APHINITY is a large, randomised phase III, double-blind, placebo-controlled study that compares the efficacy and safety of chemotherapy plus trastuzumab and placebo with that of chemotherapy plus trastuzumab and pertuzumab as adjuvant therapy in approximately 4800 patients with operable, HER2-positive, primary breast cancer. Pertuzumab and trastuzumab are two drugs that target and block the HER2 protein on the cancer cells.
Several recent studies have shown that dual inhibition of the HER2 receptor with two drugs is clinically more effective than using a single agent. APHINITY is testing this hypothesis, to find out if the combination of pertuzumab and trastuzumab is better than trastuzumab alone, in terms of efficacy, for patients who have had surgery for HER2 positive breast cancer. The study aims also at exploring the safety of the combination, by looking at the potential side effects on treated patients.
The results of the primary analysis were published by New England Journal of Medicine in June 2017, with further results published in the Journal of Clinical Oncology 2021. Follow-up is ongoing and further analyses will be presented later in 2022.
PUBLICATIONS ON THE APHINITY STUDY
Cardiac Safety in the APHINITY trial
ESMO Open has published an article confirming the cardiac safety of adjuvant anti-HER2 treatment with pertuzumab and trastuzumab.
APHINITY | Annals of Oncology
Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years’ follow-up
APHINITY | Journal of the National Cancer Institute (JNCI)
Impact of age on clinical outcomes and efficacy of adjuvant dual anti-HER2 targeted therapy
APHINITY | European Journal of Cancer (EJC)
Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial
APHINITY | AACR Cancer Research
Effect of young age at diagnosis on clinical outcomes and efficacy of anti-HER2 targeted therapy in patients with HER2-positive early breast cancer: Results from the APHINITY trial.
The APHINITY Trial: Results of the Interim Overall Survival Analysis at 6 years’ follow-up
The JCO confirms the invasive disease-free survival benefit from adding pertuzumab to standard adjuvant therapy for patients with node-positive HER2-positive early breast cancer.
The APHINITY Trial: Results of the Primary Analysis
An article published in the New England Journal of Medicine (NEJM) reports that pertuzumab, when added to chemotherapy and trastuzumab, significantly improved the rates of invasive-disease–free survival among patients with HER2-positive early breast cancer.
