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Treatment of Anemia in Myelodysplastic Syndromes
With Granulocyte Colony-Stimulating Factor Plus Erythropoietin:
Results From a Randomized Phase II Study and Long-Term Follow-Up
of 71 Patients
Eva Hellström-Lindberg,
Tomas Ahlgren,
Yves Beguin,
Magnus Carlsson,
Jan Carneskog,
Inger Marie Dahl,
Ingunn Dybedal,
Gunnar Grimfors,
Lena Kanter-Lewensohn,
Olle Linder,
Michaela Luthman,
Eva Löfvenberg,
Herman Nilsson-Ehle,
Jan Samuelsson,
Jon-Magnus Tangen,
Ingemar Winqvist,
Gunnar Öberg,
Anders Österborg, and
Åke Öst
From the Department of Hematology, Huddinge University Hospital,
Huddinge, Sweden; Department of Pathology, Karolinska University
Hospital, Stockholm, Sweden; Department of Hematology, University of
Liège, Liège, Belgium; The Scandinavian MDS Group, Sweden
and Norway.
Treatment with erythropoietin (epo) may improve the anemia of
myelodysplastic syndromes (MDS) in approximately 20% of patients. Previous studies have suggested that treatment with the combination of
granulocyte colony-stimulating factor (G-CSF) and epo may increase this
response rate. In the present phase II study, patients with MDS and
anemia were randomized to treatment with G-CSF + epo according to one
of two alternatives; arm A starting with G-CSF for 4 weeks followed by
the combination for 12 weeks, and arm B starting with epo for 8 weeks
followed by the combination for 10 weeks. Fifty evaluable patients (10 refractory anemia [RA], 13 refractory anemia with ring sideroblasts
[RARS], and 27 refractory anemia with excess blasts
[RAEB]) were included in the study, three were evaluable only for epo as monotherapy and 47 for the combined treatment. The
overall response rate to G-CSF + epo was 38%, which is identical to
that in our previous study. The response rates for patients with RA,
RARS, and RAEB were 20%, 46%, and 37%, respectively. Response rates
were identical in the two treatment groups indicating that an initial
treatment with G-CSF was not neccessary for a response to the
combination. Nine patients in arm B showed a response to the combined
treatment, but only three of these responded to epo alone. This
suggests a synergistic effect in vivo by G-CSF + epo. A long-term
follow-up was made on 71 evaluable patients from both the present and
the preceding Scandinavian study on G-CSF + epo. Median survival was
26 months, and the overall risk of leukemic transformation during a
median follow-up of 43 months was 28%. Twenty patients entered
long-term maintenance treatment and showed a median duration of
response of 24 months.The international prognostic scoring system
(IPSS) was effective to predict survival, leukemic transformation, and
to a lesser extent, duration of response, but had no impact on primary
response rates.
Blood, Vol. 92 No. 1 (July 1), 1998:
pp. 68-75
© 1998 by The American Society of Hematology.
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