Haematologica 2003 - Supplements

initial therapy. However, the role of HDT/SCT in the management
of patients with MM is still a matter of controversy. A randomized
trial by the French Intergroup showed that HDT significantly
increased the complete remission (CR) rate, progression-free
survival (PFS) and overall survival (OS) (4). More recently, the
MRC VII trial showed a significant benefit for HDT/SCT versus
conventional chemotherapy in both PFS and OS (5). In contrast with
these results, Fermand et al (6) showed, in a prospective randomized
trial, that HDT/SCT was not superior to conventional chemotherapy
in patients aged 55 to 65 years.
Aim: The objective of the present study was to compare HDT/SCT
and continued conventional chemotherapy in MM patients
responding to the initial treatment.
Patients and Methods: From May 1994 to October 1999, 216
patients (122M/94F), median age 56 yrs, stage II or III, ECOG < 3)
were registered. The diagnosis was made according to the criteria of
the Chronic Leukemia Myeloma Task Force. The initial
chemotherapy consisted of 4 courses of alternating BVMCP/VBAD.
Responding patients received either 8 additional courses of
BVMCP/VBAD (arm A) or intensification with HDT/SCT -
melphalan 140 mg/m 2 /TBI 12 Gys or melphalan 200 mg/m 2 (arm
B). Maintenance treatment consisted of alpha-interferon and
dexamethasone in both arms.
Results: One-hundred and eighty five patients responded to initial
chemotherapy (CR: 15%, PR: 68%, and MR: 17%). Twenty-one of
these responding patients were not randomized due to different
reasons. Among the 164 randomized patients 83 were allocated to
continued chemotherapy and 81 to HDT/SCT. The degree of initial
response as well as prognostic features did not differ in both groups.
The results were updated as of November 15, 2002 after a median
follow-up of 44 months from the initiation of treatment and
analyzed on an intention-to-treat basis. CR (negative
electrophoresis) was significantly higher in the HDT/SCT arm (30
vs. 11%, p=0.002). However, PFS was not significantly different
between HDT/SCT and conventional chemotherapy (median, 43 vs.
34 mos; p=NS) and the OS was similar in both groups (median, 62
vs. 56 mos.; p=NS).
Conclusions: This study shows that, as delivered in this trial,
HDT/SCT intensification significantly increases complete remission
rate but has no significant impact on PFS and OS in myeloma
patients responding to initial chemotherapy.
References
1. Crowley J, Jacobson J, Alexanian R. Standard-dose therapy for
multiple myeloma. The Southwest Oncology Group experience.
Semin Hematol 2001; 38: 2003-2008.
2. Bladé J, San Miguel JF, Fontanillas M, et al. Increased
conventional chemotherapy does not improve survival in multiple
myeloma: long-term results of two PETHEMA trials including 914
patients. The Hematol J 2001; 2: 272-278.
3. Hjorth M, Holmberg E, Rödjer S, et al. Survival in conventionally
treated younger (2mg/dL
(Table 1). With a median follow-up of 10 years for all patients,
10-year survival and event-free survival rates were markedly
higher with TT I than with SWOG SDT (33 vs 15%, p