Pivot, XVerma, SFallowfield, LMuller, VLichinitser, MJenkins, VSanchez-Muñoz, AMachackova, ZOsborne, SGligorov, J2023-01-252023-01-252017-09-28Pivot 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;86:82-90http://hdl.handle.net/10668/11633To 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.enBreast cancerHER2/neuHerceptinPatient preferenceSubcutaneousTrastuzumabAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDrug Administration ScheduleFemaleHumansInjections, IntravenousInjections, SubcutaneousKaplan-Meier EstimateMiddle AgedNeoadjuvant TherapyProtein Kinase InhibitorsReceptor, ErbB-2Time FactorsTrastuzumabTreatment Outcomeresearch article28963915Restricted AccessEfectos Colaterales y Reacciones Adversas Relacionados con Supervivencia sin ProgresiónReceptores ErbBNeoplasias de la MamaDosificaciónQuimioterapia10.1016/j.ejca.2017.08.0191879-0852http://sro.sussex.ac.uk/id/eprint/69904/1/Pivot_PrefHer_FA_EJC_resubmission.pdf