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Table 1 Baseline characteristics of subgroups (intention-to-treat population)

From: Efficacy and safety of palbociclib in combination with letrozole as first-line treatment of ER-positive, HER2-negative, advanced breast cancer: expanded analyses of subgroups from the randomized pivotal trial PALOMA-1/TRIO-18

Age group

<65 years (n = 89)

≥65 years (n = 76)

 

P+ L (n = 47)

L (n = 42)

P + L (n = 37)

L (n = 39)

Median age (range), years

55.0 (41–64)

56.5 (38–64)

72.0 (65–89)

70.0 (65–84)

ECOG performance status

 0

26 (55.3 %)

23 (54.8 %)

20 (54.1 %)

22 (56.4 %)

 1

21 (44.7 %)

19 (45.2 %)

17 (45.9 %)

17 (43.6 %)

Disease stage

 IIIB

1 (2.1 %)

1 (2.4 %)

1 (2.7 %)

0

 IV

46 (97.9 %)

41 (97.6 %)

36 (97.3 %)

39 (100.0 %)

Disease sitea

 Bone-only

9 (19.2 %)

3 (7.1 %)

8 (21.6 %)

9 (23.1 %)

 Visceral

19 (40.4 %)

22 (52.4 %)

18 (48.7 %)

21 (53.9 %)

 Other

19 (40.4 %)

17 (40.5 %)

11 (29.7 %)

9 (23.1 %)

Prior systemic treatment

 None

24 (51.1 %)

23 (54.8 %)

20 (54.1 %)

14 (35.9 %)

 Yes

23 (48.9 %)

19 (45.2 %)

17 (45.9 %)

25 (64.1 %)

Histological type

Ductal carcinoma (n = 117)

Lobular carcinoma (n = 37)

 

P+ L (n = 63)

L (n = 54)

P + L (n = 18)

L (n = 19)

Median age (range), years

63 (41–89)

65 (42–84)

60 (50–74)

62 (38–78)

ECOG performance status

 0

36 (57.1 %)

29 (53.7 %)

9 (50.0 %)

14 (73.7 %)

 1

27 (42.9 %)

25 (46.3 %)

9 (50.0 %)

5 (26.3 %)

Disease stage

 IIIB

2 (3.2 %)

1 (1.9 %)

0

0

 IV

61 (96.8 %)

53 (98.1 %)

18 (100.0 %)

19 (100.0 %)

Disease sitea

 Bone-only

11 (17.5 %)

8 (14.8 %)

4(22.2 %)

3 (15.8 %)

 Visceral

28 (44.4 %)

30 (55.6 %)

8 (44.4 %)

7 (36.8 %)

 Other

24 (38.1 %)

16 (29.6 %)

6 (33.3 %)

9 (47.4 %)

Prior systemic treatment

 None

36 (57.1 %)

26 (48.1 %)

6 (33.3 %)

7 (36.8 %)

 Yes

27 (42.9 %)

28 (51.9 %)

12 (66.7 %)

12 (63.2 %)

Prior systemic treatment

None (n = 81)

Yes (n = 84)

 

P+ L (n = 44)

L (n = 37)

P + L (n = 40)

L (n = 44)

Median age (range), years

63.0 (41–83)

62.0 (43–76)

60.0 (46–89)

65.5 (38–84)

ECOG performance status

 0

26 (59.1 %)

18 (48.6 %)

20 (50.0 %)

27 (61.4 %)

 1

18 (40.9 %)

19 (51.4 %)

20 (50.0 %)

17 (38.6 %)

Disease stage

 IIIB

1 (2.3 %)

0

1 (2.5 %)

1 (2.3 %)

 IV

43 (97.7 %)

37 (100.0 %)

39 (97.5 %)

43 (97.7 %)

Disease sitea

 Bone-only

6 (13.6 %)

5 (13.5 %)

11 (27.5 %)

7 (15.9 %)

 Visceral

24 (54.6 %)

19 (51.4 %)

13 (32.5 %)

24 (54.6 %)

 Other

14 (31.8 %)

13 (35.1 %)

16 (40.0 %)

13 (29.6 %)

Disease sitea

Bone-only (n = 29)

Visceral (n = 80)

Other (n = 56)

 

P + L (n = 17)

L (n = 12)

P + L (n = 37)

L (n = 43)

P + L (n = 30)

L (n = 26)

Median age (range), years

63.0 (46–89)

69.0 (42–73)

63.0 (41–83)

64.0 (38–84)

62.0 (52–78)

62.0 (43–75)

ECOG performance status

 0

11 (64.7 %)

10 (83.3 %)

19 (51.4 %)

19 (44.2 %)

16 (53.3 %)

16 (61.5 %)

 1

6 (35.3 %)

2 (16.7 %)

18 (48.6 %)

24 (55.8 %)

14 (46.7 %)

10 (38.5 %)

Disease stage

 IIIB

0

0

0

0

2 (6.7 %)

1 (3.8 %)

 IV

17 (100.0 %)

12 (100.0 %)

37 (100.0 %)

43 (100.0 %)

28 (93.3)

25 (96.2)

Prior systemic treatment

 None

6 (35.3 %)

5 (41.7 %)

24 (64.9 %)

19 (44.2 %)

14 (46.7 %)

13 (50.0 %)

 Yes

11 (64.7 %)

7 (58.3 %)

13 (35.1 %)

24 (55.8 %)

16 (53.3 %)

13 (50.0 %)

  1. Data are n (%) unless otherwise indicated
  2. aBased on case report form data
  3. ECOG Eastern Cooperative Oncology Group, L letrozole alone, P + L palbociclib + letrozole