Haematologica 2003 - Supplements

were not changes in the rate of TNF, VEGF, beta-2-MG,
inmunoglobulins, platelets neither other parameters.
Conclusion: The treatment with high dose of rHuEpo, corrects the
anemia in the patients with myeloma and it also interferes with
the biology from this illness when diminishing, for unknown
mechanisms, the rate of IL-6 and of PCR. The TNF-alpha and
VEGF don't modify after the treatment with rHuEpo.
Project 2PR02A006 financed by the Dirección General de
Enseñanzas Universitarias e Investigación de la Consejeria de
Educación, Ciencia y Tecnologia de la Junta de Extremadura.
255
High dose Erythropoietin in Elderly Multiple
Myeloma(MM) patients with anemia.
G. La Verde,S.Leonetti Crescenzi*
Hosp. S.Andrea, Roma , *Hosp. Umberto I, Frosinone, Italy .
Anemia occurs in almost all patients (pts) during the course of
MM and inadequate levels of erythropoietin can be detected in at
least 50% of them. Recombinant Epo (rh-Epo) therapy became
an useful component in the treatment strategy of MM giving a
respose in 50/60% of patients when administered at conventional
dosage of 10.000 IU s.c. 3 times/weeks.
The aim of the present study was to investigate: 1) the efficacy in
improving Hb level and quality of life and 2) feasibily of early
high dose rh-Epo (40.000 IU, twice a week) during induction
treatment of elderly(>60 yrs) MM patients with Hb level 12g/dl, major (MR) - stable increase of
2 gr/dl -, and minor (mR) - Hb increase >1 < 2 gr/dl -.Patients,
who did not achieve any improvement in Hb and/or maintained
the same transfusion requirement were considered non
responders.
From December 2001 to August 2002, 9 patients (7 females and 2
males, median age 68 yrs, range 60-73 yrs) entered in this study:
4 patients were at diagnosis and 5 in first progression state, 6 had
disease stage IIA, 2 IA and 1 III B at diagnosis. Before rh-Epo
therapy median Hb level was 8 gr/dl (range 6,9-9,5), median
reticulocyte count was 0,8% (range 03-2), median transferrin
saturation index was 43% (range 13-65). Three patients required
supportive therapy: 2,2 and 3 RBC unit/month, respectively. The
median fact-an evaluation was 42,7.
After three weeks of treatment ( 6 high doses rh-Epo), 8/9
patients (88%) were responders (4 MR and 4 a mR),the median
Hb level was 10,1 gr/dl (range 8,4-11,3) and median increase Hb
level was 1,5 gr/dl (range 0,7-3,5). Only 1 pt resulted refractory,
even if in this case supportive therapy requirement reduced from
3 to 1 RBC unit/month. No difference was observed between
patients treated at diagnosis or in progression phase. Only one
patient (at diagnosis) increased significantly Fact-an evaluation (
>30% ) :total median point 43,5.
After the first month of maintenance with conventional doses, all
responder pts maintained the Hb improvement (median Hb level
10,5 gr/dl, range 9,5-12 g/dl) achieved during induction. As to
February 2003, after a median follow-up of 11,8 months (range 6
–13 months), 6 pts continued to be responders, (3 MR and 3
mR)and 2 relapsed after 4 and 6 months respectively. The only
refractory patient died, because of disease progression, after 7
months of follow-up.
These results show that, in the treatment of elderly MM patients,
early HD rh-Epo seems to be an effective and safe approach in
inducing a rapid and stable increase of Hb level, which can be
successively maintained with conventional rh-Epo doses. These
data, even if promising, need to be confirmed in a larger cohort of
patients, with longer follow-up, to better evaluate the real impact
of this rh-Epo schedule both on disease outcome and quality of
life.
256
Rapid and sustained response of disease-related
anemia in patients with multiple myeloma by high
doses of epoetin alpha: the updated results of an open,
non-comparative, single centre pilot study.
Pasquale Niscola, Laura Scaramucci, *Luigi
Menichelli,Velia Bongarzoni, Roberta Ciafrino, Cinzia De
Gregoris, Marco Morucci,Vincenzo Tini, Marco Montanaro.
Hematology Unit, *Pharmacy Unit, ASL Viterbo (Italy).
The results of a pilot experience on the management of the
multiple myeloma (MM)-related anaemia, evaluating the efficacy
and tolerability of a new regimen of high doses (HD) of
erythropoietin-alpha (epoetin alpha, 40,000 IU), are reported. Ten
patients with a median age of 72 (45-87) years entered the study.
Nine patients were in IIIA and one in IIA disease stage. Median
time from diagnosis was 38 months (range: 1-74 months). Five
patients presented very advanced MM, three a stable response
and two were at the onset of the disease. The median previous
lines of anti-myeloma treatments were 2 (range: 0-5). All
patients received anti-myeloma treatments according to the phase
of disease.
The mean hemoglobin (Hb) and serum erythropoietin levels were
8.5 ± 0.7 g/dl and 43±17 mU/ml respectively. Epoetin alpha
40,000 IU, was given twice weekly (TW), SC, for 4 weeks (8
weeks in non- responders) or shorter period if patients achieved
an Hb level >12 gr/dl. After the induction phase, the dosing
interval was progressively longed. The responders received
epoetin alpha 40,000 U once weekly (OW) for two weeks and
then the same dose was given every two weeks. An I.V. iron
supplementation was given on regular basis (125 mg weekly)
during the induction phase. The responders received the same
dose of I.V. iron if presenting hypochromic erythrocytes >10% of
the total or transferrin saturation 2 gr/dl or by >1
gr/dl respectively.
Overall, 9 (90%) of 10 patients responded to the treatment: 2
achieved a minor response and 7 a major response. Out of these,
2, 3, 2 and 1 achieved the response within the first, the 2nd, the
3rd and the 4th week respectively, reaching a mean (±SD) Hb
level of 12.6±1.5 gr/dl; one patient showed a late response,
becoming transfusion independent after 7 weeks. Out of the 9
responders, 8 stopped the treatment: 6, presenting a stably
maintained erythroid response, died after 18, 24, 26,42, 46 and 58
weeks respectively; the seventh stopped epoetin alpha after 10
weeks and was undergone to an allogeneic peripheral blood stem
cell transplantation; the remaining patient lacked the response to
epoetin alpha after 52 weeks. To date, two patients have a
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