What question did this study set out to answer?

This research aims to assess the symptom burden and identify symptom clusters in cancer patients undergoing immune checkpoint inhibitor therapy.

January 16, 2026Open Access

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

Key Points

This research aims to assess the symptom burden and identify symptom clusters in cancer patients undergoing immune checkpoint inhibitor therapy.
Conducted a cross-sectional survey involving cancer patients receiving immune checkpoint inhibitors.
Utilized validated Patient-Reported Outcome tools to assess symptoms and quality of life.
Descriptive statistics summarized participant demographics and symptom prevalence.
Exploratory factor analysis identified symptom clusters related to immune checkpoint inhibitor therapy.
Multiple linear regression explored factors influencing overall symptom burden.
Sample comprised 213 participants, primarily male (72%) with stage IV lung cancer (75%).
Fatigue (79.8%) and dry mouth (69.5%) emerged as common symptoms, with fatigue being notably severe.
Five symptom clusters were identified: emotion-function, respiratory, autonomic nerve dysfunction, mucosa-related, and skin-related.
Worse performance status and shorter time from first immunotherapy correlated with greater symptom burden.
Despite symptom challenges, the overall quality of life median score was 7, with a noted relationship between symptom severity and quality of life.

Abstract

ABSTRACT 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.

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

Key Points

Abstract

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