209P - Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: fina...

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Breast Cancer, Early Stage
Presenter Xavier Pivot
Citation Annals of Oncology (2016) 27 (6): 43-67. 10.1093/annonc/mdw364
Authors X. Pivot1, S. Verma2, L. Fallowfield3, V. Müller4, M. Lichinitser5, A. Sánchez Muñoz6, Z. Machackova7, S. Osborne8, J. Gligorov9
  • 1Chemotherapy – Oncology, CHU Jean Minjoz, 25030 - Besançon/FR
  • 2Tom Baker Cancer Centre, Department Of Oncology, University of Calgary, Calgary/CA
  • 3Sussex Health Outcomes Research & Education In Cancer (shore-c), Brighton And Sussex Medical School, University of Sussex, Falmer/GB
  • 4Department Of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg/DE
  • 5Department Of Chemotherapy And Combined Therapy, N.N. Blokhin Cancer Research Center, Moscow/RU
  • 6Servicio De Oncología Médica, Hospital Universitario Virgen de la Victoria, Malaga/ES
  • 7Global Product Development/medical Affairs Oncology (pdmao), F. Hoffmann-La Roche Ltd, Basel/CH
  • 8Pdma Operations (biometrics), F. Hoffmann-La Roche Ltd, Basel/CH
  • 9Medical Oncology Department, APHP-Tenon; IUC-UPMC; Sorbonne University, Paris/FR

Abstract

Background

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.

Methods

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.

Results

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
AEs 388 (80)
Grade
1 360 (75)
2 214 (44)
3 45 (9)
4 0
5 0
SAEs 19 (4)
Related to study drugs 1 (

Conclusions

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

NCT01401166

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd

Funding

F. Hoffmann-La Roche Ltd

Disclosure

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.