Research Article

Effectiveness and Safety of Zercepac and Reference Trastuzumab in the Neoadjuvant Setting for Early-Stage Breast Cancer: A Retrospective Cohort Study

Table 4

Safety.

All gradesGrades ≥3
Zercepac (n = 65)Reference trastuzumab (n = 40)Zercepac (n = 65)Reference trastuzumab (n = 40)

Any AE65 (100.0)40 (100.0)53 (81.5)28 (70.0)0.172
Nausea28 (43.1)16 (40.0)0.7566 (9.2)3 (7.5)0.758
Vomit33 (50.8)17 (42.5)0.4109 (13.8)4 (10.0)0.561
Fatigue44 (67.7)23 (57.5)0.2912 (3.1)6 (15.0)0.025
Infusion-related reaction2 (3.1)15 (37.5)<0.00101 (2.5)0.200
Diarrhea36 (55.4)17 (42.5)0.2005 (7.7)5 (12.5)0.415
Decreased appetite31 (47.7)28 (70.0)0.0253 (4.6)4 (10.0)0.283
Elevated AST45 (69.2)26 (65.0)0.65319 (29.2)6 (15.0)0.096
Elevated ALT36 (55.4)28 (70.0)0.13615 (23.1)5 (12.5)0.180
Elevated GGT12 (18.5)11 (27.5)0.2771 (1.5)0 (0.0)0.431
Anemia33 (50.8)22 (55.0)0.67316 (24.6)5 (12.5)0.132
Thrombocytopenia32 (49.2)13 (32.5)0.0935 (7.7)2 (5.0)0.591
Hypertriglyceridemia14 (21.5)17 (42.5)0.0223 (4.6)5 (12.5)0.139
Hypokalemia3 (4.6)00.1681 (1.5)0 (0.0)0.431
Neutropenia20 (30.8)3 (7.5)0.0051 (1.5)0 (0.0)0.431
Leukopenia30 (46.2)11 (27.5)0.0572 (3.1)3 (7.5)0.301
Infection7 (10.8)2 (5.0)0.30500
Dizziness26 (40.0)15 (37.5)0.7997 (10.8)1 (2.5)0.121
Hectic fever22 (33.8)15 (37.5)0.70310 (15.4)4 (10.0)0.431
Difficulty breathing5 (7.7)2 (5.0)0.59100
Rash13 (20.0)17 (42.5)0.0131 (1.5)1 (2.5)0.726
Myalgia23 (35.4)25 (62.5)0.0072 (3.1)0 (0.0)0.263
Cough7 (10.8)9 (22.5)0.10402 (5.0)0.069
Hair loss58 (89.2)35 (87.5)0.78700
Insomnia17 (26.2)23 (57.5)0.00109 (22.5)<0.001

AST—aspartate aminotransferase; ALT—alanine aminotransferase; GGT—gamma-glutamyl transferase.