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Objectives: Muscle Invasive Bladder Cancer (MIBC) remains a lethal disease, despite aggressive local and systemic therapies with Radical Cystectomy (RC) ± Neo-Adjuvant Chemotherapy (NACT). The 5-year Overall Survival (OS) in advanced cases was around 32%. So novel treatment modalities are required. Our aim is to study the impact of adding Postoperative Radiotherapy (PORT) to standard chemotherapy on local control, survival outcomes and toxicity pattern. Methods: In this study, 123 MIBC patients’ medical records were reviewed and classified into 3 groups according to their treatment modalities; A (RC Chemotherapy), B (RC Radiotherapy), and C (RC Chemo and Radiotherapy). Results: Over a median follow-up of 18.5 months, the 5-year disease free survival (DFS) of group B was significantly higher (80.4%) compared to groups A and C (41.1% & 29.9% respectively; p= 0.0073). Additionally, the 5-year OS was higher in group B (77%) compared to groups A (33.9%) and C (28.5%), (p=0.041). However, the median Local Recurrence Free Survival (LRFS) for the whole group was 69.03 months (95% CI: 69.03 to 69.03), with no significant difference among the 3 groups (p=0.067). Conclusion: Our results suggest that the addition of adjuvant radiotherapy improved the Disease-Free Survival (DFS) and OS in MIBC patients. Although NACT remains the standard of care, incorporation of PORT should be considered in the future management of these cases.
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【Objective】 To construct an easy-to-use individual survival prognostic tool based on competing risk analyses to predict the risk of 1-, 2- and 3- year recurrence for patients with non-muscle invasive bladder cancer (NMIBC). 【Methods】 The follow-up data of 419 NMIBC patients were obtained. The patients were randomly divided into training cohort (n=293) and validation cohort (n=126). The variables included age at diagnosis, sex, history of smoking, tumor number, tumor size, histolo-gic grade, pathological stage, and bladder perfusion drug. The cumulative incidence function (CIF) of recurrence was estimated using all variables in the training cohort and potential prognostic variables were determined with Gray’s test. The Fine-Gray subdistribution proportional hazard approach was used as a multivariate competitive risk analysis to identify independent pro-gnostic variables. A competing risk nomogram was developed to predict the recurrence. The performance of the competing risk model was evaluated with the area under the receiver operating characteristic curve (AUC), calibration curve, and Brier score. 【Results】 Five independent prognostic factors including age, number of tumors, tumor size, histologic grade and pathological stage were used to construct the competing risk model. In the validation cohort, the AUC of 1-, 2- and 3- year recurrence were 0.895 (95%CI: 0.831-0.959), 0.861(95%CI: 0.774-0.948) and 0.827(95%CI: 0.721-0.934), respectively, indicating that the model had a high predictive performance. 【Conclusion】 We successfully constructed a competing risk model to predict the risk of 1-, 2- and 3-year recurrence for NMIBC patients. It may help clinicians to improve the postoperative management of patients.
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We present a summary of important research in the field of urothelial carcinoma presented at the 2023 European Society for Medical Oncology (ESMO) conference. A total of 53 studies related to urothelial carcinoma were reported, including 6 late-breaking abstract, 7 oral presentations, and 40 poster presentations. Several new treatment options were reported in the non-muscle invasive bladder cancer (NMIBC) field, providing more choices for bacillus Calmette-Guerin (BCG) failing patients. For perioperative systemic treatment of muscle-invasive bladder cancer (MIBC), studies further explored various adaptation of neoadjuvant therapy strategies. For metastatic urothelial carcinoma (mUC), the data on CheckMate-901 and EV-302 studies provided thoughts on first-line treatment options. These studies provide important guidance for clinical practice in the field of urothelial carcinoma.
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The 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) reported several advancements in the field of urothelial carcinoma. Multiple new treatment options for non-muscle invasive bladder cancer (NMIBC) were introduced, providing more choices for bladder preservation in BCG-resistant/failed NMIBC cases. In muscle invasive bladder cancer (MIBC) perioperative treatment, the updated 3-year follow-up data from the CheckMate 274 study demonstrated a clear advantage in disease-free survival for the nivolumab monotherapy adjuvant treatment group. For metastatic urothelial carcinoma (mUC), the final overall survival (OS) report from the IMvigor130 study was published, prompting further considerations for future first-line treatment options in mUC. Additionally, the conference highlighted research progress in upper tract urothelial carcinoma (UTUC).
