DOI: 10.1177/17588359261470682 ISSN: 1758-8359

Comparison of the efficacy and safety of HLX-02 plus pertuzumab versus HLX-02 plus pyrotinib in neoadjuvant therapy for HER2-positive breast cancer

Weifang Tang, Qilin Zhou, Jianjun Liu, Shikai Hong
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Background:

Whether the HLX-02 plus pertuzumab offers superior efficacy compared to the HLX-02 plus pyrotinib in the early-stage setting remains unclear, highlighting a critical gap in evidence for optimizing neoadjuvant therapy selection.

Objective:

To compare the efficacy and safety of neoadjuvant chemotherapy regimens combining the trastuzumab biosimilar HLX-02 with either pertuzumab or pyrotinib in patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Design:

This is a retrospective cohort study.

Methods:

This retrospective cohort study enrolled patients with HER2-positive breast cancer who received neoadjuvant therapy at The First Affiliated Hospital of University of Science and Technology of China between October 2021 and July 2024. Participants were divided into two treatment groups: those receiving docetaxel, carboplatin, HLX‑02 plus pertuzumab (TCbHP group), and those receiving docetaxel, carboplatin, HLX‑02 (a trastuzumab biosimilar ) plus pyrotinib (TCbHPy group). To minimize selection bias, propensity score matching (PSM) was applied in a 1:2 ratio before evaluating efficacy and safety. The primary endpoint was the pathological complete response (pCR) rate. Secondary endpoints included safety outcomes, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Results:

A total of 101 patients were initially included. After PSM, 55 patients were selected (TCbHP group: n = 36; TCbHPy group: n = 19). The overall pCR rates were comparable between the groups (TCbHP group: 58.3% vs TCbHPy group: 52.6%, p = 0.778). Subgroup analysis showed that amonghormone receptor–positive (HR+) patients, pCR rates were 50.0% in the TCbHP group and 44.4% in the TCbHPy group. For HR negative (HR−) patients, pCR rates were 63.6% and 60.0%, respectively. The overall incidence of adverse events was 80.6% in the TCbHP group and 94.7% in the TCbHPy group. Notably, non-hematologic toxicities differed significantly between the groups, with a markedly higher incidence of diarrhea (grade ⩾3+: 47.3%) observed in the TCbHPy group.

Conclusion:

Both HLX‑02‑based neoadjuvant regimens exhibited comparable efficacy in achieving pCR in patients with HER2‑positive breast cancer. These findings indicate that HLX‑02, whether combined with pertuzumab or pyrotinib, represents a viable neoadjuvant strategy.

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