Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia

William Wierda*, Susan O'Brien, Sijin Wen, Stefan Faderl, Guillermo Garcia-Manero, Deborah Thomas, Kim Anh Do, Jorge Cortes, Charles Koller, Miloslav Beran, Alessandra Ferrajoli, Francis Giles, Susan Lerner, Maher Albitar, Hagop Kantarjian, Michael Keating

*Corresponding author for this work

Research output: Contribution to journalArticle

476 Scopus citations

Abstract

Purpose: The efficacy, toxicity, and tolerability of chemoimmunotherapy with the combination of fludarabine, cyclophosphamide, and rituximab (FCR) were evaluated in previously treated patients with chronic lymphocytic leukemia (CLL). The purpose of this study was to improve the complete remission (CR) rate for previously treated patients and evaluate the quality of bone marrow response. Patients and Methods: One hundred seventy-seven previously treated patients with CLL were evaluated. Treatment consisted of rituximab 375 mg/m 2 day 1 of course 1 and 500 mg/m2 day 1 of courses 2 to 6; fludarabine 25 mg/m2/d days 2 to 4 of course 1 and days 1 to 3 of courses 2 to 6; and cyclophosphamide 250 mg/m2/d days 2 to 4 of course 1 and days 1 to 3 of courses 2 to 6. Courses were repeated every 4 weeks. Results: CR was achieved in 25% of 177 patients, and nodular partial remission and partial remission were achieved in 16% and 32% of patients, respectively; the overall response rate was 73%. Twelve (32%) of 37 complete responders tested achieved molecular remission in bone marrow. Univariate and multivariate analyses were used to identify pretreatment patient characteristics associated with CR and overall remission, longer time to progression, and overall survival. Conclusion: The FCR regimen was an active and well-tolerated treatment for previously treated patients with CLL. Myelosuppression was the most common toxicity. FCR induced the highest CR rate reported in a clinical trial of previously treated patients with CLL. Furthermore, molecular remissions were achieved in a third of patients achieving CR.

Original languageEnglish (US)
Pages (from-to)4070-4078
Number of pages9
JournalJournal of Clinical Oncology
Volume23
Issue number18
DOIs
StatePublished - Dec 1 2005

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Wierda, W., O'Brien, S., Wen, S., Faderl, S., Garcia-Manero, G., Thomas, D., Do, K. A., Cortes, J., Koller, C., Beran, M., Ferrajoli, A., Giles, F., Lerner, S., Albitar, M., Kantarjian, H., & Keating, M. (2005). Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia. Journal of Clinical Oncology, 23(18), 4070-4078. https://doi.org/10.1200/JCO.2005.12.516