Introduction
Materials and methods
Treatment
Data collection
Definitions and outcomes
Observation time
Statistics
Results
Patient baseline characteristics
Parameters | HCAG treatment (N = 47) | FALG treatment (N = 51) | P value |
---|---|---|---|
Age (years) | 48 ± 21.6 | 45 ± 20.7 | 0.071 |
Gender (male/female) | 25/22 | 32/19 | 0.247 |
De novo or secondary | 0.552 | ||
De novo (n/%) | 44 (93.6%) | 50 (98%) | |
Secondary (n/%)(n/%) | 3 (6.4%) | 1 (4.1%) | |
Abnormal chromosome (n/%) | 18 (38.30%) | 22 (43.14%) | 0.749 |
WBC ≥ 50 × 109/L (n/%) | 13 (27.7%) | 11 (21.6%) | 0.484 |
HGB ≤ 60 g/L (n/%) | 9 (19.1%) | 12 (23.5%) | 0.598 |
PLT ≤ 30 × 109/L (n/%) | 24 (51.1%) | 30 (58.8%) | 0.146 |
CEBPA (n/%) | 1 (2.1%) | 3 (5.9%) | 0.669 |
c-kit (n/%) | 3 (6.4%) | 3 (5.9%) | 1.000 |
NPM1 (n/%) | 2 (4.3%) | 9 (17.6%) | 0.075 |
NPM1andFLT3-ITD (n/%) | 4 (8.5%) | 6 (11.8%) | 0.843 |
BM blasts (%) | 45 ± 22.9 | 48 ± 23.2 | 0.066 |
CR (n/%) | 24 (51.1%) | 28 (54.9%) | 0.704 |
ORR (n/%) | 38 (80.9%) | 42 (82.4%) | 0.848 |
Treatment-related mortality(TRM) (n/%) | 0 (0) | 4 (7.8%) | 0.119 |
Clinical efficacy of the two treatments
Parameters | P value |
---|---|
Age | 0.097 |
Male (vs. Female) | 0.350 |
Abnormal chromosome (vs. normal chromosome) | 0.914 |
Secondary disease (vs.de novo) | 1.000 |
WBC | 0.353 |
PLT | 0.029 |
HGB | 0.101 |
CEBPA gene positive | 0.120 |
c-kit gene positive | 1.000 |
NPM1 gene positive | 0.408 |
Both NPM1 gene and FLT3-ITD gene positive | 0.643 |
Hematological toxicity (grade 4) | 0.888 |
Nonhematological toxicity | 0.009 |
Oral cavity toxicity (> grade 2) | 0.546 |
Pulmonary infection | 0.000 |
Gastrointestinal complications | 0.951 |
Hepatic dysfunction | 0.227 |
Renal function impairment | 0.371 |
BM blasts | 0.002 |
Parameters | Univariate logistic regression | |||
---|---|---|---|---|
P value | OR | 95% CI | ||
Lower | Upper | |||
Age | 0.006 | 0.944 | 0.906 | 0.983 |
Toxicity | 0.603 | 1.523 | 0.313 | 7.412 |
PLT | 0.947 | 1.000 | 0.994 | 1.006 |
Pulmonary infection | 0.026 | 0.164 | 0.034 | 0.804 |
BM blasts | 0.045 | 0.963 | 0.928 | 0.999 |
Parameters | P value |
---|---|
Age | 0.098 |
Male (vs. female) | 0.219 |
Hematological toxicity (grade 4) | 0.585 |
Abnormal chromosome (vs. normal chromosome) | 0.034 |
Secondary disease (vs.de novo) | 1.000 |
WBC | 0.182 |
PLT | 0.148 |
HGB | 0.600 |
CEBPA gene positive | 0.579 |
c-kit gene positive | 1.000 |
NPM1 gene positive | 0.874 |
Both NPM1 gene and FLT3-ITD gene positive | 0.704 |
Nonhematological toxicity | 0.022 |
Oral cavity toxicity (> grade 2) | 0.654 |
Gastrointestinal complications | 0.910 |
Hepatic dysfunction | 1.000 |
Renal function impairment | 0.149 |
Pulmonary infection | 0.001 |
BM blasts | 0.014 |
Parameters | Univariate logistic regression | |||
---|---|---|---|---|
P value | OR | 95% CI | ||
