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Blood, Vol. 92 No. 11 (December 1), 1998:
pp. 4059-4065
Response at Three Months Is a Good Predictive Factor for Newly
Diagnosed Chronic Myeloid Leukemia Patients Treated by Recombinant
Interferon-
F.X. Mahon,
C. Fabères,
S. Pueyo,
P. Cony-Makhoul,
R. Salmi,
J.M. Boiron,
G. Marit,
C. Bilhou-Nabera,
A. Carrère,
M. Montastruc,
A. Pigneux,
Ph. Bernard, and
J. Reiffers
From Service des Maladies du Sang, Centre Hospitalier Universitaire
de Bordeaux, Hôpital Haut-Levêque, Pessac, France; and the
Département d'Informatique Médicale, Université
Victor Segalen, Bordeaux, France.
In a single institution, we have used recombinant interferon-
(IFN-) to treat 116 newly diagnosed Philadelphia-positive (Ph+) chronic myeloid leukemia (CML) patients and
analyzed the predictive factors for response and survival. The patients
whose median age was 50.3 years (range, 9 to 70) were administered
IFN- (5 million units/m2/d) subcutaneously. The IFN-
dose was subsequently adjusted to maintain the white blood cell and
platelet counts between 1.5 and 5 × 109/L, 50 and 100 × 109/L, respectively. At diagnosis, the Sokal score was used
to classify the patients into three groups: low (n = 57),
intermediate (n = 42), and high risk (n = 16). A complete
hematological response (CHR) was achieved in 93 cases (80.2%). Of the
116 patients, 113 were available for cytogenetic evaluation. Fifty
patients (43%) achieved a major cytogenetic response (MCR) (=65%
marrow Ph cells), 37 of them having a complete
cytogenetic response (CCR). The estimated 5-year survival of the 116 patients was 68% ± 11% (95% confidence interval [CI]) with a
median follow-up of 42 months (range, 3 to 114) and 85% ± 11% (95%
CI) with a median follow-up of 30.9 (range, 3 to 111) when patients
were censored at the time of transplantation. Event-free survival at 5 years (adding death and transplant as event) was 46% ± 11% (95% CI). Using proportional hazards regression to study
time-dependent variables, we confirmed that the most significant factor
associated with survival was the cytogenetic response (MCR or CCR)
(P < .0001). This factor was independent compared with the
Sokal score and baseline variables used to calculate the Sokal score.
Moreover, using either univariate or multivariate analysis, the
achievement of CHR within 3 months was strongly correlated with MCR
(P < .0001). Minimum cytogenetic response (mCR, ie, at least
5% of Ph metaphases) at 3 months was also a significant
predictive factor for MCR (P < .0001). These results show
that IFN- can induce a high rate of hematological and cytogenetic
response when administered in doses leading to myelosuppression.
Factors such as the achievement of CHR and mCR within 3 months could be
useful to identify early those patients who will not respond to IFN-
and who need alternative treatments such as stem cell transplantation.
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