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Minimal Residual Disease in Patients with Hairy Cell Leukemia in Complete Remission Treated with 2-Chlorodeoxyadenosine or 2'-Deoxycoformycin and Prediction of Early Relapse¹

Northwestern University Medical School, Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago, Illinois 60611 [M. S. T., D. H., S. W., E. W., L. C. P.]; Fred Hutchinson Cancer Research Center Southwest Oncology Group Statistical, Seattle, Washington [K. J. K.]; University of New Mexico, Department of Pathology, Albuquerque, New Mexico 87106 [K. F.]; University of Miami, Sylvester Cancer Center, Miami, Florida 33136 [P. A. C.]; Mayo Clinic, Rochester, Minnesota 55905 [T. H.]; Johns Hopkins Oncology Center, Division of Hematologic Malignancies, Baltimore, Maryland 21287 [M. G.]; Rambam Medical Center, Technion Institute, Haifa, 31096 Israel [J. M. R.]; Eastern Cooperative Oncology Group, Brookline, Massachusetts; and Southwest Oncology Group, San Antonio, Texas

The purine nucleoside analogues 2-chlorodeoxyadenosine (2-CdA) and 2'-deoxycoformycin (2'-DCF) induce complete remission (CR) in the majority of patients with hairy cell leukemia. However, minimal residual disease (MRD) has been detected in bone marrow core biopsies using immunohistochemical techniques in patients achieving CR by conventional criteria. This study was designed to compare the prevalence of MRD with each agent in patients in CR by using conventional criteria and the relapse-free survival for patients with and without MRD.

Bone marrow biopsies from 39 patients treated with a single cycle of 2-CdA and 27 patients treated with multiple cycles of 2'-DCF were studied. The monoclonal antibodies anti-CD20, DBA.44, and anti-CD45RO were used to evaluate the paraffin-embedded bone marrow core biopsies for MRD.

Five of 39 patients (13%) treated with 2-CdA had MRD, as compared to 7 of 27 patients (26%) treated with 2'-DCF (two-tailed P = 0.21). Relapse has occurred in two of the five patients with MRD after 2-CdA treatment and in four of the seven patients with MRD after 2'-DCF treatment. In total, 6 of the 12 patients (50%) with MRD have relapsed, whereas 3 of 54 patients (6%) without MRD have relapsed, and 2 patients have died without evidence of relapse. The estimated 4-year relapse-free survival among patients with MRD is 55% (± 15%, SE), compared to 88% (± 5%, SE) among patients without MRD (two-tailed P = 0.0023).

The prevalence of MRD detected in a subset of patients in CR after either 2-CdA or 2'-DCF treatment did not differ significantly. However, the presence of MRD is associated with an increased risk of relapse.

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