Haematologica 2003 - Supplements

PBSC mobilizing regimen utilizing CTX at 1.2 gr/m2 on days 1
and 3 associated to dexametasone 40 mg daily (from day 1 to day
4) in 38 newly diagnosed MM patients (group A). Results were
compared with those obtained in a previous cohort of 25 newly
diagnosed MM patients (group B) in whom PBSC were
mobilized using 7 gr/m2 of CTX. Subcutaneous administration of
G-CSF (5 µg/kg/day) was started in all patients 24 hours after the
last dose of dexametasone (group A) or CTX (group B)
administration. Both consecutive cohorts of patients were
comparable for age, immunoglobulins subtype, stage, disease
status, time from diagnosis, previous chemo radiotherapy
regimens. The efficacy of the two different mobilizing regimens
as for the number of CD34+ collected cells was evaluated only
after the first leukapheresis considering that, differently from
patients of group B, a target of ≥ 2 x 106 CD34+ cells/Kg for
patients of group A was required. This target was reached after a
median of 1 (range 1-3) and 2 (range 1-5) leukapheresis in
patients of group A and B, respectively. Failure of mobilization
was observed in 2 patients of the group A and 1 of the B. The
median number of CD34+ cells collected at the time of the first
leukapheresis was not significant different between the two
groups. A statistically significant reduction in G-CSF utilization
was observed in group A as compared to Group B. No deaths in
both groups were observed during mobilization and all patients of
group B were hospitalized. The median duration of neutropenia
(< 0.5 x 109/L) and thrombocytopenia (< 20 x 109/L) was 5
(range 3-8) vs 9 days (range 5-14) and 6 (range 5-10) vs 13 days
(range 9-18) for patients of group A and B, respectively. Severe
hepatotoxicity after 5 days from CD34+ cells reinfusion was the
cause of death in one patient of group B. As for fever, 15/38
(39.5%) patients in group A and 20/25(80%) in group B had a
body temperature > 38° C (χ2: 10.03; 2P < 0.02). The duration of
neutropenia and thrombocytopenia following PBSC infusion as
well as the hospitalization time and the response rate were the
same in both groups. Noteworthy, for the relevant economic
implications, all patients in group A required no hospitalization
and all but two collected a satisfactory number of PBSC.
However, a longer follow-up is required for clarifying whether or
not survival duration will be different between the two groups.
This will be relevant for planning future mobilization strategies .
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DCEP IS MORE EFFECTIVE THAN hd-CTX AS
MOBILIZING REGIMEN in multiple myeloma WITH
GOOD antitumor activity
P. Zappasodi, S. Mangiacavalli, A. Corso, C. Pascutto, A.
Lorenzi, C. Rusconi, M. Varettoni, C. Castagnola, M.
Bonfichi, L. Barbarano*, E. Morra*, M. Lazzarino
Division of Hematology, IRCCS Policlinico San Matteo, University
of Pavia, Pavia, Italy and *Division of Hematology, Ospedale
Niguarda, Milano, Italy
Introduction. We previously reported the higher efficacy in
mobilizing PBSC and the lower toxicity of DCEP
(dexamethasone 40 mg x 4 d and 4-day continuous infusion of
daily doses of cyclophosphamide 400 mg/m2, etoposide 40
mg/m2, and cisplatin 10 mg/m2), with respect to HD-CTX. Few
information, however, are available about its anti-tumor activity.
Aims of the study. 1) to confirm on a large population the
efficacy of DCEP as mobilizing regimen; 2) to compare its antitumor
activity with that of HD-CTX in previously untreated MM
patients.
Patients and methods. From 1996 to 2002, 203 MM patients were
consecutively enrolled in high-dose programs including single or
double autologous transplantation. Two different mobilizing
regimens were used: from 1996 to 1999 patients (n=61) were
mobilized with HD-CTX (group I); from January 2000 we
adopted the DCEP protocol as mobilizing regimen in all MM
patients for whom high-dose therapy was indicated (n=142; group
II).
We evaluated the mobilizing capacity of DCEP on 142 MM pts
(M 74, F 68, median age 55 yrs), and the toxicity related to this
regimen. We compared the response to the induction/mobilizing
phase on a total of 142 evaluable pts: 40 pts of group 1 treated
with VAD chemotherapy (3 cycles) followed by a single cycle of
HD-CTX (4 g/mq) and 102 pts of group 2 treated with VAD
chemotherapy (2 cycles) followed by DCEP (2 cycles).
Results. At the start of mobilization with DCEP, 101 pts (71%)
were responsive to VAD; 11 pts (7%) were previously treated
with alkylating agents; the median interval from first treatment
was 3 mos (range1-54). First leukapheresis was performed after a
median of 13 days (8-18) from chemotherapy. The patients
collecting ≥4x106/kg were 92 (64.8%), while poor mobilizers
(≤2x106/kg) were 5 (3.5%). The analysis of toxicity showed
thrombocytopenia (PLT