Effect of Xiangsha Liujun Pills on preventing pyrotinib-induced diarrhea in HER2-positive advanced breast cancer patients of spleen and stomach qi deficiency
Objective To evaluate the effect of Xiangsha Liujun Pills on preventing pyrotinib-induced diarrhea in HER2-positive advanced breast cancer(ABC)patients of spleen and stomach qi deficiency.Methods HER2-positive ABC patients scheduled to receive pyrotinib treatment were screened and finally 67 patients with spleen and stomach qi deficiency syndrome were enrolled.Forty-five cases received no traditional Chinese medicine(TCM)preventive intervention(control group)and the remaining 22 patients coadministrated Xiangsha Liujun Pills with pyrotinib daily(intervention group).The defecation status(character,frequency)of all participants were recorded and the primary endpoint was incidence of any-grade diarrhea.Results The overall diarrhea rate of intervention group and control group were 95.5%and 100%respectively.Majority of cases in the intervention group experienced mild diarrhea(grade Ⅰ or Ⅱ),while patients in the control group suffered significantly higher rate of grade 3 diarrhea(P=0.020).Approximately 28.9%of ABC patients in the control group suffered more than 3 months of diarrhea,while no cases in the intervention group experienced long-term diarrhea(P=0.007).Transient pyrotinib interruption due to diarrhea occurred among 22.7%of patients in the intervention group and 53.3%of patients in the control group(P=0.044).Conclusion Prophylactic administration of Xiangsha Liujun Pills could remarkably decrease the occurrence risk,reduce the severity,shorten the duration of diarrhea,and increase quality of life and treatment compliance in patients received pyrotinib treatment.