cancer. 2008;113(8):2110-2118.
63. Hillmen P, Gribben JG, Follows GA, et al. An open-label phase II study to investigate the safety and efficacy of rituximab plus chlorambucil in previously untreated patients with CD20-positive B-Cell chronic lymphocytic leukaemia (CLL) [abstract]. Blood. 2009;114(22):3428.
64. Castro JE, James DF, Sandoval-Sus JD, et al. Rituximab in combination with high-dose methylprednisolone for the treatment of chronic lymphocytic leukemia. Leukemia. 2009;23(10):1779-1789.
65. Maloney DG, Grillo-López AJ, Bodkin DJ, et al. IDEC-C2B8: results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. J Clin Oncol. 1997;15(10):3266-3274.
66. Winkler U, Jensen M, Manzke O, et al. Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (Rituximab, IDEC-C2B8). Blood. 1999;94(7):2217-2224.
67. Lim LC, Koh LP, Tan P. Fatal cytokine release syndrome with chimeric anti-CD20 monoclonal antibody rituximab in a 71-year-old patient with chronic lymphocytic leukemia. J Clin Oncol. 1999;17(6):1962-1963.
68. Byrd JC, Waselenko JK, Maneatis TJ, et al. Rituximab therapy in hematologic malignancy patients with circulating blood tumor cells: association with increased infusion related side effects and rapid blood tumor clearance. J Clin Oncol. 1999;17(3):791-795.
69. Jensen M, Winkler U, Manzke O, Diehl V, Engert A. Rapid tumor lysis in a patient with B-cell chronic lymphocytic leukemia and lymphocytosis treated with an anti-CD20 monoclonal antibody (IDEC-C2B8, rituximab). Ann Hematol. 1998;77(1-2):89-91.
70. Law JK, Ho JK, Hoskins PJ, et al. Fatal reactivation of hepatitis B post-chemotherapy for lymphoma in a hepatitis B surface antigennegative, hepatitis B core antibody-positive patient: potential implications for future prophylaxis recommendations. Leuk Lymphoma. 2005;46(7):1085-1089.
71. Westhoff TH, Jochimsen F, Schmittel A, et al. Fatal hepatitis B virus reactivation by an escape mutant following rituximab therapy. Blood. 2003;102(5):1930.
72. Niscola P, Del Principe MI, Maurillo L, et al. Fulminant B hepatitis in a surface antigen-negative patient with B-cell chronic lymphocytic leukaemia after rituximab therapy. Leukemia. 2005;19(10): 1840-1841.
73. Carson KR, Evens AM, Richey EA, et al. Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports project. Blood. 2009;113(20):4834-4840.
74. Sehn LH, Donaldson J, Filewich A, et al. Rapid infusion rituximab in combination with corticosteroid-containing chemotherapy or as maintenance therapy is well tolerated and can safely be delivered in the community setting. Blood. 2007;109(10):4171-4173.
75. Salar A, Casao D, Cervera M, et al. Rapid infusion of rituximab with or without steroid-containing chemotherapy: 1-yr experience in a single institution. Eur J Haematol. 2006;77(4):338-340.
76. Tuthill M, Crook T, Corbet T, King J, Webb A, et al. Rapid infusion of rituximab over 60 min. Eur J Haematol. 2009;82(4):322-325.
77. Provencio M, Cerdeira S, Bonilla F, Sánchez A, España P. Rapid-infusion rituximab in lymphoma treatment. Ann Oncol. 2006;17(6): 1027-1028.