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Interferon alpha-2b as therapy for Ph'-positive chronic myelogenous
leukemia: a study of 82 patients treated with intermittent or daily
administration
G Alimena, E Morra, M Lazzarino, AM Liberati, E Montefusco, D Inverardi, P Bernasconi, M Mancini, E Donti and F Grignani
Department of Human Biopathology, University La Sapienza, Rome, Italy.
The authors treated a total of 82 patients with Ph'-positive chronic
myelogenous leukemia (CML) with recombinant interferon alpha-2b (IFN
alpha-2b). Sixty-five patients in chronic phase (CP), 28 of whom were
untreated and 37 pretreated, and nine patients in accelerated phase (AP),
were started on IFN three times a week. Patients in CP were randomized to
receive 2 or 5 X 10(6) IU/m2, while patients in AP were all given the dose
of 5 X 10(6) IU/m2, in addition to concomitant chemotherapy. Patients in CP
who were unresponsive to the lower dose were crossed to the higher dose. Of
63 evaluable patients in CP, 43 (68%) responded, 29 (46%) achieved complete
hematologic response (CHR), and 14 (22%) achieved partial hematologic
response (PHR). The response rate appeared to be significantly influenced
by the IFN dose in pretreated patients. Of the nine patients in AP, two
attained PHR and one CHR. More recently, eight previously untreated CP
cases were submitted to daily IFN administration at doses from 2 to 5 X
10(6) IU/m2. This daily schedule was also applied to patients who had
obtained, with the intermittent treatment, a PHR persisting unmodified for
six months (nine patients) or an unstable CHR (five patients). Seven of the
eight previously untreated patients, and five of the nine PHR patients
crossed to daily IFN reached CHR. In the total series of previously
untreated patients, the response rate proved to be significantly influenced
by the initial risk status. Cytogenetic improvement was seen in 37 of 53
responders (70%) treated for more than 3 months, the median of Ph'-positive
cells declining from 100% to 65% (range 0% to 95%). Complete suppression of
Ph' chromosome was observed in one case. The cytogenetic response was
persistent for over 6 months in 21 patients, but the lowest value of Ph'
positivity was usually unstable. At a median follow-up of 56 weeks, 23 of
36 (64%) CHR patients remain in continued disease control with IFN. A
blastic transformation (BT) occurred in seven of 21 unresponsive patients
and in one of the 36 CHR patients. The authors' data confirm that IFN
alpha- 2b, especially at daily doses, is effective in inducing clinical and
cytogenetic response in a good proportion of patients with CML in the
benign phase. Longer follow-ups will define the exact influence of this
agent on the natural course of the disease.
Volume 72,
Issue 2,
pp. 642-647,
08/01/1988
Copyright © 1988 by The American Society of Hematology
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