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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

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posted on 2023-06-09, 07:40 authored by X Pivot, S Verma, Lesley FallowfieldLesley Fallowfield, V Müller, M Lichinister, Valerie JenkinsValerie Jenkins, A Sánchez Muñoz, Z Machackova, S Osborne, J Gligorov
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 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. 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.

Funding

PrefHer; Hoffman Le Roche

History

Publication status

  • Published

File Version

  • Accepted version

Journal

European Journal of Cancer

ISSN

0959-8049

Publisher

Elsevier

Volume

86

Page range

82-90

Department affiliated with

  • Sussex Health Outcomes Research & Education in Cancer (SHORE-C) Publications

Research groups affiliated with

  • Sussex Health Outcomes Research and Education in Cancer Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2017-08-24

First Open Access (FOA) Date

2018-09-27

First Compliant Deposit (FCD) Date

2017-08-24

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