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Long-Term Results of Chemoimmunotherapy With Fludarabine, Cyclophosphamide, and Rituximab for Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia
Abstracts From: 14th Annual International Congress on Hematologic Malignancies
Clinical and Laboratory Studies Abstract 9 Clinical Lymphoma, Myeloma & Leukemia, Vol. 10, No. 3, E35, 2010; DOI: 10.3816/CLML.2010.n.044
Long-Term Results of Chemoimmunotherapy With Fludarabine, Cyclophosphamide, and Rituximab for Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia Xavier Badoux,1 Michael J. Keating,1 Alessandra Ferrajoli,1 Susan Lerner,1 Xuemei Wang,2 Susan O’Brien,1 William G. Wierda1 1Department
of Leukemia; 2Department of Biostatistics, University of Texas M. D. Anderson Cancer Center, Houston, TX
Abstract Introduction: The majority of patients with progressive chronic lymphocytic leukemia (CLL) will relapse after front-line treatment and will require salvage therapy. The addition of rituximab (R) to fludarabine (F) and cyclophosphamide (C) is associated with improved responses and relapse-free survival in untreated patients with CLL (Hallek et al, 2009) and patients with CLL in first relapse (Robak et al, 2008). We present an update of FCR in patients with relapsed or refractory CLL. Patients and Methods: We administered FCR between November 1999 and 2008 to 284 patients with relapsed CLL. Patients received a combination of fludarabine 25 mg/m2 day 1-3, cyclophosphamide 250 mg/m2 day 1-3, and rituximab on day 1 at 375mg/m2 for cycle 1, and 500 mg/m2 for cycles 2 to 6. Patients were assessed for response by 1996 National Cancer Institute (NCI) Working Group response criteria and for time to failure of therapy (TTF) and overall survival (OS). We assessed standard pretreatment characteristics including response to prior therapy. Results: Patients entered into the study had a median age of 60 years (31-84 years). Median number of prior treatments was 2 (range, 1-10). Responses included 86 patients with CR (31%), 41 nPR (15%), and 84 PR (30%); OR was 75%. Median OS is 46 months (95% CI, 41-54 months), and median TTF is 21 months (95% CI, 19-27 months). On multivariate analysis, the variables independently associated with longer TTF were younger age, higher platelets, lower lactate dehydrogenase (LDH) or serum creatinine, lower number of prior treatment, fludarabine sensitivity, and absence of chromosome 17 abnormalities on karyotype. Six full dose cycles of FCR were administered to 104 patients (36%). The most common hematologic toxicity was grade 3 and 4 neutropenia complicating 22% and 34% of treatment courses. Forty-six patients (16%) experienced one or more episodes of pneumonia or sepsis during or following treatment. Conclusion: FCR is an effective regimen in patients with relapsed CLL. FCR should be considered as salvage therapy for patients in third relapse or less, not refractory to fludarabine or without chromosome 17 abnormalities or complex karyotype. Elderly patients (> 70 years) experienced more treatment-related toxicity and should be assessed for comorbidities prior to therapy.
Clinical Lymphoma, Myeloma & Leukemia June 2010
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E35
Clinical and Laboratory Studies Abstract 9 Clinical Lymphoma, Myeloma & Leukemia, Vol. 10, No. 3, E35, 2010; DOI: 10.3816/CLML.2010.n.044
Long-Term Results of Chemoimmunotherapy With Fludarabine, Cyclophosphamide, and Rituximab for Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia Xavier Badoux,1 Michael J. Keating,1 Alessandra Ferrajoli,1 Susan Lerner,1 Xuemei Wang,2 Susan O’Brien,1 William G. Wierda1 1Department
of Leukemia; 2Department of Biostatistics, University of Texas M. D. Anderson Cancer Center, Houston, TX
Abstract Introduction: The majority of patients with progressive chronic lymphocytic leukemia (CLL) will relapse after front-line treatment and will require salvage therapy. The addition of rituximab (R) to fludarabine (F) and cyclophosphamide (C) is associated with improved responses and relapse-free survival in untreated patients with CLL (Hallek et al, 2009) and patients with CLL in first relapse (Robak et al, 2008). We present an update of FCR in patients with relapsed or refractory CLL. Patients and Methods: We administered FCR between November 1999 and 2008 to 284 patients with relapsed CLL. Patients received a combination of fludarabine 25 mg/m2 day 1-3, cyclophosphamide 250 mg/m2 day 1-3, and rituximab on day 1 at 375mg/m2 for cycle 1, and 500 mg/m2 for cycles 2 to 6. Patients were assessed for response by 1996 National Cancer Institute (NCI) Working Group response criteria and for time to failure of therapy (TTF) and overall survival (OS). We assessed standard pretreatment characteristics including response to prior therapy. Results: Patients entered into the study had a median age of 60 years (31-84 years). Median number of prior treatments was 2 (range, 1-10). Responses included 86 patients with CR (31%), 41 nPR (15%), and 84 PR (30%); OR was 75%. Median OS is 46 months (95% CI, 41-54 months), and median TTF is 21 months (95% CI, 19-27 months). On multivariate analysis, the variables independently associated with longer TTF were younger age, higher platelets, lower lactate dehydrogenase (LDH) or serum creatinine, lower number of prior treatment, fludarabine sensitivity, and absence of chromosome 17 abnormalities on karyotype. Six full dose cycles of FCR were administered to 104 patients (36%). The most common hematologic toxicity was grade 3 and 4 neutropenia complicating 22% and 34% of treatment courses. Forty-six patients (16%) experienced one or more episodes of pneumonia or sepsis during or following treatment. Conclusion: FCR is an effective regimen in patients with relapsed CLL. FCR should be considered as salvage therapy for patients in third relapse or less, not refractory to fludarabine or without chromosome 17 abnormalities or complex karyotype. Elderly patients (> 70 years) experienced more treatment-related toxicity and should be assessed for comorbidities prior to therapy.
Clinical Lymphoma, Myeloma & Leukemia June 2010
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E35