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Objective:To evaluate the feasibility and safety of carbon ion radiotherapy (CIRT) in the treatment of muscle-invasive bladder cancer in phase Ⅰ/Ⅱ clinical trials.Methods:Clinical stage T 2-3 patients with muscle-invasive bladder cancer (without distant metastasis) were studied. A three-fraction treatment was applied, including the local irradiation with the dose from 12 Gy to 24 Gy and 11 fractions of whole-bladder irradiation with a dose of 44 Gy. The carbon ion irradiation dose is determined with relative biological effectiveness (RBE) of 3.0. The total dose for bladder tumor was 56-68 Gy in 14 fractions. The primary endpoints included tumor treatment-related side effects, dose-limiting toxicity (DLT) responses, and local control (LC) rate, and the secondary endpoints included progression-free survival (PFS). Results:Nine patients received CIRT of various doses in the clinical trials, with the dose gradually increasing to 68 Gy. The patients did not suffer from DLT response, acute adverse effects of radiation therapy of grade ≥3, and late radiation adverse reactions during follow-up. When the dose to the tumor reached 68 Gy, there were 2 cases of grade 2 acute urogenital tract reaction and 1 case of acute lower gastrointestinal tract symptom. For the group with a dose above 62 Gy, three cases of grade 1 late radiation bladder reaction were observed and their symptoms included urinary frequency and microscopic hematuria. At the end of treatment, hematuria disappeared, dysuria was relieved, and urine red blood cell value significantly decreased for all the patients. Three months and six months after treatment, the LC rates were 100% and 88.9%, respectively, and the objective response rates were both 88.9%. One patient developed local recurrence and was treated with salvage surgery six months after treatment.Conclusions:The preliminary efficacy observation of CIRT in the treatment of muscle-invasive bladder cancer showed significant short-term efficacy, obvious symptom relief, and good tolerability for patients, without DLT. Therefore, CIRT is safe and feasible.
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With the development of new drugs, advances in medical technology and progressions in tumor molecular biology, organ preservation surgery has become the new trend for tumor treatment. Here, we discussed how to select right muscle-invasive bladder cancer patient with strict criteria for multimodality bladder-sparing treatment, and we reviewed the new treatment options, outcomes and trend of development for bladder-sparing treatments.
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Objective:To investigate the long-term survival and safety in patients with muscle-invasive bladder cancer (MIBC) who experienced a noninvasive down-staging (≤pT 1)after transurethral resection of bladder tumor (TURBT) plus systemic chemotherapy and received bladder-sparing treatment. Methods:The records of patients with MIBC who underwent maximal TURBT plus systemic chemotherapy-guided bladder-sparing treatment were reviewed retrospectively from Dec 2013 to Dec 2020. Eventually, 22 patients who achieved noninvasive down-staging underwent conservative management. The total patient cohort contained 10 males and 12 females. A majority of patients had single lesion and stage T2 disease. The median age of the patients was 66 years and the median tumor size was 3.0 cm. All patients underwent maximal TURBT to resect all visible diseases and followed by 3-4 cycles platinum-based systemic chemotherapy. After achieving noninvasive down-staging, 14 patients received concurrent chemoradiotherapy, and the other 8 patients underwent surveillance. Overactive bladder symptom score (OABSS) was used to assess the bladder function after treatment.Results:Twelve patients achieved pT 0 and 10 patients were down-staged to cT a-T 1. At a median follow-up of 36.7 months, 90.9%(20/22) patients retained their bladder function successfully. Among the 14 patients who received concurrent chemoradiotherapy, 4 had grade 3 or 4 adverse events. Among the 8 patients who underwent surveillance, 3 had grade 3 or 4 adverse events after systemic chemotherapy.Nine patients experienced tumor recurrence in the bladder, and 2 patients died of bladder cancer. Seven (31.8%) patients experienced Ⅲ/Ⅳ grade complications. The 5-year recurrence-free survival (RFS) and overall survival (OS) in patients achieved pT0 were 66.7% and 100.0%, respectively. The 5-year RFS and OS in patients achieved cTa-T1 were 40% and 72%, respectively. The OABSS score of 20 patients who retained their bladder successfully was (1.00±1.03). Conclusions:MIBC patients who achieved noninvasive down-staging might be candidates for the bladder-sparing treatment with maximum TURBT followed by systemic chemotherapy.The patients who achieved pT 0 might have better prognosis with functional bladder.
