| Background:China is a high-risk area for esophageal cancer,and cancer deaths rank fourth.There are obvious regional differences in the incidence rate.Taihang Mountain in North China is a high-incidence area,with more than ten counties and cities such as Lin County in Henan Province,Ci County in Hebei Province,and Yangcheng in Chongshan West Province.In China,the average age of death in esophageal cancer is between 49 and 63 years old.Thus,esophageal cancer is a common disease in the elderly.Despite significant advances in treatments such as surgery,radiation therapy,and chemotherapy,the long-term efficacy of advanced esophageal cancer remains unsatisfactory.Synchronous chemoradiotherapy is still the standard program for non-surgical treatment of regional regional esophageal cancer in the West.The 5-year survival rate is 27%,but the serious adverse events above grade 3 are more than 63%.RTOG9504,Ohtsu,JVOG9516,Japanese scholar Koto K and many other studies have shown that cisplatin + 5-Fu is a traditional chemotherapeutic drug for concurrent chemoradiotherapy.Great progress has been made.However,there is no accurate study on survival in China.Objective:To explore the overall survival(OS)and progression free survival(PFS)of diamminedichloroplatinum(DDP)5-Fu synchronous radiotherapy versus radical surgery in patients with locally advanced esophageal squamous cell carcinoma in China.,toxic side effects,quality of life,and the impact of the objective rate(Response Rate).Methods:This randomized,open study was conducted in several hospitals including Luoyang,Anyang,Zhengzhou and Nanyang.The patients with newly diagnosed esophageal squamous cell carcinoma with clinical stage T1bN+M0 ~ T2-4aN0-2M0 since January 2017 were selected as subjects.The eligible patients were randomly divided into two groups,the radical concurrent radiotherapy and chemotherapy group:the chemotherapy regimen was cisplatin +5-FU(cisplatin: 75 mg/m2 d1,29 +5-Fu:750 mg/m2 CIV24 h d1-4,d29-32)regimen chemotherapy and concurrent radiotherapy(IMRT 50 Gy,2 Gy/d,5 days/week);2 cycles in total.Neoadjuvantconcurrent chemoradiotherapy combined with chemotherapy,chemotherapy regimen with radical concurrent radiotherapy and chemotherapy,and concurrent radiotherapy(IMRT 42Gy/21 times).Radical surgery for esophageal cancer was performed within 2months of neoadjuvant concurrent chemoradiotherapy until the progression or toxicity of the disease was intolerable.Cardiac test or T test was used to statistically describe the adverse reactions,quality of life and objective efficiency of each group.Kaplan-Meier method was used to analyze the related survival of PFS and OS in each group.Results:1.After the preparatory registration(registration number: NCT02972372),preparation of test documents,and training of test personnel,the study was officially started in July 2018 and is currently being grouped in Luoyang,Anyang,Nanyang and other hospitals.Twenty patients were randomized to 1:1 in 10 patients with radical concurrent chemoradiotherapy,10 patients with neoadjuvant chemoradiotherapy plus surgery.Treatment has been completed and adverse events and quality of life assessments have been performed.Eight patients in the concurrent chemoradiotherapy group were evaluated for efficacy,including 3 with complete remission(CR),4 with partial remission(PR),and 1 with stable(SD);disease-effectiveness(CR+ PR)was 7/8(87.5%);the disease local control rate(CR+PR+SD)was 8/8(100%).The patients in the surgical group achieved R0 resection after surgery.The baseline data of the two groups of patients were basically balanced,and the patients in the current group survived.2.Evaluation of adverse events,the incidence of adverse events in this experiment was higher,such as esophageal pain,nausea,vomiting,and leukopenia.Compared with neoadjuvant chemoradiotherapy + surgery group,the incidence of nausea(40% vs 80%)and fever(0% vs 60%)was lower in the radical concurrent radiotherapy group(P<0.05).The incidence of other adverse events was not statistically different(P>0.05).3.In terms of quality of life,QLQ-C30 version 3.0 evaluation found that the total health status,emotional function,cognitive function and social function of the radical concurrent radiotherapy and chemotherapy group after 9 weeks and 16 weeks were aggravated compared with before treatment(P<0.05).There was no statistically significant difference in the scores of the remaining areas before and after treatment(P>0.05).The quality of life,physical function,and role were compared between the9-week and 16-week treatments of neoadjuvant chemoradiotherapy plus surgery.The function was aggravated compared with that before treatment(P<0.05).There was no statistical difference before and after treatment in the other areas(P>0.05).Comparison of quality of life after 16 weeks of treatment showed that the radical concurrent radiotherapy and chemotherapy group was superior to neoadjuvant chemoradiotherapy + surgery group in terms of total health status,physical function,role function,nausea and vomiting,pain and economic difficulties.P<0.05);there was no statistical difference in the scores of the remaining areas(P>0.05).This research is ongoing.Conclusion:For Chinese advanced advanced esophageal squamous cell carcinoma,5-FU+cisplatin synchronous radiotherapy may be slightly better than neoadjuvant+radical surgery in terms of safety;radical concurrent radiotherapy and chemotherapy may be slightly higher than neoadjuvant+surgery in terms of quality of life.All patients in the current group survived.Because the current sample size is small,the next step is to continue to expand the number of cases,while long-term follow-up,compare the difference in survival between the two treatment options. |
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