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Table 2 Progression-free survival (PFS) and clinical benefit response (CBR) rate 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 PFS (95 % CI), months

18.8 (12.8–26.1)

7.7 (2.8–10.9)

26.2 (12.6–NE)

12.9 (5.7–22.2)

HR (95 % CI)

0.315 (0.184–0.539)

0.505 (0.269–0.948)

CBR* rate (95 % CI), %

80.9 (66.7–90.9)

54.8 (38.7–70.2)

81.1 (64.8–92.0)

61.5 (44.6–76.6)

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 PFS (95 % CI), months

24.4 (13.1–35.3)

11.1 (7.3–13.3)

9.4 (7.8–18.8)

4.8 (1.9–16.4)

HR (95 % CI)

0.393 (0.239–0.647)

0.626 (0.282–1.391)

CBR* rate (95 % CI), %

82.5 (70.9–90.9)

63.0 (48.7–75.7)

72.2 (46.5–90.3)

42.1 (20.3–66.5)

Prior systemic treatment

None (n = 81)

Yes (n = 84)

 

P + L (n = 44)

L (n = 37)

P + L (n = 40)

L (n = 44)

Median PFS (95 % CI), months

24.4 (13.1–35.3)

8.2 (5.7–12.5)

16.1 (11–NE)

10.9 (3.5–16.6)

HR (95 % CI)

0.341 (0.194–0.599)

0.539 (0.302–0.962)

CBR* rate (95 % CI), %

84.1 (69.9–93.4)

70.3 (53.0–84.1)

77.5 (61.5–89.2)

47.7 (32.5–63.3)

   

Prior anti-hormone treatment (n = 55)

   

P + L (n = 27)

L (n = 28)

Median PFS (95 % CI), months

NA

18.8 (9.7–NE)

12.9 (2.1–21.8)

HR (95 % CI)

NA

0.460 (0.222–0.956)

CBR* rate (95 % CI), %

NA

77.8 (57.7–91.4)

53.6 (33.9–72.5)

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 PFS (95 % CI), months

NE (9.4–NE)

13.3 (1.8–NE)

12.8 (9.7–17.2)

7.4 (3.7–11.1)

24.4 (18.1–35.3)

11.2 (3.5–16.4)

HR (95 % CI)

0.294 (0.092–0.945)

0.547 (0.317–0.944)

0.402 (0.200–0.808)

CBR* rate (95 % CI), %

88.2 (63.6–98.5)

58.3 (27.7–84.8)

75.5 (58.5–88.2)

60.5 (44.4–75.0)

83.3 (65.3–94.4)

53.8 (33.4–73.4)

  1. *The CBR was determined by investigator assessment
  2. aBased on case report form data
  3. CI confidence interval, HR hazard ratio, L letrozole alone, NA not applicable, NE not estimable, P + L palbociclib + letrozole