(Breast Cancer) Is Pyrotinib + Xeloda Combination Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
At ASCO 2019 (American Society of Clinical Oncology Annual Meeting) held in Chicago from May 31 to June 4, 2019, results were presented from a Phase III clinical trial evaluating the efficacy and safety of Pyrotinib (an RTK inhibitor) combined with capecitabine (Xeloda) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes.
This multicenter, double-blind, randomized Phase III trial enrolled previously treated HER2-positive metastatic breast cancer patients (N=279) in a 2:1 ratio. The primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate (ORR) and overall survival (OS).
Treatment group:
- Pyrotinib + Xeloda combination group: Pyrotinib 400 mg once daily on Day 1 of each 21-day cycle + capecitabine 1000 mg/m² twice daily on Days 1–14 (N=185)
- Placebo control group
The rationale for this trial was that Phase I and II trials of Pyrotinib + Xeloda in metastatic breast cancer patients had demonstrated meaningful anti-tumor activity with tolerable adverse events, warranting a confirmatory Phase III study.
Results:
Primary endpoint (PFS):
- Pyrotinib + Xeloda group: 11.1 months vs. placebo group: 4.1 months
- Hazard ratio: 0.69 — a statistically significant improvement in the Pyrotinib group
Secondary endpoint (ORR):
- Pyrotinib + Xeloda group: 68.6% vs. placebo group: 16.0%
Safety:
Grade ≥3 adverse events occurred in more than 5% of patients. Notable differences between groups:
- Diarrhea (Grade ≥3): Pyrotinib group 30.8% vs. placebo group 12.8%
- Hand-foot syndrome (Grade ≥3): Pyrotinib group 15.7% vs. placebo group 5.3%
Based on the Phase III trial results, Zefei Jiang concluded: In previously treated HER2-positive metastatic breast cancer patients, Pyrotinib combined with capecitabine significantly improved progression-free survival.
Source: Pyrotinib combined with capecitabine in women with HER2+ metastatic breast cancer previously treated with trastuzumab and taxanes: A randomized phase III study. (2019 ASCO Annual Meeting, Abstract No: 1001)
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