Key clinical point: The 6-year follow-up data from APHINITY trial confirm invasive disease-free survival (IDFS) benefits of adding pertuzumab to adjuvant trastuzumab and chemotherapy in node-positive human epidermal growth factor receptor 2-positive (HER2+) early breast cancer.
Major finding: At 6 years, IDFS was longer in pertuzumab vs. placebo (91% vs. 88%; hazard ratio [HR], 0.76; 95% CI, 0.64-0.91) group, particularly in node-positive cohort (HR, 0.72; 95% CI, 0.59-0.87) but not in node-negative cohort. The overall survival analysis did not reach the required statistical significance (HR, 0.85; P = .17).
Study details : Findings are from a second interim analysis of the phase 3 APHINITY trial including 4,805 patients with node-positive or high-risk node-negative HER2+ breast cancer randomly allocated to receive chemotherapy with either 1 year of trastuzumab + placebo (n = 2,404) or trastuzumab + pertuzumab (n = 2,400) post-surgery.
Disclosures: This study was supported by F. Hoffmann-La Roche Ltd/Genentech. The lead author reported ties with AstraZeneca, Lilly, MSD, Novartis, Pfizer, Debiopharm Group, Odonate Therapeutics, Menarini, Seattle Genetics, Camel-IDS, Immunomedics, Roche/Genentech, Immutep, Radius Health, Synthon, Servier, Oncolytics, and EU Cancer Mission Board. Other investigators declared ties with various pharmaceutical companies including Roche/Genentech.
Source: Piccart M et al. J Clin Oncol. 2021 Feb 4. doi: 10.1200/JCO.20.01204 .