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

Pivot, X, Verma, S, Fallowfield, L, Muller, V, Lichinister, M, Jenkins, V, Sanchez-Munoz, A, Machackova, Z, Osborne, S and Gligorov, J (2017) 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. European Journal of Cancer. ISSN 0959-8049 (Accepted)

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Abstract

Aim: To assess efficacy (event-free survival, EFS) and safety in patients followed up for 3 years in the PrefHer study (NCT01401166). Patients and methods: Post-surgery and -chemotherapy in the (neo)adjuvant setting, patients with 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 and-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. Results: 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). Conclusions: 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.

Item Type: Article
Keywords: breast cancer, HER2/neu, Herceptin, patient preference, subcutaneous, trastuzumab
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Research Centres and Groups: Sussex Health Outcomes Research and Education in Cancer
Subjects: R Medicine
Depositing User: Valerie Jenkins
Date Deposited: 24 Aug 2017 08:26
Last Modified: 24 Aug 2017 23:44
URI: http://sro.sussex.ac.uk/id/eprint/69904

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Project NameSussex Project NumberFunderFunder Ref
PrefHerUnsetHoffman Le RocheUnset