Table 6.
Subgroup analyses of ORR and DCR between the experimental and control group
| Parameter | Factors at study level | Experimental group No. of patients (n) | Control group No. of patients (n) | Analysis method | Heterogeneity | Odds Ratio (OR) | 95% CI | P-value | |
|---|---|---|---|---|---|---|---|---|---|
| I2 (%) | P-value | ||||||||
| ORR | Therapeutic regimen | ||||||||
| Cinobufotalin+FOLFOX | 215 | 200 | Fixed | 0 | 0.99 | 1.84 | 1.23 to 2.76 | 0.003 | |
| Cinobufotalin+XELOX | 92 | 86 | Fixed | 0 | 0.41 | 2.43 | 1.30 to 4.53 | 0.005 | |
| Cinobufotalin+EOF | 55 | 55 | Fixed | 22 | 0.26 | 1.93 | 0.91 to 4.10 | 0.09 | |
| Cinobufotalin+Capecitabine | 272 | 294 | Fixed | 0 | 0.85 | 1.98 | 1.29 to 3.04 | 0.002 | |
| Drug form of cinobufotalin | |||||||||
| Cinobufotalin capsule | 186 | 185 | Fixed | 9 | 0.36 | 2.47 | 1.54 to 3.98 | 0.0002 | |
| Cinobufotalin injection | 724 | 723 | Fixed | 0 | 0.98 | 1.78 | 1.41 to 2.25 | <0.00001 | |
| Study sample size | |||||||||
| >60 | 634 | 641 | Fixed | 0 | 0.67 | 2.05 | 1.58 to 2.65 | <0.00001 | |
| ≤60 | 318 | 305 | Fixed | 0 | 0.99 | 1.64 | 1.18 to 2.28 | 0.003 | |
| Type of control trials | |||||||||
| RCT | 833 | 829 | Fixed | 0 | 0.96 | 1.93 | 1.55 to 2.41 | <0.00001 | |
| Overall | 952 | 946 | Fixed | 0 | 0.96 | 1.88 | 1.54 to 2.31 | <0.00001 | |
| DCR | Therapeutic regimen | ||||||||
| Cinobufotalin+FOLFOX | 215 | 200 | Fixed | 0 | 0.97 | 2.26 | 1.26 to 4.04 | 0.006 | |
| Cinobufotalin+XELOX | 92 | 86 | Fixed | 0 | 0.39 | 2.55 | 1.24 to 5.23 | 0.01 | |
| Cinobufotalin+EOF | 55 | 55 | Fixed | 0 | 0.71 | 1.70 | 0.52 to 5.57 | 0.38 | |
| Cinobufotalin+Capecitabine | 272 | 294 | Fixed | 0 | 0.63 | 1.63 | 1.11 to 2.38 | 0.01 | |
| Drug form of cinobufotalin | |||||||||
| Cinobufotalin capsule | 186 | 185 | Fixed | 0 | 0.49 | 2.78 | 1.69 to 4.58 | <0.0001 | |
| Cinobufotalin injection | 696 | 694 | Fixed | 0 | 0.87 | 1.88 | 1.45 to 2.45 | <0.00001 | |
| Study sample size | |||||||||
| >60 | 634 | 641 | Fixed | 0 | 0.53 | 2.21 | 1.68 to 2.90 | <0.00001 | |
| ≤60 | 290 | 276 | Fixed | 0 | 0.94 | 1.73 | 1.13 to 2.64 | 0.01 | |
| Type of control trials | |||||||||
| RCT | 805 | 800 | Fixed | 0 | 0.86 | 2.16 | 1.69 to 2.77 | <0.00001 | |
| Overall | 924 | 917 | Fixed | 0 | 0.86 | 2.05 | 1.63 to 2.58 | <0.00001 | |
Notes: Control group, chemotherapy alone group; Experimental group, chemotherapy and cinobufotalin combined group.
Abbreviations: ORR, overall response rate; DCR, disease control rate; FOLFOX, Oxaliplatin+Calcium folinate+5-Fluorouracil; XELOX, oxaliplatin+capecitabine; EOF, epirubicin+oxaliplatin+calcium folate+fluorouracil; RCT, randomized controlled trial.