Patient‐Reported Symptom and Symptom Clusters During Immune Checkpoint Inhibitor Therapy for Cancer Patients: A Cross‐Sectional Survey

Background and Aims: Cancer treatment management necessitates comprehensive symptom burden assessment, particularly with therapies like immune checkpoint inhibitors (ICIs), known for unique toxicities. While ICIs show promising outcomes, they also induce immune-related adverse events (irAEs), posing challenges due to their varied onset, duration, and severity. Traditional clinician-reported tools may overlook nuances, hence the importance of Patient-Reported Outcomes (PRO). Symptom clusters, representing interrelated symptoms sharing biological mechanisms, offer a holistic approach to symptom management yet are understudied in ICI therapy. Methods: A cross-sectional survey at Guang'anmen Hospital, China, from January 2021 to March 2023, enrolled cancer patients undergoing ICI therapy. Validated PRO tools captured symptoms, interference, and quality of life. Descriptive statistics summarized demographics, while exploratory factor analysis identified symptom clusters. Multiple linear regression analyzed factors influencing symptom burden, and Pearson correlation examined relationships. Results: Among 213 participants, predominantly male (72%) with lung cancer (75%), most had Stage IV disease (59%). Fatigue (79.8%) and dry mouth (69.5%) were prevalent, with fatigue being the highest incidence of moderate to severe cases. Five symptom clusters were identified: emotion-function, respiratory, autonomic nerve dysfunction, mucosa-related, and skin-related. Poor Eastern Cooperative Oncology Group performance status and time from the first immunotherapy ≤ 3 months correlated with higher symptom burden. Participants reported overall good health-related quality of life, with a median score of 7 (IQR 5-8). The severity of symptom burden correlates with poorer quality of life. Conclusion: During ICI treatment, cancer patients endure multi-faceted symptoms, forming clusters that may have distinct biological underpinnings. Early recognition and mechanism-driven management of these clusters are crucial for mitigating treatment toxicities and improving patient outcomes. Further research is warranted to deepen our understanding and refine symptom management strategies. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.