Table 2.
With induction therapy | Without induction therapy | |||
---|---|---|---|---|
Pertuzumab plus trastuzumab arm | Trastuzumab arm | Pertuzumab plus trastuzumab arm | Trastuzumab arm | |
Patients, n (%) | (n = 74) | (n = 69) | (n = 53) | (n = 55) |
Any AE | 73 (98.6) | 69 (100) | 49 (92.5) | 53 (96.4) |
NCI-CTCAE grade ≥3 AEs | 53 (71.6) | 34 (49.3) | 19 (35.8) | 17 (30.9) |
AEs related to pertuzumab | 50 (67.6) | 0 | 32 (60.4) | 0 |
SAEs | 30 (40.5) | 15 (21.7) | 16 (30.2) | 13 (23.6) |
SAEs related to pertuzumab | 4 (5.4) | 0 | 6 (11.3) | 0 |
AEs leading to discontinuation of pertuzumab | 11 (14.9) | 0 | 5 (9.4) | 0 |
Number of deaths | 39 (52.7) | 31 (44.9) | 23 (43.4) | 26 (47.3) |
Deaths due to study treatment | 0 | 0 | 0 | 0 |
Abbreviation: NCI-CTCAE, National Cancer Institute's Common Terminology Criteria for Adverse Events.