Efficacy And Safety Of Radiotherapy For Primary Rectal Cancer During Chemotherapy For Stage ? Rectal Cancer

Purpose:The purpose of our study is to investigate the clinical efficacy and safety of primary tumor with radiotherapy during systemic chemotherapy for stage IV rectal cancer.Methods:30 patients with stage IV rectal cancer diagnosed in our hospital from December2015 to September 2017 were enrolled,they were no disease progression after treated with XELIRI three or four cycles.The patients were randomly divided into two groups according to 1:1,15 patients in the experimental group were treated with XELIRI chemotherapy plus primary radiotherapy,15 patients in the control group continued to use XELIRI chemotherapy.The main endpoint was local progression free survival(PFS).Secondary endpoints were objective response rate(ORR),disease control rate(DCR),toxicity,and quality of life.Patients were followed up every 4-8weeks after the end of the treatment.The curative effect was evaluated according to the evaluation standard of solid tumor curative effect RECIST 1.1;the rectal lesions and distant metastases in all patients were evaluated respectively;toxicity assessment was based on the National Cancer Society general toxicity standard CTC4.0 version;the quality of life was evaluated according to Karnofsky functional status score standard.SPSS 17.0 was used to statistics,the classification variables were tested by?~2,and the frequency and composition ratio were expressed.Continuous variables are tested by T or nonparametric tests according to normality.It is expressed by mean standard deviation or median.P<0.05 indicated that the difference was statistically significant.Results:1?30 cases of patients according to the standard of entry and discharge,there were 23 males and 7 females;The median age was 56.6 years,24 cases more than 50years old and 6 cases younger than 50 years old;The average distance from the primary to the edge of the anus was 7.1cm;The median follow-up time was 12months and no treatment related death was found.At the end of follow-up,20 patients were tumor progression,including 6 cases of rectum region,15 cases of distant metastasis and 13 cases of death.2?There was no significant difference in baseline characteristics between the two groups.Patients in the experimental group had 14.0 months of local mPFS(95%of CI:11.3 months to 16.7 months),and patients in the control group had 10.4 months of local mPFS(95%of CI:7.7 to 12.7 months).(p<0.05).The mPFS in the experimental group was 13.0 months(95%CI:10.3 months–15.7 months),and the mPFS in the control group was 9 months(95%CI:7.0 months–11.0 months).p<0.05).3?The results of recent curative effect evaluation with local lesions of the rectum showed that the objective remission rate(ORR)in the experimental group was80%,which was significantly higher than the control group(40%)(P=0.028),the disease control rate(DCR)in the experimental group was 100%,which was significantly higher than that the control group(73.3%)(P=0.041).In the distance metastasis showed that the objective remission rate(ORR)in the experimental group was 53.3%,while the control group was 33.3%(P=0.334),the disease control rate(DCR)of the experimental group was 93.3%,while the control group was 73.3%(P=0.189).4?There was no significant difference in the incidence of side effects such as loss of appetite,nausea,vomiting,diarrhea,bone marrow suppression and hand foot syndrome between the two groups(P>0.05).The incidence of radiation dermatitis in the experimental group is higher than control group(P<0.05).No grade 4-5 toxic side effects were observed.There were three patients with grade 3 toxicity of radiation dermatitis which all three appeared in the experimental group,and three patients had diarrhea grade 3 toxicity(20%),two patients(13.3%)in the experimental group,and one patient in the control group(6.7%).There were three patients with bone marrow suppression grade 3 toxicity(20%),two patients(13.3%)in the experimental group,and one patient in the control group(6.7%).but the toxic side effects can be alleviated after alleviating the dosage and symptomatic supportive treatment.5?The two groups were scored according to Karnofsky functional status score standard after 3 months after primary radiotherapy.Compared with scores when entering the group,the results of quality of life evaluation showed that two scores for the experimental group had a statistically significant(P=0.019).Two scores for the control group were no statistically significant(P=0.189).Conclusions:Stage IV rectal cancer treated by three or four cycles XELIRI chemotherapy have been assessed by oncologist with no progress,and then have been added primary tumors radiotherapy after chemotherapy.The treat method have significantly prolonged the patient's progression-free survival,improved the objective remission rate and disease control rate of local rectal lesions,and improved the patient's quality of life and can tolerate side effects.