Progress in the treatment of chronic lymphocytic leukemia: Results of the German CLL8 trial

Expert Review of Anticancer Therapy

Volumn 11, Issue 9, 2011, Pages 1333-1340

  Molica, Stefano ^a  

^a PUGLIESE CIACCIO HOSPITAL   (Italy)

Author keywords

chemoimmunotherapy; chronic lymphocytic leukemia; CLL08 trial; fit patients; rituximab; safety

Indexed keywords

CYCLOPHOSPHAMIDE; FLUDARABINE; RITUXIMAB;

ADULT; AGED; ARTICLE; CANCER IMMUNOTHERAPY; CHRONIC LYMPHATIC LEUKEMIA; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; ETHNIC GROUP; FOLLICULAR LYMPHOMA; GERMAN; HUMAN; LEUKEMIA REMISSION; LEUKOPENIA; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SINGLE DRUG DOSE; TREATMENT DURATION; TREATMENT RESPONSE;

AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CLINICAL TRIALS, PHASE III AS TOPIC; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MIDDLE AGED; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; VIDARABINE;

EID: 80053085439     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.11.118     Document Type: Article

References (39)

1. SEER Cancer Statistics Review, 1975-2007 Altekruse KC, Krapcho M, Neyman N et al. (Eds).National Cancer Institute, Bethesda, MD, USA (2010).
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. 338(21), 1506-1514 (1998). (Pubitemid 28226278)
3. Shustik C, Mick R, Silver R, Sawitsky A, Rai K, Shapiro L. Treatment of early chronic lymphocytic leukemia: intermittent chlorambucil versus observation. Hematol. Oncol. 6(1), 7-12 (1988).
4. Hallek M, Cheson BD, Catovsky D 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(12), 5446-5456 (2008).
5. Binder M, Otto F, Mertelsmann R, Veelken H, Trepel M. The epitope recognized by rituximab. Blood 108(6), 1975-1978 (2006). (Pubitemid 44395009)
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 83(2), 435 (1994).
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 88, 637 (1996).
8. Johnson P, Glennie M. The mechanisms of action of rituximab in the elimination of tumor cells. Semin. Oncol. 30(1 Suppl. 2), 3-8 (2003). (Pubitemid 36337346)
9. 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 90(6), 2188-2195 (1997). (Pubitemid 27392702)
10. Nguyen DT, Amess JA, Doughty H, Hendry L, Diamond LW. IDEC-C2B8 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. 62(2), 76-82 (1999). (Pubitemid 29071265)
11. Manshouri T, Do KA, Wang X et al. Circulating CD20 is detectable in the plasma of patients with chronic lymphocytic leukemia and is of prognostic significance. Blood 101(7), 2507-2513 (2003). (Pubitemid 36857605)
12. Keating MJ, O'Brien S. High-dose rituximab therapy in chronic lymphocytic leukemia. Semin. Oncol. 27(6 Suppl. 12), 86-90 (2000).
13. O'Brien SM, Kantarjian H, Thomas DA et al. Rituximab dose-escalation trial in chronic lymphocytic leukemia. J. Clin. Oncol. 19(8), 2165-2170 (2001). (Pubitemid 32366970)
14. 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. 19(8), 2153-2164 (2001). (Pubitemid 32366969)
15. Hainsworth JD, Litchy S, Barton JH et al. Single-agent rituximab as first-line 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. 21(9), 1746-1751 (2003). (Pubitemid 46638587)
16. 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. 114(4), 800-809 (2001). (Pubitemid 32953735)
17. Woyach JA, Ruppert AS, Heerema NA et al. Chemoimmunotherapy with fludarabine and rituximab produces extended overall survival and progression-free survival in chronic lymphocytic leukemia: long-term follow-up of CALGB study 9712. J. Clin. Oncol. 29(10), 1349-1355 (2011).
18. 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. 23, 4079-88 (2005). (Pubitemid 46211313)
19. Hallek M, Fischer K, Fingerle-Rowson G et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukemia: a randomized, open-label, Phase 3 trial. Lancet 376, 1164-1174 (2010).