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Bladder cancer(BC) ranks the first of genitourinary tumor in China and is one of the most common urological malignancies, in which 25%-30% of patients were diagnosed with muscle-invasive bladder cancer. Radical cystectomy combined with pelvic lymph node dissection is the standard procedure for treatment, which can effectively avoid tumor recurrence or distant metastasis as well as improve the prognosis of patients. However, some patients may not tolerate or refuse to undergo radical bladder surgery due to worry about high complication rate, high morbidity and poor postoperative quality of life. With the increasing understanding of bladder cancer heterogeneity and biological behavior, the treatment of bladder cancer has changed from a surgery-based treatment model to an individualized and comprehensive treatment model by multidisciplinary collaboration. The bladder-preserving treatment can achieve the same oncological prognosis as that of radical bladder surgery with a better quality of life of the patients, which has become a hot topic and focus of research in muscle-invasive bladder cancer treatment. This article reviewed the progress of research related to the comprehensive treatment of muscle-invasive bladder cancer with preservation of the bladder.
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Neoadjuvant therapy leads to the eradication of micrometastasis, thereby providing survival benefit to patients with muscle-invasive bladder cancer (MIBC). In the recent years, multiple clinical trials have corroborated the safety and durability of immune checkpoint inhibitors in the treatment of MIBC. Notably, there is a significantly higher response rate (e.g. pathologic complete response) and comparable occurrence of adverse events in patients treated with neoadjuvant dual immunotherapy, immunotherapy combined with chemotherapy or targeted therapy as compared with that treated with neoadjuvant single-agent immunotherapy. With an overview of breakthroughs in the past years, we believe that immune combination therapy is of great promise and expected to revolutionize the landscape of neoadjuvant therapy of MIBC.
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Bladder cancer is one of the most common tumors of the urinary system. More than a quarter of the new bladder cancer cases in China are muscle invasive bladder cancer. The standard treatment of muscle invasive bladder cancer is radical cystectomy plus pelvic lymph node dissection. This operation has limitations such as large trauma, high postoperative complication rate and serious impact on the quality of life of patients. To control the condition of bladder cancer and improve the quality of life of patients, a comprehensive treatment and follow-up system after bladder sparing are being explored. In addition to the classic trimodal treatment which is consisted of "maximum transurethral resection of the tumor, chemotherapy and external radiotherapy" , the treating modes of single drug, multi-drug or combined chemotherapy/radiotherapy based on immune checkpoint inhibitors are in their heyday. Meanwhile, antibody-drug conjugates have been in the ascendant. The purpose of this article is to review the current situation of bladder sparing therapy for muscle invasive bladder cancer and look forward to the development direction of bladder sparing therapy in the current era of oncoimmunology.
