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Blood, 1 January 2005, Vol. 105, No. 1, pp. 49-53.
Prepublished online as a Blood First Edition Paper on May 11, 2004; DOI 10.1182/blood-2004-03-0796.
 Previous Article | Table of Contents | Next Article 
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011
John C. Byrd,
Kanti Rai,
Bercedis L. Peterson,
Frederick R. Appelbaum,
Vicki A. Morrison,
Jonathan E. Kolitz,
Lois Shepherd,
John D. Hines,
Charles A. Schiffer, and
Richard A. Larson
From the Division of Hematology-Oncology, Department of Medicine, The Ohio State University, Columbus, OH; the Divisions of Hematology and Oncology, Long Island Jewish Medical Center, New Hyde Park, NY; the Cancer and Leukemia Group B (CALGB) Statistical Center, Durham, NC; the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; the Section of Hematology/Oncology, Veterans Affairs Medical Center, University of Minnesota, Minneapolis; the Department of Medicine, North Shore University Hospital-Cornell University Medical College, Manhasset, NY; the Department of Pathology, Kingston General Hospital, National Cancer Institute of Canada-Clinical Trials Group, Kingston, ON, Canada; the Department of Medicine, The Case Western Reserve University School of Medicine, Cleveland, OH; the Department of Medicine, Wayne State University School of Medicine, Detroit, MI; and the Department of Medicine, The University of Chicago, Chicago IL.
Fludarabine and rituximab combination therapies in chronic lymphocytic leukemia (CLL) have yielded promising early results, but no comparative efficacy data relative to standard fludarabine treatment regimens have been reported. To assess the effect of the addition of rituximab to fludarabine therapy, we retrospectively compared the treatment outcome of patients with similar clinical characteristics enrolled on 2 multicenter clinical trials performed by the Cancer and Leukemia Group B and the US Intergroup that used fludarabine and rituximab (CALGB 9712, n = 104) or fludarabine (CALGB 9011, n = 178). In multivariate analyses controlling for pretreatment characteristics, the patients receiving fludarabine and rituximab had a significantly better progression-free survival (PFS; P < .0001) and overall survival (OS; P = .0006) than patients receiving fludarabine therapy. Two-year PFS probabilities were 0.67 versus 0.45, and 2-year OS probabilities were 0.93 versus 0.81. Infectious toxicity was similar between the 2 treatment approaches. These comparative data are retrospective and could be confounded by differences in supportive care or dissimilar enrollment of genetic subsets on each trial. Confirmation of these findings will require a prospective randomized trial comparing fludarabine and rituximab to fludarabine.
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