Table 2.

Baseline clinical characteristics of patients with HR+/HER2- advanced disease treated with endocrine therapy and a CDK4/6 inhibitor

Cohort	CDK-Validation-1				CDK-Validation-2
	All patients		Patients with TF ≥3%		All patients		Patients with TF ≥3%
	N	%	N	%	N	%	N	%
Number of patients	124		87		121		65
Median age (range)	61 (34-86)		62 (34-86)		60 (31-88)		60 (41-83)
Sex
Female	122	98.4%	87	100.0%	121	100%	121	100%
Male	2	1.6%	0	0.0%	0	0%	0	0%
CDK4/6 inhibitor
Palbociclib	70	56.5%	48	55.2%	48	39.7%	22	33.8%
Ribociclib	50	40.3%	36	41.4%	52	43.0%	26	40.0%
Abemaciclib	4	3.2%	3	3.5%	21	17.4%	17	26.2%
Setting in advanced disease
1st line	71	57.3%	52	59.8%	72	59.5%	37	56.9%
2nd line	27	21.8%	15	17.2%	18	14.9%	10	15.4%
≥3rd line	26	21.0%	20	23.0%	31	25.6%	18	27.7%
Number of metastases
<3	74	59.7%	50	57.5%	56	46.3%	44	67.7%
≥3	50	40.3%	37	42.5%	64	52.9%	21	32.3%
Unknown	0	0.0%	0	0.0%	1	0.8%	0	0.0%
Type of metastasis
Visceral metastasis	66	53.2%	34	39.1%	67	55.4%	38	58.5%
De novo metastasis	30	24.2%	19	21.8%	34	28.1%	22	33.9%
Bone only	12	9.7%	0	0.0%	20	16.5%	12	18.5%
Prior endocrine therapy sensitivity
Sensitive	103	83.1%	73	83.9%	94	77.7%	48	73.8%
Resistant	19	15.3%	14	16.1%	26	21.5%	17	26.2%
Unknown	2	1.6%	0	0.00%	1	0.8%	0	0.0%
ECOG Performance status
0	50	40.3%	38	43.7%	62	51.2%	33	50.8%
1	61	49.2%	39	44.8%	49	40.0%	27	41.5%
2	12	9.7%	10	11.5%	5	4.1%	4	6.2%
Unknown	1	0.8%	0	0.0%	5	4.1%	1	1.5%

*Previous systemic treatments are available for the CDK-Validation-1 cohort (Supplementary Data 17).