Literature Scan
Multivariate Analysis of OS Associated With
Exclusion Criteria
TABLE 3.
Exclusion Criteria HR 95% CI p Value
ECOG PS (3 or 4 vs. <3) 1.86 1.19-2.92 0.007
Platelet count ≤1.5x10 /L 2.08 1.53-2.82 <0.001
Creatinine level >2.5 mg/dL 1.49 1.20-1.85 <0.001
AHCT 0.38 0.31-0.45 <0.001
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OS = overall survival; HR = hazard ratio; ECOG PS = Eastern Cooperative Oncology Group performance status;
AHCT = autologous hematopoietic cell transplantation
Except for previous invasive malignancy
and ISS stage, the factors also were
statistically significant in a multivariate
analysis, with a 2.08-fold increase in
the risk of death related to low platelet
count (p<0.001), a 1.49-fold increase
for patients with elevated creatinine
levels (p<0.001), and a 1.86-fold increase
for ECOG performance status score
of 3 or 4 (p=0.007; see TABLE 3 ). “The
multivariate analysis of OS and eligibility
criteria reinforces the premise that RCT
eligibility criteria deselect patients with
more advanced disease,” the authors
wrote.
Serious adverse events (AEs) were
reported in a similar proportion of RCT-
ineligible (66.8%) and -eligible (62.5%) pa-
tients. Infections occurred in 29.3 percent
and 23.1 percent of patients, respectively,
and pneumonia occurred in 13.1 percent
and 12.5 percent, respectively. Serious AEs