RT Journal Article
T1 Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study.
A1 Pivot, X
A1 Verma, S
A1 Fallowfield, L
A1 Muller, V
A1 Lichinitser, M
A1 Jenkins, V
A1 Sanchez-Muñoz, A
A1 Machackova, Z
A1 Osborne, S
A1 Gligorov, J
K1 Breast cancer
K1 HER2/neu
K1 Herceptin
K1 Patient preference
K1 Subcutaneous
K1 Trastuzumab
AB To assess efficacy (event-free survival, EFS) and safety in patients followed up for 3 years in the PrefHer study (NCT01401166). Post surgery and post chemotherapy in the (neo)adjuvant setting, patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomised to receive four cycles of the subcutaneous form of trastuzumab (Herceptin® SC [H SC] via single-use injection device [Cohort 1] or delivery via a hand-held syringe from an SC Vial [Cohort 2]; 600 mg fixed dose) followed by four of the intravenous form of trastuzumab (Herceptin® [H IV]; 8 mg/kg loading, 6 mg/kg maintenance doses) in the adjuvant setting or vice versa every 3 weeks. Patients could have received H before randomisation. H was then continued to complete a total of 18 cycles, including any cycles received before randomisation. A total of 488 patients were randomised across both cohorts. After median follow-up of 36.1 months, 3-year EFS across both groups in the evaluable intention-to-treat population (467 patients) was 90.6% overall, 89.9% in Cohort 1, and 91.1% in Cohort 2. No new safety signals were identified during long-term follow-up, with only one cardiac serious adverse event in the safety population (483 patients). Three-year EFS data following H SC and H IV treatment are consistent with those reported by previous trials for H in the adjuvant setting. The overall safety profile during adjuvant treatment was as expected.
PB Elsevier
YR 2017
FD 2017-09-28
LK http://hdl.handle.net/10668/11633
UL http://hdl.handle.net/10668/11633
LA en
NO Pivot X, Verma S, Fallowfield L, Müller V, Lichinitser M, Jenkins V, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017 Nov;86:82-90
DS RISalud
RD Apr 12, 2025