20. Dohner H, Fischer K, Bentz M et al. p53 gene deletion predicts for poor survival and non-response to therapy with purine analogs in chronic B-cell leukemias. Blood 85, 1580-1589 (1995).
21. Grever MR, Lucas DM, Dewald GW et al. Comprehensive assessment of genetic and molecular features predicting outcome in patients with chronic lymphocytic leukemia: results from the US Intergroup Phase III Trial E2997. J. Clin. Oncol. 25, 799-804 (2007). (Pubitemid 350010635)
22. Zenz T, Stilgenbauer S. Therapy with the FCR regimen does not overcome chronic lymphocytic leukemia biology: aberrant p53 expression predicts response and survival. Leuk. Lymphoma 50(10), 1559-1561 (2009).
23. Zenz T, Eichhorst B, Busch R et al. TP53 mutation and survival in chronic lymphocytic leukemia. J. Clin. Oncol. 28(29), 4473-4479 (2010).
24. Rai KR, Peterson BL, Appelbaum FR et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N. Engl. J. Med. 343(24), 1750-1757 (2000).
25. Eichhorst BF, Busch R, Hopfinger G et al. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood 107(3), 885-891 (2006). (Pubitemid 43156283)
26. Hallek M, Fischer K. Update on Frontline Therapy for Chronic Lymphocytic Leukemia: Is FCR the Treatment of Choice? American Society of Clinical Oncology, Educational Book, Alexandria, VA, USA, 246-249 (2011).
27. Gribben JG, O'Brien S. Update on therapy of chronic lymphocytic leukemia. J. Clin. Oncol. 29(5), 544-550 (2011).
28. 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. 27(27), 4578-4584 (2009).
29. 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. 27, 498-503 (2009).
30. Reynolds C, Di Bella N, Lyons RM et al. Phase III trial of fludarabine, cyclophosphamide, and rituximab vs. pentostatin, cyclophosphamide, and rituximab in B-cell chronic lymphocytic leukemia. ASH Annual Meeting Abstracts 112, 327 (2008).
31. Fischer K, Stilgenbauer S, Schweighofer CD et al. Bendamustine in combination with rituximab (BR) for patients with relapsed chronic lymphocytic leukemia (CLL).A multicenter Phase II trial of the German CLL Study Group (GCLLSG).ASH Annual Meeting Abstracts 112, 330 (2008).
32. Fischer K, Cramer P, Stilgenbauer S et al. Bendamustine combined with rituximab (BR) in first-line therapy of advanced CLL: A multicenter Phase II trial of the German CLL Study Group (GCLLSG).ASH Annual Meeting Abstracts 114, 205 (2009).
33. Coiffier B, Lepretre S, Pedersen LM et al. Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a Phase 1-2 study. Blood 111, 1094-1100 (2008). (Pubitemid 351213387)
34. Wierda WG, Kipps TJ, Mayer J et al. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J. Clin. Oncol. 28, 1749-1755 (2010).
35. Wierda WG, Kipps TJ, Durig J et al. Ofatumumab combined with fludarabine and cyclophosphamide (O-FC) shows high activity in patients with previously untreated chronic lymphocytic leukemia (CLL), Results from a randomized, multicenter, international, two-dose, parallel group, Phase II trial. ASH Annual Meeting Abstracts 114, 207 (2009).
36. Mossner E, Brunker P, Moser S et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity. Blood 115, 4393-4402 (2010).
37. Patz M, Isaeva P, Forcob N et al. Comparison of the in vitro effects of the anti-CD20 antibodies rituximab and GA101 on chronic lymphocytic leukemia cells. Br. J. Hematol. 152, 295-306 (2011).
38. Goede V, Fischer K, Raymonde B et al. Chemoimmunotherapy with chlorambucil and the type II CD20-antibody GA101 in patients with chronic lymphocytic leukemia and comorbidity: results of the run-in phase of the CLL11 (BO21004) trial. ASH Annual Meeting Abstracts 116, 1387 (2010).
39. Engert A, Gercheva L, Pilipenko G et al. Overall survival advantage and acceptable safety profile with fludarabine in combination with alemtuzumab (FluCam) in previously treated patients with advanced stage chronic lymphocytic leukemia. ASH Annual Meeting Abstracts 116, 919 (2010).