Efficacy and safety analysis of a docetaxel-plus-trastuzumab regimen in patients with early-stage HER2-positive breast cancer: a retrospective single-arm study.

Abstract

Background: A regimen of weekly paclitaxel and trastuzumab (WPH) is the standard treatment for patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer but has certain limitations. Weekly hospital visits are burdensome for patients and increase healthcare resource use. Docetaxel is currently used in several chemotherapy regimens for HER2-positive breast cancer, such as four cycles of docetaxel and cyclophosphamide plus trastuzumab (TC4H) or THP (paclitaxel, trastuzumab plus pertuzumab), and its safety and efficacy have been well established. Therefore, for patients who cannot visit the hospital for treatment every week, we have implemented a 3-week docetaxel regimen to replace the weekly paclitaxel schedule for these early-stage HER2-positive breast cancer patients. Our retrospective analysis conducted from 2014 to 2019 assessed the efficacy and safety of a docetaxel-and-trastuzumab (TH) regimen in patients with early-stage HER2-positive breast cancer, with the aim of establishing a more accessible and efficient treatment approach.

Methods: This is a single-arm retrospective study analysis of TH therapy for early-stage HER2-positive breast cancer conducted in The First Affiliated Hospital, School of Medicine, Zhejiang University between January 2015 and December 2019. Patients included were lymph node-negative, aged 50 years or older, and had received TH regimen after surgery, with comprehensive follow-up data available. Patients received six cycles of docetaxel (100 mg/m²) every 3 weeks and trastuzumab (8 mg/kg in cycle 1, followed by 6 mg/kg) every 3 weeks for 1 year. Disease-free survival (DFS), overall survival (OS), and adverse events were evaluated as prognosis outcomes of the TH regimen.

Results: A total of 144 breast cancer patients were enrolled. The median age of the patients was 61.5 years and 80 patients (55.6%) had hormone receptor-positive disease. In the entire study population, 34.7% of patients had tumors 1 cm or smaller. The median follow-up time of the included patients was 7.1 years, the 5-year DFS rate was 96.5%, and the OS rate was 98.6%. Among the five patients who experienced invasive disease events or death, three had local or regional recurrences. Three patients (2.1%) experienced at least one episode of grade 3 neuropathy, and five patients had a significant decrease in ejection fraction, leading to a 3.5% interruption of trastuzumab treatment. None of the patients experienced grade 3 or 4 hypersensitivity reactions to the study treatment.

Conclusions: The TH regimen demonstrated promise as a novel treatment alternative for patients with early-stage HER2-positive breast cancer. It offers a similar degree of efficacy and safety to those of the conventional WPH regimen while requiring fewer hospital visits, which could result in reduced healthcare costs and enhanced patient convenience.