VI Autologous Bone Marrow Transplantation.pdf - Blog Science ...

or ZRB 200 mg/m 2
/d d5-6. After hemopoietic recovery, marrow was collected.
No in vitro manipulation was done. Pts were then randomized between a second
course of ICC (ICC2) and ABMT. The second course was m AMSA150 mg/
m 2
/d dl to d5 and VP16100 mg/m 2
/d dl to d5. The preparative regimen for
ABMT was the Baltimore protocol of Busulfan 4mg/kg/d for 4 days and Cyclophosphamide
50 mg/kg/d for 4 days.
RESULTS
The median age of the 308 évaluable pts was 36.5 years. There was no significant
difference between the IDR arm (154 pts) and the ZRB arm (154 pts) regarding
the following initial characteristics: sex, age, performance status, fever,
DIC, WBC count, FAB classification, karyotypic abnormalities.
INDUCTION TREATMENT
Of the 308 pts, 241 (78%) achieved CR with no significant difference between
the IDR arm (76.5%) and the ZRB arm (80%). CR was achieved in one
course in 92% of the cases. There were 5 early deaths, 10 deaths in aplasia and 52
(17%) failures, with no significant difference between the two groups.
FIRST INTENSIFICATION
Of the 241 pts in CR, 56 (23%) underwent an allogeneic BMT 40 to 220 days
(median 64) after CR achievement. Twenty-nine pts who should have received
ICC1 were excluded for the following reasons: protocol violation 13, infection 8,
other visceral complication 5, refusal 2, relapse 1. In 5 cases data are not yet
available and 1 pt is lost to follow up. Thus 150 pts are évaluable for ICC1. The
median time between CR achievement and ICC1 was 20 days (1-112). The median
duration of neutropenia after ICC1 was 29 days and 5 toxic deaths (3%)
were recorded.
SECOND INTENSIFICATION
Of the 145 pts still in CR after ICC1, only 106 have been randomized (52
ICC2,54 ABMT). Nine pts in the ABMT arm and 2 pts in ICC2 arm did not receive
the assigned treatment. Thus 50 pts are nonevaluable for the second intensification
(poor or slow hemopoietic reconstitution 20, refusal 12, protocol violation
7, relapse 6, toxicity of ICC1 5). Only 95 pts (50ICC2,45 ABMT) actually underwent
the randomized treatment. Overall, 151 pts (49% of the 308 pts and 63%
of the 251 pts in CR) did receive the assigned intensive post remission therapy.
SURVIVAL
The median follow up is 34 months (10-60). By November 1992, there were
13 relapses and 9 procedure related deaths in the BMT group, 23 relapses in the
ICC group, 20 relapses and 1 toxic death in the ABMT group. The actuarial risk
of relapse at 4 years is 51 % in the ICC group, 49% in the ABMT group and 30%
in the BMT group Fig 1. The event free survival (EFS) curves for pts in CR are
shown in Fig 2. The ICC and ABMT actuarial curves are strictly superposable.
The comparison with BMT is statistically invalid since all BMT pts did not receive
the same post remission therapy and the same conditioning regimen.
However, the EFS after BMT appears to be identical (52.4% at 4 years). More-
SIXTH INTERNATIONAL SYMPOSIUM ON AUTOLOGOUS BONE MARROW TRANSPLANTATION 17