On January 29, 2025, a Chinese research team published an article titled “Neoadjuvant pyrotinib and trastuzumab in HER2 positive breast cancer with no early response (NeoPaTHer): effectiveness, safety, and biomarker analysis of a prospective, multicenter, response adapted study” in the journal “Signal Transduction and Targeted Therapy”。
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer, which accounts for ~15% to 25% of all breast cancers, is recognised as a distinct and aggressive subtype. It is characterised by the overexpression of HER2, a transmembrane receptor tyrosine kinase that promotes cancer cell proliferation and survival. Patients with HER2-positive breast cancer face a significantly higher risk of recurrence and mortality compared to those with other breast cancer subtypes, making it a particularly challenging disease to treat. However, the landscape of HER2-positive breast cancer treatment has undergone remarkable transformation in the last two decades, primarily due to the introduction of HER2-targeted therapies. In particular, the advent of trastuzumab has fundamentally changed the trajectory of HER2-positive breast cancer from a highly fatal disease to one with more manageable and less dire outcomes.
Between October 2020 and March 2022, a total of 129 patients from five hospitals were enroled in this study.Of the 129 patients enroled, 62 (48.1%) were identified as MRI-responders (cohort A), 26 non-responders continued with four more cycles of TCbH (cohort B), and 41 non-responders received additional pyrotinib (cohort C). The tpCR rate was 30.6% (95% CI: 20.6–43.0%) in cohort A, 15.4% (95% CI: 6.2–33.5%) in cohort B, and 29.3% (95% CI: 17.6–44.5%) in cohort C. Multivariable logistic regression analyses demonstrated comparable odds of achieving tpCR between cohorts A and C (odds ratio = 1.04, 95% CI: 0.40–2.70). No new adverse events were observed with the addition of pyrotinib. Patients with co-mutations of TP53 and PIK3CA exhibited lower rates of early partial response compared to those without or with a single gene mutation (36.0% vs. 60.0%, P = 0.08). These findings suggest that adding pyrotinib may benefit patients who do not respond to neoadjuvant trastuzumab plus chemotherapy. Further investigation is warranted to identify biomarkers predicting patients’ benefit from the addition of pyrotinib.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
References
https://www.nature.com/articles/s41392-025-02138-6
Post time: Feb-08-2025