Antibody-drug conjugates (ADCs) have demonstrated effectiveness in treating various cancers, particularly exhibiting specificity in targeting human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Recent advancements in phase 3 clinical trials have broadened current understanding of ADCs, especially trastuzumab deruxtecan, in treating other HER2-expressing malignancies. This expansion of knowledge has led to the US Food and Drug Administration\'s approval of trastuzumab deruxtecan for HER2-positive and HER2-low breast cancer, HER2-positive gastric cancer, and HER2-mutant nonsmall cell lung cancer. Concurrent with the increasing use of ADCs in oncology, there is growing concern among health care professionals regarding the rise in the incidence of interstitial lung disease or pneumonitis (ILD/p), which is associated with anti-HER2 ADC therapy. Studies on anti-HER2 ADCs have reported varying ILD/p mortality rates. Consequently, it is crucial to establish guidelines for the diagnosis and management of ILD/p in patients receiving anti-HER2 ADC therapy. To this end, a panel of Chinese experts was convened to formulate a strategic approach for the identification and management of ILD/p in patients treated with anti-HER2 ADC therapy. This report presents the expert panel\'s opinions and recommendations, which are intended to guide the management of ILD/p induced by anti-HER2 ADC therapy in clinical practice.

Trastuzumab deruxtecan (T-DXd) is one of the new generation antibody-drug conjugates (ADCs) targeting human epidermal growth factor receptor 2 (HER-2) with bystander effect. T-DXd can not only significantly improve the survival of HER-2-positive advanced breast cancer patients, but also enable advanced breast cancer patients with low HER-2 expression to benefit from HER-2-targeted therapy. T-DXd has been approved by the National Medical Products Administration (NMPA) for the treatment of HER-2-positive or HER-2-low breast cancer patients. It is foreseeable that T-DXd will be widely used in clinical practice in the future. However, T-DXd has also shown different safety characteristics compared to previous HER-2 targeted drugs in clinical trials. How to manage T-DXd adverse events more reasonably and fully utilize the efficacy of T-DXd is an urgent clinical problem. Based on the existing clinical evidence and guideline consensus, combined with clinical practice experience, the expert group finally reached the consensus of clinical care pathway and adverse reaction management of trastuzumab deruxtecan after many discussions. This consensus content includes the clinical use method of T-DXd, pre-treatment patient education, and management of common or noteworthy adverse events of T-DXd. The adverse events include infusion related adverse events, digestive system adverse events (nausea/vomiting, constipation, diarrhea, and decreased appetite), hematological adverse events (neutropenia, febrile neutropenia, anemia, thrombocytopenia), respiratory adverse events (interstitial lung disease/pneumonia), cardiovascular adverse events (decreased left ventricular ejection fraction), adverse events in liver function (elevated transaminases) and other common adverse events (alopecia, fatigue, etc). This consensus focuses on the prevention of adverse events, dose adjustment and treatment when adverse events occur, and recommendations for patients\' lifestyle, aiming to improve clinicians\' understanding of T-DXd and provide practical guidance for clinical oncologists on T-DXd clinical management.
德曲妥珠单抗（T-DXd）是靶向人表皮生长因子受体2（HER-2）的新一代抗体药物偶联物，具备旁观者效应。T-DXd不仅可以大幅改善HER-2阳性晚期乳腺癌患者的生存，还可以使HER-2低表达晚期乳腺癌患者从HER-2靶向治疗中获益。T-DXd已被国家药品监督管理局批准用于治疗HER-2阳性和HER-2低表达乳腺癌患者，未来T-DXd在临床实践中会很快被广泛应用。然而，T-DXd在临床试验中也显示出了与既往抗HER-2靶向药不同的安全性特征，如何更合理地管理T-DXd不良事件，充分发挥T-DXd疗效是当下临床亟需解决的问题。德曲妥珠单抗临床管理路径及不良反应处理共识专家组基于现有的临床循证证据和指南共识，结合临床实践经验，经过多次研讨，最终达成德曲妥珠单抗临床管理路径及不良反应处理中国专家共识（2024版）。共识内容包括T-DXd的临床使用方法、治疗前患者教育和T-DXd常见及需要关注的不良事件及管理等方面，其中T-DXd常见及需要关注的不良事件涵盖了输液相关不良事件、消化系统不良事件（恶心/呕吐、便秘、腹泻和食欲下降）、血液学不良事件（中性粒细胞减少、发热性中性粒细胞减少、贫血、血小板减少）、呼吸系统不良事件（间质性肺病/肺炎）、心血管不良事件（左心射血分数下降）、肝功能不良事件（转氨酶升高）以及其他常见不良事件（脱发、疲乏）等。共识重点介绍了各不良事件的预防、发生不良事件时的剂量调整和治疗以及对患者生活方式的建议，旨在提高临床医师对T-DXd的认识水平，为广大临床肿瘤医师提供T-DXd临床管理及不良事件处理的实践指导。.

