Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia - PubMed (original) (raw)
Clinical Trial
. 2005 Jun 20;23(18):4079-88.
doi: 10.1200/JCO.2005.12.051. Epub 2005 Mar 14.
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
Affiliations
- PMID: 15767648
- DOI: 10.1200/JCO.2005.12.051
Clinical Trial
Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia
Michael J Keating et al. J Clin Oncol. 2005.
Abstract
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%).
Comment in
- Changing the way we think about chronic lymphocytic leukemia.
Lin TS, Grever MR, Byrd JC. Lin TS, et al. J Clin Oncol. 2005 Jun 20;23(18):4009-12. doi: 10.1200/JCO.2005.08.964. Epub 2005 Mar 14. J Clin Oncol. 2005. PMID: 15767640 No abstract available. - Initial chemotherapy for chronic lymphocytic leukemia: what's the standard of care?
Kalaycio M. Kalaycio M. Curr Hematol Malig Rep. 2006 Mar;1(1):41-2. doi: 10.1007/s11899-006-0016-5. Curr Hematol Malig Rep. 2006. PMID: 20425330 No abstract available.
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