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Table 3 Safety analysis of subgroups (as treated 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 = 86) ≥65 years (n = 74)
  P+ L (n = 46) L (n = 40) P + L (n = 37) L (n = 37)
AEs (all causality), n (%) 46 (100.0 %) 33 (82.5 %) 37 (100.0 %) 32 (86.5 %)
Grade 3–4 AEs (all causality), n (%) 37 (80.4 %) 4 (10.0 %) 27 (73.0 %) 12 (32.4 %)
5 most common AEs that had a higher (>10 %) incidence in the P + L arm than in the L arm Neutropenia, leukopenia, fatigue, anemia, alopecia Neutropenia, leukopenia, fatigue, anemia, nausea
SAEs (all causality), n (%) 7 (15.2 %) 1 (2.5 %) 11 (29.7 %) 4 (10.8 %)
Permanent discontinuation due to AEs (all causality), n (%) 6 (13.0 %) 1 (2.5 %) 6 (16.2 %) 1 (2.7 %)
Dose reductions due to AEs (all causality), n (%) 18 (39.1 %) NA 14 (37.8 %) NA
Histological type Ductal carcinoma (n = 113) Lobular carcinoma (n = 36)
  P+ L (n = 62) L (n = 51) P + L (n = 18) L (n = 18)
AEs (all causality), n (%) 62 (100.0 %) 44 (86.3 %) 18 (100.0 %) 13 (72.2 %)
Grade 3–4 AEs (all causality), n (%) 47 (75.8 %) 13 (25.5 %) 14 (77.8 %) 2 (11.1 %)
5 most common AEs that had a higher (>10 %) incidence in the P + L arm than in the L arm Neutropenia, fatigue, leukopenia, anemia, nausea Neutropenia, anemia, leukopenia, asthenia, alopecia
SAEs (all causality), n (%) 12 (19.4 %) 5 (9.8 %) 4 (22.2 %) 0
Permanent discontinuation due to AEs (all causality), n (%) 8 (12.9 %) 1 (2.0 %) 4 (22.2 %) 1 (5.6 %)
Dose reductions due to AEs (all causality), n (%) 27 (43.5 %) NA 5 (27.8 %) NA
Prior systemic treatment None (n = 80) Yes (n = 80)
  P+ L (n = 43) L (n = 37) P + L (n = 40) L (n = 40)
AEs (all causality), n (%) 43 (100.0 %) 32 (86.5 %) 40 (100.0 %) 33 (82.5 %)
Grade 3–4 AEs (all causality), n (%) 30 (69.8 %) 5 (13.5 %) 34 (85.0 %) 11 (27.5 %)
5 most common AEs that had a higher (>10 %) incidence in the P + L arm than in the L arm Neutropenia, fatigue, leukopenia, anemia, alopecia Neutropenia, leukopenia, anemia, nausea, thrombocytopenia
SAEs (all causality), n (%) 7 (16.3 %) 2 (5.4 %) 11 (27.5 %) 3 (7.5 %)
Permanent discontinuation due to AEs (all causality), n (%) 7 (16.3 %) 1 (2.7 %) 5 (12.5 %) 1 (2.5 %)
Dose reductions due to AEs (all causality), n (%) 17 (39.5 %) NA 15 (37.5 %) NA
Disease sitea Bone-only (n = 28) Visceral (n = 80) Other (n = 52)
  P + L (n = 17) L (n = 11) P + L (n = 37) L (n = 43) P + L (n = 29) L (n = 23)
AEs (all causality), n (%) 17 (100.0 %) 10 (90.9 %) 37 100.0 %) 36 (83.7 %) 29 (100.0 %) 19 (82.6 %)
Grade 3–4 AEs (all causality), n (%) 15 (88.2 %) 2 (18.2 %) 27 (73.0 %) 12 (27.9 %) 22 (75.8 %) 2 (8.7 %)
5 most common AEs that had a higher (>10 %) incidence in the P + L arm than in the L arm Neutropenia, fatigue, leukopenia, nausea, anemia Neutropenia, leukopenia, fatigue, anemia, decreased appetite Neutropenia, leukopenia, anemia fatigue, hot flush
SAEs (all causality), n (%) 4 (23.5 %) 1 (9.1 %) 10 (27.0 %) 3 (7.0 %) 4 (13.8 %) 1 (4.3 %)
Permanent discontinuation due to AEs (all causality), n (%) 2 (11.8 %) 0 7 (18.9 %) 1 (2.3 %) 3 (10.3 %) 1 (4.3 %)
Dose reductions due to AEs (all causality), n (%) 5 (29.4 %) NA 14 (37.8 %) NA 13 (44.8 %) NA
  1. aBased on case report form data
  2. AE adverse event, L letrozole alone, NA not applicable, P + L palbociclib + letrozole, SAE serious adverse event