Comparative efficacy and safety of the trastuzumab biosimilar HLX02 versus originator trastuzumab in the neoadjuvant THP-EC regimen for early-stage HER2-positive breast cancer: a real-world study.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
추출되지 않음
I · Intervention 중재 / 시술
tive efficacy and safety of the trastuzumab biosimilar HLX02
C · Comparison 대조 / 비교
originator trastuzumab in the neoadjuvant THP
O · Outcome 결과 / 결론
Safety profiles, including cardiac toxicity, were similar between groups. [CONCLUSION] HLX02 demonstrated equivalent efficacy and safety to the originator trastuzumab in this setting, representing a cost-effective treatment alternative.
[OBJECTIVES] HER2-positive breast cancer is an aggressive subtype.
APA
Wang M, Sheng X, et al. (2026). Comparative efficacy and safety of the trastuzumab biosimilar HLX02 versus originator trastuzumab in the neoadjuvant THP-EC regimen for early-stage HER2-positive breast cancer: a real-world study.. Expert opinion on biological therapy, 26(3), 355-362. https://doi.org/10.1080/14712598.2026.2649512
MLA
Wang M, et al.. "Comparative efficacy and safety of the trastuzumab biosimilar HLX02 versus originator trastuzumab in the neoadjuvant THP-EC regimen for early-stage HER2-positive breast cancer: a real-world study.." Expert opinion on biological therapy, vol. 26, no. 3, 2026, pp. 355-362.
PMID
41860104
Abstract
[OBJECTIVES] HER2-positive breast cancer is an aggressive subtype. High-cost originator trastuzumab limits treatment access, making biosimilars like HLX02 a valuable alternative.
[METHODS] This retrospective real-world study compared HLX02 ( = 42) with originator trastuzumab ( = 237) within the neoadjuvant THP-EC regimen for early HER2-positive breast cancer. The primary endpoint was total pathological complete response (tpCR).
[RESULTS] Before propensity score matching (PSM), the tpCR rate was higher with HLX02 (73.81% vs. 43.04%, < 0.001). After PSM, tpCR rates were comparable (HLX02: 73.81% vs. originator: 72.27%; = 0.448), with no significant subgroup differences. Safety profiles, including cardiac toxicity, were similar between groups.
[CONCLUSION] HLX02 demonstrated equivalent efficacy and safety to the originator trastuzumab in this setting, representing a cost-effective treatment alternative.
[METHODS] This retrospective real-world study compared HLX02 ( = 42) with originator trastuzumab ( = 237) within the neoadjuvant THP-EC regimen for early HER2-positive breast cancer. The primary endpoint was total pathological complete response (tpCR).
[RESULTS] Before propensity score matching (PSM), the tpCR rate was higher with HLX02 (73.81% vs. 43.04%, < 0.001). After PSM, tpCR rates were comparable (HLX02: 73.81% vs. originator: 72.27%; = 0.448), with no significant subgroup differences. Safety profiles, including cardiac toxicity, were similar between groups.
[CONCLUSION] HLX02 demonstrated equivalent efficacy and safety to the originator trastuzumab in this setting, representing a cost-effective treatment alternative.
MeSH Terms
Humans; Trastuzumab; Female; Breast Neoplasms; Biosimilar Pharmaceuticals; Retrospective Studies; Erb-b2 Receptor Tyrosine Kinases; Middle Aged; Neoadjuvant Therapy; Antineoplastic Combined Chemotherapy Protocols; Antineoplastic Agents, Immunological; Adult; Aged; Treatment Outcome; Neoplasm Staging
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