Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval

Abstract

Purpose Adjuvant pertuzumab and neratinib are independently FDA-approved for treatment of early-stage HER2-positive breast cancer in combination with or following trastuzumab for one year, respectively. Both agents reduce the risk of recurrence; however, the absolute benefit is modest for many patients with added risk of adverse effects. The purpose of this study was to evaluate the clinical use of adjuvant pertuzumab and neratinib in patients with early-stage HER2-positive breast cancer. Methods Patients diagnosed with stage I–III HER2-positive breast cancer treated with trastuzumab at four University of Colorado Health hospitals between July 2016 and April 2019 were identified. Patient demographics, cancer stage, treatment, and administration of pertuzumab and/or neratinib were obtained. Results We identified a total of 350 patients who received adjuvant trastuzumab for stage I–III HER2-positive breast cancer; 253 (73.1%) had tumors that were ≥ T2 or node-positive disease. The rate of adjuvant pertuzumab use increased following FDA approval; pertuzumab was administered to the majority of patients with node-positive HER2-positive breast cancer. The use of adjuvant pertuzumab was associated with younger age, premenopausal status, and node-positive disease. Rates of administration of adjuvant neratinib were lower, with only 15.2% of patients receiving this therapy within 3 months of completing adjuvant trastuzumab. Conclusion In our cohort of patients treated within a diverse healthcare network, the majority of patients with node-positive HER2-positive breast cancer received adjuvant pertuzumab following FDA approval. The use of adjuvant neratinib was less common, potentially as a result of adverse effects, prolongation of therapy, previous administration of adjuvant pertuzumab, and modest benefit.

Neratinib for HER2-positive breast cancer with an overlooked option

“…Neratinib irreversibly binds to the epidermal growth factor receptors (EGFRs) HER1, HER2, and HER4(Dai et al 2021 ; Nasrazadani and Brufsky 2020 ; Paranjpe et al 2019 ; Roskoski 2019 ). In the I-SPY2 neoadjuvant trial, neratinib in combination with trastuzumab resulted in an improvement in the pathologic complete response (pCR) rate in HER2-positive, hormone receptor (HR)-negative BC patients(Park et al 2016 ; Stoen et al 2021 ). Neratinib has been confirmed to be effective in extended adjuvant therapy following trastuzumab for HER2-positive early BC in the ExteNET trial(Chan et al 2021 ; Harbeck 2022 ; Martin et al 2017 ; Singh et al 2018 ).…”