| ObjectiveTo explore the survival effect and treatment effect of TCM combined with chemotherapy on patients with advanced triple-negative breast cancer(TNBC),and to explore the characteristics of beneficiaries of TCM combined with chemotherapy in the treatment of advanced TNBC,so as to provide reliable data for the treatment strategy of integrated Traditional Chinese and Western medicine for patients with advanced TNBC.MethodsThe clinical data of 128 patients with advanced TNBC who visited the outpatient or inpatient department of the First Affiliated Hospital of Tianjin University of Chinese Medicine or Tianjin Cancer Hospital from January 1,2016 to December 31,2020 were retrospectively collected.According to whether the patients were treated with Chinese herbal compound intervention after the first occurrence of metastasis,they were divided into the Chinese herbal combined chemotherapy group(abbreviation: Combined group,65 cases)and chemotherapy alone group(abbreviation: Chemotherapy group,63 cases),median progression-free survival(mPFS)and median overall survival(mOS)were compared between the two groups.Evaluation and comparison of solid tumor efficacy,carcinoembryonic antigen(CEA)content,carbohydrate antigen CA153 content,Karnofsky score(KPS),TCM symptom score and the incidence of adverse reactions after medication between the two groups before and after treatment.Kaplan-meier univariate analysis and Cox multivariate regression model were further used to screen out the related factors affecting the survival and prognosis of patients with advanced TNBC treated with TCM combined with chemotherapy.Results(1)Main research indicators1)mPFS: Compared with chemotherapy alone,TCM combined with chemotherapy could bring more PFS benefits to patients with advanced TNBC.The mPFS in the combined group was 10.0 months,and that in the chemotherapy group was 8.8 months,indicating a statistically significant difference between the two groups(P =0.040 < 0.05).2)mOS: The mOS was 22.3 months in the combination group and 20.8 months in the chemotherapy group,and there was no statistical significance between the two groups(P=0.586 > 0.05).(2)Secondary research indicators1)Efficacy evaluation of solid tumor: In the combined group,8 cases were in partial response,41 cases were stable,16 cases were advanced,the objective response rate was12.3%,the disease control rate was 75.4%;In the chemotherapy group,there were 6 cases of partial response,37 cases of stability,and 20 cases of progression.The objective response rate was 9.5%,and the disease control rate was 68.2%.The comparison of objective response rate and disease control rate between the two groups showed no statistical significance(P=0.636 > 0.05).2)Tumor markers: TCM combined with chemotherapy significantly reduced the contents of tumor markers CEA and CA153 in patients with advanced TNBC,and there was no statistical significance compared with chemotherapy group(P > 0.05).3)KPS score efficacy: In the combined group,27 patients improved,28 patients were stable and 10 patients were decreased after treatment,the sum of improvement rate and stability rate was 84.6%.In the chemotherapy group,13 cases were improved,30 cases were stable,and 20 cases were decreased after treatment.The sum of improvement rate and stability rate was 68.2%,and there was a statistical difference between the two groups(P=0.001 < 0.05).4)TCM symptom score: After treatment,fatigue,dizziness,spontaneous sweating,night sweats,loss of appetite,nausea and vomiting,five irritability fever,and chest and hypoxia were better in the combined group than in the chemotherapy group,and the difference between the two groups was statistically significant(P < 0.05).There were no significant differences in insomnia,pain,irritability,soreness of waist and knee,diarrhea,constipation and other symptoms between the two groups(P > 0.05).After treatment,13 cases were significantly improved,32 cases were partially improved,16 cases were not improved and 4cases were aggravated,the total improvement rate was 69.2%.In the chemotherapy group,there were 9 cases of significant improvement,18 cases of partial improvement,30 cases of no improvement and 6 cases of aggravation,with a total improvement rate of 42.9%.Non-parametric rank sum test showed that the difference between the two groups was statistically significant(P =0.011 < 0.05).(3)The occurrence of adverse reactions: The safety of patients with advanced TNBC treated by TCM combined with chemotherapy was good.Compared with the chemotherapy group,the incidence and graded distribution of adverse events in the combined group were generally lower,especially in digestive tract reactions such as nausea,vomiting and dyspepsia,and the difference was statistically significant(P < 0.05).The incidence of bone marrow suppression and liver and kidney function injury was lower in combined group,but the difference was not statistically significant(P > 0.05).(4)Subgroup survival prognostic factors: Univariate analysis results showed that patients with tumor length ≤5cm,Ki-67≤30%,lymph node negative,number of treatment cycles≥5,no cranial secondary,and two-drug chemotherapy regimen could get more PFS benefits in the first-line treatment of advanced TNBC with TCM combined with chemotherapy.Multivariate analysis suggested that lymph node positivity was an independent risk factor for PFS,and appropriate extension of first-line treatment time could increase PFS in the patients with advanced TNBC.ConclusionTCM combined with first-line chemotherapy can prolong PFS,reduce CEA and CA153 level,improve clinical symptoms,improve quality of life,and alleviate toxic and side reactions after chemotherapy in patients with advanced TNBC.Especially for the tumor length≤5cm,Ki-67≤30%,lymph node negative,number of treatment cycles≥5,no brain metastases,two-drug chemotherapy is better. |
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