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Objective:We aim to investigate the clinical characteristics and prognosis of upper tract urothelial carcinoma (UTUC) in patients with non-muscle invasive bladder cancer (NMIBC) after renal transplantation.Methods:We retrospectively analyzed the clinical and follow-up information of 13 kidney recipients with NMIBC admitted to our hospital from January 2014 to June 2022 who subsequently underwent complete transperitoneal laparoscopic nephroureterectomy. There were 8 males and 5 females, aged (56.1±11.5), 3 cases with history of smoking and 10 cases without history of smoking, 4 cases with history of Aristolochic acids and 9 cases with no history of Aristolochic acids. Six and seven cases were treated with transurethral resection of bladder tumor for hematuria and bladder tumors detected by ultrasound or imaging respectively. Single and multiple bladder tumors were 9 and 4 cases; bladder tumor size ≤ 3 cm, >3 cm were 9 and 4 cases respectively; low-and high-grade bladder tumors were 3 and 10 cases separately, with; T a and T 1 of 3 and 10 cases respectively; recurrent bladder cancer and non-recurrent bladder cancer were 5 and 8 cases respectively. Follow-up after transurethral resection of bladder tumor showed that 6 cases with imaging evidence of UTUC for 6-52 months after transurethral resection of bladder tumor were treated with ipsilateral laparoscopic nephroureterectomy, including 2 cases of hydronephrosis, 1 case of renal pelvis mass, and 3 cases of ureteral mass, and 7 cases without imaging evidence of UTUC were performed with bilaterally prophylactic laparoscopic nephroureterectomy. The Kaplan-Meier curve and log-rank test were used for survival analysis to evaluate the prognostic effect of UTUC in kidney recipients with NMIBC. Results:Six of 13 patients named UTUC group were diagnosed with UTUC and 7 of 13 patients named no-UTUC group were not detected with UTUC. There was no statistical difference between these two groups in terms of clinical characteristics, including age( P=0.10), sex( P=0.10), smoking( P=0.19), history of Aristolochic acids( P=0.99), number( P=0.56), grade( P=0.19), stage ( P=0.19)and recurrence of bladder tumor number( P=0.10), and radiological findings of UTUC ( P=0.29). However, patients with larger-sized bladder tumors (larger than 3cm) had a higher rate of UTUC compared to patients with equal or smaller than 3 cm ( P=0.29). In addition, two patients with negative radiological findings developed UTUC following the detection of a large bladder tumor size (larger than 3 cm). The median survival of overall survival time and cancer specific survival time after laparoscopic nephroureterectomy were 42(17, 65) months. Two patients died from any cause during follow-up in patients with UTUC, whereas no significant difference between UTUC group and non-UTUC group in overall survival time and cancer specific survival time, as evaluated by the Kaplan-Meier curves and log-rank tests. ( P=0.29). Conclusions:After kidney transplantation, the diameter of the bladder tumor in NMIBC patients with UTUC was significantly larger than that in patients without UTUC, and no significant difference was observed in the remaining clinical features. Considering the non-functioning kidney after kidney transplantation, prophylactic laparoscopic nephroureterectomy can be considered for NMIBC patients with bladder tumor size >3 cm. Survival analysis showed no significant difference between UTUC group and non-UTUC group.
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Bladder cancer is one of the most common malignant tumors in the urinary system, and the current standard treatment for muscle-invasive bladder cancer(MIBC) is radical cystectomy combined with pelvic lymphadenectomy.However, radical cystectomy is a surgical method with serious damege and high incidence of perioperative complications, leading to a low postoperative quality of life for patients.In recent years, with the improvement of chemotherapy regimens and the development of radiotherapy techniques, bladder preservation comprehensive therapy based on partial cystectomy(PC) has attracted the attention of domestic and foreign scholars again.This article reviews the current application and treatment progress of PC.
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OBJECTIVE@#To determine the efficacy of sequential intravesical Gemcitabine and Docetaxel (siGD) in patients with non-muscle invasive bladder cancer (NMIBC) in preventing disease recurrence after transurethral resection, as an alternative to BCG-naïve patients or to failed intravesical BCG therapy.@*METHODS@#An extensive literature search on the use of siGD for BCG-naïve or BCG-refractory NMIBC was done using the following terms: non-muscle invasive bladder cancer, intravesical Gemcitabine and Docetaxel. Search results were filtered to include all retrospective studies and randomized controlled trials reporting the oncological outcomes of siGD published over the last 5 years from the conception of this study. Information on the safety profile and adverse events related to therapy were also reported, if available.@*RESULTS@#The authors’ search yielded 8 retrospective articles describing the efficacy of siGD for NMIBC, 5 of which had complete and accessible English manuscripts. A total of 476 low to high-risk NMIBC patients were included in the 5 eligible studies, 31 (6.5%) of which were BCG-naïve, while the rest failed BCG therapy. The reported one and two-year success rates were 54-69% and 34-55%, respectively. The recurrence-free survival rates at 1 and 2 years were 49-60% and 29-46%, respectively. Bladder cancer-specific mortality at 1 and 2-years were 1-3% and 4-11%, respectively. Treatment-related adverse reactions were mostly mild, the most common of which were urinary frequency, urgency, hematuria, and dysuria.@*CONCLUSION@#Sequential intravesical Gemcitabine and Docetaxel is a feasible alternative for BCG-naïve and BCG-refractory NMIBC patients. Oncological outcomes are comparable to BCG therapy with less adverse effects.
