PrefHer (NCT01401166) revealed a compelling and consistent patient preference for adjuvant subcutaneous trastuzumab (Herceptin® SC; H SC) over intravenous H (H IV) in HER2-positive early breast cancer, regardless of single-use injection device (Cohort 1) or hand-held syringe (Cohort 2) delivery. We report 3-year event-free survival (EFS) and safety.
Post-surgery and (neo)adjuvant chemotherapy, patients were randomised to receive four adjuvant cycles of H SC (600 mg fixed dose) followed by four of H IV (8 mg/kg loading, 6 mg/kg maintenance doses), or vice versa every 3 weeks. Following this crossover period, patients continued H SC or H IV therapy to complete 18 standard cycles. H IV was allowed prior to randomisation. EFS was assessed using the Kaplan–Meier approach and is shown for the overall evaluable intention-to-treat population (patients who completed the primary preference question and ≥1 administration of both H SC and H IV) in both cohorts combined. Adverse events (AEs) and serious AEs (SAEs) were reported according to NCI-CTCAE v4 and ICH E2A; data shown are combined from both cohorts (overall safety population) and include the crossover, H continuation and follow-up periods.
Across 12 countries and 74 sites, 488 patients were randomised and 483 assessed for safety. The evaluable intention-to-treat population comprised 467 patients. Median follow-up was 36.1 months (range 0–45.9). The 3-year EFS rate in the overall evaluable intention-to-treat population was 90.6% (95% confidence interval 87.4–92.9). The AE profile is shown in the table.
|Patients, n (%)*||Overall safety population N = 483|
|Related to study drugs||1 (|
EFS results confirm previous efficacy findings of H in the adjuvant setting. H SC was well tolerated and no new safety signals were identified compared with the known profiles of H IV or H SC from previous reports in HER2-positive early breast cancer.
Clinical trial identification
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd
F. Hoffmann-La Roche Ltd
X. Pivot: Consultant with honorarium for Roche, Amgen, Novartis, Eisai, Pierre Fabre. S. Verma: Advisory Board: Amgen, Astra Zeneca, BI, Novartis, Pfizer, Roche, Spectrum Health; Other: Medical Director and Co-Founder, OncologyEducation.com. L. Fallowfield: Grant support for the PrefHer study from Roche. V. Müller: Speaker honoraria from Roche and consultancy honoraria from Roche. Z. Machackova: Stock ownership (F. Hoffmann-La Roche); Other substantive relationships (employee of F. Hoffmann-La Roche). S. Osborne: Other substantive relationships (Employee of F. Hoffmann-La Roche). J. Gligorov: Consultancy: Roche-Genentech; Eisai; Honoraria: Teva; Novartis-GSK; GenomicHealth. All other authors have declared no conflicts of interest.