Table 4.
SURVIVAL1 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
EFS ± SE(%) | OS ± SE(%) | Relapse Cin ± SE(%) | ||||||||
n | year 5 | p-value | year 5 | p-value | year 5 | p-value | ||||
Protocol | 17 | 17.6±9.2 | 0.276 | 17.6±9.2 | 0.383 | 76.6±12.9 | 0.069 | |||
Non-Protocol | 5 | 40.0±17.9 | 40.0±17.9 | 33.3±33.3 | ||||||
GVHD2 | ||||||||||
Any | Acute | Chronic# | ||||||||
n | No | Yes | No | Yes | No | Yes | ||||
Protocol | 17 | 8 | 9 | 9 | 8 | 7 | 3 | |||
Non-Protocol | 5 | 1 | 4 | 2 | 3 | 2 | 2 | |||
p = 0.3602 | p = 1.00 | p = 0.9051 |
ENGRAFTMENT3 | |||||||
---|---|---|---|---|---|---|---|
n | Experienced ANC >500 | Days to ANC >500 cells/μL | |||||
Mean | Median | SD | Range | p-value | |||
Protocol | 17 | 16 (94%) | 15.9 | 15.5 | 2.3 | 13–20 | **0.0018 |
Non-Protocol | 5 | 5 (100%) | 12.4 | 12.0 | 0.5 | 12–13 | |
n | Experienced Platelets >20 | Days to Platelets >20×103 cells/μL | |||||
Mean | Median | SD | Range | p-value | |||
Protocol | 17 | 12 (71%) | 24.0 | 17.5 | 21.9 | 7.0–91.0 | 0.6115 |
Non-Protocol | 5 | 3 (60%) | 22.7 | 25.0 | 6.8 | 15.0–28.0 |
Survival distributions compared using log-rank test. Cumulative incidence compared using Gray’s test.
Association of GVHD incidence with protocol status assessed with Fisher’s Exact test.
Continuous variables compared between groups with Wilcoxon signed-rank test.
of patients alive at day +100
EFS = event free survival; SE = standard error; OS = overall survival; Cin = cumulative incidence; ANC = absolute neutrophil count