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The incidence of bladder cancer is increasing in China. Each year, nearly one third of newly diagnosed cases are muscle invasive bladder cancer (MIBC). The standard treatment for patients with MIBC is radical cystectomy (RC) with pelvic lymphadenectomy. Orthotopic neobladder (ONB) surgery is the primary method of urinary diversion after RC. However, ONB surgery is associated with many post-operative complications related to the urinary tract, intestine, and incision site. Here, we review the mechanism, prevention, and treatment measures of incision complications after ONB surgery.
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Background: Transurethral resection of bladder tumour (TURBT) is the primary treatment modality for Non-muscle invasive bladder cancer (NMIBC). Restaging transurethral resection of bladder tumour (RETURBT) is indicated to reduce risk of residual disease and correct staging errors after primary TURBT. The aim of the study is to evaluate the risk of residual tumour and upstaging in NMIBC after TURBT and to investigate the risk factors for the same.Methods: A prospective observational study was carried out over 4 years and 87 patients were included in the study. Patients with NMIBC underwent RETURBT after 2-6 weeks of primary TURBT. The incidence of residual tumour and upstaging in RETUBRT was correlated with various histopathological and morphological parameters in primary TURBT.Results: Out of 87 patients, who underwent RETURBT, residual disease was present in 51 patients (58.6%) and upstaging occurred in 22 patients (25.2%).On univariate analysis, T1 stage (p=0.01), high grade (p=0.01), Carcinoma in situ(CIS) (p=0.01) and multifocality (p=0.05) were predictive for residual disease in RETURBT. High grade (p=0.01), CIS (p=0.01) and absence of detrusor muscle in specimen (p=0.03) were risk factors for upstaging in RETURBT.Conclusions: NMIBC have high incidence of residual disease and upstaging after primary TURBT. T1 stage, high tumour grade, CIS, and multifocality are risk factors for residual disease after primary TURBT. High tumour grade, CIS and absence of detrusor muscle are strongly associated with upstaging during RETURBT.
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Background: There is a dearth of reliable blood and urine markers for transitional cell carcinoma of urinary bladder. CA 19-9 is a well-known marker for gastrointestinal malignancies and is being investigated for other malignancies including carcinoma bladder. In this prospective study, we evaluated the role of serum CA 19-9 as a tumor marker and correlated its level with tumor grade and stage.Methods: One hundred and fifteen patients with transitional cell carcinoma of urinary bladder and 69 healthy volunteers, as controls were included in the study. Preoperative blood sample was analysed for level of CA 19-9 using ELISA kit (normal - 0 U/ml to 37U/ml) and were correlated with grade and TNM stage of tumor.Results: The range of the control group is 2-38U/ml (mean: 17.67±9.68U/ml); TCC group is 1-94U/ml (mean: 37.12±31.52U/ml) (p=0.304). When CA 19-9 level >37IU/ml was taken as cut-off for a positive test, sensitivity of detecting T3 disease, T4 disease, MIBC, presence of node and high grade tumour were 80%, 75%, 70.3%, 78% and 57.8% respectively. However, there was a statistically significant increase in levels of CA19-9 in relation to higher grade (<0.001), presence of muscle invasion (<0.001), T stage (<0.001) and N stage (<0.001).Conclusions: Serum CA19-9 is almost invariably raised in patients with high grade and invasive disease. Thus, it has a place as a prognostic marker rather than as a diagnostic tool due to its low sensitivity for TCC bladder.
