Haematologica 2003 - Supplements

229
EFFECTIVENESS OF STANDARD CHEMOTHERAPY
PROTOCOLS IN MULTIPLE MYELOMA -
COMPARATIVE STUDY
D. Jawniak A. Dmoszyäska, M. G¢rska, M. Maˆek, A.
Gor¥cy, W. Legie†
Department of Hematooncology and Bone Marrow Transplantation
Center; University Medical School, 20-954 Lublin, Jaczewskiego 8,
Poland
Introduction: There is known large number of standard
chemotherapy protocols in the treatment of multiple myeloma
(MM). In this study we evaluated the effectiveness of first line
chemotherapy in the treatment of MM and its influence on overall
survival.
Methods: One hundred and twenty multiple myeloma patients (61
female and 59 male) treated in Department of Hematooncology in
Lublin (Poland) between 1992 and 2001 were enrolled in this
study. Patients age ranged from 38 to 79 years (mean value 60.6).
In our study group the predominant type of disease was classic
multiple myeloma with IgG monoclonal proteins (82,2%). The
response for treatment was assessed according to EBMT criteria.
Patients were qualified for particular type of chemotherapy
protocol according to generally used criteria (i.e. age).
Results: The best response was observed after VAD protocol -
60% of patients acquired complete remission (CR) or partial
remission (PR). Good response (CR+PR) was obtained in 46% of
patients after VMBCP protocol, but only in 10,7% of patients
after MP protocol. In 16,7% of patients partial remission was
observed after single intravenous infusion of cyclophosphamide
and melfalan as transplantation protocol according to Palumbo et
all. After chemotherapy with Ida+Dex we noticed only
stabilization of disease parameters. In more than 50% of patients
we studied also the expression of adhesion molecules on multiple
myeloma cells using flow cytometry technique. The expression of
fibronectin receptor CD49e (VLA-5) and laminin receptor CD49f
(VLA-6) significantly correlated with effects of chemotherapy. In
patients with negative expression of CD49e, the percentage of
CR+PR was 47.2, while in group with positive CD49e
expression, the percentage of CR+PR was 27.6. Considering the
positive and negative expression of CD49f, the percentage of
good response was adequately 47.4 vs 25.9. No significant
differences in follow-up time between particular treatment
protocols were found. In group with VAD, VMBCP and MP
protocol follow-up time was adequately 23.6 and 35 months.
Statistically significant shorter follow-up time (23.6 months) was
observed in patients with positive expression of CD49d (VLA-4)
vs 30.8 months in patients with negative CD49d expression.
Conclusion: On the basis of our study we confirmed that none of
evaluated first line chemotherapy protocols significantly
prolonged overall survival. We found that the high expression of
CD49d on the surface of myeloma cells may be considered as
poor prognosistic factor.
230
Interim Analysis of Randomized Trial “4W“ of Czech
Myeloma Group: Maintenance Therapy Interferon
Alpha or Sequential Maintenance Therapy Interferon
Alpha and Dexametazonea after High-Dose
Chemotherapy and Peripheral Blood Stem Cell
Transplantation in Newly Diagnosed Patients with
Multiple Myeloma.
Hajek R., Scudla V., Krejci M., Bacovsky J., Schützová M.,
Koza V., Tothova E., Papajik T., Franková H., Stavarová
Y., Lehanka F., Vranova M., Kessler P., Pozdenova V.,
Walterova L., Stefanek I., Novosadová L., Vytrasova M.,
Meluzinová I., Hausdorf P., Seifertova N., Sumna E. ,
Dušek L., Svobodnik A., Vorlíček J a Adam Z
For the Czech Myeloma Group; Office: Masaryk University Hospital
Jihlavska 20, Brno 639 00, Czech Republic
Optimal maintenance therapy after autologous transplantation is
unclear. In order to assess the role of interferon alfa (IFN) and
IFN plus dexamethasone (IFN/DEX) as the maintenance therapy
after ASCT, 246 previously untreated patients with multiple
myeloma (MM) were enrolled to trial 4W from 1996 to 2002.
Patients received primary therapy with four cycles of VAD
regimen (vincristine, doxorubicin, dexamethasone) followed by
mobilization with cyclophosphamide 5g/m2 and G-CSF 10
µg/kg. A conditioning regimen with melphalan 200mg/m2 was
used for first and second transplantation. The later was indicated
only in patients who did not achieve a good remission (>75%
reduction of M-component). After transplantation patients were
randomized to two arms of maintenance therapy: IFN 3 x 106
units three times weekly s.c. or the same dose of IFN in
alternating cycles with dexamethasone 40 mg in days 1-4, 10-13,
20-23.
Data of 183 randomized patients (pts.) to 31st August 2002 were
evaluated in this analysis. One month after transplantation 6 % of
pts. achieved complete remission (M-component 0% and negative
immunofixation), overall response rate was 88 % (>50 %
reduction of M-component). Transplant related mortality at day
+100 was 2.0 %. All 183 randomized patients received the
maintenance therapy, 94 pts. in the IFN arm and 89 patients in the
IFN/DEX arm. Median of EFS for all 183 pts. was 42.1 months
and median of OS was not yet achieved.
In analysis, the OS and EFS curves have shown no significant
statistical differences between the IFN and IFN/DEX groups
(44.6 vs. 35.5 months; p = 0.913 for EFS), although difference is
9 months. Data from more than 180 randomized patients (interim
analysis to 31st August 2002) will be available for comparison of
the two types of maintenance therapy after autologous
transplantation. Substantial number of pts. in IFN group (23% vs.
13% in ID group) premature finished MT due to IFN toxicity.
231
Quality of Life(QOL) comparison at 6 months between
VAD based treatment and standard chemotherapy for
Multiple Myeloma(MM)
Crofts S E, Twine T J , Smith A G
Haematology Departement, Southampton University Hopsitals
NHS Trust, Southampton General Hospiatl, Southampton SO16
6YD, United Kingdom
Data on Quality of Life (QOL) measurement in Multiple
Myeloma (MM) remain limited. QOL is important to patients
given the varied treatment options available in myeloma at
diagnosis and relapse. This study sought to confirm that treatment
results in improved QOL and to assess differences in QOL for
S190