Adding pertuzumab to adjuvant therapy for high-risk HER2-positive early breast cancer in APHINITY: a GRADE analysis

Abstract

Aim: Adding pertuzumab to standard trastuzumab-based adjuvant therapy significantly improved invasive disease-free survival (IDFS) in the APHINITY trial. However, the magnitude of benefit was marginal in the overall population. Methods: We used GRADE (Grading of Recommendations Assessment, Development and Evaluation) analysis on data from APHINITY to build summary-of-findings tables to evaluate the efficacy, safety and quality of evidence of predefined clinical outcomes for the addition of pertuzumab to trastuzumab-based adjuvant therapy in patients with high-risk HER2-positive early breast cancer. Results: Pertuzumab significantly improved 3-year, event-free, absolute benefit in disease-free survival, IDFS and distant relapse-free interval (DFRI) in patients with node-positive or hormone receptor-negative disease. The analysis provides strength of evidence supporting the addition of pertuzumab in this patient population.

Introducing Volume 10 of the Journal of Comparative Effectiveness Research

“…In their research article published in issue 6, Zambelli et al conducted a GRADE analysis on data from the APHINITY trial, a randomized, placebo-controlled trial of 1 year of adjuvant pertuzumab added to standard adjuvant chemotherapy plus trastuzumab in patients with HER2-positive early breast cancer, to ascertain the strength of the emerging recommendations with the aim of supporting physicians in their clinical practice [12].…”