Real-World Outcomes of Adjuvant Paclitaxel and Trastuzumab Therapy in Lymph Node-Negative, HER2-Positive Early-Stage Breast Cancer: A Multicenter Retrospective Data Analysis

TL;DR

This study shows that adjuvant trastuzumab and paclitaxel therapy is safe and effective for early-stage HER2-positive breast cancer patients without lymph node involvement.

Contribution

The study provides real-world evidence supporting the use of trastuzumab and paclitaxel in lower-risk HER2-positive breast cancer patients.

Findings

Patients had excellent long-term survival with 5-year OS and RFS rates of 95.3% and 96.8%, respectively.

Treatment was well tolerated with mostly mild neuropathy in 53.5% of patients.

Outcomes were consistent regardless of tumor size, hormone receptor status, or other factors.

Abstract

Breast cancer is among the most frequently seen cancers in women, and certain subtypes may grow rapidly and have a higher chance of coming back after treatment. HER2-positive breast cancer is one of these subtypes. Although intensive treatments have significantly improved survival rates, patients with smaller tumors and no lymph node involvement might not require such aggressive approaches. This study evaluated the outcomes of early-stage HER2-positive breast cancer patients who received trastuzumab and paclitaxel following surgery. The treatment was generally well tolerated, with excellent long-term survival and low recurrence observed. Importantly, these results reflect real-world clinical practice rather than being limited to controlled clinical trial settings. This suggests that the therapy is a reliable and safe option for lower-risk patients. The findings may assist physicians in tailoring treatment plans that offer strong protection against cancer recurrence while minimizing potential side effects.

Background: Approximately 15–20% of early-stage breast cancers overexpress HER2, which is associated with an increased risk of recurrence. Although adjuvant anti-HER2 therapies have significantly improved patient outcomes, the optimal treatment strategy remains uncertain, particularly for patients with small, lymph node-negative tumors, where concerns about potential overtreatment and toxicity persist. The objective of this study was to evaluate overall survival (OS), recurrence-free survival (RFS), and treatment-related neuropathy in patients with early-stage HER2-positive breast cancer treated with adjuvant trastuzumab and paclitaxel. Methods: A total of 129 patients, aged 18 to 75 years, diagnosed with early-stage HER2-positive breast cancer, were retrospectively analyzed in this multicenter study. All patients had received adjuvant treatment with trastuzumab and paclitaxel (TH regimen) between November 2016 and July 2023. The study involved the collection of demographic information, pathological features, and treatment-related details. Overall survival (OS) was defined as the primary study endpoint, while recurrence-free survival (RFS), disease control rate (DCR), and treatment-related neuropathy were evaluated as secondary outcomes. Results: The median follow-up time was 70.9 months. The 2-year and 5-year OS rates were 95.3%, and the 5-year RFS rate was 96.8%. No statistically significant differences in OS or RFS were observed in relation to tumor size (T1 vs. T2), hormone receptor status, Ki-67 index, tumor grade, or the use of adjuvant endocrine or radiotherapy (all p > 0.05). Neuropathy developed in 53.5% of patients, mostly grade 1. Conclusions: Adjuvant TH therapy shows favorable long-term outcomes in early-stage HER2-positive breast cancer.

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