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

12 th Congress of the European Hematology Association
these new drugs in the lymphoma drug armamentarium. More experience
with this new regimen for Mantle cell lymphoma is needed to confirm
this initial appealing experience.
1177
THE GEMOX-R (GEMCITABINE, OXALIPLATIN, RITUXIMAB) REGIMEN IS A HIGHLY
EFFECTIVE SALVAGE REGIMEN IN ELDERLY PATIENTS WITH REFRACTORY-RELAPSING
DIFFUSE LARGE B-CELL LYMPHOMA (DLCL) NO CANDIDATES TO AUTOLOGOUS STEM
CELL TRANSPLANTATION (ASCT). A PHASE II STUDY
J. Rodriguez, 1 A. Lopez, 2 A. Gutierrez, 1 A. Palacios, 2 I. Blancas, 3
M. Navarrete, 2 M. Morey, 1 A. Perello, 1 J. Alarcon, 1 J. Rodriguez1 1 University Hospital Son Dureta, PALMA DE MALLORCA; 2 Hospital Vall
d'Hebron, BARCELONA; 3Hospital Clínico de Granada, GRANADA, Spain
Background. The prognosis of old or immunocompromised patients
with refractory or relapsing DLCL is very poor. The current standard of
salvage therapy followed by consolidation with ASCT for patients
chemosensitive to the salvage regimen is not feasible for most of these
patients. Thus, new active regimens with an acceptable toxicity profile
are needed. Aims. To report the results of a phase II trial of 33 patients
with refractory or relapsing DLCL treated with GEMOX-R. Methods.
Thirty-three elderly patients with refractory or relapsing DLCL not suitable
for ASCT enter into a phase II study with GEMOX-R. Treatment
consisted on Rituximab (375 mg/m 2 ) day 1, Gemcitabine (1000 mg/m 2 )
day 1 and Oxaliplatin (100 mg/m 2 ) day 1. Treatment was repeated in 2
weeks intervals if feasible or every 3 weeks for a planned 6-8 courses
with staging after the third course. Response was evaluated according
to Cheson criteria (Cheson et al. J. Clin. Oncol. 1999; 17: 1244). Results.
Median age of the population was 69 (32-85). Sixty-one% of the patients
were males. One patient with severe cardiac disease was treated in firstline
and the rest had received CHOP-R (61%), CHOP (21%), EPOCH-
R (12%) and CNOP (3%) as first-line therapy. Thirty six percent of the
patients were primary refractory and 42% of the patients received
GEMOX-R at first relapse. At GEMOX-R, 73% of patients presented
with an Ann Arbor stage III-IV, high LDH in 55% of cases, an ECOG>1
was present in 52%, a-IPI>1 was observed in 67% of the cases. The
median number of GEMOX-R cycles administered was 4. The response
rate to GEMOX-R was 47% with 36% CR. Neutropenia grade III-IV was
observed in 39% of the patients and thrombopenia grade III-IV was presented
in 36% of the patients. Neurotoxicity grade III-IV was observed
in 6% of cases. The median follow up for alive patients is 11 months,
and the median survival is 10.8 months. At 12 months the OS is 47%
and the PFS is 31%. One HIV patient primarily refractory to CHOP-R
achieved a CR with 3 courses of GEMOX-R and received an ASCT as
consolidation. This patient remain alive free of disease 26 months after
the transplant. Factors related with overall survival were ECOG performance
status and a-IPI at GEMOX-R as well as response to GMOX-
R. Summary/conclusions. GEMOX-R is a new salvage regimen for DLCL
with high activity and relatively safe toxicity profile, which can be
offered to elderly patients not candidates of ASCT consolidation. The
high efficacy of the regimen in this unfavourable population and also in
immunocompromised situations warrant further investigation of this
regimen in all salvage situations of this type of lymphomas.
1178
A COMBINATION CHEMOTHERAPY WITH BORTEZOMIB, BENDAMUSTINE
AND PREDNISONE FOR PATIENTS WITH REFRACTORY/RELAPSED MULTIPLE
MYELOMA: AN UNICENTRIC RETROSPECTIVE TRIAL
W. Pönisch, M. Bourgeois, S.Y. Wang, S. Heyn, N. Jäkel, L. Braunert,
R. Pfannes, C. Nehring, C. Nehring, C. Becker, C. Becker, H. Al Ali,
G. Hensel, D. Niederwieser
University of Leipzig, LEIPZIG, Germany
Introduction. Bortezomib is a novel proteasome inhibitor that has
shown important clinical efficacy either as a single agent or in combination
with other cytostatic agents in relapsed/refractory multiple
myeloma (MM). The combinated treatment of bortezomib with bendamustine
and prednisone (BPV) was retrospectively assessed to determine
the efficacy and toxicity of this regiment in patients with advanced
MM. Clinical studies in patients with newly diagnosed and relapsed
MM have shown that bendamustine is effective as single agent as well
as in combination with prednisone. In a phase III study, overall response
rate for bendamustine and prednisone was 75% at first line therapy.
