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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