Outcomes of patients with fludarabine-refractory chronic lymphocytic leukemia: a population-based study from a well-defined geographic region

• Published in: Leukemia & lymphoma Vol. 55; no. 8; pp. 1774 - 1780
• Main Authors: Eketorp Sylvan, Sandra, Hansson, Lotta, Karlsson, Claes, Norin, Stefan, Lundin, Jeanette, Österborg, Anders
• Format: Journal Article
• Language: English
• Published: United States Informa Healthcare 01.08.2014; Taylor & Francis
• Subjects: Aged; Aged, 80 and over; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; CLL; Female; fludarabine-refractory; Follow-Up Studies; Humans; Leukemia, Lymphocytic, Chronic, B-Cell - diagnosis; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy; Leukemia, Lymphocytic, Chronic, B-Cell - epidemiology; Leukemia, Lymphocytic, Chronic, B-Cell - mortality; Male; Medicin och hälsovetenskap; Middle Aged; Neoplasm Staging; Public Health Surveillance; Registries; Salvage Therapy; survival; Sweden - epidemiology; time to treatment failure; Treatment Outcome; Vidarabine - analogs & derivatives; Vidarabine - therapeutic use; Sweden; CLL; fludarabine-refractory; survival; time to treatment failure
• ISSN: 1042-8194; 1029-2403; 1029-2403
• DOI: 10.3109/10428194.2013.827786

Abstract Patients with fludarabine-refractory (FR) chronic lymphocytic leukemia (CLL) receive novel agents in pivotal, non-randomised phase-2 trials. Understanding outcome of FR-CLL in health-care may provide important contextual information. Records from 1301 patients (Stockholm-Cancer-Registry 1991-2010) identified 92 FR-patients; bulky lymph-nodes (BFR-group), double-refractory (DR-group), or Others'-group for outcome-analysis. Median age was 69 years 67% had Rai-stage III/IV with median 3 prior therapies. Overall response-rate was 20%; significantly lower in BFR (8%, p = 0.01) and DR (20%, p = 0.01) than in 'Others' (31%). Time-to-treatment-failure (months) was significantly longer in 'Others' (9.2) than in BFR/DR (5.3/4.4) (p < 0.01) and significantly longer (p < 0.05) in antibody-treated patients (9.1) compared to other regimens (5.2). Early-death occurred in 5%, ≥ grade III-infections in 20%. Median overall-survival (OS) was 18 months; 29 in BFR vs 13 in DR (p = 0.054). Male sex was the only prognostic factor on OS (p = 0.01, HR 2.2, multivariate-Cox-regression). Our results, without external referrals, facilitate interpretation of non-randomised trials/novel drugs in advanced-stage-CLL.