• Apostolia M Tsimberidou, Hagop M Kantarjian, Jorge Cortes, Deborah A Thomas, Stefan Faderl, Guillermo Garcia-Manero, Srdan Verstovsek, Alessandra Ferrajoli, William Wierda, Yesid Alvarado, Susan M O'Brien, Maher Albitar, Michael J Keating, and Francis J Giles.
• Department of Leukemia, University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
• Cancer. 2003 Apr 1; 97 (7): 1711-20.

BackgroundTherapy for patients with Richter syndrome (RS) or fludarabine-refractory chronic lymphocytic leukemia (CLL) is unsatisfactory. A Phase II study was conducted to evaluate an alternating combination cytotoxic regimen given with rituximab and granulocyte-macrophage-colony stimulating factor (GM-CSF) in these patients.MethodsFludarabine-refractory CLL was defined as failure to respond to most recent prior fludarabine-containing regimen. Patients received up to six cycles of fractionated cyclophosphamide, vincristine, liposomal daunorubicin, and dexamethasone (hyper-CVXD) plus rituximab and GM-CSF alternating with methotrexate and cytarabine plus rituximab and GM-CSF. Response, toxicity, and survival data were compared with data from prior therapy with hyper-CVXD alone in this patient group.ResultsForty-nine patients with RS (n = 30 patients) or refractory CLL (n = 19 patients) were treated on study. Nine patients (18%) achieved a complete remission, and 11 patients achieved a partial remission (22%), for an overall objective response (OR) rate of 41%. With a median follow-up of 7.5 months and a maximum follow-up of 15.2 months, the 12-month failure free survival (FFS) rate was 27%, and the overall survival (OS) rate was 39%. Nine patients (18%) died during the first cycle of therapy, and two patients (4%) died during the second cycle. There were no significant differences between the rates of OR, OS, and FFS in the current study and those obtained with hyper-CVXD alone on a prior study.ConclusionsThe study regimen had activity and significant toxicity in patients with RS or fludarabine-refractory CLL. It was not clearly better compared with hyper-CVXD alone in this patient population.Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11238

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