Procedures
death, neutropenia, leukopenia, diarrhea, Tumor, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, NEUTROPENIA, LEUKOPENIA, TUMOR, CANCER
Eligible patients received daily oral pyrotinib 400 mg and intravenous docetaxel 75 mg/mDue to the high incidence of diarrhea, leukopenia, and/or neutropenia observed during the first stage of the study, the study protocol was modified during the second stage. Primary prophylaxis for diarrhea with loperamide was recommended for the first six weeks of pyrotinib treatment (day 1 to day 14: 2 mg three times daily; day 14 to day 42: 2 mg twice daily). Additionally, subcutaneous PEG-rhG-CSF at a dose of 6 mg or 100 μg/kg was recommended 24-48 h before docetaxel dosing to prevent leukopenia and/or neutropenia.Tumor assessments using enhanced computed tomography or magnetic resonance imaging were performed every 6 weeks until disease progression or death, following the RECIST version 1.1. The response had to be confirmed in the next assessment. Any AEs during the study were recorded and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.