The Japanese Breast Cancer Society Clinical Practice Guidelines are published as timely guidance on clinical issues in breast cancer treatment in Japan. In the recent edition of these guidelines, we addressed a new clinical question 34 (CQ 34, systemic treatment part) \"Is trastuzumab deruxtecan recommended for patients with unresectable or metastatic HER2-low breast cancer?\" and a new future research question 7 (FRQ 7, pathological diagnosis part) \"How is HER2-low breast cancer diagnosed for the indication of trastuzumab deruxtecan?\". These questions address use of trastuzumab deruxtecan in patients with unresectable or metastatic HER2-low breast cancer who have previously received chemotherapy for metastatic disease. The strengths of evidence and recommendation were determined through a quantitative and qualitative systematic review using multiple outcomes, including efficacy and safety. We conclude that trastuzumab deruxtecan is recommended for this patient population (strength of recommendation: 1; strength of evidence: moderate; CQ34) and that HER2-low expression for the indication of trastuzumab deruxtecan should be diagnosed using companion diagnostics based on appropriate criteria (FRQ7).

The Korean Society of Gynecologic Oncology (KSGO) had been making an effort to standardize and enhance the quality of domestic uterine corpus cancer treatment by developing updated clinical practice guidelines in 2021. The KSGO revised the guidelines based on a literature search using 4 key elements: Population, Intervention, Comparison, and Outcome framework. These elements include the evaluation of the efficacy and safety of immune checkpoint inhibitor treatment in recurrent/advanced endometrial cancer patients who have failed platinum-based chemotherapy, as well as the effect of combined treatment with trastuzumab in patients with HER2/neu-positive endometrial cancer. Additionally, the guideline assessed the efficacy and safety of omitting lymph node dissection in low-risk endometrial cancer patients, investigated the effect of sentinel lymph node mapping in early-stage endometrial cancer surgery, addressed the outcome of chemoradiation therapy as a postoperative treatment in patients with advanced (stage III-IVA) endometrial cancer, and explored the impact of initial treatment with immune checkpoint inhibitors on survival in patients with advanced or recurrent endometrial cancer patients.

To guide clinicians and policymakers in three global resource-constrained settings on treating patients with metastatic breast cancer (MBC) when Maximal setting-guideline recommended treatment is unavailable.
A multidisciplinary, multinational panel reviewed existing ASCO guidelines and conducted modified ADAPTE and formal consensus processes.
Four published resource-agnostic guidelines were adapted for resource-constrained settings; informing two rounds of formal consensus; recommendations received ≥75% agreement.
Clinicians should recommend treatment according to menopausal status, pathological and biomarker features when quality results are available. In first-line, for hormone receptor (HR)-positive MBC, when a non-steroidal aromatase inhibitor and CDK 4/6 inhibitor combination is unavailable, use hormonal therapy alone. For life-threatening disease, use single-agent chemotherapy or surgery for local control. For premenopausal patients, use ovarian suppression or ablation plus hormone therapy in Basic settings. For human epidermal growth factor receptor 2 (HER2)-positive MBC, if trastuzumab, pertuzumab, and chemotherapy are unavailable, use trastuzumab and chemotherapy; if unavailable, use chemotherapy. For HER2-positive, HR-positive MBC, use standard first-line therapy, or endocrine therapy if contraindications. For triple-negative MBC with unknown PD-L1 status, or if PD-L1-positive and immunotherapy unavailable, use single-agent chemotherapy. For germline BRCA1/2 mutation-positive MBC, if poly(ADP-ribose) polymerase inhibitor is unavailable, use hormonal therapy (HR-positive MBC) and chemotherapy (HR-negative MBC). In second-line, for HR-positive MBC, Enhanced setting recommendations depend on prior treatment; for Limited, use tamoxifen or chemotherapy. For HER2-positive MBC, if trastuzumab deruxtecan is unavailable, use trastuzumab emtansine; if unavailable, capecitabine and lapatinib; if unavailable, trastuzumab and/or chemotherapy (hormonal therapy alone for HR-positive MBC).Additional information is available at www.asco.org/resource-stratified-guidelines. It is ASCO\'s view that healthcare providers and system decision-makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

