autologous blood and marrow transplantation - Blog Science ...

Santini et al. 197
cytosine arabinoside (BEAM) regimen and autoBMT procedure because of
patient's refusal or progression. Forty-five patients underwent autoBMT after
which 14 (22%) additional PR patients achieved CR. Five of these patients
received involved-field radiotherapy. In conclusion, 46 (73%) of 63 patients
achieved CR. Grade 3 and 4 WHO hematological toxicity with leukopenia and
granulocytopenia was observed in about 18% of patients with anemia (7%),
infection (13%), and mucositis (2%) during VACOP-B therapy. All patients
experienced nausea and vomiting (grade 2 and 3). Mucositis was observed in all
patients. Most patients suffered infection during the aplastic phase and required
antibiotic therapy. Only one patient developed a severe grade 4 liver toxicity.
Treatment-related death occurred in four patients (6%), two from infection, one
from cardiac failure, and one from liver toxicity. Eighteen (29%) died of early or
late progression. Currently, 41 of 63 patients are alive.
According to an intent-to-treat analysis, the difference in complete remission
response rate in the two groups of patients was not statistically significant: 75% in
arm A and 73% in arm B.
Survival
The median follow-up survival of the 124 patients is 42 months with 65% of
patients estimated to be alive at 6 years. No significant difference in 6-year survival
was observed between arms A and B, with 65% (95% confidence interval [CI]
50-79%) and 65% (95% CI 53-77%), respectively (P=0.5). Univariate analysis for
overall survival showed B symptoms to be the only adverse factor (P=0.01).
Multivariate analysis showed that B symptoms remained as an adverse factor
(P=0.03) while all other factors were not significant. There was no significant
difference in DFS between the two randomized groups. The 6-year probability of
DFS was 60% (95% CI 44-76%) in arm A and 80% (95% CI 68-92%) in arm B
(P=0.l). Univariate analysis showed that male sex and bulky disease (>10 cm)
were adverse factors predicting a poor outcome (P=0.02 and 0.05, respectively),
while all other factors were not significant. Multivariate analysis maintained bulky
disease as an adverse factor (P=0.01). At 6 years, the rate of PFS was 48% (95%
CI 33-61%) for the patients receiving conventional treatment and 60% (95% CI
48-72%) for those treated with HDT plus autoBMT (P=0A). Univariate and
multivariate analysis did not show any adverse factor affecting outcome (Fig. 1).
Subgroup analysis
The International Prognostic Index (IPI) model 4
was used for a retrospective
analysis of patients randomized to arm A or B. Arm A: low risk, eight patients;
low/intermediate risk, 17 patients; intermediate-high risk, 27 patients; high risk,