Sleep Quality and Its Determinants Among Patients with Metastatic Cancer Treated with Immune Checkpoint Inhibitors: A Two-Center Cross-Sectional Study.
Over half of patients treated with immune checkpoint inhibitors experienced clinically relevant sleep disturbance, with poor performance status, advanced disease burden, and later-line therapy independently predicting impaired sleep.
Key Findings
Results
Clinically relevant sleep disturbance was observed in more than half of metastatic cancer patients receiving immune checkpoint inhibitors.
97 of 187 patients (51.9%) had sleep disturbance defined as PSQI score > 5
Mean PSQI score for the entire cohort was 7.54 ± 5.39
Study was a retrospective, two-center, cross-sectional design with sleep quality assessed at three months of ICI therapy
Patients had advanced or metastatic cancers across multiple tumor types
Results
The most affected Pittsburgh Sleep Quality Index components were sleep disturbance and daytime dysfunction.
Mean score for the sleep disturbance component was 1.33 ± 1.05
Mean score for the daytime dysfunction component was 1.21 ± 1.04
Sleep quality was measured using the validated Pittsburgh Sleep Quality Index (PSQI)
PSQI score ≤ 5 was classified as no sleep disturbance; PSQI > 5 was classified as sleep disturbance
Results
ECOG performance status ≥ 1 was an independent predictor of sleep disturbance in multivariate analysis.
In univariate analysis: OR 3.29, 95% CI 1.77–6.08, p < 0.001
In multivariate analysis: OR 2.33, 95% CI 1.17–4.62, p = 0.015
ECOG performance status is a standardized measure of a patient's functional ability and disease impact on daily activities
Results
Receiving second-line or beyond ICI therapy was an independent predictor of sleep disturbance.
In univariate analysis: OR 3.76, 95% CI 1.92–7.34, p < 0.001
In multivariate analysis: OR 2.43, 95% CI 1.14–5.16, p = 0.021
Later-line therapy likely reflects more refractory or progressive disease, representing greater overall disease burden
Results
Having two or more metastatic sites was an independent predictor of sleep disturbance.
In univariate analysis: OR 2.69, 95% CI 1.47–4.92, p = 0.001
In multivariate analysis: OR 2.10, 95% CI 1.06–4.16, p = 0.032
This finding suggests that greater metastatic disease burden independently contributes to impaired sleep quality
Results
Receiving six or more ICI cycles was associated with sleep disturbance in univariate analysis but did not remain significant in multivariate analysis.
Univariate OR: 1.85, 95% CI 1.04–3.32, p = 0.036
This variable did not remain an independent predictor after adjustment in multivariate logistic regression
This suggests the association with number of cycles may be confounded by other disease-related factors
Conclusions
The study supports routine assessment of sleep quality in patients receiving immune checkpoint inhibitors.
Authors note that immune-related mechanisms during ICI therapy may influence sleep disturbance
The study included 187 patients across two centers
Logistic regression analyses were used to identify both univariate and multivariate predictors of sleep disturbance
The authors conclude that findings support 'the routine assessment of sleep during ICIs'
What This Means
This research studied sleep problems in 187 cancer patients with advanced or metastatic disease who were being treated with a type of immunotherapy called immune checkpoint inhibitors (ICIs). Using a validated questionnaire called the Pittsburgh Sleep Quality Index, researchers assessed patients' sleep quality at three months into their treatment. They found that more than half of patients (51.9%) had clinically meaningful sleep disturbances, with the most problematic areas being sleep disruption during the night and difficulty functioning during the day.
The study identified three key factors that independently predicted worse sleep quality: having a poorer physical functioning status (measured by the ECOG scale), being on a second or later line of cancer treatment (indicating the cancer had progressed through prior therapies), and having cancer spread to two or more sites in the body. These findings suggest that patients with a greater overall burden of disease and those who are further along in their treatment journey are particularly vulnerable to sleep problems.
This research suggests that sleep disturbance is a common and underappreciated issue for cancer patients on immunotherapy, and that clinicians should routinely screen for sleep problems—especially in patients with more advanced disease or reduced physical function. Identifying at-risk patients early could open the door to interventions that may improve quality of life during treatment.
Aktepe B, Ulasli T, Dama P, Unek I, Karaoglu A, Boztas M, et al.. (2025). Sleep Quality and Its Determinants Among Patients with Metastatic Cancer Treated with Immune Checkpoint Inhibitors: A Two-Center Cross-Sectional Study.. Medicina (Kaunas, Lithuania). https://doi.org/10.3390/medicina61122131