Methods. Between January 2005 and October 2006, 31 patients (median
age 63; range 31-77 years) with relapsed or refractory MM (20 patients
432 | haematologica/the hematology journal | 2007; 92(s1)
stage IIIa, 11 patients IIIb) were treated with bendamustine 60 (-80)
mg/m 2 on day 1 and 2, bortezomib 1,3 mg/m 2 on day 1,4,8 and 11, and
prednisone 100 mg on day 1,2,4,8 and 11. Cycles were repeated every
21 days until maximum response or progressive disease. The time from
first diagnosis ranged from 6 to 183 (median 40) months. The duration
of the last remission before beginning the BPV-therapy was 6 (range 0-
36) months. Previous therapy lines from 1 to 6 (median 2), and included
13 x thalidomide, 11 x autologous PBSCT, and 7 x allogeneic PBSCT.
11 patients were refractory to the last treatment. The majority of the
patients (n=18) had preexistent severe thrombocytopenia or leukocytopenia
(WHO grade 3 or 4). Response was assessed using EBMT criteria
modified to include near complete remission (nCR) and very good
partial remission (VGPR). Results. 22 patients responded after at least
one cycle of chemotherapy with 5 nCR, 4 VGPR, 10 PR and 3 MR. 4
patients had stable disease and 5 patients had a progress. With a median
follow up of 7 months, EFS and OS at twelve months were 37% and
50%, respectively. The median number of the BPV-treatment was 2 (1-
6) cycles. 14 of 22 responding patients showed a rapid decrease of the
myeloma protein and reached the best response after the first cycle and
6 after the second cycle. The regimen was well-tolerated with few significant
side effects reported. New cytopenias occured infrequently (two
patients had a thrombocytopenia grade 3, and 1 patient had a grade 4
thrombocytopenia). 3 patients had a mild new polyneuropathy (grade
1). Summary. These early results indicate that the combination of bortezomib,
bendamustine and prednisone is well tolerated in a heavily pretreated
population of patients with relapsed or refractory MM. Because
of these encouraging clinical responses, we plan to further evaluate this
combination in a larger group of patients with relapsed/refractory
myeloma.
1179
POSITRON EMISSION TOMOGRAPHY USING 18F-FLUORODEOXY GLUCOSE FOR
EVALUATION OF RESIDUAL FOLLICULAR NON HODGKIN LYMPHOMA
E. Ruiz de Gaona, P. Serra, P. Rodriguez-Otero, J. Rifón, M. Bendandi,
M.J. Garcia-Velloso, C. Panizo
Clinica Universitaria de Navarra, PAMPLONA, Spain
Background. Positron emission tomography (PET) using 18F-fluorodeoxyglucose
(FDG) has emerged as a useful method for monitoring
responses and evaluate residual lesion in a variety of cancers. Aims. The
present study was performed to evaluate the utility of PET-FDG to determine
the persistence of residual disease in follicular non-Hodgkin lymphoma
patients resting with residual lesion in computed tomography
(CT) after chemotherapy. Methods. Twenty two consecutive follicular
non-Hodgkin lymphoma patients with a residual lesion in CT documented
one month after therapy completion entered the study. A PET-
FDG was prospectively performed within one week from the CT scan.
Evaluation by means of biopsy with pathological study was proposed
to all FDG-PET positive patients. Results. FDG-PET was positive in 10
patients. The median uptake value (suv) of these patients was 5,6 (range
1,4-28,3). Among these 10 positive patients, seven agree to perform a
biopsy, resulting in six positive residual lymphoma cells and one negative.
All three FDG-PET positive patients who did not agree to the pathologic
study progressed. FDG-PET was negative in 12 patients. With a
median follow up of 15 months from PET execution, no relapse was
recorded among 11 patients. Just one patient progressed within three
months. In the present study, FDG-PET had sensitivity of 90% and a
specifity of 91,7%, a positive predictive value of 90% and a negative predictive
value of 91,7 %. Conclusions. PET-FDG is a reliable method for
the diagnosis of residual tumor in follicular non-Hodgkin lymphoma
and may contribute to improve the management of these patients.
1180
LONG TERM THERAPY AND EFFICACY OF LOW-DOSE THALIDOMIDE
IN RELAPSED-REFRACTORY MULTIPLE MYELOMA PATIENTS
L. Canepa, S. Aquino, F. Ballerini, M. Balocco, M. Miglino, M. Gobbi
Hematology, GENOVA, Italy
Background and Aim. Actually Thalidomide, often combined with other
agents, is the drug of choice in the treatment of relapsed/refractory
MM, and recently its role as first line therapy and in maintenance after
HDT has been emphasized. Except progression of disease, the most
common reason for thalidomide withdrawal is long term toxicity, especially
peripheral neuropathy (PN). Thalidomide sensory neurotoxicity
was found to be cumulative dose dependent and occurs when the total
dose is beyond 20 g (Cavaletti). Therefore the lower effective daily dose