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

(range 1-7) and 28,6% of patients had undergone prior autotransplant.
Results. The response was evaluated according to the EBMT criteria in
48 patients ( 85,7%) with a media of 6cycles completed of treatment (
1-16). The evaluation at 4º cycle was: complete response (CR):8,33%;
near complete response (CnR): 20,83%; partial response (PR): 33,3%;
minimal response (MR): 10,4%; stable disease (SD): 6,25%; progression:
14,58%. At the end of the treatment (with a media of 6 cycles) 35
patients had been evaluated (62,5%); obtaining the following responses:
CR:28,57%; CnR: 14,28%; PR: 14,28%; MR: 8,57%; progression:
8,57%. Overall survival 83,92%. Toxicity profile WHO grade 3-4: thrombocytopenia:
19.6%; neuropathy 12,5%; gastrointestinal: 5,3%; zoster
herpex virus infection:14%. In 48% of patients a dose reduction was
required. Conclusion. Bortezomib is an effective agent with acceptable
toxicity for the treatment of patients with relapsed/ refractory MM. The
response rates, overall survival and toxicity in our series is similar to
data described in previous studies although a longer follow up is needed
in order to confirm these results.
1341
PROGNOSTIC FACTORS OF ANTITHYMOCYTE GLOBULIN FOR APLASTIC ANEMIA
A. Mori, 1 N. Toyoshima, 1 M. Saito, 1 T. Irie, 1 M. Asaka, 2 M. Imamura, 2
M. Morioka1 1 2 Aiiku Hospital, SAPPORO, Japan; Hokkaido University Graduate School of
M, SAPPORO, Japan
Background. Immunosuppressive treatment with a combination of
antithymocyte globulin (ATG) and cyclosporine (CsA) is the most effective
treatment for patients with aplastic anemia (AA). Further, it is suitable
for patients of advanced age. Several prospective randomized studies
have been reported, however, definite prognostic factor associated
with response rate has not been cleared. Aims. To assess long-term outcomes
after immunosuppressive treatment, and analyze the potent prognostic
factors. Methods. We retrospectively evaluated 24 ATG with CsA
treatments (ATG treatments) which include re-treatment of ATG in
patients who had not responded to the first ATG treatment or relapsed
after the first remission. Results. The median age was 66 years, and the
median follow-up period was 52 months. The response and relapse rate
of ATG treatment were 70.8% and 23.1%, respectively. The response
rate of ATG re-treatment was 57.1%. Overall survival and event free survival
at 10 years were 66.7% and 50.7%, respectively. Initial reticulocyte
count correlated with the response rate of ATG treatment (responders
v.s. non-responders = 23331±14201 (±SD) /mm 3 v.s. 8856±4885 /mm 3 ,
p=0.045). Further, the longer duration from diagnosis to ATG treatment
(responders v.s. non-responders = 0.615±0.18 v.s. 8.50±4.98 months,
p=0.0077) and male correlated with the poor response rate independently.
On the other hand, patient age, initial platelet count, initial granulocyte
count, initial nuclear cell count of bone marrow, total dose of ATG,
and co-administration of granulocyte colony-stimulating factor did not
significant influence response rate. Although almost all ATG treatments
were tolerable, as the long-term complication, two developed monosomy
7 clonal abnormality. Conclusions. These results suggest that ATG
treatment can achieve a high response rate and long-term survival among
adult patients with AA. Initial reticulocyte count, the duration from diagnosis
to ATG treatment, and sex could be the potent prognostic factors
with ATG treatment. However, we have to pay attention to the development
of the clonal diseases.
Figure 1.
12 th Congress of the European Hematology Association
1342
THE ANTILEUKEMIC ACTIVITY OF THALIDOMIDE (THAL) IN COMBINATION
WITH FLUDARABINE (F) IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
M. Kowal, A. Dmoszynska, K. Giannopoulos, P. Wlasiuk, A. Bojarska-
Junak, T. Gromek, M. Podhorecka, E. Wasik-Szczepanek, J. Rolinski
Medical University Lublin, LUBLIN, Poland
Background. Thalidomide (THAL) is an immunomodulatory agent
with pleiotropic activities. It may enhanced proapoptic activity of fludarabine
(F) with the resultant improvement of clinical responses. We
report the interim findings of the efficacy and safety of THAL+F combined
therapy in B-CLL patients. Methods. 31 patients (pts) were enrolled
in this study. The median age was 62 yrs (range 43-75). 14 of them (10M,
4F) were newly diagnosed and 17 (7M, 10F) pts were refractory or
relapsed. Of these 3 had low risk, 20 pts intermediate risk, 8 pts high risk
disease acc to modified Rai staging, 71% of pts had elevated serum β-2
microglobulin. The increased Zap70 and/or CD38 expression had 64%
and/or 28% of pts respectively. 16 pts (55%) had short LDT < 6 months.
