| Objective:In this study,301 patients with IB-IIA cervical cancer were stratified by postoperative pathological recurrence risk factors,and the efficacy and safety of consolidation chemotherapy after concurrent chemoradiotherapy in patients with high-risk recurrence factors（positive lymph nodes,parametrial invasion,and positive surgical margin）were investigated,the efficacy and safety of concurrent chemoradiotherapy（CCRT）,sequential chemoradiotherapy（SCRT）and radiotherapy（RT）were compared in patients with 2 or more intermediate-risk（lymphatic vascular space involvement,deep stromal invasion,large tumor size）factors for recurrence,to evaluate the effect of different clinicopathological factors on the prognosis of patients,and provide more accurate guidance for the selection of adjuvant therapy for patients with early-stage cervical cancer.Methods:According to the inclusion criteria,the clinical data of 301 patients with IB-IIA cervical cancer treated in the cancer center of Jilin University’s first hospital from January 1,2013 to December 31,2017,were retrospectively analyzed,including 134 patients with a high risk of recurrence,of whom 64 cases were treated with concurrent chemoradiotherapy and 70 cases were treated with consolidation therapy,and 5-year disease-free survival（DFS）,overall survival（OS）,recurrence and metastasis patterns,adverse reactions were compared,the survival curve was plotted by Kaplan-Meier method.167 patients with 2 or three intermediaterisk factors were pooled and divided into three groups based on adjuvant therapy methods:CCRT（n=66）,SCRT（n=50）and RT（n=51）,the survival curves were plotted by Kaplan-Meier method and 5-year DFS,5-year OS,recurrence and metastasis models,adverse reactions were compared,and Cox proportional hazard model was used to analyze the prognosis of the patients with high or intermediate risk factors for recurrence.Results:Population with high-risk recurrence factors: the 5-year disease-free survival rates of CCRT group and consolidation chemotherapy group was statistically significant（56.3% vs65.7%,P=0.042）.The 5-year survival rate was not statistically significant（75.0% vs 81.4%,P=0.254）.In terms of recurrence and metastasis,the local recurrence rate was no statistically significant（15.6% vs 21.4%,P=0.389）,while the distant metastasis rate was statistically significant（26.6% vs 14.3%,P=0.047）.In terms of adverse reactions,the recent toxic reactions mainly included radiation-induced epidermitis,gastrointestinal reactions and myelosuppression,and the grade III/IV myelosuppression rate was higher in the consolidation chemotherapy group（24.3% vs 10.9%,P=0.045）.The late adverse reactions mainly included radiation proctitis and radiation cystitis,there was no statistical significance between the two groups（P>0.05）.The univariate analysis of prognosis for high-risk recurrence factors showed that the number of lymph nodes（P=0.001）,LVSI（P=0.031）,pathological type（P=0.040）,the number of intermediate-risk factors（P=0.035）,and treatment methods（P=0.042）were related to DFS,and the number of lymph nodes（P=0.024）,LVSI（P=0.008）were related to OS.Multivariate analysis showed that the number of lymph nodes ≥ 3 were independent risk factors affecting DFS（HR=2.87,95%CI: 1.04-7.90,P=0.008）and OS（HR=3.91,95%CI: 1.09-14.08,P=0.037）.Population with 2-3 intermediate-risk factors for recurrence: the five-year DFS rates of CCRT,SCRT and RT groups were statistically significant（75.8% vs 80.0% vs 60.8%,P=0.024）;the five-year OS rates of CCRT,SCRT and RT groups were statistically significant（90.9% vs 92.0% vs 76.5%,P=0.024）.In terms of recurrence and metastasis,the local recurrence rate of the three groups was not statistically significant（9.1% vs 10.0% vs 9.8%,P=0.901）.The distant metastasis rate of the three groups was statistically significant（12.1%vs 10.0% vs 29.4%,P=0.014<0.0167,corrected by Bonferroni）.In terms of adverse reactions,CCRT group,SCRT group and RT group with grade III/IV myelosuppression were statistically significant（22.7% vs 16.0% vs 3.9%,P=0.013<0.0167,corrected by Bonferroni）.Grade I/II nausea in three treatment groups were statistically significant（33.3% vs 30.3% vs 9.8%,P=0.001<0.0167,corrected by Bonferroni）.Acute digestive tract reaction,radiation dermatitis,radiation cystitis and radiation proctitis were not statistically significant among the three groups（P>0.05）.The univariate analysis of prognosis in the population with intermediate-risk recurrence factors showed that LVSI（P=0.010）,pathological type（P=0.008）,and treatment（P=0.024）were related to DFS,and pathological type（P=0.048）,and treatment（P=0.024）were related to OS.Multivariate analysis showed that treatment was an independent risk factor for DFS and OS.LVSI（HR=2.54,95% CI: 1.21-5.34,P=0.014）and pathological type（HR=2.43,95%CI: 1.24-4.74,P=0.010）were independent risk factors for DFS.Conclusions:1.Consolidation chemotherapy after concurrent chemoradiotherapy for IB-IIA cervical cancer patients with high-risk recurrence factors can reduce the risk of distant metastasis and improve the 5-year DFS rate without OS benefit.2.The efficacy of postoperative concurrent chemoradiotherapy and sequential chemoradiotherapy in IB-IIA cervical cancer patients with 2～3 intermediate-risk recurrence factors was better than that of radiotherapy alone.3.Sequential chemoradiotherapy can be used as the optimal adjuvant therapy for IB-IIA cervical cancer patients with intermediate-risk factors for recurrence.4.For people with high-risk recurrence factors,the number of lymph node metastasis ≥3 is an independent risk factor affecting DFS and OS.5.For people with 2～3 intermediate-risk recurrence factors,treatment,LVSI and pathological type are independent risk factors affecting DFS,and treatment is an independent risk factor affecting OS. |
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