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Bladder cancer is one of the common malignant tumors that threaten human health
.
It is of great significance to standardize and improve the diagnosis and treatment of bladder cancer .
Transurethral resection of bladder tumor (TURBT) is the first choice for the diagnosis and treatment of non-muscular invasive bladder cancer (NMIBC), but up to 45% of patients relapse within 1 year after TURBT treatment alone, and 6% to 17% of patients will progress
.
Bladder perfusion therapy is to inject cytotoxic drugs into the bladder to directly kill tumor cells, or to inject immune agents such as Bacille Calmette-Guerin (BCG) to directly or indirectly induce immune responses in the body, thereby reducing the risk of tumor recurrence and progression
.
Bladder perfusion therapy can be used alone or as a local adjuvant treatment after transurethral surgery.
It is currently one of the most common treatments in urology
.
The indications of bladder perfusion are based on the recommendations of domestic and foreign guidelines.
The 2021 version of the non-muscular invasive bladder cancer bladder perfusion therapy expert consensus recommends the use of the 2019 version of the Chinese Guidelines for the Diagnosis and Treatment of Bladder Cancer to classify the risk of NMIBC
.
Low-risk patients: A single dose of bladder infusion chemotherapy is given immediately after the operation, and subsequent bladder induction and maintenance perfusion are not recommended
.
Intermediate-risk patients: A single dose of bladder infusion chemotherapy is given immediately after surgery, followed by bladder induction and maintenance infusion, chemotherapy drugs or BCG infusion can be selected, and the infusion time does not exceed 1 year
.
High-risk patients: A single dose of bladder perfusion chemotherapy is given immediately after the operation.
Follow-up is recommended for bladder induction and maintenance perfusion.
BCG bladder perfusion is the first choice, and the perfusion time is 1 to 3 years
.
In cases where BCG is not available or the patient refuses to use it, bladder perfusion with chemotherapy drugs can be considered
.
Very high-risk patients: In the case of unsuitable or unwilling to undergo radical cystectomy, BCG bladder induction and maintenance perfusion can be considered.
Bladder induction and maintenance perfusion should be as much as possible for 3 years
.
Contraindications for bladder perfusion: Contraindications for bladder perfusion with chemotherapy drugs: bladder perforation during TURBT operation, obvious gross hematuria after operation, severe chemical cystitis, acute urinary tract infection
.
Contraindications of BCG bladder perfusion: within 2 weeks after TURBT, patients with gross hematuria, traumatic catheterization, symptomatic urinary tract infection
.
Classification of bladder perfusion: immediate bladder perfusion: a single dose of immediate bladder perfusion chemotherapy can kill the tumor cells spread during the operation and the tumor cells remaining on the wound
.
Immediate perfusion is suitable for low-risk, intermediate-risk, and high-risk NMIBC, and it is recommended to complete it within 24 hours after surgery.
If possible, it can be completed in the operating room or within 6 hours after surgery
.
Induction perfusion: suitable for medium-risk and high-risk NMIBC, chemotherapy drugs or immune preparations can be used, generally starting 1 to 2 weeks after surgery, once a week, a total of 6 to 8 times
.
The start time of induced infusion of chemotherapeutics can be advanced to about 1 week after the operation according to the specific conditions of the patient, and the start time of BCG induction infusion must be arranged after 2 weeks after the operation
.
Maintenance perfusion: suitable for intermediate-risk and high-risk NMIBC
.
Chemotherapy drugs or immune preparations can be selected for maintenance perfusion, which is generally performed after the induction perfusion, and once every 2 to 4 weeks until the end of the maintenance perfusion regimen
.
Commonly used drugs for bladder perfusion therapy, adverse reactions Bladder perfusion chemotherapy Mitomycin C (MMC): is an antibiotic chemotherapy drug, has an alkylating effect, can cross-link with tumor cell DNA double strands or degrade DNA, inhibiting its replication , Play an anti-tumor effect, the therapeutic dose is generally 20~60mg, dissolved in water for injection (concentration of 1~2mg/ml)
.
MMC bladder perfusion can also use hyperthermic perfusion chemotherapy or electric perfusion chemotherapy
.
Adverse reactions include chemical cystitis, bladder contracture, and genital rash
.
Epirubicin: An anthracycline anti-tumor drug made through a semi-synthetic route.
