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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.
Acknowledgements
This study was supported by grants from The Swedish Cancer Society, The Cancer Society in Stockholm, King Gustav V Jubilee Fund, The Cancer and Allergy Foundation, The Karolinska Institutet Foundations, The Stockholm County Council and GlaxoSmithKline Ltd. We thank Murat Ipek at PAREXEL GmbH for statistical expertise, Yvonne Lis for editorial assistance and Leila Relander for expert secretarial help.
Potential conflict of interest:
Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal.