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Originally published as JCO Early Release 10.1200/JCO.2005.12.051 on March 14 2005

Journal of Clinical Oncology, Vol 23, No 18 (June 20), 2005: pp. 4079-4088
© 2005 American Society of Clinical Oncology.
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Early Results of a Chemoimmunotherapy Regimen of Fludarabine, Cyclophosphamide, and Rituximab As Initial Therapy for Chronic Lymphocytic Leukemia

Michael J. Keating, Susan O’Brien, Maher Albitar, Susan Lerner, William Plunkett, Francis Giles, Michael Andreeff, Jorge Cortes, Stefan Faderl, Deborah Thomas, Charles Koller, William Wierda, Michelle A. Detry, Alice Lynn, Hagop Kantarjian

From the Departments of Leukemia, Hematopathology, Experimental Therapeutics, Blood and Marrow Transplantation, and the Biostatistics and Applied Mathematics, The University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Michael Keating, MB, BS, Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 428, Houston, TX 77030; e-mail: mkeating{at}mdanderson.org

PURPOSE: Fludarabine and cyclophosphamide (FC), which are active in treatment of chronic lymphocytic leukemia (CLL), are synergistic with the monoclonal antibody rituximab in vitro in lymphoma cell lines. A chemoimmunotherapy program consisting of fludarabine, cyclophosphamide, and rituximab (FCR) was developed with the goal of increasing the complete remission (CR) rate in previously untreated CLL patients to ≥ 50%.

PATIENTS AND METHODS: We conducted a single-arm study of FCR as initial therapy in 224 patients with progressive or advanced CLL. Flow cytometry was used to measure residual disease. Results and safety were compared with a previous regimen using FC.

RESULTS: The median age was 58 years; 75 patients (33%) had Rai stage III to IV disease. The CR rate was 70% (95% CI, 63% to 76%), the nodular partial remission rate was 10%, and the partial remission rate was 15%, for an overall response rate of 95% (95% CI, 92% to 98%). Two thirds of patients evaluated with flow cytometry had less than 1% CD5- and CD19-coexpressing cells in bone marrow after therapy. Grade 3 to 4 neutropenia occurred during 52% of courses; major and minor infections were seen in 2.6% and 10% of courses, respectively. One third of the 224 patients had ≥ one episode of infection, and 10% had a fever of unknown origin.

CONCLUSION: FCR produced a high CR rate in previously untreated CLL. Most patients had no detectable disease on flow cytometry at the end of therapy. Time to treatment failure analysis showed that 69% of patients were projected to be failure free at 4 years (95% CI, 57% to 81%).

Supported in part by a grant from Genentech Inc.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.


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Pentostatin, Cyclophosphamide, and Rituximab Is an Active, Well-Tolerated Regimen for Patients With Previously Treated Chronic Lymphocytic Leukemia
J. Clin. Oncol., April 1, 2006; 24(10): 1575 - 1581.
[Abstract] [Full Text] [PDF]

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C. S. Tam and J. F. Seymour
The infectious consequences of rituximab addition to fludarabine-containing regimens.
Blood, April 1, 2006; 107(7): 3013 - 3014.
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N. E. Kay
Treatment and evaluation of CLL: a complicated affair
Blood, February 1, 2006; 107(3): 848 - 848.
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W. G. Wierda
Current and Investigational Therapies for Patients with CLL
Hematology, January 1, 2006; 2006(1): 285 - 294.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
B. L. Abbott
Chronic Lymphocytic Leukemia: Recent Advances in Diagnosis and Treatment
Oncologist, January 1, 2006; 11(1): 21 - 30.
[Abstract] [Full Text] [PDF]

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 Mayo Clin Proc.Home page
F. Ravandi and S. O'Brien
Chronic Lymphoid Leukemias Other Than Chronic Lymphocytic Leukemia: Diagnosis and Treatment
Mayo Clin. Proc., December 1, 2005; 80(12): 1660 - 1674.
[Abstract] [PDF]

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 JCOHome page
W. G. Wierda, T. J. Kipps, and M. J. Keating
Novel Immune-Based Treatment Strategies for Chronic Lymphocytic Leukemia
J. Clin. Oncol., September 10, 2005; 23(26): 6325 - 6332.
[Abstract] [Full Text] [PDF]

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T. S. Lin, M. R. Grever, and J. C. Byrd
Changing the Way We Think About Chronic Lymphocytic Leukemia
J. Clin. Oncol., June 20, 2005; 23(18): 4009 - 4012.
[Full Text] [PDF]

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 ASH Education BookHome page
M. Hallek and On Behalf Of The German CLL Study Group
Chronic Lymphocytic Leukemia (CLL): First-Line Treatment
Hematology, January 1, 2005; 2005(1): 285 - 291.
[Abstract] [Full Text] [PDF]


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