BACKGROUND: Breast cancer is a global health concern, with a significant portion of patients exhibiting human epidermal growth factor receptor 2 (HER2) overexpression. Trastuzumab is one of the pivotal therapies for HER2-positive breast cancer, but it carries the risk of cardiotoxicity. Guidelines for cardiac monitoring are essential to detect early signs of cardiotoxicity. However, adherence to these guidelines remains uncertain.
METHODS: In this single-center retrospective cohort study, we analyzed data from 167 female patients diagnosed with HER2-positive breast cancer who were treated with trastuzumab. We meticulously assessed the level of adherence to cardiac monitoring guidelines and determined the incidence of trastuzumab-induced cardiotoxicity (TIC). Factors affecting adherence were subsequently investigated using appropriate statistical methods.
RESULTS: Adherence to monitoring guidelines was only 31.7%. TIC incidence was 7.8%. Patients with concurrent use of cardiotoxic medications demonstrated higher adherence. A significant association was found between the number of trastuzumab doses and adherence.
CONCLUSIONS: Adherence to monitoring guidelines was suboptimal. Those at a higher risk of cardiac issues showed greater adherence. Improved risk assessment methods are needed to individualize monitoring and intervention. Future research should focus on patient-centered, evidence-based monitoring to optimize the balance between cancer therapy and cardiac safety in the field of cardio-oncology.

Breast cancer represents the most commonly diagnosed neoplasm worldwide and the HER2-positive subtype accounts for nearly 1 in 5 breast cancers. The majority of patients with breast cancer present with an early-stage disease upon diagnosis, which is thus susceptible to virtually curative treatment strategies. For a stage, I T1a/b N0 HER2-positive disease, upfront surgery followed by adjuvant therapy is the preferred approach. However, there is some uncertainty regarding the appropriate management of stage cT1c cN0, as both the neoadjuvant approach and upfront surgery have been proven to be feasible therapeutic options. The aim of this Delphi consensus was to define the best strategies for the treatment of early HER2-positive breast cancer. This work may help clinicians in the management of early HER2-positive breast cancer.

Salivary duct carcinoma (SDC) is aggressive with limited therapeutic options. A subset of SDC display human epidermal growth factor receptor 2 (HER2) protein overexpression by immunohistochemistry, and some show ERBB2 gene amplification. Guidelines for HER2 scoring are not firmly established. Recent advances in breast carcinoma have established a role for anti-HER2 therapies in lesions with low HER2 expression lacking ERBB2 amplification. Delineating HER2 staining patterns in SDC is critical for evaluating anti-HER2 treatments. In total, 53 cases of SDC resected at our institution between 2004 and 2020 were identified. Androgen receptor (AR) and HER2 immunohistochemistry and ERBB2 fluorescence in situ hybridization were performed in all cases. AR expression was scored for percentage positive cells and categorized as positive (>10% of cells), low positive (1%-10%), or negative (<1%). HER2 staining levels and patterns were recorded, scored using 2018 ASCO/CAP guidelines, and categorized into HER2-positive (3+ or 2+ with ERBB2 amplification), HER2-low (1+ or 2+ without ERBB2 amplification), HER2-very low (faint staining in <10% of cells), or HER2-absent types. Clinical parameters and vital status were recorded. Median age was 70 years, with a male predominance. ERBB2-amplified tumors (11/53; 20.8%) presented at lower pT stages (pTis/pT1/pT2; P = .005, Fisher exact test) and more frequently had perineural invasion (P = .007, Fisher exact test) compared with ERBB2 nonamplified tumors; no other pathologic features differed significantly by gene amplification status. In addition, 2+ HER2 staining by 2018 ASCO/CAP criteria was most common (26/53; 49%); only 4 cases (8%) were HER2-absent status; 3+ HER2 staining was found in 9 tumors, and all were ERBB2 amplified. Six patients with HER2-expressing tumors received trastuzumab therapy, including 2 with ERBB2-amplified tumors. Overall survival and recurrence-free survival did not differ significantly based on ERBB2 status. This work suggests that 2018 ASCO/CAP guidelines for HER2 evaluation in breast carcinoma could be applied to SDC. Our findings also show broad overexpression of HER2 in SDC raising the possibility that more patients may benefit from anti-HER2-directed therapies.

