Table 4.

Risk factors for treatment-related death in patients receiving irinotecan therapy

Variable	na	Treatment-related death
		Univariate			Multivariate (n = 11 249)
		Odds	(95% CI)	P valuec	Odds	(95% CI)	P valuec
Gender (female/male)	13 934	0.67	(0.49–0.91)	0.0118	0.59	(0.41–0.86)	0.0054
Age (≥65/≤64 years)	13 931	1.90	(1.41–2.56)	0.0001	1.91	(1.37–2.68)	0.0002
PS (≥3/≤2)	13 686	4.72	(3.08–7.22)	0.0001	3.03	(1.84–5.00)	0.0001
Tumor stage (I, II/III, IV)	12 965	1.51	(0.85–2.67)	0.1571
Prior chemotherapy	13 822	1.27	(0.92–1.75)	0.1523
Prior radiotherapy	13 770	1.12	(0.79–1.59)	0.5168
Pleural effisionb	13 345	1.83	(1.19–2.83)	0.0064
Massive ascitesb	13 341	2.65	(1.65–4.26)	0.0001	2.11	(1.20–3.71)	0.0098
Watery stoolb	13 471	0.81	(0.11–5.83)	0.8327
Infectionb	13 388	3.82	(1.93–7.60)	0.0001	2.25	(1.04–4.89)	0.0405
Jaundiceb	12 789	3.18	(0.99–10.21)	0.0513
Ileusb	13 680	4.21	(1.00–17.60)	0.049
Concurrent disease at the start of treatment	13 771	1.87	(1.38–2.52)	0.0001
Hepatic dysfunctionb	13 771	1.93	(1.11–3.35)	0.0199
Renal dysfunctionb	13 771	5.08	(3.15–8.20)	0.0001	4.82	(2.87–8.10)	0.0001
Diabetesb	13 680	0.32	(0.12–0.88)	0.0263
Chemotherapy	13 935	0.75	(0.54–1.04)	0.0834
(mono/combined)
Combination therapy with radiation	13 935	1.30	(0.76–2.21)	0.3423
Total no. of doses (1–3/4–)	13 930	0.31	(0.22–0.42)	0.0001	0.344	(0.24–0.49)	0.0001

PS, performance status.

^aNo. of patients for univariate analysis.

^bAt the beginning of irinotecan treatment.

^cWald chi-square test.