Trial reportThe oncologist2025
Efficacy and safety of pyrotinib in patients with previously treated HER2-positive non-breast solid tumors: a phase 2, open-label basket trial.
Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAmplification/overexpression of the human epidermal growth factor receptor 2 (HER2) gene drives cell proliferation, differentiation, and migration of breast cancer. However, HER2-targeted therapies are not standard treatment for HER2-positive non-breast solid tumors currently. This phase II open-label basket trial evaluated pyrotinib's efficacy and safety in patients with non-breast solid tumors.
methodsPatients with previously treated HER2-positive advanced non-breast solid tumors were enrolled at Zhongshan Hospital, Fudan University. All participants received pyrotinib in 21-day cycles. Primary endpoint was objective response rate (ORR) at 6 weeks, assessed per RECIST version 1.1. Circulating tumor DNA (ctDNA) analysis was conducted to identify biomarkers of efficacy.
resultsFifty-three patients were enrolled and 51 evaluable for efficacy analysis. The median follow-up was 32.2 months. ORR was 18.9% (95% CI: 10.2%-31.7%) and disease control rate was 73.6% (95% CI: 60.1%-84.2%). Median progression-free survival (mPFS) was 5.1 (95% CI: 4.2-8.1) months and median overall survival (mOS) was 17.2 (95% CI: 16.2-33.2) months. Patients with colorectal cancer had the highest ORR and the longest mOS (33.2 months, 95% CI: 14.9-51.5). Among patients with HER2 overexpression, those with immunohistochemistry 3+ had longer mPFS and mOS. Sixteen patients required dose reductions due to grade 3 adverse events (AEs); no ≥grade 4 AEs occurred. Analysis of ctDNA revealed that patients with progression disease had higher mutation frequency, more diverse mutational profiles, and higher copy number burden.
conclusionPyrotinib demonstrated a favorable safety profile and modest efficacy in patients with previously treated HER2-positive advanced non-breast solid tumors.
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