Multicenter phase 3 trial of pyrotinib plus trastuzumab and docetaxel for HER2-positive metastatic breast cancer: long-term survival results

The placebo-controlled phase 3 PHILA trial, at 40 centers in China, evaluated addition of the irreversible pan-HER inhibitor pyrotinib to first-line trastuzumab and docetaxel for HER2-positive metastatic breast cancer (mBC). Long-term survival outcomes have now been published. Five-hundred and ninety patients were randomized and treated (297 in the pyrotinib group and 293 in the placebo group). During a median follow-up of 35.7 months in the pyrotinib group and 34.2 months in the placebo group, 20% and 30% of patients died, respectively. Overall survival was longer in the pyrotinib group (HR 0.64; p=0.004), as was progression-free survival (HR 0.44; p<0.001). Adverse event profiles remained consistent with the interim analysis for type, frequency, and severity. The authors conclude that this updated analysis confirmed the efficacy of this dual anti-HER2 regimen (pyrotinib plus trastuzumab) for HER2-positive mBC.