12th Congress of the European Hematology ... - Haematologica

of the drug is crucial to allow long term therapy. We report here a single
centre experience with low dose thalidomide in relapsed/refractory
patients. Methods and Results. From October 1999 to September 2006 we
treated 34 patients affected by relapsed/refractory MM with Thalidomide;
in the first year we used the dose escalation (from 100 to 800 mg)
suggested by Barlogie, but the low compliance of our cohort of patients
prompt us to utilize a fixed dose of 100mg/die from start of therapy. Dexamethasone
(40 mg i.v. dd 1-4 every 28 days for 4 cycles) was added, in
the case of lack of response, intended as less than 25% monoclonal protein
(MP) reduction after 2 months of therapy. Thalidomide was maintained
at 100 mg daily dose until progression of disease or intolerable
toxicity. Informed consent was obtained prior to therapy. Characteristic
of patients are shown in Table 1. The total response rate was 82%
(28 out of 34 patients) : 1 VGPR (>90% MP reduction), 7 GPR (between
75% and 90%), 15 PR (between 50% and 75%), 5 MR between 25% and
50%). Treatment interruption was necessary for neurotoxicity (grade 3-
4) only in 3 patients, whereas 11 patients had progressive disease. The
median survival from thalidomide start is 20 months; the median time
of therapy is 18 months. Although PN occurred after a variable period
of time in more than 70% of patients, low daily dose of Thalidomide
allowed us to prolong consistently the treatment phase, with neurologic
toxicity < 2 in the majority of patients. Conclusions. Although Barlogie
found that a cumulative dose of more than 42 g in the first 3 months of
treatment was significantly associated with a better response, satisfactory
response rates were also observed with low dose thalidomide alone
or in association with Dex or cytotoxic regimen. Durie reported in 2000
a dose escalation phase II study where doses between 50 and 400 mg
were utilized, with dose escalation based upon a lack of response. A
remarkable observation was that in responding patients the magnitude
(% of regression) and duration of response did not appear to be influenced
by dose. Relationship between Thalidomide doses, response rate
and survival in MM has not been investigated with large prospective
studies; nevertheless most clinical studies utilize a dose of 200 mg or
more, although some spontaneous clinical trials testing Thalidomide at
lower dosage have already shown its efficacy. Thalidomide withdrawal
is often associated with a shorter time to progression. For this reason
the possibility to prolong treatment in relapsed/refractory MM patients
as long as possible should be the goal of the salvage therapy. In our experience
low-dose Thalidomide without escalation is associated with a
better tolerance and a longer treatment opportunity.
Table 1.
1181
SERUM FREE LIGHT-CHAIN MEASUREMENTS FOR MONITORING MINIMAL RESIDUAL
DISEASE AFTER STEM CELL TRANSPLANTATION IN MULTIPLE MYELOMA PATIENTS
C.A. De Souza, G. Oliveira-Duarte, D.F. Dias, P.V. Bottini, A.C. Vigorito,
F.J.P. Aranha, K.A.B. Eid, I. Lorand-Metze
State University of Campinas, CAMPINAS, Brazil
The quantitative assay for free light chains (FLC) has been reported to
be sensitive and specific for detecting and monitoring monoclonal gammopathies.
In order to determine the status of disease and the presence of
minimal residual disease, we used immunofixation electrophoresis (IFE)
12 th Congress of the European Hematology Association
in urine and serum and routine laboratory tests for all the patients prior
and after the transplantation. After the transplantation, the patients were
evaluated by FLC and IFE in serum and urine. 19 patients underwent an
autologous peripheral blood stem cell transplantation (SCT) and 6 of them
received a second reduced-intensity allogeneic SCT and one receive a second
autologous SCT, between may-2001 and june-2006. At the time of
diagnosis, 10 patients were IgG, 4 IgA, 4 light chain secretor and 1 nonsecretory.
All patients received 6 cycles of VAD as induction chemotherapy
and cyclophosphamide (4-7 g/m 2 ) as mobilization for bone marrow harvesting.
Prior the first autologous transplant, 4 patients were in complete
remission (CR), 9 partial remission (PR), 3 minimal disease (MR) and 3 in
progression disease (PD) and prior the second, 2 were in CR, 1 PR, 1 stable
disease (SD) and 3 in PD. After a 1560 median follow up days (742-
4100 days), 12 patients were in CR, 2 in PD and 5 showing only positive
IFE in urine and/or serum. However, when the patients were evaluated by
FLC, 10 patients were in CR, 2 in PD and 7 with only FCL positive in
urine or serum. The FLC did not confirm CR in 2 patients evaluated by IFE.
In conclusion, it seems that FLC is more sensitive and useful for minimal
residual disease evaluation in myeloma patients after SCT.
1182
A CASE-CONTROL STUDY OF POSSIBLE RISK FACTORS IN PRIMARY CUTANEOUS
LYMPHOMAS
S. Rupoli, 1 G. Goteri, 2 S. Pulini, 3 A. Tassetti, 1 P. Picardi, 1 ,M. Nicolini, 4
A.M. Scortechini, 1 S. Mulattieri, 1 A. Stronati, 1 M. Giangiacomi, 2
M. Offidani, 1 R. Santilli, 5 I. Cataldi, 6 A. Cellini, 6 G. Tucci, 5 L. Morresi, 5
P. Leoni1 1 Clinic of Hematology, TORRETTE DI ANCONA; 2 Institute of Pathology,
ANCONA; 3 Department of Hematology, Pescara Hospit, PESCARA; 4 Division
of Dermatology, Jesi Hospital, JESI; 5 Division of Dermatology, INRCA, Ancona,
ANCONA; 6 Clinic of Dermatology, ANCONA, Italy
Backgrounds. Epidemiologic studies have indicated some occupational
and life style factors, like toxic exposure and smoking, as risk factors
for primary cutaneous lymphomas (PCL), especially Mycosis Fungoides.
Aims. The socio-demographic characteristics, occupational history, life
style factors, personal and familiar history of patients with PCL were
compared to a control group of healthy subjects, homogeneous for
numerosity and matched for sex, age and geographical provenience, in
order to evaluate the incidence of possible risk factors in the two populations.
Methods. All the patients with PCL diagnosed and treated at
our Institution from January 1990 to September 2006 were included in
the study. Healthy controls were selected from the families of patients
referred to our Institutions and matched to the patients for sex, age and
geographical provenience. Patients and controls gave their informed
consent to fill out a form with data regarding socio-demographic characteristics;
occupational history; life style factors (smoking habits and
alcohol intake); eye and hair color, type of sun exposure, phototype, and
reaction to sun-light; exposure to toxic factors; familiar and personal history
for cutaneous disease, burnings, immunologic, hematological, respiratory
disorders and neoplasms. Patients’ and controls’ characteristics
and descriptive data were expressed as median and range for continuous
variables and by frequency tabulations for categorical variables. All
statistical analyses were performed using the SPSS statistical package
(SPPS Inc. Chicago, IL). Statistical significance was set at p