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Blood, Vol. 94 No. 5 (September 1), 1999:
pp. 1517-1536
REVIEW ARTICLE
An Evidence-Based Analysis of the Effect of Busulfan, Hydroxyurea,
Interferon, and Allogeneic Bone Marrow Transplantation in Treating the
Chronic Phase of Chronic Myeloid Leukemia: Developed for the American
Society of Hematology
Richard T. Silver,
Steven H. Woolf,
Rüdiger Hehlmann,
Frederick R. Appelbaum,
James Anderson,
Charles Bennett,
John M. Goldman,
Francois Guilhot,
Hagop M. Kantarjian,
Alan E. Lichtin,
Moshe Talpaz, and
Sante Tura
From the New York Presbyterian Hospital-Weill Medical College of
Cornell University, New York, NY; Medical College of Virginia, Fairfax,
VA; Universitat Heidelberg, Mannheim, Germany; Fred Hutchinson Cancer
Research Center, Seattle, WA; University of Nebraska Medical Center,
Omaha, NE; VA Chicago Health Care System, Lakeside Division, Chicago,
IL; Royal Postgraduate Medical School, London, UK; Hopital Jean Bernar,
Poitiers, France; M.D. Anderson Cancer Center, Houston, TX; Cleveland
Clinic Foundation, Cleveland, OH; and St Ursula Hospital, Bologna,
Italy.
Because there are differing opinions regarding treatment of patients
in the chronic phase of chronic myeloid leukemia (CML), the American
Society of Hematology convened an expert panel to review and document
evidence-based benefits and harms of treatment of CML with busulfan
(BUS), hydroxyurea (HU), recombinant interferon- (rIFN-), and
bone marrow transplantation (BMT). The primary measure for defining
efficacy was survival. Analysis indicated a survival advantage for HU
over BUS. Observational studies of rIFN- suffer from numerous biases
including sample size, variations in study populations, definitions of
hematologic and cytogenetic remissions, and dose. That rIFN- is more
efficacious than chemotherapy is demonstrated by 6 prospective
randomized trials. For patients with favorable clinical features in
chronic phase, compared to HU and BUS, rIFN- improves survival by a
median of about 20 months. Most evidence suggests that rIFN- is most
effective when combined with other drugs and when given during the
earliest stage of the chronic phase. Adding cytarabine to rIFN- adds
further survival benefit but increases toxicity. Limitations for
evaluating the long-term benefits of allogeneic BMT include the
retrospective nature of most studies, incomplete documentation of the
clinical characteristics of the patients, paucity of the details on
patient selection, lack of control groups, and limitations of survival calculations. Survival curves for BMT show that at least half of the
patients transplanted remain alive 5 to 10 years after treatment,
whereas similar curves for rIFN- show a continuous relapse rate over
time with the curves crossing at about 7 to 8 years. Estimates of
long-term survival may be confounded by the selection biases mentioned
and the analytic methods used. The magnitude of the incremental
increase in benefit with BMT must be weighed against the potential
serious harm and death that may accompany the procedure in the short
term. The best results with BMT have been obtained when it is performed
within 1 to 2 years from diagnosis. Since each treatment option
involves tradeoffs between benefit and harm, patient choice must be
based on the examination of facts presented in an unbiased fashion.
Newly diagnosed younger patients and older patients who are candidates
for BMT should also be offered information about IFN-based regimens,
the tradeoffs involved, and, if possible, share in the treatment
decision. Hopefully this analysis will provide the stimulus for
evaluation of other important aspects of CML.
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