Its main function is to directly intercalate between DNA base pairs, interfere with the transcription process, and prevent the formation of mRNA
.
The usual dosage is 50~80mg, and it can be diluted to a solution with a concentration of 1~1.
6 mg/ml with normal saline or 5% glucose solution
.
Epirubicin bladder perfusion has less local irritation and fewer serious adverse reactions
.
Pirubicin (THP): It is a derivative of doxorubicin with strong anti-tumor activity and a broad anti-cancer spectrum
.
THP can quickly enter cancer cells, by directly inhibiting nucleic acid synthesis, blocking the cell cycle in the G2 phase of cell division, thereby killing cancer cells.
The bladder perfusion dose is 30-50 mg, and diluted with water for injection or 5% glucose solution as a solvent.
It is a solution with a concentration of 1 mg/ml
.
The main adverse reaction is chemical cystitis
.
Gemcitabine: Gemcitabine is a class of anti-metabolic chemotherapeutic drugs with extensive anti-cancer activity
.
When ingested by cells, gemcitabine is phosphorylated into active metabolites (gemcitabine diphosphate and gemcitabine triphosphate), which block DNA synthesis and cause cell apoptosis, which is a cell cycle specific drug
.
The commonly used bladder perfusion dose of gemcitabine is 1000~2000mg, diluted with 50ml of normal saline, and configured into a solution with a concentration of 20~40 mg/ml
.
Local irritation of the bladder perfused with gemcitabine is rare, and there are occasional systemic adverse reactions such as nausea and vomiting
.
Hydroxycamptothecin: Hydroxycamptothecin is a type of plant-based chemotherapeutic agent, which is mainly sensitive to proliferating cells.
It is a cell cycle specific drug that acts in S phase
.
The usual bladder perfusion dose is 10-20mg, and the drug concentration is 0.
5-1mg/ml
.
Hydroxycamptothecin bladder perfusion can cause adverse reactions such as nausea, vomiting, bone marrow suppression, and chemical cystitis is rare
.
Bladder perfusion immunotherapy BCG is suitable for the treatment of high-risk NMIBC, which can reduce the recurrence rate and progression of bladder cancer
.
BCG cannot change the course of low-risk NMIBC, and because of the adverse effects of BCG perfusion, BCG perfusion therapy is not recommended for low-risk patients
.
BCG can also be used for bladder perfusion for intermediate-risk NMIBC, but it needs to be combined with the individual's risk of recurrence and progression and the adverse effects of BCG treatment
.
The domestically marketed BCG strain is a therapeutic BCG cultured from China's D2PB302 strain
.
Judging from the effect of clinical application in recent years, domestically produced BCG
.
The short-term efficacy of the treatment of high-risk NMIBC is definite, and the 1-year recurrence-free survival rate is 79% to 91.
5%
.
Combined with foreign recommendations and current domestic clinical practice, the consensus expert group recommends the following: Patients with intermediate-risk NMIBC can use bladder infusion chemotherapy instead of BCG
.
For high-risk NMIBC patients, full-dose BCG should be given priority, and the perfusion time is 1 to 3 years
.
If BCG is not available or the patient refuses to use it, bladder infusion chemotherapy can be considered
.
For extremely high-risk NMIBC, a radical cystectomy should be implemented as soon as possible in communication with the patient
.
For high-risk NMIBC patients who are unsuitable or unwilling to undergo radical cystectomy, if BCG is not available or the patient refuses to use it, MMC hyperthermic perfusion chemotherapy or electrokinetic perfusion chemotherapy can be used as an alternative
.
For high-risk NMIBC with failed BCG perfusion, radical cystectomy is the first choice.
If the patient refuses or cannot tolerate the operation due to physical reasons, he can participate in clinical trials of new drugs, including immunotherapy (PD-L1/PD-L1 antibody, ALT-803), gene therapeutic antibody-drug conjugates and oncolytic adenovirus
.
The results of previous studies have shown that the effective rates (3 and 12 months) of these new drugs are 40% to 82% and 17% to 44%, respectively.
The long-term efficacy remains to be further observed
.
Source: Expert consensus on bladder perfusion therapy for non-muscular invasive bladder cancer (2021 version).
Urology and Oncology Group of China Cancer Hospital.
Corresponding author: Ye Dingwei, Department of Urology, Fudan University Cancer Hospital
.
