Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial

Lancet

Volumn 370, Issue 9583, 2007, Pages 230-239

  Catovsky, D ^a   Richards, S ^b   Matutes, E ^a   Oscier, D ^c   Dyer, MJS ^d   Bezares, RF ^e   Pettitt, AR ^f   Hamblin, T ^c   Milligan, DW ^g   Child, JA ^h   Hamilton, MS ^k   Dearden, CE ^a   Smith, AG ⁱ   Bosanquet, AG ^j   Davis, Z ^c   Brito Babapulle, V ^a   Else, M ^a   Wade, R ^b   Hillmen, P ^h  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b CLINICAL TRIAL SERVICE UNIT   (United Kingdom)

^c ROYAL BOURNEMOUTH HOSPITAL   (United Kingdom)

^d LEICESTER ROYAL INFIRMARY   (United Kingdom)

^e Hospital General De Agudos Teodoro Alvarez   (Argentina)

^f UNIVERSITY OF LIVERPOOL   (United Kingdom)

^g BIRMINGHAM HEARTLANDS HOSPITAL   (United Kingdom)

^h LEEDS GENERAL INFIRMARY   (United Kingdom)

ⁱ SOUTHAMPTON GENERAL HOSPITAL   (United Kingdom)

^j UNIVERSITY OF BATH   (United Kingdom)

^k UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; ALLOPURINOL; CHLORAMBUCIL; COTRIMOXAZOLE; CYCLOPHOSPHAMIDE; FLUDARABINE; GRANULOCYTE COLONY STIMULATING FACTOR; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; PREDNISOLONE;

ADULT; AGED; ALOPECIA; ARTICLE; BONE MARROW TOXICITY; CANCER SURVIVAL; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOGENETICS; DIARRHEA; DISEASE COURSE; DISEASE FREE INTERVAL; FEMALE; FEVER; GENE MUTATION; HEMOLYTIC ANEMIA; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYELODYSPLASIA; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

EID: 34447530283     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(07)61125-8     Document Type: Article

References (35)