5 pts were refractory to F, 6 pts to alkylating agents and 6 pts were
relapsed. Median prior lines of therapy were 3, range 1-6. THAL 100 mg
po, alone was given for the first 7 days of cycle 1 and continued a la
longue for 6 months, F 25 mg/m2 iv or 40 mg/m2 po, was given for 5 days
every 28 days for up to 6 cycles, starting on the seventh day after initiating
THAL. Acetylsalicylic acid 75 mg was used for preventation of
venous thromboembolism. Results. Median duration of follow-up was
6months (range 1-14). Pts completed 1- 6 cycles, mean 5. Monotherapy
of THAL decreased mean 30% (range 3-57) of white blood cells (WBC)
in 26 pts. Directly after 1 cycle of therapy 31 pts showed subsequent
reduction in WBC. 22 pts have received treatment for at least 3 months
and are therefore evaluable for clinical response acc to NCI-WG criteria.
Overall response rate among evaluable pts was 91% with CR in 18%
(n=4) and PR in 72% (n=16) of the pts. 2 heavily pretreated pts attained
stable disease after 2 cycles but therapy was stopped due to toxicity. 8
pts finshed treatment. The median duration of progression-free survival
was 4 months (range1-7). 4 pts were inevaluable (unable to complete 2
treatment cycles; either for toxicity or progression), 5 pts are too early
for response evaluation. Toxicity: All 31 pts are evaluable for toxicity.
Constipation and fatigue were noted in nearly all pts. A tumor flare reaction
developed in 23% of pts during the first week of treatment with
THAL. Infections occured in 52% of pts, severe > G3 were observed in
4 pts. The main hematological toxicites were > G3 neutropenia (26%)
and AIHA (13%). Correlative studies: Levels of TNF-α and IL-10 were
assessed D0, D7 and D12. T regulatory cells were identified as
CD4 + CD25highFOXP3 + . This data will be presented at the meeting. Conclusions.
Monotherapy of THAL and in combination with F is active not
only as a first line therapy but also as a treatment in heavily pretreated
pts with B-CLL, with tolerable toxicity. These results warrant further
investigation of larger group of pts .
1343
PALPEBRAL OEDEMA REVEALING ORBITAL INTRAMUSCULAR OEDEMA AND ADIPOUS
PALPEBRAL INFILTRATION IN CML PATIENTS TREATED WITH IMATINIB MESYLATE
Ph. Rousselot, 1 P. Rousselot, 1 D. Réa, 2 J.P. Beressi, 1 F. Calvo, 2
V. Levy, 2 H. Bruzzoni, 2 M.T. Ibazizen, 3 L. Jablon3 1 Hôpital de Versailles, LE CHESNAY, France; 2 Hôpital Saint-Louis, PARIS,
France; 3 Hôpital des Quinze-Vingts, PARIS, France
Background. Imatinib Mesylate is now the first line therapy for patients
(pts) with chronic phase chronic myelogenous leukaemia (CP CML). In
most pts side effects are moderate to mild and easily corrected by appropriate
medications. Fluid retention and oedema are common and occur
in 50% of patients. In most cases, diuretics are efficient. Periorbital oedema
is the most frequent manifestation of fluid retention and appears to
be dose related. We report 4 cases of palpebral oedema with additional
ophtalmological signs such as retraction of the upper lid and slight exophtalmia.
Patients and Methods. CP CML pts treated with imatinib 300 to 600
mg per day at Saint-Louis hospital were included in the study if they presented
major periorbital oedema or oedema with additional ophtalmological
manifestations. Patients were then referred to the ophthalmologist
for clinical evaluation. MRI was proposed to all patients at the
National Ophtalmological Center, Hôpital des Quinze-Vingts. Results.
Four pts out of 120 were explored. They received imatinib at the dose of
300 to 600 mg per day during a median of 31 months. Oedemas were
noted after 12 months of therapy (1-19 months) and were associated
with generalized oedema and weight gain in 2 cases. Patients with generalized
oedema developed the palpebral complication earlier compare
haematologica/the hematology journal | 2007; 92(s1) | 483