Clinical study of Kanglixin Capsules combined with TX regimen in treatment of advanced triple-negative breast cancer
Objective To investigate the clinical efficacy of Kanglixin Capsules combined with TX regimen in treatment of advanced triple-negative breast cancer. Methods A total of 116 patients with advanced triple-negative breast cancer admitted to the First Affiliated Hospital of Hainan Medical College from January 2020 to January 2024 were selected and divided into control group and treatment group according to random number table method,with 58 cases in each group. Patients in the control group were given TX regimen,and Docetaxel Injection 75 mg/m2 were injected intraventically on the first day. And they swallowed Capecitabine Tablets with warm water 30 min after meals,from day 1 to 14,twice daily. Patients in treatment group were po administered with Kanglixin Capsule with warm water 30 min after meal on the basis of control group,3 capsules/time,3 times daily. 21 d was as 1 course,both groups were treated for 4 consecutive cycles. The clinical efficacy of the two groups was observed,and the changes of lesion size,DASS-21 score,FACT-B score,serum tumor markers,interleukin-6 (IL-6),CC chemokine ligand 20 (CCL20) and peripheral blood T lymphocyte subsets before and after treatment were compared between two groups. The adverse reaction of drugs in two groups were analyzed. Results After treatment,ORR and DCR in treatment group were 50.00％ and 86.21％,respectively,which were significantly higher than 31.03％ and 70.69％ in the control group (P<0.05). After treatment,the maximum lesion diameter and DASS-21 score were significantly decreased in both groups (P<0.05). After treatment,the improvement of lesion maximum diameter and DASS-21 score in treatment group was significantly better than that in control group (P<0.05). After treatment,FACT-B scores and total scores in both groups were significantly higher than before treatment (P<0.05). After treatment,the FACT-B score of treatment group was higher than that of control group (P<0.05). After treatment,the serum levels of carcinoembryonic antigen (CEA),carbohydrate antigen 15-3 (CA15-3),IL-6 and CCL20 were significantly decreased in both groups,and CD4+and CD4+/CD8+were significantly increased in treatment group (P<0.05). After treatment,the levels of serum tumor markers,IL-6,CCL20 and peripheral blood T lymphocyte subsets in treatment group were better than those in control group. During the treatment,the incidence of thrombocytopenia,leukopenia,and gastrointestinal reaction in treatment group were 10.34％,13.79％ and 15.52％,respectively,which were significantly lower than those in control group (24.14％,31.03％,and 34.48％) (P<0.05). Conclusion Kanglixin Capsules combined with TX regimen can improve the short-term efficacy of advanced triple-negative breast cancer patients,effectively reduce tumor load,improve tumor microenvironment and anti-tumor immune effect,which can improve patients' bad mood and quality of life.
Kanglixin CapsuleDocetaxel InjectionCapecitabine Tabletsadvanced triple-negative breast cancerDASS-21 scoreFACT-B scoreIL-6CCL20
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