| Objective To observe the real-world efficacy,safety and clinical benefit of pyrotinib-based combination therapy in patients with human epidermal growth factor receptor-2(HER-2)positive advanced breast cancer.To analyze the risk factors related to the prognosis of patients treated with pyrotinib and the choice of treatment options after disease progression,and to accumulate real-world experience to provide reference for clinical work.Methods The clinical data of patients with HER-2 positive advanced breast cancer who received pyrotinib maleate treatment in the Second Affiliated Hospital of Anhui Medical University from January 2019 to January 2021 were collected.The curative effect evaluation was carried out according to the solid tumor curative effect evaluation standard,calculating the progression-free survival(PFS)of all patients.Record the safety data during the medication.Statistical software was used to incorporate various clinical data into the survival analysis model,draw the survival curve,estimate the median PFS,and analyze the independent risk factors affecting PFS.At the same time,observe the benefits of treatment options after disease progression.Results A total of 43 patients with HER-2 positive advanced breast cancer who were treated with pyrotinib maleate were included in this study.The median follow-up time for all patients was approximately 11 months.The median age of the patients was 50 years old.There were 21 patients(48.8%)with positive hormone receptor(HR)and 22patients(51.2%)with negative HR.Among the 43 patients,38 cases were pyrotinib+chemotherapy(88.4%),2 cases were pyrotinib+trastuzumab+chemotherapy(4.7%),and 3 cases were pyrotinib+endocrine therapy(7.0%).Combination chemotherapy regimens include capecitabine,gemcitabine,vinorelbine,taxanes,S-1and etoposide.The curative effect of the patients was 3 cases of complete remission,20 cases of partial remission,18 cases of stable disease,and 2 cases of disease progression.The objective response rate was 53.5%,and the disease control rate was95.3%.The first median progression-free survival(PFS1)was 12 months.Among the 8patients treated with pyrotinib as first-line therapy,1 case had complete remission,5cases had partial remission,and 2 cases had stable disease;the objective remission rate was 75.0%,and the disease control rate was 100%.The median PFS1 is 18 months,which is better than that of patients with second-line and later treatment.Statistical analysis showed that there was a statistically significant difference in PFS1 between HR positive patients and HR negative patients,and HR positive was an independent risk factor affecting the progression-free survival of patients(P<0.05).The treatment plan for 19 patients with disease progression after pyrotinib treatment included cross-line oral pyrotinib and so on.The second median progression-free survival(PFS2)after oral administration of pyrotinib was 13 months.Diarrhea occurred in 32 cases(74.4%),including 26 cases(60.5%)with grade 1 ～ 2 diarrhea and 6 cases(13.9%)with grade 3 diarrhea.Conclusion Pyrotinib-based regimens are safe and effective in the treatment of HER-2-positive advanced breast cancer.In addition to combined chemotherapy drugs with capecitabine,gemcitabine,vinorelbine,taxanes,S-1,etoposide and other drugs can also be used in clinical applications according to the individual conditions of patients.In addition to being used as the standard second-line treatment for breast cancer,pyrotinib can also achieve certain curative effect in the first-line treatment of advanced breast cancer.HR-positive is an independent risk factor affecting PFS in patients with HER-2-positive advanced breast cancer treated with pyrotinib,and among HER-2-positive advanced breast cancer patients,HR-positive patients may benefit less than HR-negative patients.Patients with disease progression after pyrotinib treatment may also consider continuing to choose this drug for cross-line treatment. |
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