. 2020 Apr 28;112(12):1222–1230. doi: 10.1093/jnci/djaa054

Table 3.

Hazard ratios for DFS and OS calculated for both standard analysis and sensitivity analysis at 14 months after cycle 1 trastuzumab using Cox model

		Group B^a		Group C^b		Group D^c
Study outcome		HR^d (95% CI)	P ^e	HR^d (95% CI)	P ^e	HR^d (95% CI)	P ^e
Standard analysis
Time since 1st cycle trastuzumab
DFS	6 mo	5.3 (3.32 to 8.58)	<.001	6.13 (4.04 to 9.30)	<.001	5.30 (3.83 to 7.32)	<.001
	1 y	5.03 (3.27 to 7.73)	<.001	5.39 (3.73 to 7.79)	<.001	4.73 (3.55 to 6.31)	<.001
	5 y	3.15 (2.13 to 4.65)	<.001	1.94 (1.30 to 2.89)	.001	1.92 (1.46 to 2.52)	<.001
	10 y	1.75 (0.69 to 4.40)	.24	0.54 (0.20 to 1.48)	.23	0.62 (0.31 to 1.24)	.18
OS	6 mo	8.11 (4.71 to 13.98)	<.001	11.76 (7.45 to 18.56)	<.001	9.32 (6.44 to 13.49)	<.001
	1 y	6.99 (4.31 to 11.33)	<.001	9.16 (6.18 to 13.57)	<.001	7.64 (5.54 to 10.54)	<.001
	5 y	2.12 (1.25 to 3.58)	.01	1.24 (0.72 to 2.13)	.44	1.56 (1.11 to 2.18)	.01
	10 y	0.48 (0.13 to 1.75)	.26	0.10 (0.03 to 0.40)	.001	0.21 (0.09 to 0.52)	<.001
Sensitivity analysis
Time since 1st cycle trastuzumab + 14 mo
DFS	6 mo	2.96 (1.81 to 4.82)	<.001	2.11 (1.31 to 3.38)	.002	2.03 (1.45 to 2.82)	<.001
	1 y	2.94 (1.90 to 4.55)	<.001	2.09 (1.38 to 3.17)	<.001	2.01 (1.50 to 2.69)	<.001
	5 y	2.78 (1.68 to 4.62)	<.001	1.94 (1.18 to 3.20)	.01	1.89 (1.34 to 2.66)	.001
	10 y	2.60 (0.78 to 8.63)	.12	1.78 (0.51 to 6.21)	.37	1.74 (0.74 to 4.12)	.20
OS	6 mo	3.61 (2.09 to 6.21)	<.001	3.31 (2.02 to 5.43)	<.001	2.92 (2.05 to 4.16)	<.001
	1 y	3.31 (2.05 to 5.35)	<.001	2.96 (1.94 to 4.51)	<.001	2.74 (2.02 to 3.71)	<.001
	5 y	1.68 (0.82 to 3.47)	.16	1.21 (0.59 to 2.48)	.61	1.61 (1.04 to 2.51)	.03
	10 y	0.72 (0.13 to 4.04)	.71	0.39 (0.07 to 2.31)	.30	0.83 (0.28 to 2.53)	.75

^{^a}

Group B had a cardiac event within the study period. CI = confidence interval; DFS = disease-free survival; HR = hazard ratio; OS = overall survival.

^{^b}

Group C had 16 or fewer cycles of trastuzumab, had no cardiac events, and stopped treatment within 30 days of the last cardiac imaging test.

^{^c}

Group D had 16 or fewer cycles of trastuzumab, had no cardiac events, and stopped treatment more than 30 days after the last cardiac imaging test.

^{^d}

Hazard ratios are adjusted for age at treatment, Charlson comorbidity index, hospital type (teaching or community), breast cancer stage, estrogen receptor status, progesterone receptor status, neighborhood income quintile, rurality, anthracycline treatment history, and cardiologist visit history.

^{^e}

P values were calculated using 2-sided Wald χ² test.