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Objective To investigate the clinical value of preoperative lymphocyte-to-monocyte ratio(LMR)in evaluating the prognosis of patients with stage T1 non-muscle invasive bladder cancer(NMIBC).Methods A total of 215 patients with stage T1 NMIBC who underwent transurethral resection of bladder tumor were enrolled.Clinical data were collected.Patients were followed up and their disease-free survival(DFS)and overall survival(OS)were recorded.The receiver operating characteristic(ROC)curve of preoperative LMR in detecting patient prognosis was used to determine the optimal cut-off value for LMR.Patients were divided into low LMR group(LMR <3.86,=77)and high LMR group(LMR ≥ 3.86,=138).Kaplan-Meier survival curves were explored to compare cumulative DFS and OS rates in patients with different LMR levels,and COX proportional hazards regression model was used to analyze factors associated with DFS and OS.Results All these 215 patients with T1 stage NMIBC were followed up for 2-92 months,and the DFS rate was 59.07% and OS rate was 65.12%.Kaplan-Meier curves showed that the cumulative DFS rate(=4.784,=0.029)and cumulative OS rate(=7.146, =0.008)in the low LMR group were significantly lower than those in the high LMR group.Tumor size ≥ 3 cm(=1.398,95% :1.042-1.875,=0.025),pathological grade G3(=1.266,95% :1.026-1.563,=0.028),and LMR ≥ 3.86(=2.347,95% :1.080-5.101,=0.031)were independent factors associated with DFS in patients with stage T NMIBC.In addition,tumor size ≥ 3 cm(=1.228,95% :1.015-1.484,=0.034),pathological grade G3(=1.366,95% :1.017-1.834,=0.038),and LMR<3.86(=2.008,95% :1.052-3.832,=0.035)were independent factors associated with OS in patients with T1 stage NMIBC. Conclusion Preoperative LMR is an independent factor associated with patients' prognosis in T1 stage NIMBC.Patients with low LMR tend to have higher risk of NMIBC progression and death.
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Humans , Disease-Free Survival , Lymphocytes , Cell Biology , Monocytes , Cell Biology , Prognosis , Retrospective Studies , Survival Rate , Urinary Bladder Neoplasms , Diagnosis , PathologyABSTRACT
Objective To assess the efficacy and side effects of intravesical instillation of BCG after transurethral resection of the bladder tumor (TURBT) in non-muscle invasive bladder cancer (NMIBC) patients.Methods The clinical data of patients treated with BCG 120 mg per course induced perfusion or more after TURBT from December 2013 to October 2016 in 18 hospitals of northeast China region,were analyzed retrospectively.The first part,data of 106 patients with moderate,high-risk NMIBC were collected.A total of 83 patients were male,while the other 23 patients were female.The average age was 66.7 years old.The clinical staging were T1 in 86(81.1％) cases,Ta in 20(18.9％) cases and carcinoma in situ in 6 (5.7％) patients.Intravesical instillation of BCG was executed after transurethral resection of the bladder tumor.The incidence rate of recurrence and progression during more than 6 months' follow-up time were observed.Multivariate analyses were done by using logistic analysis and Cox proportional hazards regression model with Kaplan-Meier method.The second part,treatment compliance of 276 patients with bladder cancer,including moderate/high-risk NMIBC in 263 cases,moderate/high-risk NMIBC followed with renal pelvis/ureteral carcinoma in 8 cases were and moderate/high-risk NMIBC with renal pelvis/ureteral carcinoma in 5 cases who treated with BCG after the surgeries,were observed.Patients consisted of 211 males and 65 females with average age of 68.3 years.Results With a median follow-up of 12 months,9 (8.5％) patients experienced tumor recurrence and 2 (1.9％) patients were found progression in the first part.The one-year cancer free recurrence rate of the patients was 91.5％.Statistically significant prognostic factors for recurrence identified by multivariable analyses were prior recurrence of the tumors (OR =3.214,95％CI0.804-12.845,P =0.099).In the second port,an incidence rate of adverse effects was 64.1％ (177/276).The Ⅲ/Ⅳ degree complications were occurred in 11 patients and satisfactory outcomes achieved with active treatment.A total of 36 patients withdrawal with the major causes were recurrence and progression of bladder tumor in 12 cases (4.4 ％),9 cases (3.3 ％) with economic reasons and 11 cases (4.0％) with serious complications.Conclusions NMIBC patients treated with intravesical BCG therapy have approving cancer free recurrence rates and acceptable adverse effects.Prior recurrence may be prognostic factor of recurrence after intravesical BCG therapy.
