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Blood, Vol. 92 No. 5 (September 1), 1998:
pp. 1541-1548
Long-Term Follow-Up of the Italian Trial of Interferon- Versus
Conventional Chemotherapy in Chronic Myeloid Leukemia
The Italian Cooperative Study Group on Chronic Myeloid Leukemia*
Several prospective randomized studies have shown that the treatment
of chronic myeloid leukemia with interferon- (IFN-) prolongs the
survival by comparison with conventional chemotherapy. However,
although IFN- can induce cytogenetic responses, true complete
remissions are rarely achieved and information on the long-term effects
of IFN- treatment is limited. For that purpose, we updated and
analyzed a prospective comparative trial of IFN- and conventional
chemotherapy that was initiated in 1986. The first analysis of the
trial was already published, and showed a survival advantage for
IFN- (N Engl J Med 12:820, 1994). The observation period of
living patients now ranges between 95 and 129 months and we examined
the long-term effects of IFN- treatment, always by comparison with
conventional chemotherapy and according to the intention-to-treat
principle. The patients who were submitted to allogeneic bone marrow
transplantation (BMT) in chronic phase (38 of 322 or 12%) were
censored at the date of BMT. Seventy-three of the original 284 nontransplanted patients were alive, 56 (30%) in the IFN- arm and
17 (18%) in the chemotherapy arm. Forty-one patients overall (14%)
were still receiving IFN-. In the IFN- arm 9 patients were in
continuous complete cytogenetic remission and 11 were in major or minor
cytogenetic remission. Median and 10-year survival of low-risk patients
were 104 months (95% CI, 85 to 127 months) and 47% (95% CI, 36% to
59%) in IFN- arm versus 64 months (95% CI, 49 to 98 months) and
30% (95% CI, 16% to 44%) in chemotherapy arm (P = .03).
Median and ten-year survival of non-low-risk patients were 69 months
(95% CI, 56 to 76 months) and 16% (95% CI, 8% to 24%) in IFN-
arm versus 46 months (95% CI, 39 to 61 months) and 5% (95% CI, 0%
to 11%) in chemotherapy arm (P = .006). A low Sokal's
risk, hematologic response, and cytogenetic response were associated
with a longer survival. No major or unusual side effects were recorded
after the 5th year of IFN- treatment. Fourteen patients died in
chronic phase, 9 (4%) in IFN- arm and 5 (5%) in chemotherapy arm,
mainly of cardiovascular accidents (6 cases) and of other cancers (5 cases). We conclude that a policy of chronic treatment with IFN-
maintained a significant survival advantage over conventional
chemotherapy on a long-term basis and irrespective of the
risk. However, the great majority of the long-term survivors were in
the low-risk group. The question of treatment discontinuation was not
addressed in this study.
© 1998 by The American Society of Hematology.
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