Table 2.
Comparison of patient between the Study Group and the Historical Group.
| Variable | Historical Group (n=153) | Study Group (n=54) | P value |
|---|---|---|---|
| Sex, n (%) | 0.307 | ||
| Male | 86 (56.2) | 26 (48.1) | |
| Female | 67 (43.8) | 28 (51.9) | |
| Age (years) | 0.423 | ||
| Median | 66 | 68 | |
| Range | 51–90 | 55–87 | |
| Weight (kg) | 0.204 | ||
| Mean | 68.5 | 70.4 | |
| SD | 17.2 | 15.6 | |
| Height (cm) | 0.363 | ||
| Mean | 166.7 | 168.0 | |
| SD | 9.7 | 8.5 | |
| Baseline BSA (m2) | 0.427 | ||
| Average | 1.82 | 1.84 | |
| SD | 0.21 | 0.19 | |
| Pretreatment ECOG status | 0.624 | ||
| 0 | 75 | 30 | |
| 1 | 45 | 18 | |
| 2 | 24 | 6 | |
| Starting infusional 5-FU dose (mg/m2) | 0.125 | ||
| Average | 2453 | 2384 | |
| SD | 182 | 164 | |
| Protocol of chemotherapy, n | 0.835 | ||
| FOLFOX4 | 39 (4) | 14 | |
| mFOLFOX6 | 68 () | 26 | |
| FOLFIRI | 46 () | 14 | |
| Treatment cycles | 0.999 | ||
| 1 | 87 | 54 | |
| 2 | 85 | 54 | |
| 3 | 78 | 50 | |
| 4 | 70 | 47 | |
| 5 | 65 | 44 | |
| 6 | 62 | 40 | |
| Total | 447 | 289 | |
| Adverse events | <0.001* | ||
| No toxicity or mild toxicity | 262 | 259 | |
| Severe toxicity | 185 | 30 | |
| Chemotherapy response | 0.032* | ||
| CR+PR | 82 | 38 | |
| SD+PD | 71 | 16 |
*
P<0.05 represents statistical difference.
SD – standard deviation; FOLFOX – oxaliplatin, folinate, 5-FU; FOLFIRI – irinotecan, folinate, 5-FU.