OVERVIEW
ESMO Open has published an article co-authored by a member of our Biostatistics team. Results of the exploratory analysis conclude that after >6 years of median follow-up, pertuzumab and trastuzumab did not increase cardiotoxicity risk compared to trastuzumab, and therefore, the analysis confirms the cardiac safety of adjuvant anti-HER2 treatment with pertuzumab and trastuzumab.
APHINITY was a randomised, double-blind, phase III study comparing the addition of pertuzumab or placebo to adjuvant trastuzumab and chemotherapy in patients with HER2-positive early breast cancer.
The APHINITY trial was supported by F. Hoffmann-La Roche Ltd/Genentech and was designed by the Breast International Group (BIG) in collaboration with the sponsor.
The database was maintained at the Institut Jules Bordet Clinical Trials Support Unit (Brussels, Belgium), and the statistical analyses were carried out by Frontier Science Scotland.
TITLE OF PUBLICATION
Cardiac safety of dual anti-HER2 blockade with pertuzumab plus trastuzumab in early HER2-positive breast cancer in the APHINITY trial
AUTHORS
E. de Azambuja; E. Agostinetto; M. Procter; D. Eiger; N. Pondé; S. Guillaume; D. Parlier; M. Lambertini; A. Desmet; C. Caballero; C. Aguila; G. Jerusalem; J.M. Walshe; E. Frank; J. Bines; S. Loibl; M. Piccart-Gebhart; M.S. Ewer; S. Dent; C. Plummer; T. Suter; on behalf of the APHINITY Steering Committee and Investigators
Publication Reference
ESMO Open | Volume 8 | Issue 1 | 100772 | February 2023
Marion Procter
Marion is a Senior Statistician who has worked in clinical trials at FSS since 2002.
The research area of her PhD thesis was the influence of missing explanatory variables and longitudinal assessments.
Her work in breast cancer trials includes collaborating on the statistical analysis plan and protocol amendments, producing reports for the data monitoring committee, preparing manuscripts for publication and working with investigators on research projects. The first efficacy results from the breast cancer trials were published in the New England Journal of Medicine. Research projects from these trials have been published in several journals including the Journal of Clinical Oncology.
Statistical methods in research projects include competing risks in survival analysis and nested case control analysis.
Marion has been a statistical review for scientific journals and has been accepted as the Independent Statistician for the RaTIO trial in oncology.
