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Low Doses of Interferon-α Are as Effective as Higher Doses in Inducing Remissions and Prolonging Survival in Chronic Myeloid Leukemia

Jill R. Schofield, BS; William A. Robinson, MD, PhD; James R. Murphy, PhD; and Douglas K. Rovira, MD
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From the University of Colorado Health Sciences Center, Denver, Colorado. Requests for Reprints: William A. Robinson, MD, PhD, University of Colorado Health Sciences Center, Division of Medical Oncology, Box B171, 4200 East Ninth Avenue, Denver, CO 80262. Acknowledgments: The authors thank Mrs. Kathie Baca for assistance with manuscript preparation and the Schering Corporation and Hoffman La Roche, Inc., for providing the interferon-α.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1994;121(10):736-744. doi:10.7326/0003-4819-121-10-199411150-00002
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Objective: To determine the toxicity and efficacy of low-dose interferon-α therapy in inducing remissions and prolonging survival in patients with chronic myeloid leukemia.

Design: Phase II evaluation and comparison with historical control patients and other series in which the investigators used higher interferon-α doses.

Setting: Tertiary care leukemia research clinic.

Patients: 41 patients with newly diagnosed or previously treated chronic-phase, Philadelphia chromosome-positive chronic myeloid leukemia received interferon-α at a dose of 2 × 106 U/m2 body surface area daily for 28 days and then three times weekly.

Measurements: Complete blood counts and physical examinations were done monthly to determine hematologic remission and toxicity. To determine karyotypic response, bone marrow cytogenetic analyses were done at 6 monthly intervals in patients who achieved a complete hematologic remission. In addition, Kaplan-Meier survival curves and median survival values were generated from diagnosis and the start of therapy with interferon-α.

Results: 70% of patients treated with low-dose interferon-α within 1 year of diagnosis achieved a complete hematologic remission, and 22% of these patients had a major or complete karyotypic response. Investigators who used higher interferon-α doses in similar patient populations have reported complete hematologic remission rates of 59% to 70% and major and complete cytogenetic response rates of 16% to 29%. The Kaplan-Meier estimated 5-year survival rate of minimally pretreated patients in our study is 73% (95% CI, 51% to 95%), which compares favorably with survivals reported by investigators who used higher doses. The estimated yearly cost of the interferon-α used in our study is $5953 compared with a median of $24 375 for the higher doses used by other investigators. Less toxicity was also observed.

Conclusion: Low-dose interferon-α is as effective as higher-dose interferon-α in inducing remissions and prolonging survival in patients with chronic myeloid leukemia but is considerably less expensive and toxic.


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Figure 1.
The Kaplan-Meier survival curves shown from the time of diagnosis (dotted line) and from the start of interferon therapy (broken line) for 41 patients with chronic-phase chronic myeloid leukemia treated with low-dose interferon-α compared with the actuarial survival from the diagnosis of 122 control patients treated with hydroxyurea (solid line).

IFN α = interferon-α.

Grahic Jump Location
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Figure 2.
The Kaplan-Meier survival curves for 27 patients with chronic myeloid leukemia treated with interferon-α within 1 year of diagnosis (broken line) compared with that of 14 patients who started interferon therapy more than 1 year after diagnosis (dotted line).

Survival is shown from the start of interferon therapy. IFN α = interferon-α.

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