Therapeutic efficacy of radical concurrent chemoradiotherapy combined with sintilimab on stage ⅢC1-ⅣA cervical cancer
Objective To observe the efficacy and safety of radical concurrent chemoradiotherapy combined with sintilimab in patients with stage Ⅲ C1-Ⅳ A cervical cancer.Methods In 70 stage Ⅲ C1-Ⅳ A cervical cancer patients with pelvic lymph node short-axis diameter ≥1.5 cm,positive lymph nodes ≥4,or para-aortic lymph node metastasis,35 patients received radical concurrent chemoradiotherapy combined with sintilimab(combined immunotherapy group),and 35 patients received radical concurrent chemoradiotherapy alone(concurrent chemoradiotherapy group)in the Affiliated Cancer Hospital of Zhengzhou University from October 2019 to October 2022.In concurrent chemoradiotherapy group,external beam radiotherapy and intracavitary irradiation were administered,with concurrent cisplatin sensitization chemotherapy for 5 weeks starting from the first week of radiotherapy.In combined immunotherapy group,after concurrent chemoradiotherapy,sintilimab was administered for 6 cycles.The patients were followed up for 1 year after treatment,and pelvic plain scan,dynamic contrast-enhanced MRI and contrast-enhanced CT scans of the neck,chest and abdomen were done for evaluation every 4 to 6 weeks.The objective response rate,progression-free survival rate,and adverse drug reactions of grade 3 or above were recorded.Univariate and multivariate Cox regression analyses were conducted to identify the influencing factors of the disease progression of patients with cervical cancer.Results(1)There were no significant differences in the age,histopathological classification,maximal tumor diameter,comorbidities,ECOG performance status,number of positive lymph nodes,lymph node short-axis diameter,programmed cell death ligand 1 expression,squamous cell carcinoma antigen expression,and para-aortic lymph node metastasis between two groups(P>0.05).(2)Till May 2023,there were no deaths during the follow-up period in two group.The therapeutic results were complete response in 16 patients,partial response in 10,stable disease in 5,and disease progression in 4 in combined immunotherapy group;complete response in 11 patients,partial response in 7,stable disease in 5,and disease progression in 12 in concurrent chemoradiotherapy group.The one-year progression-free survival rate and objective response rate were higher in combined immunotherapy group(88.6%.74.3%)than those in concurrent chemoradiotherapy group(65.7%,51.4%)(x2=6.293,P=0.012;x2=3.916,P=0.048).(3)The maximal tumor diameter(≥4 cm)(HR=3.442,95%CI:1.310-9.039,P=0.0121)and no administration of sintilimab(HR=2.511,95%CI:1.006-6.266,P=0.049)were the risk factors of disease progression in patients with cervical cancer after concurrent chemoradiotherapy.(4)There were no significant differences in the incidence rates of grade 3 or above leukopenia,thrombocytopenia,fatigue,nausea/vomiting and diarrhea between combined immunotherapy group(45.7%,17.1%,2.9%,2.9%,2.9%)and concurrent chemoradiotherapy group(51.4%,8.6%,2.9%,5.7%,0)(P>0.05).Conclusion Concurrent chemoradiotherapy combined with sintilimab can prolong the progression-free survival without increasing the incidence of adverse drug reactions in patients with stage Ⅲ C1-Ⅳa cervical cancer when pelvic lymph node short-axis diameter is ≥1.5 cm,number of positive lymph nodes is≥4,or para-aortic lymph node is metastatic.