1. CLL Trialists' Collaborative Group. Chemotherapeutic options in chronic lymphocytic leukemia: a meta-analysis of the randomized trials. J Natl Cancer Inst 91 (1999) 861-868
2. O'Brien S., Kantarjian H., Cortes J., et al. Results of the fludarabine and cyclophosphamide combination regimen in chronic lymphocytic leukemia. J Clin Oncol 19 (2001) 1414-1420
3. Damle R., Wasil T., Fais F., et al. Ig V gene mutation status and CD38 expression as novel prognostic indicators in chronic lymphocytic leukemia. Blood 94 (1999) 1840-1847
4. Hamblin T., Davis Z., Gardiner A., Oscier D., and Stevenson F. Unmutated Ig V(H) genes are associated with a more aggressive form of chronic lymphocytic leukemia. Blood 94 (1999) 1848-1854
5. Dohner H., Stilgenbauer S., Benner A., et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med 343 (2000) 1910-1916
6. Crespo M., Bosch F., Villamor N., et al. ZAP-70 expression as a surrogate for immunoglobulin-variable-region mutations in chronic lymphocytic leukemia. N Engl J Med 348 (2003) 1764-1775
7. Rassenti L., Huynh L., Toy T., et al. ZAP-70 compared with immunoglobulin heavy-chain gene mutation status as a predictor of disease progression in chronic lymphocytic leukemia. N Engl J Med 351 (2004) 893-901
8. Moreau E., Matutes E., A'Hern R., et al. Improvement of the chronic lymphocytic leukemia scoring system with the monoclonal antibody SN8 (CD79b). Am J Clin Pathol 108 (1997) 378-382
9. Cheson B., Bennett J., Grever M., et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 87 (1996) 4990-4997
10. Machin D., and Campbell M. Statistical tables for the design of clinical trials (1987), Blackwell Scientific Publications, Oxford
11. Early Breast Cancer Trialists' Collaborative Group. Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. 133 randomised trials involving 31 000 recurrences and 24 000 deaths among 75 000 women. Lancet 339 (1992) 71-85
12. Antiplatelet Trialists' Collaboration. Secondary prevention of vascular disease by prolonged antiplatelet treatment. BMJ (Clin Res Ed) 296 (1988) 320-331
13. Hillmen P., Richards S., Catovsky D., and UK NCRI CLL Trials Group. Comparison of Oral and Intravenous Fludarabine in the LRF CLL4 Trial. Blood 106 (2005) 722 (ASH annual meeting abstracts)
14. Oscier D., Wade R., Orchard J., et al. Prognostic Factors in the UK LRF CLL4 Trial. Blood 108 (2006) 299 (ASH annual meeting abstracts)
15. Osoba D., Rodrigues G., Myles J., et al. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16 (1998) 139-144
16. Eichhorst B., Busch R., Hopfinger G., et al., German CLL Study Group. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood 107 (2006) 885-891
17. Flinn I., Neuberg D., Grever M., 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 25 (2007) 793-798
18. Parmar M., Torri V., and Stewart L. Extracting summary statistics to perform meta-analysis of the published literature for survival endpoints. Stat Med 17 (1998) 2815-2834
19. Rai K., Peterson B., Appelbaum F., et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med 343 (2000) 1750-1757
20. 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 98 (2001) 2319-2325
21. Kröber A., Bloehdorn J., Hafner S., et al. Additional genetic high-risk features such as 11q deletion, 17p deletion, and V3-21 usage characterize discordance of ZAP-70 and VH mutation status in chronic lymphocytic leukemia. J Clin Oncol 24 (2006) 969-975
22. Byrd J., Gribben J., Peterson B., et al. Select high-risk genetic features predict earlier progression following chemoimmunotherapy with fludarabine and rituximab in chronic lymphocytic leukemia: justification for risk-adapted therapy. J Clin Oncol 24 (2006) 437-443
23. Lozanski G., Heerema N., Flinn I., et al. Alemtuzumab is an effective therapy for chronic lymphocytic leukemia with p53 mutations and deletions. Blood 103 (2004) 3278-3281
24. Osuji N., Del Giudice I., Matutes E., Wotherspoon A., Dearden C., and Catovsky D. The efficacy of alemtuzumab for refractory chronic lymphocytic leukemia in relation to cytogenetic abnormalities of p53. Haematologica 90 (2005) 1435-1436
25. Pettitt A., Matutes E., and Oscier D. Alemtuzumab in combination with high-dose methylprednisolone is a logical, feasible and highly active therapeutic regimen in chronic lymphocytic leukaemia patients with p53 defects. Leukemia 20 (2006) 1441-1445
26. Johnson S., Smith A., Loffler H., et al. Multicentre prospective randomised trial of fludarabine versus cyclophosphamide, doxorubicin, and prednisone (CAP) for treatment of advanced-stage chronic lymphocytic leukaemia. The French Cooperative Group on CLL. Lancet 347 (1996) 1432-1438
27. Robak T., Blonski J., Kasznicki M., et al. Cladribine with prednisone versus chlorambucil with prednisone as first-line therapy in chronic lymphocytic leukemia: report of a prospective, randomized, multicenter trial. Blood 96 (2000) 2723-2729
28. Robak T., Blonski J., Gora-Tybor J., et al., Polish Leukemia Group (PALG CLL2). Cladribine alone and in combination with cyclophosphamide or cyclophosphamide plus mitoxantrone in the treatment of progressive chronic lymphocytic leukemia: report of a prospective, multicenter, randomized trial of the Polish Adult Leukemia Group (PALG CLL2). Blood 108 (2006) 473-479
29. Zhu Q., Tan D., Samuel M., Chan E., and Linn Y. Fludarabine in comparison to alkylator-based regimen as induction therapy for chronic lymphocytic leukemia: a systematic review and meta-analysis. Leuk Lymphoma 45 (2004) 2239-2245
30. Steurer M., Pall G., Richards S., Schwarzer G., Bohlius J., Greil R., and on behalf of the Cochrane Haematologic Malignancies Group. Single-agent purine analogues for the treatment of chronic lymphocytic leukaemia: a systematic review and meta-analysis. Cancer Treat Rev 32 (2006) 377-389
31. Robak T., Blonski J., Kasznicki M., Gora-Tybor J., Dmoszynska A., and Skotnicki A. The effect of subsequent therapies in patients with chronic lymphocytic leukemia previously treated with prednisone and either cladribine or chlorambucil. Haematologica 90 (2005) 994-996
32. Barlogie B., Tricot G., Anaissie E., et al. Thalidomide and hematopoietic-cell transplantation for multiple myeloma. N Engl J Med 354 (2006) 1021-1030
33. O'Brien S., Guilhot F., Larson R., et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 348 (2003) 994-1004
34. Keating M., 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 (2005) 4079-4088
35. Wierda W., O'Brien S., Wen S., et al. Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia. J Clin Oncol 23 (2005) 4070-4078