Lower | Upper | |||
Age | 0.036 | 0.943 | 0.892 | 0.996 |
Nonhematological toxicity | 0.896 | 1.180 | 0.100 | 13.942 |
Abnormal chromosome (vs. normal chromosome) | 0.125 | 2.795 | 0.751 | 10.403 |
Pulmonary infection | 0.151 | 0.187 | 0.019 | 1.838 |
BM blasts | 0.038 | 0.961 | 0.925 | 0.998 |
Parameters | Univariate Cox regression | Multivariate Cox regression | ||||||
---|---|---|---|---|---|---|---|---|
P value | HR | 95% CI | P value | HR | 95% CI | |||
Lower | Higher | Lower | Higher | |||||
Age | 0.000 | 1.094 | 1.059 | 1.130 | 0.000 | 1.152 | 1.099 | 1.207 |
Male (vs. female) | 0.957 | 1.016 | 0.581 | 1.777 | 0.533 | 0.806 | 0.409 | 1.588 |
Nonhematological toxicity | 0.002 | 2.564 | 1.400 | 4.697 | 0.783 | 1.254 | 0.251 | 6.252 |
Oral cavity toxicity (> grade 2) | 0.441 | 0.787 | 0.429 | 1.446 | 0.368 | 0.674 | 0.286 | 1.591 |
Gastrointestinal complications | 0.406 | 1.380 | 0.646 | 2.946 | 0.176 | 2.428 | 0.672 | 8.775 |
Hepatic dysfunction | 0.143 | 1.902 | 0.805 | 4.492 | 0.061 | 2.771 | 0.953 | 8.061 |
Renal function impairment | 0.000 | 4.582 | 1.975 | 10.632 | 0.167 | 2.395 | 0.695 | 8.252 |
Pulmonary infection | 0.002 | 2.453 | 1.389 | 4.333 | 0.119 | 3.363 | 0.731 | 15.464 |
Hematological toxicity (grade 4) | 0.004 | 0.244 | 0.093 | 0.636 | 0.198 | 0.433 | 0.121 | 1.548 |
Abnormal chromosome | 0.356 | 0.766 | 0.435 | 1.350 | 0.634 | 1.203 | 0.563 | 2.569 |
Secondary disease (vs.de novo) | 0.357 | 0.394 | 0.054 | 2.865 | 0.096 | 0.149 | 0.016 | 1.403 |
WBC | 0.911 | 1.001 | 0.987 | 1.015 | 0.248 | 1.014 | 0.990 | 1.038 |
HGB | 0.191 | 0.992 | 0.980 | 1.004 | 0.908 | 1.001 | 0.981 | 1.021 |
PLT | 0.749 | 0.999 | 0.995 | 1.004 | 0.187 | 0.997 | 0.993 | 1.001 |
CEBPA gene positive | 0.167 | 0.247 | 0.034 | 1.797 | 0.884 | 0.846 | 0.089 | 8.079 |
c-kit gene positive | 0.634 | 0.753 | 0.234 | 2.420 | 0.820 | 1.173 | 0.298 | 4.618 |
NPM1 gene positive | 0.596 | 0.805 | 0.362 | 1.791 | 0.296 | 2.588 | 0.436 | 15.377 |
Both NPM1 gene and FLT3-ITD gene positive | 0.883 | 0.926 | 0.332 | 2.581 | 0.426 | 0.422 | 0.050 | 3.535 |
BM blasts | 0.424 | 1.007 | 0.990 | 1.023 | 0.111 | 1.019 | 0.996 | 1.043 |
CR | 0.000 | 0.152 | 0.081 | 0.284 | 0.001 | 0.235 | 0.098 | 0.562 |
ORR | 0.000 | 0.153 | 0.080 | 0.291 | 0.001 | 0.177 | 0.061 | 0.512 |
Toxicity
Toxicity | HCAG treatment (N = 47) | FALG treatment (N = 51) | P value |
---|---|---|---|
Hematological toxicity (grade 4) | 42 | 51 | 0.023 |
Nonhematological toxicity | 19 (40.4%) | 40 (78.4%) | 0.000 |
Oral cavity toxicity (≥ grade 2) | 8 (17.02%) | 27 (52.94%) | 0.000 |
Gastrointestinal complications (n/%) | 6 (12.8%) | 7 (13.7%) | 0.889 |
Hepatic dysfunction (n/%) | 2 (4.3%) | 8 (15.7%) | 0.117 |
Renal function impairment (n/%) | 4 (8.5%) | 5 (9.8%) | 1 |
Pulmonary infection (n/%) | 15 (31.9%) | 32 (62.7%) | 0.002 |