| BACKGROUNDEsophageal cancer is the main malignant tumor with high incidence in China.More than half of the 500,000 new cases of esophageal cancer worldwide each year occur in China,ranking sixth in the incidence of malignant tumors and the fourth in mortality rate in China.The survival rate is only 20%.Squamous cell carcinoma accounts for the vast majority of esophageal cancer in China.Surgery is the main radical cure while early symptoms are not obvious.It is difficult to detect early so that surgical treatment is lost.Radiotherapy and chemotherapy have become the treatment options for these patients.However,there are many adverse reactions of radiotherapy and chemotherapy,and the occurrence of adverse reactions is exacerbated by the superposition of treatment methods,and even persists.On the other hand,the rate of local recurrence and distant metastasis after radiotherapy and chemotherapy is as high as 50%,and there is currently no optimal rescue treatment.After the treatment of diseases such as radiotherapy and chemotherapy,how to improve related adverse reactions,improve the quality of life,stabilize the tumor,and delay the disease progression as much as possible to achieve the ultimate goal of survival?What role can Traditional Chinese Medicine(TCM)play in this?The study focuses on this issue.OBJECTIVETCM is an important means of tumor treatment.Relevant research shows that radiotherapy and chemotherapy or combination of TCM treatment after radiotherapy and chemotherapy can reduce the occurrence of adverse reactions,improve the short-term efficiency and long-term survival rate.Qizhuyuling decoction is an empirical formula for the treatment of esophageal cancer in the department of oncology,Guang’anmen Hospital,China Academy of Chinese Medical Sciences.In this study,based on the previous study,the core prescription Qizhuyuling decoction is used to treat patients with newly treated non-operative esophageal squamous cell carcinoma(ESCC)who have completed radiotherapy and chemotherapy.The purpose of this study is to explore the effect of TCM on the quality of life and survival of patients with esophageal cancer after radiotherapy and chemotherapy.METHODSThis study uses a prospective design to screen newly treated non-operative patients with ESCC who have completed western medicine treatment such as chemoradiation and chemotherapy.Prescription once,continuous TCM time≥3 months,fill in the esophageal cancer specific questionnaire EORTC QLQ-OES18,the quality of life-core 30 questionnaire EORTC QLQ-C30(V3.0),KPS score and weight at the time of enrollment and disease progression or observation deadline.Statistical analysis of progression-free survival(PFS),through the analysis of self-control before and after treatment of patients’ quality of life changes.RESULTS1.Clinical InformationA total of 57 non-surgical ESCC patients after radiotherapy and chemotherapy were included in this study.Among the included cases,there were 49 males,accounting for 85.96%,and 8 females,accounting for 14.04%.The ratio of males to females was 6.13:1.The age ranged from 41 to 85 years,the average age was 62.28±10.17 years,the median age was 60 years old,14 cases(24.56%)were<55 years old,25 cases(43.8%)were 55-65 years old,18 patients(31.58%)were>65 years old.47 cases(82.46%)had a history of smoking,46 cases(80.70%)had a history of drinking alcohol,and 36 cases(63.16%)had a family history of cancer.The most lesions were located in the lower thoracic segment,21 cases,accounting for 36.84%,followed by the middle thoracic segment,15 cases,accounting for 26.32%,11 cases(19.30%)and 3 cases(5.26%)in the upper chest and neck,respectively 7 cases(12.28%)occurred in multiple segments.53 cases(92.98%)with lymph node metastasis,14 cases(24.56%)with distant metastasis.In clinical staging,there are the most cases of stage Ⅲ,with 27 cases,accounting for 47.37%,followed by 25 cases of stage Ⅳ(43.86%),including 11 cases of stage ⅣA(19.30%);14 cases of stage ⅣB(24.56%),and there were 5 cases(8.77%)in stage Ⅱ.45 cases received radiotherapy and chemotherapy,accounting for 78.95%,52 cases received radiotherapy,accounting for91.23%,50 cases received chemotherapy,accounting for 87.72%.2.Symptoms and Signs of TCMThe common