It is of great significance to standardize and improve the diagnosis and treatment of bladder cancer .
Transurethral resection of bladder tumor (TURBT) is the first choice for the diagnosis and treatment of non-muscular invasive bladder cancer (NMIBC), but up to 45% of patients relapse within 1 year after TURBT treatment alone, and 6% to 17% of patients will progress
.
Bladder perfusion therapy is to inject cytotoxic drugs into the bladder to directly kill tumor cells, or to inject immune agents such as Bacille Calmette-Guerin (BCG) to directly or indirectly induce immune responses in the body, thereby reducing the risk of tumor recurrence and progression
.
Bladder perfusion therapy can be used alone or as a local adjuvant treatment after transurethral surgery.
It is currently one of the most common treatments in urology
.
The indications of bladder perfusion are based on the recommendations of domestic and foreign guidelines.
The 2021 version of the non-muscular invasive bladder cancer bladder perfusion therapy expert consensus recommends the use of the 2019 version of the Chinese Guidelines for the Diagnosis and Treatment of Bladder Cancer to classify the risk of NMIBC
.
Low-risk patients: A single dose of bladder infusion chemotherapy is given immediately after the operation, and subsequent bladder induction and maintenance perfusion are not recommended
.
Intermediate-risk patients: A single dose of bladder infusion chemotherapy is given immediately after surgery, followed by bladder induction and maintenance infusion, chemotherapy drugs or BCG infusion can be selected, and the infusion time does not exceed 1 year
.
High-risk patients: A single dose of bladder perfusion chemotherapy is given immediately after the operation.
Follow-up is recommended for bladder induction and maintenance perfusion.
BCG bladder perfusion is the first choice, and the perfusion time is 1 to 3 years
.
In cases where BCG is not available or the patient refuses to use it, bladder perfusion with chemotherapy drugs can be considered
.
Very high-risk patients: In the case of unsuitable or unwilling to undergo radical cystectomy, BCG bladder induction and maintenance perfusion can be considered.
Bladder induction and maintenance perfusion should be as much as possible for 3 years
.
Contraindications for bladder perfusion: Contraindications for bladder perfusion with chemotherapy drugs: bladder perforation during TURBT operation, obvious gross hematuria after operation, severe chemical cystitis, acute urinary tract infection
.
Contraindications of BCG bladder perfusion: within 2 weeks after TURBT, patients with gross hematuria, traumatic catheterization, symptomatic urinary tract infection
.
Classification of bladder perfusion: immediate bladder perfusion: a single dose of immediate bladder perfusion chemotherapy can kill the tumor cells spread during the operation and the tumor cells remaining on the wound
.
Immediate perfusion is suitable for low-risk, intermediate-risk, and high-risk NMIBC, and it is recommended to complete it within 24 hours after surgery.
If possible, it can be completed in the operating room or within 6 hours after surgery
.
Induction perfusion: suitable for medium-risk and high-risk NMIBC, chemotherapy drugs or immune preparations can be used, generally starting 1 to 2 weeks after surgery, once a week, a total of 6 to 8 times
.
The start time of induced infusion of chemotherapeutics can be advanced to about 1 week after the operation according to the specific conditions of the patient, and the start time of BCG induction infusion must be arranged after 2 weeks after the operation
.
Maintenance perfusion: suitable for intermediate-risk and high-risk NMIBC
.
Chemotherapy drugs or immune preparations can be selected for maintenance perfusion, which is generally performed after the induction perfusion, and once every 2 to 4 weeks until the end of the maintenance perfusion regimen
.
Commonly used drugs for bladder perfusion therapy, adverse reactions Bladder perfusion chemotherapy Mitomycin C (MMC): is an antibiotic chemotherapy drug, has an alkylating effect, can cross-link with tumor cell DNA double strands or degrade DNA, inhibiting its replication , Play an anti-tumor effect, the therapeutic dose is generally 20~60mg, dissolved in water for injection (concentration of 1~2mg/ml)
.
MMC bladder perfusion can also use hyperthermic perfusion chemotherapy or electric perfusion chemotherapy
.
Adverse reactions include chemical cystitis, bladder contracture, and genital rash
.
Epirubicin: An anthracycline anti-tumor drug made through a semi-synthetic route.
