Outcome of First Salvage Therapy in Patients With Chronic Lymphocytic Leukemia Relapsing After First-line Fludarabine, Cyclophosphamide, and Rituximab

Abstract

Brief Abstract Patients receiving salvage therapy for relapsed CLL following first-line FCR have overall response rates of 60% and median survival of 38 months. We describe pre-treatment characteristics predicting for outcome after salvage therapies. Patients receiving chemoimmunotherapy had better response rates and duration compared to antibody therapy alone. Brief Abstract Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR) is an effective initial therapy with an estimated 40% relapse rate at 6 years. There is no consensus salvage therapy for relapsed patients. All patients with chronic lymphocytic leukemia (CLL) who relapsed or were refractory following first-line FCR administered between July 1999 and December 2003 were included for analysis. Patients with Richter's transformation were excluded. We analyzed the impact of pre-treatment characteristics (Table 1) and response duration following FCR on responses and survival after salvage therapy. Response outcomes were analyzed using 1996 National Cancer Institute response criteria. Overall survival (OS) and time to treatment failure (TTF) were calculated using the method of Kaplan and Meier. Of 300 patients treated with first-line FCR, 111 patients (37%) have required salvage therapy. Median age at relapse was 61 years, and 36% of patients had Rai stage III or IV disease (Table 1). The salvage regimen included antibody alone, chemoimmunotherapy, or novel therapeutic approaches including lenalidomide. Responses included 17% CR, 12% nodular PR, and 32% PR with an overall response (OR) of 60%. Median OS was 38 months, and median TTF was 9 months. Rai stage III/IV disease, β2M > 4 mg/L, deletion of 17p by fluorescence in situ hybridization and TTF