symptoms of esophageal cancer after radiotherapy and chemotherapy are eating choking(84.21%)and fatigue(78.95%),which are also classified as one in the cluster analysis and are closely related.More than half of the patients had foreign body sensation(61.40%),hiccups(61.40%),acid reflux(59.65%),dry mouth(57.89%),cough(56.14%),heartburn(52.63%),and loss of appetite(52.63%),expectoration(52.63%),chest and back pain(50.88%),which are grouped into a large category.The syndrome types are mainly phlegm-air obstruction syndrome,with 35 cases,accounting for 61.40%,followed by 10 cases with blood stasis syndrome(17.54%),6 cases with Jin deficiency heat syndrome,and Qi deficiency yang syndrome(10.53%).3.Survival AssessmentSurvival period is the main evaluation index to determine whether patients with malignant tumors benefit from treatment.In this study,PFS was used to evaluate.PFS is defined as the time from the beginning of the treatment of TCM after the completion of radiotherapy and chemotherapy and other western medicine treatment to the first occurrence of tumor progression and/or death of any cause.The 57 enrolled patients were followed up to March 1,2020.The PFS ranged from 3 to 26 months.The 6-month(0.5 year)PFS rate was 49.43%,the 12-month(1 year)PFS rate was 32.61%,and the median PFS was 6.00±0.74 months(95%CI was 4.54～7.46).The 1-year PFS rate of stage Ⅱ is 80.00%,the median PFS is 22.00 ± 0.00 months;the 1-year PFS rate of stage Ⅲ is 39.96%,the median PFS is 7.00±1.13 months;the 1-year PFS rate of stageⅣA is 12.12%,The median PFS was 5±0.64 months;the median PFS of stage ⅣB was 4±0.37 months,and the 1-year PFS rate was 16.33%.Univariate analysis showed that age,disease location,distant metastasis,clinical staging,radiotherapy,KPS score,and dysphagia grading were the relevant factors affecting PFS(P=0.033,0.008,0.003,0.002,0.000,0.010,0.024).COX multivariate analysis showed that age,distant metastasis,clinical stage,radiotherapy,KPS score,dysphagia grading(P=0.000,0.002,0.012,0.013,0.020,0.032)are independent risks that affect the prognosis of patients with esophageal cancer after radiotherapy and chemotherapy factor.The influencing factors are similar to previous studies.Compared with esophageal cancer patients without traditional Chinese medicine after radiotherapy and chemotherapy,Qizhuyuling decoction has the advantage of prolonging PFS.4.Quality of Life AssessmentAfter treatment,patients with disease progression improved significantly in dysphagia,speech,fatigue,insomnia,role function,social function,and overall health level,P<0.05,score changes were statistically significant.Symptoms such as eaten,dry mouth,decreased appetite,cough,reflux,nausea and vomiting,diarrhea,pain,physical function,emotional function,cognitive function,KPS score,weight and other aspects also improved,P>0.05,which the difference was not statistically significant.For patients with esophageal cancer who have developed disease,the symptoms of reflux have been significantly improved after treatment with TCM,and the degree of economic difficulty has increased,other symptoms scores,P<0.05,KPS scores and body weight have no significant changes,and the difference is not statistically significant.CONCLUSION1.Compared with esophageal cancer patients without TCM after radiotherapy and chemotherapy in the same period,to a certain extent,it can be explained that Qizhuyuling decoction has the effect of prolonging PFS in patients with esophageal cancer after radiotherapy and chemotherapy.Patients with young age,no distant metastasis,early clinical stage,radiotherapy,high KPS score,and low dysphagia grading score have a relatively good prognosis after receiving traditional Chinese medicine treatment.2.The combination of Qizhuyuling decoction combined with disease differentiation,syndrome differentiation and symptom differentiation can improve the symptoms of patients without disease progression(dysphagia,speech,fatigue,insomnia,role function,social function,and overall health level improved significantly)to improve quality of life;those with disease progression which most of the symptoms have no obvious changes could maintain a relatively stable quality of life. |
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