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    Home > Active Ingredient News > Urinary System > Clinical necessity Consensus on the safety of clinical application of urothelial carcinoma antibody conjugate drugs

    Clinical necessity Consensus on the safety of clinical application of urothelial carcinoma antibody conjugate drugs

    • Last Update: 2022-11-01
    • Source: Internet
    • Author: User
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    A number of antibody conjugates (ADCs) have been used in the treatment of urothelial carcinoma at home and abroad, including enoximab (EV), gosastuzumab (SG) and widicitumab (study code: RC48).

    At present, the treatment of ADC drugs for advanced urothelial carcinoma in China has not been widely carried out, and there is a lack
    of experience in its rational application and adverse reaction management.

    The effective use of ADC drugs is of great significance to ensure and improve the efficacy of ADC drugs and the quality of life of patients, and the Urology Promotion Branch of China Healthcare International Promotion and Exchange Association and the Urology Professional Committee of the Chinese Research Hospital Association have formulated a consensus on the safety of clinical application of ADC drugs in patients with advanced urothelial carcinoma It aims to promote the safe application of
    ADC drugs in urothelial carcinoma patients in China.
    The main points of Yimaitong are as follows

    Clinical specific implementation operations


    Rationalization of patient indications

    There are three ADC drugs at home and abroad for the treatment of advanced urothelial carcinoma, namely EV, SG and RC48, all of which have shown superior efficacy

    Table 1 Recommended ADC drug guidelines for advanced urothelial carcinoma


    Pre-medication evaluation and contraindications

    (1) Adverse reactions related to ADC drug treatment can affect multiple organs of the body, and due to the different antibodies and cytotoxic drugs, there are differences
    between the spectrum of adverse drug reactions.
    Therefore, patients should undergo a thorough and systematic evaluation
    before administering ADC drug therapy.
    In addition to the routine performance status (ECOG performance status score), hematological parameters, and comorbidities, the functional status of the target organ where adverse reactions occur should also be assessed
    before administration.
    If there is rash, itching, vitiligo, etc.
    , it is necessary to record the location and severity of the occurrence, evaluate the basic cardiopulmonary function, whether there are underlying eye diseases, and the basic status of metabolic and endocrine systems such as blood sugar and blood lipids

    (2) EV is not recommended for patients with active keratitis or corneal ulcers, and EV or RC48
    is not recommended for patients with previous sensory or motor neuropathy of grade 2 or above.
    Hypersensitivity to the active ingredient or any excipients in ADC drugs is a contraindication to ADC drugs


    Medication method and efficacy evaluation

    (1) The dosage regimen and dose of three ADC drugs are shown in Table 2, and the administered dose is calculated
    according to body weight.
    The department performing chemotherapy must have ECG monitoring, necessary rescue drugs and measures
    Patients need ECG monitoring during infusion, and specialist nurses or physicians need to closely monitor the infusion response at the bedside during infusion (especially during the first infusion) and observe it for at least 1 h after the infusion ends, especially for patients who
    are taking the drug for the first time.

    Table 2 ADC drug dosage regimen and dose

    (2) Patients should be evaluated according to the efficacy evaluation standard of solid tumors (RECIST1.
    1) before and during treatment of ADC drugs, and pay attention to the evaluation
    of patients' quality of life during the treatment of ADC drugs.

    Expert consensus recommendations:

    According to the existing evidence-based medical evidence and the current situation in China, after discussion by the Urology Oncology Multidisciplinary Joint Diagnosis (MDT) team, ADC drug treatment
    was received with the patient's knowledge and full communication.
    Before and during medication, the patient's physical condition should be comprehensively assessed, including the baseline state of each important organ and the changes in treatment, especially the adverse reactions of ADC drugs that need attention, so as to ensure the safe use of ADC drugs to the greatest extent
    ADC drugs should be administered
    strictly according to the recommended medication regimen and dosage.
    Be alert to the occurrence of infusion reactions, pretreat drugs if necessary, ensure the smooth progress of treatment, and evaluate the treatment process in accordance with RECIST 1.
    1 standards

