Table 2. Cox regression models1 for the incidence of TIC2 by risk factors.
Variables | Number of Patients | Incidence | HR | 95% CI for HR | P-Value | ||
---|---|---|---|---|---|---|---|
No | % | ||||||
Median (range) for continuous variables | |||||||
Age (years) | 59 (30–80) | 1.16 | 1.03–1.31 | 0.019 | |||
Gender | |||||||
Male | 52 | 4 | 7.7 | 1.49 | 0.17–13.4 | 0.722 | |
Female | 18 | 1 | 5.6 | 1 | |||
BMI (kg/m2) | 21.4 (13.8–32.5) | 0.94 | 0.69–1.28 | 0.701 | |||
Hypertension | |||||||
Yes | 18 | 2 | 11.1 | 1.74 | 0.29–10.5 | 0.545 | |
No | 52 | 3 | 5.8 | 1 | |||
Diabetes | |||||||
Yes | 8 | 0 | 0 | N/A | N/A | ||
No | 62 | 5 | 8.1 | ||||
Smoking | |||||||
Current/Former | 38 | 0 | 0 | N/A | N/A | ||
Never | 32 | 5 | 15.6 | ||||
Baseline LVEF (%) | |||||||
≥55 and ≤60 | 20 | 1 | 5.0 | 1.60 | 0.18–14.3 | 0.677 | |
≥60 | 50 | 4 | 8.0 | 1 | |||
Baseline serum CRP (mg/L) | 13.3 (0–201) | 1.00 | 0.98–1.02 | 0.799 | |||
Total cholesterol (mg/dL) | 153.5 (74–343) | 1.00 | 0.99–1.02 | 0.769 | |||
Cycle (number) | 9 (1–62) | 0.99 | 0.92–1.08 | 0.844 | |||
Cumulative dose (mg/kg) | 56 (8–374) | 1.00 | 0.98–1.02 | 0.927 | |||
Combined cytotoxic chemotherapy | |||||||
FP | 31 | 4 | 12.9 | 6.74 | 0.74–61.6 | 0.091 | |
SP/XP | 39 | 1 | 2.6 | 1 |
BMI, body mass index; CRP, C-reactive protein; FP, fluorouracil plus cisplatin chemotherapy; HR, hazard ratio; LVEF, left ventricular ejection fraction; SP, TS-1 plus cisplatin chemotherapy; TIC, trastuzumab-induced cardiotoxicity; XP, capecitabine plus cisplatin chemotherapy; 1trastuzumab treatment group only; N=70; 2TIC was defined as at least one of the following: decreased LVEF ≥10% points to a value of <55%, severe congestive heart failure, or cardiac death.