Haematologica 2003 - Supplements

With a median follow-up of 38 months from the start of VAD
therapy, no statistically significant difference in OS was observed
between the two groups (median, 56 months for Tx-1 vs. 60
months for Tx-2). Patients who died due to treatment-related
causes were 3% in group A and 4.9% in group B. Compared to
group A, patients assigned to the the double transplant arm of the
study had a significantly longer duration of remission (median
TTR, 27 vs. 44 months, respectively; p = .005) and extended EFS
(median, 34 months for patients randomized to group B vs.25
months for those assigned to group A; p= .05).
Results of the present analysis confirmed that double
autotransplants as primary therapy for MM could be timely
performed in slightly less than two thirds of patients aged below
60 with a risk of treatment-related mortality that did not exceed
5%. Nonhematological toxicity of sequential HDT consisting of
MEL and Bu-Mel was minimal and no cumulative toxicity was
observed in the Tx-2 arm of the study compared to Tx-1. Double
autotransplants, albeit not correlated with significantly higher CR
rates in comparison with Tx-1, effected responses of “better
quality”. This finding ultimately resulted in extended duration of
remission and longer EFS for patients assigned to receive double
autotransplants in comparison with those randomized to a single
autotransplant. With a median follow-up of approximately 3
years no difference in OS was disclosed between the two
treatment groups. It is worthy of note that data similar to those
herein described were reported by the French Myeloma
Intergroup at a preliminary analysis of the IFM-94 trial of single
versus double autologous transplants, both prepared with TBI and
MEL, 140 mg/m², preceded by MEL in case of double transplants
(8). More recently, the same group updated the results of the trial
with a longer follow-up and found that double autotransplants
significantly extended the 5-year projected probability of OS and
EFS in comparison with a single transplant (9). Mature data
derived from the final analysis of our study must be awaited
before definite conclusions can be given concerning the impact of
double autotransplants on the ultimate outcome of MM.
Supported in part by Università di Bologna, Progetti di Ricerca
ex-60% (M.C.)
Appendix
The following physicians actively participated in the “Bologna
96” study:R. Giustolisi, F. Di Raimondo, Catania; E. Volpe,
Avellino; G. Broccia, M.G. Cabras, Cagliari; L. Gugliotta, L.
Masini, Reggio Emilia; B. Rotoli, L. Catalano, Napoli; G. Torelli,
F. Narni, Modena; F. Dammacco, V.M. Lauta, Bari; F. Lauria,
P.Galieni, A. Gozzetti, Siena; L. Cavanna, G. Civardi, Piacenza;
P. Leoni, M. Offidani, Ancona; M. Gobbi, F. Ballerini, Genova;
D. Amadori, P. Gentilini, Forlì; D. Mamone, Messina; R.
Battista, Chioggia; F. Ricciuti, D. Vertone, Potenza; L.
Guardigni, S. Pasini, Cesena; L. Contu, A. Ledda, Cagliari; M.
Longinotti, F. Dore, Sassari; M.G. Michieli, Aviano; A. Zaccaria,
A.L. Molinari, Ravenna; R. Fanin, F. Patriarca, Udine.
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P10.2.5
SINGLE VS. TANDEM AUTOLOGOUS
TRANSPLANTATION IN MULTIPLE MYELOMA: THE
GMMG EXPERIENCE
Goldschmidt H
On behalf of the German-Speaking Myeloma Multicenter Group,
GMMG
High-dose (HD) therapy followed by autologous stem cell
transplantation (ASCT) has improved event-free (EFS) and
overall survival (OS) in multiple myeloma (MM), but nonetheless
virtually all patients eventually relapse. Single center experience
of the Arkansas group has indicated that total therapy including
tandem ASCT improves clinical outcome further, and results of
the French IFM-group have shown in a randomized trial that MM
patients benefit from tandem ASCT. No significant benefit of
double ASCT could be demonstrated in the studies performed by
the HOVON-group, the Bologna-group and in the MAG95-study.
Melphalan without total body irradiation is currently considered
as the best high-dose therapy regimen.
Between 1996 and 2000, patients with MM who had received no
more than 6 previous cycles of conventional chemotherapy were
included in the GMMG-HD2 trial. In the study two
randomizations were possible. The first randomization was
optional and compared standard VAD vs. vincristine, oral
idarubicine and dexamethasone (VID) as induction treatment.
Results showed no difference in response and number of stem
cells mobilized. Hematological toxicity was higher after VID
compared to VAD. The second randomization was obligatory and
compared a single cycle of HD-melphalan vs. two sequential
cycles of HD-melphalan, each followed by peripheral blood
ASCT. Interferon-alpha was started as maintenance treatment for
all patients at a dose of 13.5 million units per week. The median
follow up of the patients in the study is 36 month. The GMMG
will present results of the first trial comparing a single vs. two
sequential cycles of HD-melphalan (200 mg/m 2 ) followed by
ASCT.
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