In a nutshell
This study compared the safety and effectiveness of pyrotinib (SHR-1258) plus capecitabine (Xeloda) versus lapatinib (Tyverb) plus capecitabine in patients with metastatic human epidermal growth factor (HER2)-positive breast cancer (BC) after previous treatment with trastuzumab (Herceptin) and chemotherapy. The data showed that the pyrotinib plus capecitabine combination significantly improved survival without cancer worsening with manageable side effects for these patients.
Breast cancer (BC) is classified into different subtypes depending on the presence or absence of certain receptors (proteins found on the surface of the cancer cells). HER2 is a protein that promotes the growth of some BCs. This subtype of BC is called HER2-positive (+) BC. Patients with metastatic HER2+ BC that has spread to distant organs have limited treatment options. Trastuzumab and pertuzumab (Perjeta) are targeted therapy drugs used to treat metastatic HER2+ BC. However, some patients become resistant and stop responding to trastuzumab treatment.
Lapatinib is a targeted therapy that blocks HER2 and stops BC growth. Capecitabine (Xeloda) is a chemotherapy drug used to treat BC. Pyrotinib is a type of targeted therapy known as a tyrosine kinase inhibitor (TKI). It is a new drug that targets HER2 and stops the cells from growing and spreading.
Lapatinib plus capecitabine has been approved for HER2+ metastatic BC in patients who have received previous trastuzumab treatment. However, the safety and effectiveness of pyrotinib plus capecitabine combination in patients with metastatic HER2+ BC after previous treatment with trastuzumab and chemotherapy remain under investigation.
Methods & findings
This study involved 266 women with metastatic HER2+ BC. Patients were randomly assigned to 2 groups. Group 1 included 134 patients who received pyrotinib plus capecitabine. Group 2 included 132 patients who received lapatinib plus capecitabine. The average follow-up time was 10.5 months in group 1 and 9.7 months in group 2.
The average survival without cancer worsening was significantly longer for group 1 (12.5 months) than for patients in group 2 (6.8 months). Patients who received pyrotinib had a 61% lower risk of cancer worsening compared to patients who received lapatinib.
The most common severe side effects were diarrhea (31% in group 1 vs 8% in group 2) and hand–foot syndrome (redness, swelling, and blistering in the palms and feet).
The bottom line
This study concluded that pyrotinib plus capecitabine significantly improved survival without cancer worsening compared with lapatinib plus capecitabine, with manageable side effects for patients with HER2-positive metastatic BC after previous treatment with trastuzumab and chemotherapy.
The fine print
The study was sponsored by Jiangsu Hengrui Medicine, the manufacturers of pyrotinib. The study was conducted in China only.
Published By :
The Lancet. Oncology
Feb 11, 2021
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