Table 2.
Adverse events during the first cycle of treatment with S‐1 plus oxaliplatin or S‐1 plus cisplatin by creatinine clearance
| SOX | CS | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female (n = 81) | Male (n = 257) | Fisher P a | OR, 95%CI | P | Female (n = 92) | Male (n = 243) | Fisher P a | OR, 95%CI | P | |||||
| n | % | n | % | n | % | n | % | |||||||
| Leukopenia | 33 | 41 | 68 | 27 | .018 | 1.9, 1.1‐3.2 | .015 | 46 | 50 | 121 | 50 | 1.0 | 1.0, 0.62‐1.6 | .97 |
| CCr 70 mL/min > | 16 | 46 | 29 | 30 | .098 | 2.0, 0.91‐4.4 | .086 | 23 | 64 | 50 | 60 | 0.84 | 1.2, 0.52‐2.6 | .71 |
| 70 mL/min≤ | 17 | 37 | 38 | 24 | .092 | 1.9, 0.92‐3.7 | .085 | 23 | 42 | 71 | 45 | 0.75 | 0.88, 0.47‐1.6 | .69 |
| Neutropenia | 42 | 52 | 84 | 33 | .0024 | 2.2, 1.3‐3.7 | .002 | 49 | 53 | 150 | 62 | 0.17 | 0.71, 0.44‐1.1 | .16 |
| CCr 70 mL/min> | 22 | 63 | 36 | 37 | .0098 | 2.9, 1.3‐6.5 | .009 | 25 | 69 | 58 | 70 | 1.0 | 0.98, 0.42‐2.3 | .96 |
| 70 mL/min≤ | 20 | 44 | 48 | 30 | .11 | 1.8, 0.90‐3.5 | .099 | 24 | 44 | 91 | 58 | 0.085 | 0.57, 0.31‐1.1 | .075 |
| Thrombocytopenia | 16 | 20 | 66 | 26 | .30 | 0.71, 0.39‐1.3 | .28 | 31 | 34 | 121 | 50 | 0.0097 | 0.51, 0.31‐0.85 | .009 |
| CCr 70 mL/min> | 5 | 14 | 26 | 27 | .17 | 0.46, 0.16‐1.3 | .15 | 17 | 47 | 46 | 55 | 0.43 | 0.72, 0.33‐1.6 | .41 |
| 70 mL/min≤ | 11 | 24 | 39 | 25 | 1.0 | 0.96, 0.45‐2.1 | .92 | 14 | 26 | 75 | 48 | 0.0044 | 0.38, 0.19‐0.75 | .005 |
| Nausea | 46 | 57 | 103 | 40 | .010 | 2.0, 1.2‐3.3 | .009 | 55 | 60 | 123 | 51 | 0.14 | 1.5, 0.89‐2.4 | .13 |
| CCr 70 mL/min> | 21 | 60 | 41 | 42 | .077 | 2.1, 0.95‐4.6 | .067 | 23 | 64 | 44 | 53 | 0.32 | 1.6, 0.70‐3.5 | .27 |
| 70 mL/min≤ | 25 | 54 | 61 | 39 | .064 | 1.9, 0.98‐3.7 | .059 | 32 | 58 | 78 | 49 | 0.28 | 1.4, 0.77‐2.7 | .26 |
| Vomiting | 30 | 37 | 45 | 18 | <.001 | 2.8, 1.6‐4.8 | <.001 | 38 | 41 | 48 | 20 | <0.001 | 2.9, 1.7‐4.8 | <.001 |
| CCr 70 mL/min> | 13 | 37 | 22 | 22 | .12 | 2.0, 0.89‐4.7 | .093 | 20 | 56 | 21 | 25 | 0.0029 | 3.7, 1.6‐8.4 | .002 |
| 70 mL/min≤ | 17 | 37 | 23 | 15 | .0014 | 3.4, 1.6‐7.2 | .001 | 18 | 33 | 27 | 17 | 0.021 | 2.4, 1.2‐4.7 | .016 |
| Diarrhea | 30 | 37 | 76 | 30 | .22 | 1.4, 0.83‐2.4 | .21 | 37 | 40 | 78 | 32 | 0.20 | 1.4, 0.87‐2.3 | .16 |
| CCr 70 mL/min> | 13 | 37 | 37 | 38 | 1.0 | 0.97, 0.44‐2.2 | .95 | 17 | 47 | 29 | 35 | 0.22 | 1.7, 0.75‐3.7 | .21 |
| 70 mL/min≤ | 17 | 37 | 39 | 25 | .13 | 1.8, 0.89‐3.6 | .10 | 20 | 36 | 48 | 30 | 0.41 | 1.3, 0.69‐2.5 | .41 |
| Stomatitis | 6 | 7 | 24 | 9 | .82 | 0.78, 0.31‐2.0 | .60 | 29 | 32 | 50 | 21 | 0.043 | 1.8, 1.0‐3.0 | .036 |
| CCr 70 mL/min> | 3 | 9 | 13 | 13 | .56 | 0.61, 0.16‐2.3 | .47 | 10 | 28 | 23 | 28 | 1.0 | 1.0, 0.42‐2.4 | .99 |
| 70 mL/min≤ | 3 | 7 | 11 | 7 | 1.0 | 0.93, 0.25‐3.5 | .92 | 19 | 35 | 26 | 17 | 0.0070 | 2.7, 1.3‐5.4 | .006 |
Abbreviations: 95%CI, 95% confidence interval; CCr, creatinine clearance rate; CS, cisplatin plus S‐1; OR, odds ratio; SOX, S‐1 plus oxaliplatin.
a Fisher's exact test; comparing frequency of adverse events.