Table 2:

Associations with Recurrence Free Survival in Tamoxifen Treated and Untreated Patients in Univariate and Multivariable Analyses.

Model/Variable	HR	95% Cl	p-value	HR	95% Cl	p-value
Univariate Analysis	Tamoxifen Treated (n=476)			Tamoxifen Untreated (n=481)
CYP2D6 non-PM Status (AS>0)	0.68	0.33–1.40	0.29	0.44	0.22–0.89	0.023
CYP2D6 AS (continuous)	1.16	0.84–1.62	0.37	0.72	0.52–1.00	0.051
Age (continuous)	0.98	0.96–1.00	0.07	0.98	0.97–1.00	0.044
Age (>50 vs. <50)	0.67	0.34–1.32	0.24	0.71	0.41–1.23	0.22
PR status (Positive vs. negative)	0.83	0.53–1.31	0.43	0.66	0.41–1.09	0.10
Tumor Size (vs. <2 cm)
>2 and <5 cm	2.01	1.28–3.14	0.0003	2.43	1.50–3.94	0.0002
>5 cm	4.03	1.95–8.35		4.12	1.70–9.99
Nodes (vs. negative)
1–3	1.29	0.80–2.07	<0.0001	1.85	1.04–3.28	0.010
4–9	3.77	2.24–6.36		1.47	0.46–4.70
>10	6.52	3.39–12.54		4.41	1.60–12.20
Database (P01 vs. SPORE)a	2.06	1.40–3.05	0.0003	4.46	2.70–7.36	<0.0001
CYP2D6 PM Status Multivariable Modelb	Tamoxifen Treated		(n=469)d	Tamoxifen Untreated (n=476)d
Age (continuous)	0.98	0.96–1.00	0.059	0.99	0.97–1.01	0.19
Tumor Size
>2 and <5 cm	1.77	1.12–2.79	0.034	1.84	1.10–3.09	0.014
>5 cm	2.07	0.96–4.46		3.20	1.27–8.06
Nodes
1–3	1.12	0.69–1.83	<0.0001	1.33	0.72–2.47	0.44
4–9	3.11	1.82–5.34		1.19	0.36–3.93
>10	5.14	2.49–10.62		2.26	0.76–6.74
CYP2D6 non-PM Status	1.11	0.50–2.44	0.80	0.41	0.20–0.84	0.015
CYP2D6 AS Multivariable Modelc	1.43	1.00–2.04	0.050	0.66	0.47–0.92	0.015

Abbreviations: AS: Activity score, Cl: Confidence Interval, HR: Hazard Ratio, PM: Poor Metabolizer

^aViolated proportional hazards assumption

^bAnalysis stratified by database (P01 and SPORE)

^cHR, 95% Cl, and p-values reported are for the covariates in the final multivariable that includes CYP2D6 non- PM status. Covariate values for the models with CYP2D6 AS were not meaningfully different.

Tamoxifen treated models were stratified by database, untreated and overall models were stratified by database and PR status.

^d12 Patients missing age data were excluded from multivariable analyses