| Background:Colorectal cancer is one of the high incidence of malignant tumors in the world,According to statistics,colorectal cancer is the third most common malignant tumorand the second or the third most common cause of cancer deaths in allcancer,rectal cancer accounts for one-third of colorectal cancer,The incidence of colorectal cancer is increasing year by year with the increase of the early imaging technology and the life extension the population.At present,The Primarily of treatment for rectal cancer is surgery.Most of the current studies show that the 5 year survival rate of patients with rectal cancer who just had surgerytreatment is about 50%.Along with the improvement of medical technology and the use of some new drugs,in the past 30 years,the treatment of rectal cancer has changed from simple operation to comprehensive treatment,especially in the period ofpathological stage Ⅱand Ⅲrectal cancer.Although preoperative concurrent chemoradiotherapy combined TME surgery make local recurrence is reduced to 5%-6%,but distant metastasis patients still accounts for about 25% in all patients,Postoperative adjuvant therapy isessential for rectal cancer patients and should be independent of preoperative treatment.Especially,postoperative adjuvant therapy is paly animportant role for patients without anypreoperativetreatment.Clinical studies confirmed the capecitabine synchronous radiation therapy has good safety and tolerability for patients,The current research showscolorectal cancer patients with risk factors who used the scheme of Oxaliplatin in the capecitabine-based postoperative chemoradiotherapy can benefit more,This research through the prospective randomized controlled study in both chemoradiation scheme above select one of the better.Materials and methods:In this clinical research,123 patients who has confirmed pathological stage Ⅱ or Ⅲ rectal adenocarcinoma were enrolled in our hospital from January 2008-January 2014,According topatients with 2 to 8 weeks after the eradicative resection of rectal cancer who were randomly divided into experimental group(Capox-RT group)and control group(Cap-RT group).The experimental group received the XELOX regimen concurrentradiotherapy and chemotherapy,(the chemotherapy drug usage:Oxaliplatin:70mg/m2,used for per week w1,2,4 and 5 intravenous infusion;capecitabine:1300mg/m2,oral administration of the morning and evening meal,used for day1-14,7 days off,and then start next cycle of chemotherapy for day22-35;Finished 2 cycles of chemotherapy;pelvic radiotherapy:DT50Gy/25f/5w.);The control groupreceived Xeloda regimen alone concurrent radiotherapy.(capecitabine: 1600 mg/m2,oral administration of the morning and evening meal,used for day1-14,7days off,and then start next cycle of chemotherapy for day 22-35;Finished 2 cycles of chemotherapy;pelvic radiotherapy:DT 50Gy/25f/5w).we would evaluate the tolerance and acute adverse reactions of the patients who received the different treatment options in during the course of radiotherapy and chemotherapy.Patients with 3-4 weeks rest coutinue to receive chemotherapy with Platinum chemical drugs or single capecitabine,4-6 cycles of chemotherapy were recommended.The primary endpoint in this study was 3-year disease-free survival rate(DFS)、3-year DFS rate、cumulative incidence of local recurrence and distant metastasis Secondary research endpoint in this study for the two kind of schemes is the 3-4 degrees incidence of adverse reactions.Results:Thestage Ⅱ or Ⅲ rectal cancer patients in this study,No significant statistical differences was observed in 3 years overall survival(OS)betweentheexperimental group (Capox-RT)and control group(Cap-RT)(85.9%VS.83.5%,p=0.685);No significant statistical differences was observedin 3 years of local regional recurrence rate(LR)between Capox-RT and Cap-RTgroups(3.1%VS.8.5%,p=0.204).There were no significant statistical differences in 3 years disease-free survival(DFS)between experimental group and control group(75.0%VS.71.2%,p=0.667).There were no significant statistical differences in 3 years distant metastasis rate(DM)between experimental group and control group(25.0%VS.25.4%,p=0.937).Respectively,In stage Ⅲ rectal cancer patients,No significant statistical differences was observedin 3 years(OS)between experimental group and control group(85.7%VS.83.3%,p=0.945),No significant statistical differences was observed in 3 years(LR)between Capox-RT and Cap-RTgroups(2.4%VS.8.4%,p=0.207),No significant statistical differences was observed in 3 year(DFS)between experimental group and control group(71.4%VS.72.1%,p=0.716),No significant statistical differences was observed in 3 years(DM)between experimental group and control group(28.6%VS.27.7%,p=0.947).There were no differentin all level of the acute toxicity between Capox-RT and Cap-RTgroups(98.4%VS.93.2%,P=0.138),but have significant statistical different at level 3-4 acute toxic effects between the two groups(43.8%VS.25.4%,P=0.033),The experimental group(Capox-RT)and control group(Cap-RT)according to the requirement completed radiotherapy were respectively(90.6%VS.94.9%,p=0.361),The Capox-RTgroup and Cap-RTgroupcompleted synchronization chemotherapy were respectively(84.3%VS.93.2%,p=0.123),in which dose adjustment were respectively(14.1%VS.6.8%,p=0.189)due to grade 3-4 acute reaction,There were no significant statistical difference indose adjustment aspect between two groups(P > 0.05),Adjuvant chemotherapy in experimental group(Capox-RT)and control group(Cap-RT)was completed respectively(84.4%VS.76.3%,P=0.257),(figure 4,5,and table2,3)。Conclusion:This study show there is no different in survival benefit betweenCapox-RT and Cap-RT groups for the patients with pathologically confirmed stage Ⅱ and Ⅲ rectal cancer.The Capox-RT group did not show a significantincrease in 3 years LR but has a tendency to benefit for thestage Ⅲ rectal cancer patients.the 3-4 acute toxicity reaction increased significantlybut still tolerated in the Capox-RT group. |
PDF Full Text Request