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Table 4 Neutropenia clinical patterns in the overall safety population (as treated population) of the PALOMA-1/TRIO-18 trial

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

  Palbociclib + letrozole
(n = 83)
Letrozole
(n = 77)
Patients with neutropenia*, n (%)a
 All Grades 63 (75.9 %) 4 (5.2 %)
 Grade 3 41 (49.4 %) 1 (1.3 %)
 Grade 4 5 (6.0 %) 0
Laboratory abnormality: neutrophils, n (%)
 All Grades 77 (93.9 %) 13 (16.9 %)
 Grade 3 47 (57.3 %) 2 (2.6 %)
 Grade 4 4 (4.9 %) 0
Neutropenia episodes per patient, n (%)a
 1 10 (12.1 %) 2 (2.6 %)
 2 9 (10.8 %) 1 (1.3 %)
 3–5 15 (18.1 %) 0
 ≥ 6 29 (34.9 %) 1 (1.3 %)
Median time (range) from first dose to first episode of neutropenia onset, days
 Any grade 20.0 (13–757) 49.5 (15–113)
 Grade ≥3 28.0 (14–757) 225.0 (225–225)
 Grade 4 16.0 (14–246)
Total number of episodes of neutropenia in the study
 All Grades 472 16
 Grade ≥3 265 4
 Grade 4 11 0
Median duration (range) of neutropenia by episode, days
 Grade ≥3 8 (2–58) 30 (27–31)
 Grade 4 7 (3–16)
Dose reductions, dose interruptions, or cycle delays due to any grade neutropenia, n (%)a 43 (51.8 %)
Permanent discontinuation from the study due to Grade 3–4 neutropenia, n (%)a 5 (6.0 %) 0
All Grades neutropenia with overlapping all Grades infections, n (%)b
 Yes 23 (36.5 %) 0
 No 40 (63.5 %) 4 (100.0 %)
All Grades neutropenia with overlapping Grade 3–4 infections, n (%)b
 Yes 1 (1.6 %) 0
 No 62 (98.4 %) 4 (100.0 %)
Grade 3–4 neutropenia with overlapping all Grades infections, n (%)c
 Yes 13 (28.2 %) 0
 No 33 (71.7 %) 1 (100.0 %)
Grade 3–4 neutropenia with overlapping Grade 3–4 infections, n (%)c
 Yes 0 0
 No 46 (100.0 %) 1 (100.0 %)
  1. *Neutropenia included preferred terms “neutropenia” and “neutrophil count decreased” (MeDRA 16.1 coding dictionary)
  2. The number of patients who had at least one on-study assessment for absolute neutrophil count was 82 in the palbociclib plus letrozole arm and 77 in the letrozole arm
  3. aPercentages are based on the number of patients in each arm (n) of the study: 83 in the palbociclib plus letrozole arm, 77 in the letrozole arm
  4. bPercentages are based on the number of patients with all Grades neutropenia: 63 in the palbociclib plus letrozole arm, 4 in the letrozole arm
  5. cPercentages are based on the number of patients with Grade 3–4 neutropenia: 46 in the palbociclib plus letrozole arm, 1 in the letrozole arm