    Management and control of clinical risk events

    Adverse effects vary between ADC drugs due to differences in antibodies, linkers, and cytotoxic drugs
    This consensus classifies the common adverse reactions of three ADC drugs according to different systems of adverse reactions, namely skin reactions, ocular toxicity, digestive tract reactions, hematological toxicity, neurotoxicity, hepatotoxicity, pulmonary toxicity, metabolic abnormalities and other adverse reactions

    Expert consensus recommendations:

    ADC drugs due to the unique tissue structure and mechanism of action, different from previous chemotherapy drugs, targeted drugs and immunotherapy drugs, its adverse reactions mainly come from the target monoclonal antibody to produce off-target effects and conjugated cytotoxic drugs, etc.
    , can affect multiple organ systems, severe cases can be life-threatening, the treatment of adverse reactions should be fully combined with the MDT mechanism, early detection, timely treatment, to avoid serious adverse reactions
    。 The Nectin-4 molecule targeted by EV is associated with the expression of normal skin tissue and corneal epithelium, so special attention to skin reactions and ocular toxicity is required when applying EV, and dermatological and ophthalmic evaluations
    are performed regularly.
    Among the adverse reactions caused by ADC drugs coupled with cytotoxic drugs, digestive tract reactions, bone marrow suppression, and neurotoxicity are common adverse reactions
    The incidence of SG-induced diarrhea and neutropenia is relatively high, while EV and RC48 require special attention for neurotoxicity
    For ADC drugs combined with PD-1/PD-L1 monoclonal antibody and other treatments, high vigilance
    should be exercised against the possibility of more serious adverse reactions.

    The principle of dose reduction and discontinuation

    ADC drug-related adverse reactions are mainly graded according to the Common Adverse Reaction Evaluation Criteria (CTCAE), and the treatment of dose reduction or discontinuation is carried out according to the different levels of occurrence (Table 3).

    Clinically, special adverse reactions should be paid attention to in the management of adverse reactions, and MDT consultation should be established and actively carried out to ensure the safety
    of patients.
    The general principle is that grade 1 adverse reactions can be continued; The vast majority of grade 2 adverse reactions can maintain the original dose and continue to be used, and some adverse reactions such as thrombocytopenia, neurotoxicity and corneal lesions need to be suspended and continued after recovery to grade 1; For grade 3 adverse reactions, ADC drug treatment should be suspended in time, and dose reduction therapy should be given after the adverse reactions have recovered to level 1; Discontinuation of treatment should be considered for grade 4 adverse reactions or repeated grade 3 reactions (Table 4).

    Table 3 ADC drug dose reduction plan


    Table 4 Basic principles of ADC drug dose adjustment

    Expert consensus recommendations:

    For adverse reactions that may occur during the application of ADC drugs, active preventive treatment should be given before treatment; After medication, relevant adverse reactions should be closely monitored, timely diagnosis and corresponding treatment plans should be given, and drug treatment regimens should be re-evaluated at the same time, and postponed treatment or dose reduction should be carried out if necessary; For serious adverse reactions, the drug should be stopped in time, and multidisciplinary consultation should be actively carried out to explore solutions

    Special population treatment



    ADC drugs affect glucose and lipid metabolism in the body, and diabetic patients are recommended to stabilize blood sugar control before starting treatment
    Both EV and RC48 reported a blood glucose increase of more than 10%, and SG reported a lower incidence of blood glucose increase of less than 1%.


    Eye diseases

    Patients with active keratitis or corneal ulcers are not recommended for EV treatment


    Renal insufficiency

    Patients with renal insufficiency do not need to adjust the EV dose, including severe renal insufficiency (creatinine clearance < 30 mL/min).
    <b10> SN-38 is rarely cleared from the kidney, but there are no pharmacokinetic data
    for renal insufficiency or end-stage renal disease.
    RC48 does not require dose adjustment in patients with mild and moderate renal impairment, and there are no research data
    in patients with severe renal impairment.

    Expert consensus recommendations:

    The basic organ function of patients before ADC drug treatment should be fully assessed, and patients with specific underlying diseases should be used under close monitoring after eliminating contraindications to ensure the safety
    of patients.


    [1] Urology Health Promotion Branch of China Healthcare International Promotion and Exchange Association, Urology Professional Committee of China Research Hospital Association.
    Safety consensus on clinical application of antibody conjugate drugs for urothelial carcinoma (1st edition)[J].
    Modern Journal of Urology,2022,27(8):628-634.

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