[Guidelines for managing adverse reactions to antibody-drug conjugates in breast cancer (2025 edition)].
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Breast cancer is the most common malignancy among women worldwide, with its incidence continuing to rise, posing a serious threat to women's health. In recent years, with the widespread adoption of molecular subtyping in diagnosis and treatment, breast cancer therapy has entered an era of individualized precision medicine. Early-stage breast cancer is primarily managed with surgery, combined with chemotherapy, radiotherapy, endocrine therapy, and targeted therapies (such as trastuzumab and pertuzumab), significantly improving cure rates. However, for recurrent or metastatic breast cancer, particularly refractory subtypes such as triple-negative and HER2-positive breast cancer, the efficacy of traditional treatments remains limited, and patients still face a poor prognosis. Antibody-drug conjugates (ADCs), as an innovative targeted therapy strategy, combine the precise targeting of monoclonal antibodies with the potent cytotoxicity of payload drugs, delivering cytotoxic agents directly to tumors through targeted chemotherapy, achieving "precision delivery and efficient killing". ADCs represent a relatively novel class of highly targeted anticancer biologics. In the field of breast cancer treatment, ADCs have made groundbreaking progress. Agents such as T-DM1 and T-DXd have significantly prolonged progression-free survival and overall survival in HER2-positive patients, providing critical treatment options for advanced-stage patients, markedly improving survival outcomes, and are now being explored in earlier lines of therapy, reshaping the treatment landscape of breast cancer. Although ADCs are generally well-tolerated, their unique structure-comprising antibodies, cytotoxic payloads, linkers, and conjugation processes-leads to distinct adverse effects and heterogeneous safety profiles within the class. Based on the latest research advances in ADC therapy for breast cancer and incorporating clinical experience from both domestic and international settings, the Breast Cancer Professional Committee of China Anti-Cancer Association, along with Breast Cancer Prevention and Treatment Research Professional Committee of Maternal and Child Health Research Society of China have jointly developed the "Guidelines for managing adverse reactions to antibody-drug conjugates in breast cancer (2025 edition)". This guideline aims to provide healthcare professionals with practical guidance on the early identification, regular assessment, timely management, and follow-up monitoring of ADC-related adverse reactions or events.