Table 1 Baseline patient demographics and disease characteristics.

From: Abemaciclib in combination with pembrolizumab for HR+, HER2− metastatic breast cancer: Phase 1b study

Characteristics

Cohort 1 N = 26

Cohort 2 N = 28

Sex, n (%)

 Female

26 (100.0)

27 (96.4)

 Male

—

1 (3.6)

Age, years, median (range)

58 (34–79)

55 (31–76)

Race, n (%)

 White

24 (92.3)

25 (89.3)

 Asian

2 (7.7)

1 (3.6)

 Black or African American

—

1 (3.6)

 Not reported

—

1 (3.6)

ECOG PS, n (%)

 0

19 (73.1)

19 (67.9)

 1

7 (26.9)

9 (32.1)

Nature of disease, n (%)

 Viscerala

17 (65.4)

23 (82.1)

 Bone-only

2 (7.7)

1 (3.6)

 Others

7 (26.9)

4 (14.3)

Disease locations, n (%)

 Liver

12 (46.2)

18 (64.3)

 Lung

6 (23.1)

10 (35.7)

 Bone

19 (73.1)

19 (67.9)

 Nodal

17 (65.4)

17 (60.7)

 Otherb

5 (19.1)

12 (42.8)

Number of metastatic sitesc, n (%)

 1

5 (19.2)

4 (14.3)

 2

7 (26.9)

4 (14.3)

 ≥3

14 (53.8)

20 (71.4)

PD-L1 status, n (%)

 Positive

3 (11.5)

12 (42.9)

 Negative

15 (57.7)

12 (42.9)

 Unknown

8 (30.8)

4 (14.3)

Transaminase elevationsd, n (%)

 ALT increased

6 (23.1)

5 (18.5)

 AST increased

8 (30.7)

7 (26.9)

  1. Enrolled population. Data cutoff: August 19, 2020.
  2. ALT alanine aminotransferase, AST aspartate aminotransferase, ECOG PS Eastern Cooperative Oncology Group performance status, N number of randomized patients, n number of patients in category, PD-L1 programmed death-ligand 1.
  3. aIncluded brain, central nervous system (non-brain), liver, lung, peritoneum, pleura, and other visceral sites.
  4. bIncluded soft tissue and other sites (visceral and non-visceral).
  5. cAny metastatic site.
  6. dInclusion criterion ≤3.0 × ULN OR ≤ 5 × ULN if the liver had tumor involvement. Note: excludes one missing value for ALT and two missing values for AST in cohort 2.
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