Its main function is to directly intercalate between DNA base pairs, interfere with the transcription process, and prevent the formation of mRNA
.
The usual dosage is 50~80mg, and it can be diluted to a solution with a concentration of 1~1.
6 mg/ml with normal saline or 5% glucose solution
.
Epirubicin bladder perfusion has less local irritation and fewer serious adverse reactions
.
Pirubicin (THP): It is a derivative of doxorubicin with strong anti-tumor activity and a broad anti-cancer spectrum
.
THP can quickly enter cancer cells, by directly inhibiting nucleic acid synthesis, blocking the cell cycle in the G2 phase of cell division, thereby killing cancer cells.
The bladder perfusion dose is 30-50 mg, and diluted with water for injection or 5% glucose solution as a solvent.
It is a solution with a concentration of 1 mg/ml
.
The main adverse reaction is chemical cystitis
.
Gemcitabine: Gemcitabine is a class of anti-metabolic chemotherapeutic drugs with extensive anti-cancer activity
.
When ingested by cells, gemcitabine is phosphorylated into active metabolites (gemcitabine diphosphate and gemcitabine triphosphate), which block DNA synthesis and cause cell apoptosis, which is a cell cycle specific drug
.
The commonly used bladder perfusion dose of gemcitabine is 1000~2000mg, diluted with 50ml of normal saline, and configured into a solution with a concentration of 20~40 mg/ml
.
Local irritation of the bladder perfused with gemcitabine is rare, and there are occasional systemic adverse reactions such as nausea and vomiting
.
Hydroxycamptothecin: Hydroxycamptothecin is a type of plant-based chemotherapeutic agent, which is mainly sensitive to proliferating cells.
It is a cell cycle specific drug that acts in S phase
.
The usual bladder perfusion dose is 10-20mg, and the drug concentration is 0.
5-1mg/ml
.
Hydroxycamptothecin bladder perfusion can cause adverse reactions such as nausea, vomiting, bone marrow suppression, and chemical cystitis is rare
.
Bladder perfusion immunotherapy BCG is suitable for the treatment of high-risk NMIBC, which can reduce the recurrence rate and progression of bladder cancer
.
BCG cannot change the course of low-risk NMIBC, and because of the adverse effects of BCG perfusion, BCG perfusion therapy is not recommended for low-risk patients
.
BCG can also be used for bladder perfusion for intermediate-risk NMIBC, but it needs to be combined with the individual's risk of recurrence and progression and the adverse effects of BCG treatment
.
The domestically marketed BCG strain is a therapeutic BCG cultured from China's D2PB302 strain
.
Judging from the effect of clinical application in recent years, domestically produced BCG
.
The short-term efficacy of the treatment of high-risk NMIBC is definite, and the 1-year recurrence-free survival rate is 79% to 91.
5%
.
Combined with foreign recommendations and current domestic clinical practice, the consensus expert group recommends the following: Patients with intermediate-risk NMIBC can use bladder infusion chemotherapy instead of BCG
.
For high-risk NMIBC patients, full-dose BCG should be given priority, and the perfusion time is 1 to 3 years
.
If BCG is not available or the patient refuses to use it, bladder infusion chemotherapy can be considered
.
For extremely high-risk NMIBC, a radical cystectomy should be implemented as soon as possible in communication with the patient
.
For high-risk NMIBC patients who are unsuitable or unwilling to undergo radical cystectomy, if BCG is not available or the patient refuses to use it, MMC hyperthermic perfusion chemotherapy or electrokinetic perfusion chemotherapy can be used as an alternative
.
For high-risk NMIBC with failed BCG perfusion, radical cystectomy is the first choice.
If the patient refuses or cannot tolerate the operation due to physical reasons, he can participate in clinical trials of new drugs, including immunotherapy (PD-L1/PD-L1 antibody, ALT-803), gene therapeutic antibody-drug conjugates and oncolytic adenovirus
.
The results of previous studies have shown that the effective rates (3 and 12 months) of these new drugs are 40% to 82% and 17% to 44%, respectively.
The long-term efficacy remains to be further observed
.
Source: Expert consensus on bladder perfusion therapy for non-muscular invasive bladder cancer (2021 version).
Urology and Oncology Group of China Cancer Hospital.
Corresponding author: Ye Dingwei, Department of Urology, Fudan University Cancer Hospital
