To assess the therapeutic value of sequentia high-dose therapy (SHDT) including autologous stem cell transplantation in chronic lymphocytic leukemia (CLL) we performed a risk-matched comparison between 66 patients who had undergone a uniform SHDT regimen and a database of 291 patients treated conventionally. Matching variables were age, Binet stage, IgV(H) (variable region of the immunoglobulin heavy chain) gene mutational status, and lymphocyte count. Forty-four pairs fully matched for all 4 variables were identified. Patient groups were well balanced for additional risk factors including adverse genomic abnormalities and CD38 expression. With an overall median follow-up time of 70 and 86 months, respectively, survival was significantly longer for the SHDT patients than for the conventionally treated patients when calculated from diagnosis (hazard ratio [HR] 0.39; P =.03 [log rank]) or from study entry (HR 0,32; P =.006). The benefit for the SHDT group remained significant when the analyses were restricted to those 58 patients who had an unmutated VH Status-Cox regression analysis confirmed SHDT as independent favorable prognostic factor for survival from diagnosis (HR 0.38, P =.04) as well as from study entry (HR 0.38, P =.03). These data suggest a survival benefit for patients with poor-risk CLL receiving SHDT during the course of their disease. (C) 2004 by The American Society of Hematology.
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