Shuguang Zhang,1 Wenying Chen,2 Jihong Zhou,3 Qi Liang,1 Yu Zhang,4 Ming Su,3 Zilong Zhang,1 Jian Qu5,6 

1Department of Pharmacy, Shenzhen Bao’an Chinese Medicine Hospital, The Seventh Clinical College of Guangzhou University of Chinese Medicine, Shenzhen, People’s Republic of China; 2Department of Pharmacy, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, People’s Republic of China; 3Department of Respiratory and Critical Care Medicine, Shenzhen Bao’an Chinese Medicine Hospital, The Seventh Clinical College of Guangzhou University of Chinese Medicine, Shenzhen, People’s Republic of China; 4Department of Intensive Care Unit, Shenzhen Bao’an Chinese Medicine Hospital, The Seventh Clinical College of Guangzhou University of Chinese Medicine, Shenzhen, People’s Republic of China; 5Department of Pharmacy, the Second Xiangya Hospital, Central South University, Institute of Clinical Pharmacy, Central South University, Changsha, People’s Republic of China; 6Hunan Key Laboratory of the Research and Development of Novel Pharmaceutical Preparations, Changsha Medical University, Changsha, People’s Republic of China

Correspondence: Jian Qu, Department of Pharmacy, the Second Xiangya Hospital, Central South University; Hunan Key Laboratory of the Research and Development of Novel Pharmaceutical Preparations, Changsha Medical University, Changsha, 410011, People’s Republic of China, Email qujianstanley@csu.edu.cn

Abstract: Monoclonal antibodies (mAbs) have transformed cancer treatment by providing highly targeted and effective therapies that specifically attack cancer cells, thus reducing the likelihood of adverse events (AEs) in patients. mAbs exert their action through various mechanisms, such as receptor blockade, antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and inhibition of immune checkpoints (eg, PD-1, PD-L1, and CTLA-4). These therapies have led to significant improvements in the treatment of several cancers, including HER2-positive breast cancer, non-small cell lung cancer (NSCLC), and melanoma. The efficacy of mAb therapy in cancer treatment is influenced by various intrinsic and extrinsic factors, such as environmental exposures, psychosocial factors, infection status, ways of life, and tumor microenvironment (TME), all of which can impact immune responses and treatment outcomes. Notably, the therapeutic benefits of mAbs are often accompanied by immune-related AEs (irAEs), which can vary from mild to severe and affect multiple organ systems. The dual nature of mAbs—stimulating antitumor immune responses while also inducing immune-related side effects—presents a notable challenge in clinical practice. This review highlights the importance of proactive strategies for managing irAEs, such as early detection, corticosteroid use, targeted immunosuppressive treatments, and the urgent need for reliable predictive biomarkers to improve treatment outcomes. Advancements in the prevention, prediction, and management of irAEs are essential to enhance the safety and effectiveness of mAb-based therapies, ultimately aiming to improve cancer patient outcomes.

Keywords: monoclonal antibody, immune-related adverse event, immune checkpoint blockade, cancer immunotherapy, treatment strategy