As a newly emerged class of anticancer bioagents in the most precise and selectively targeted way, antibody-drug conjugate (ADC) combines the cancer-targeting abilities of monoclonal antibodies with the cytotoxicity potency of payload, delivering highly cytotoxic drug into tumors via \'targeted chemotherapy\'. ADC has revolutionized the treatment landscape of human epidermal growth factor receptor 2 positive and triple negative subtypes in breast cancer. Three ADCs have been approved by U. S. Food and Drug Administration with breast cancer indications, including trastuzumab emtansine (T-DM1; also approved in China), trastuzumab deruxtecan (T-DXd, DS-8201) and sacituzumab govitecan (IMMU-132; also approved in China). Antibodies, cytotoxic drug, linker, and conjugation process are implicated in ADC profile, resulting in unique adverse drug reactions and toxicity heterogeneity within ADC class. For example, more attention should be paid to the management of thrombocytopenia, hepatotoxicity, and reductions in left ventricular ejection fraction (LVEF) in patients treated with trastuzumab emtansine; clinical physicians should pay attention to the risk of neutropenia, interstitial lung disease/pneumonitis, and reductions in LVEF when treated with trastuzumab deruxtecan; sacituzumab govitecan most frequently caused neutropenia, anemia and diarrhea requiring close monitor. ADC has generally favorable safety profiles, and dose modifications and/or symptomatic supporting treatment are effective in terms of toxicity management. This consensus aims at providing guidance for clinical oncologists of early detection, regular assessment, timely management and follow-up monitor of ADC-associated adverse reactions/events.
抗体药物偶联物(ADC)将单克隆抗体的选择性与有效载荷的细胞杀伤特性合二为一，通过靶向化疗的方式将细胞毒性药物释放至肿瘤，是一类相对新颖的具有高度靶向性的抗癌生物制剂。在乳腺癌领域中，ADC改变了人类表皮生长因子受体2阳性以及三阴性乳腺癌的治疗格局。目前获得美国食品药品监督管理局批准的3种ADC有乳腺癌适应证，分别为恩美曲妥珠单抗、Trastuzumab deruxtecan和戈沙妥珠单抗，其中恩美曲妥珠单抗和戈沙妥珠单抗也在中国获得批准上市。鉴于ADC涉及抗体、细胞毒性制剂、连接子以及偶联过程，因此导致了ADC不良反应的独特性及其类别内安全谱的异质性。接受恩美曲妥珠单抗治疗的患者需特别关注血小板减少、肝不良反应以及左心室射血分数(LVEF)降低；Trastuzumab deruxtecan治疗期间应关注中性粒细胞减少、间质性肺疾病或非感染性肺炎以及LVEF降低的风险；戈沙妥珠单抗治疗常导致中性粒细胞减少、贫血，同时需密切监测腹泻。ADC总体上安全性良好，剂量调整和(或)对症支持治疗为有效的管理方式。中国医师协会肿瘤医师分会乳腺癌学组和中国抗癌协会国际医疗交流分会组织专家共同制定了中国乳腺癌抗体药物偶联物安全性管理专家共识，旨在为临床肿瘤医师提供ADC相关不良反应或不良事件的早期识别、定期评估、及时管理以及随访监测的实践指导。.

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