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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