Haematologica 2003 - Supplements

at 3 years was 78% (72-83%) in the ITG-60 and 57% (49-66%) in
the CG-60. The survival advantage persisted (risk ratio 0.46,
95%CI 0.31-0.69; p=.0002) after statistical analysis of prognostic
factors and correction for differences between the groups.
Also for patients 60-64 years survival was prolonged with a risk
ratio of 0.58 (95%CI 0.38-0.87; p=.01). Survival at 3 years was
65% (54-75%) in the ITG-65 and 47% (38-57%) in the CG-65.
However, after correction for differences in prognostic factors
between the groups the survival advantage only reached
borderline significance (risk ratio 0.65, 95%CI 0.31-1.03; p=.06).
To conclude, in this population-based study patient age was
found to influence outcome after intensive therapy. Intensive
therapy prolongs survival also at ages between 60 and 65, but
with less superiority than in younger patients.
264
High-dose Idarubicine, Busulphan and Melphalan for
autologous stem cell transplantation in multiple
myeloma. Comparison with an historical control
S. Capria, MT Petrucci, M Ribersani, G Ferrazza, A
Micozzi, F Simone, MC Torromeo, SM Trisolini, G Meloni
Dipartimento di biotecnologie Cellulari ed Ematologia Università
degli studi La Sapienza, Roma
OBJECTIVES. We have analysed newly diagnosed MM patients
(pts) (A group) receiving DAV 1st line therapy and stem cell
autograft (ASCT) after a intensified conditioning regimen with
idarubicine, busulphan and melphalan (IDA-BU-MEL); we have
evaluated the toxicity and the impact on overall survival (OS) and
progression-free survival (PFS), comparing the results with
historical controls receiving BU-MEL regimen (B group).
METHODS. The pts A were 32 (M=22), median age 53 ys (30-
60). At diagnosis 28 were stage>II. Paraproteins were detected in
all patients. At the time of ASCT 7 pts were already in complete
remission (CR) and 25 in partial remission (PR).
Pts received a median of 5,4x106 CD34+ cells/Kg (2,2-23,1)
collected after Cy (1,2 g/m2, d 1,3) and Dex, followed by daily
subcutaneous rhG-CSF 5 microg/Kg.
The conditioning regimen consisted of IDA 21 mg/m2 by
continuous infusion over 24 hours on d–12 to–11, BU 4 mg/kg/d
on d–8 to d–5 and MEL 60 mg/m2 i.v. on d–4; ASCT was
performed on d 0.
On d+1 from ASCT rhG-CSF was started at dose of 5
mcg/Kg/day and continued until granulocyte (PMN) count
exceeded 1x109/l.
Maintenance treatment with recombinant alpha2-interferon was
started after the complete recovery and continued at dose of 3
MU 3 times a week until relapse.
RESULTS. In pts A the recovery was reached at a median of 10 d
(8-15) for PMN>0,5x109/l and at 16 d (9-74) for platelets (PLTs)
>50x109/l. The median duration of profound neutropenia was 12
d (8-14); 31/32 pts had fever: 25 agents were isolated in 18 pts.
30/32 oral mucositis grade >III WHO and 7 extrahematological
complications (21%) were observed.
Currently 25 pts are alive after a median of 40 ms (9-62) and 18
are progression-free after a median of 32 ms (9-60); 13 pts
relapsed after a median of 22 ms (5-47).
5 ys OS is 73% and PFS is 37%.
Data were compared with the results obtained in 38 pts receiving
ASCT after BU-MEL regimen. Patients’ details were comparable
in both series.
The comparison with the historical control showed an increased
toxicity of the intensified regimen, in particular concerning
duration of neutropenia (p