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Non-muscle-invasive bladder cancer (NMIBC) is the most common stage of bladder cancer.Although it is the early stage of the malignancy,the diversity of tumor biological behavior and prognosis leads to underdiagnosis and inadequate treatment of the disease.To state the present modality of management of NMIBC,we review the database of Chinese Bladder Cancer Consortium (CBCC) and synthesis updated evidence in NMIBC.
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Objective To investigate the efficacy and safety of intravesical instillation of BCG vaccine in the prevention of early recurrence of middle and high risk non-muscle invasive bladder cancer.Methods From July 2015,patients with non-muscle invasive bladder cancer aged 18-75 years with informed consent were screened and underwent transurethral resection of bladder tumor (TURBT).Immediately intravesical instillation of epirubicin 50 mg was given postoperatively.After pathology was comfirmed,patients was enrolled in group 1 (BCG15) or group 2 (BCG 19) or the control group (epirubicin 18) randomly with SAS 9.3 software.Data of follow-up and Adverse event was collected and analyzed.Results By May 31,2019,531 patients were enrolled in the study.The drop-off rate was 20.1％.167 patients (143 males and 24 females)in group 1,172 patients (141 males and 31 females)in group2 and 84(75 males and 9 females) in the control group with follow-up data were analyzed.There were no significant differences in age,gender,BMI,ECOG score,risk stratification between the three groups (P =0.8641,P =0.2906,P =0.9384,P =0.6126).The median follow-up time makes no statistical difference between the groups (P =0.9251),12.0 (6.0,22.5) months,13.0 (6.0,22.3) months,and 13.0 (7.0,22.3) months.The median recurrence time of the three groups was 4.0 (3.0,6.0) months,4.5 (3.0,9.8) months,4.5 (3.0,8.8) months.There was no statistical difference between the three groups (P =0.2852).Risk stratification in the patients got no significant difference between the three groups (P ＞ 0.05).The 1-year recurrence-free survival rates were 80.0％ in the group 1 and 88.3％ in the group 2 and 73.7％ in the control group.The group 2 was superior to the group 1 and the control group (P =0.0281,P =0.0031).There was no significant difference between group 1 and control group (P =0.2951).There was no significant difference in the cumulative recurrence-free survival between the experimental group 1 and the experimental group 2,(95％ CI 0.80-2.43,P =0.2433).The cumulative recurrence-free survival in the group 1 and the group 2 was better than the control group (95 ％ CI 0.31-0.92,P =0.0266;95 ％ CI 0.20-0.65,P =0.0008).All the cases underwent instillation were analyzed for adverse events.The incidence of overall AE(adverse events) in group 1 was 68.5％ (152/222),the incidence of grade Ⅰ-Ⅱ AE was 53.2％ (118/222),the incidence of grade Ⅲ-Ⅳ AE was 15.3％ (32/222).The incidence of overall AE in the group 2 was 71.8％ (160/223),the incidence of grade Ⅰ-Ⅱ AE was 60.1％ (134/223),and the incidence of grade Ⅲ-Ⅳ AE was 11.7％ (26/223).The overall AE rate in the control group was 53.2％ (59/111),of which the incidence of grade Ⅰ-Ⅱ AE was 42.4％ (47/111),and the incidence of grade Ⅲ-Ⅳ AE was 10.8％ (12/111).There was no difference in the incidence of overall AE between the group 1 and the group 2 (P =0.4497).The incidence of AE in the two experimental groups was higher than that in the control group (P =0.0062,P =0.0008).There was no difference in the incidence of grade Ⅲ-Ⅳ AE between the three groups (P =0.3902).Conclusions BCG(19 instillation schedule) has a better effect on preventing recurrence after 1 year of bladder surgery,which is superior to epirubicin group.The long-term efficacy of BCG in preventing recurrence and the efficacy of different schedules need to be further followed up.The lower urinary tract symptoms,which are mainly urinary frequency,are one of the causes of case fallout and should be fouced in future.Compared with epirubicin,BCG perfusion does not increase the incidence of grade Ⅲ-Ⅳ adverse reactions,and is safe to use.