Intervention Study Of Traditional Chinese Medicine In Preventing Postoperative Recurrence And Metastasis Of Triple-negative Breast Cancer Patients

Objective:To evaluate the efficacy and safety of traditional Chinese medicine in preventing recurrence and metastasis of triple-negative breast cancer(TNBC).This study is a phased study on the intervention of traditional Chinese medicine on postoperative TNBC patients in their recurrence and metastasis,which funded by the Beijing Municipal Science and Technology Commission.Methods:Journals reviewed the current research status and treatment progress of triple-negative breast cancer and the previous clinical study on the treatment of TNBC by traditional Chinese medicine.TNBC is a breast cancer with negative estrogen receptor(ER),progesterone receptor(PR)and human epidermal growth factor receptor-2(HER-2).This study uses a multi-center,prospective cohort study method.TNBC patients visit department of oncology,Beijing Chinese Medicine Hospital affiliated to Capital Medical University,Oncology department of integrated traditional Chinese and Western Medicine of China-Japan Friendship Hospital,Peking University People's Hospital breast surgery,Department of traditional Chinese medicine of General Hospital of PLA,Breast surgery in the Cancer Hospital of the Chinese Academy of Medical Sciences,Oncology Department of Guang'anmen Hospital of Chinese Academy of Chinese Medicine,Breast surgery of Beijing Tiantan Hospital affiliated to Capital Medical University,Breast surgery,Beijing Luhe Hospital Affiliated to Capital Medical University,Breast surgery of Beijing Shijitan Hospital,CMU affiliated to Capital Medical University between March 1,2016 and October 1,2016 have the opportunity to participate in the study.After screening,there were 108cases of TNBC patients,including 78 cases of traditional Chinese medicine cohort and 30 cases of observation cohort take part in this study.All the patients completed the chemotherapy/radiotherapy prescribed by the guideline.The time of completion of chemotherapy/radiotherapy is not more than 6 months,and no recurrence or metastasis was confirmed by examination.According to the core and common syndrome of TNBC patients,study out the basic formulation prescription of Chinese medicine and the addition and subtraction of the prescription for the traditional Chinese medicine cohort.Take the prescription one time in the morning and evening,one doses each time for more than 15 days per month until recurrence or distant metastasis arises.The observational cohort patients do not accept traditional Chinese medicine treatment for cancer(including Chinese herbal medicine,Chinese patent drug,etc),just follow up 3-6 months regularly.Patients take traditional Chinese medicine less than 15 days per month were divided into the observational cohort.The main index of observation is one-year disease-free survival rate.Secondary observation indicators included tumer maker,quality of life assessment,Breast cancer related symptom assessment,including sleep quality evaluation,using the Pittsburgh sleep quality index,the degree of anxiety and depression,using the hospital anxiety and depression scale evaluation.Safety indicators include blood,urine,routine,liver and kidney function,electrocardiogram and so on.The adverse reactions were evaluated during the treatment.Patients were followed up every 3 to 6 months,and the results of the examination and evaluation were recorded on the case report form at each follow-up.Result:The 1 year disease-free survival rate of the Chinese medicine cohort was 97.2%,and the 1 year disease-free survival rate of the observational cohort was 96.4%,the difference between the two cohorts were not statistically significant(P=0.818).The number of CEA in the cohort and observation queue of Chinese medicine was decreased in twelfth months compared with the baseline,and the decline of the observation queue was more significant.The two queue was compared,and the difference was statistically significant(P<0.05).The differences of CA125 and CA153 between TCM cohort and observation cohort was not statistically significant(P>0.05).The scores of TCM main syndrome and TCM secondary symptoms,physiologic status and additional concern score of TCM cohort and observation cohort were lower than those at baseline in twelfth months follow-up,and the difference was statistically significant(P<0.05).The quality of life(FACT-B),the score of the two cohorts' physiological status at the twelfth-month follow-up was higher than that of the baseline,the increase of the TCM cohhot was higher,the difference was statistically significant(P<0.05),the other four dimension scores and the FACT-B total score,the twelfth-month follow-up were also higher than the baseline,there was no statistically significant difference between the two teams(P>0.05).The sleep status of the patients in the TCM cohort decreased by 5.11±0.86 compared with the baseline at the twelfth-month follow-up,and the score of twelfth months in the observation queue increased by 4.28±1.70 compared with the baseline,and the difference between the two cohorts was statistically significant(P<0.05).TCM cohort:The number of CEA and CA125 of the TCM cohort were lower than the baseline at twelfth-month follow-up.The scores of TCM main symptom,TCM secondary symptom,anxiety and depression state and sleep condition of the twelfth-month follow-up were lower than baseline,the difference was statistically significant(P<0.05).The physical condition,additional attention and FACT-B scores increased at twelfth-months follow-up,and the differences were statistically significant(P<0.05).The change in the number of CA153,social/family statue,emotional state scores and functional statue scores were not obvious,and the difference was not statistically significant(P>0.05).Observational cohort:The twelfth-months follow-up number of CEA in the observational cohort was lower than the baseline,the difference was statistically significant(P<0.05).At twelfth months follow-up,the social/family status,FACT-B scores and sleep status scores were higher than those at baseline,and the difference were statistically significant(P<0.05).The value of CA125,CA153,physiological status,emotional state,functional status and additional concern score increased at the twelfth-months follow-up,and the differences were not statistically significant(P>0.05).The score of TCM symptoms,anxiety and depression,physiological statue and additional concern scores were decreased at the twelfth-month follow-up when compared with the baseline,the difference was not statistically significant(P>0.05).Conclusion:There was no significant difference in one year disease-free survival rate of patients with triple-negative breast cancer treated with traditional Chinese medicine after operation.However,traditional Chinese medicine can relieve symptoms such as fatigue and palpitation,improve physiological condition and sleep condition.Chinese medicine treatment of three negative breast cancer has better safety.