Retrospective Analysis Of The Efficacy And Safety Of Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin In Patients With High Risk Muscle Invasive Urothelial Carcinoma Of Bladder

Background and objectiveBladder cancer is the most common malignant tumor in the urinary system.Radical cystectomy combined with pelvic lymphadenectomy is the standard treatment for muscle invasive bladder cancer(MIBC).However,the recurrence and metastasis rate of patients treated by surgery alone is a bit high,and the survival time of patients can not be prolonged.Currently neoadjuvant chemotherapy(NAC)based on cisplatin together with surgery can improve the prognosis of MIBC patients,which is supported with level 1 evidence.However,it doesn’t widely used in clinical practice and starts late at home.Methotrexate-vinblastine-adriamycin-cisplatin(MVAC)is the standard of care for muscle-invasive urothelial bladder cancer,while gemcitabine plus cisplatin(GC)shows similar efficacy and less toxicity and become more commonly used in clinic recently.Both domestic and foreign guidelines recommend NAC for patients with muscle invasive bladder cancer(cT2-T4aN0M0).However,there’s controversy about the application of the crowd for NAC,with some studies arguing that NAC cannot improve the long-term outcomes for patients with low risk bladder cancer.Therefore,the main purpose of this study is to explore the efficacy and safety of NAC with GC in patients with high-risk MIBC(cT3-T4a,N0/N+,M0)MethodsSixty-two patients with high-risk muscle invasive bladder urothelial carcinoma were analyzed retrospectively,who were treated in the Department of Urology,Zhujiang Hospital,Southern Medical University from August 2015 to December 2019.And the study group comprised twenty patients who received NAC before surgery while the control group inlcuded forty-two patients who underwent surgery alone.We compared the rate of Complete pathological response(pCR),pathological downstaging(<pT2),Overall survival(OS),relapse free survival(RFS)and so on with each group.ResultsIn the study group,there were 13 patients with cT3 and 7 patients with cT4,among which 5 patients were diagnosed as N+;in the control group,there were 30 patients with cT3,12 patients with ct4a and 7 patients with N+.In the study group,10 patients underwent 1 cycles of GC chemotherapy,7 patients received 2 cycles of chemotherapy,and the remaining 3 patients received 3 cycles of chemotherapy.The average time from the first day of chemotherapy to operation was 43.4 days.The average maximum diameter of the tumor was(37.70±16.61)mm before chemotherapy,and(25.00±13.35)mm after chemotherapy.The tumor volume was significantly reduced(t=4.58,P=0.00).And 1 case(5.0%)had no residual lesions after operation,5 cases(25.0%)were dianosed NMIBC,and 3 cases(15.0%)had positive lymph nodes and no urethra margin.While in the control group,6 patients(14.6%)reached the stage of pathological decline,11 patients(26.2%)confirmed lymph node metastasis after operation,and 1 patient(2.4%)showed positive resection margin of urethra.In the course of chemotherapy,gastrointestinal reactions,blood and bone marrow reactions were highly common,only 3(15.0%)patients had grade 3/4 adverse reactions.At the same time,chemotherapy did not increase the operation time and postoperative hospital stay.The study group was followed up for an average of 17.90±17.96 months,with a median time of 13 months,while the control group was followed up for an average of 26.23±15.53 months,with a median time of 27 months.By the end of the follow-up period,3 patients in the study group had died,2 patients had recurrence and metastasis after surgery,and 2 patients had lost follow-up.The OS of the study group was 85.0%and the RFS was 75.0%.In the control group,14 patients died,6 patients relapsed and metastasized,and 5 patients lost to follow-up.The OS of the control group was 66.7%,and the RFS was 54.8%.By means of log-rank test,there was no significant difference between OS and RFS of the two groups(P>0.05).ConclusionsFor high-risk(cT3-T4a,N0N+,M0)patients with muscle invasive bladder urothelial carcinoma,GC neoadjuvant chemotherapy can significantly reduce tumor volume and clinical stage.However,there was no significant difference in the pathological remission rate,pathological decline rate and lymph node positive rate in the two groups.GC is a safe neoadjuvant chemotherapy for bladder cancer.Due to the limitation of sample size and follow-up time,this study failed to confirm that GC neoadjuvant chemotherapy can improve the long-term survival benefit of high-risk MIBC patients.