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Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical
Laura Pala1,2, Isabella Sala3, Chiara Oriecuia4,5
1Division of Melanoma, Sarcomas, and Rare Tumors, European Institute of Oncology, Milan, Italy.
Importance:
The association of immune checkpoint inhibitors (ICIs) with patient quality of life has been poorly explored.
Objective:
To evaluate patient-reported outcomes (PROs) assessed in randomized clinical trials (RCTs) of immunotherapy-based treatments.
Data Sources:
This systematic review and random-effects meta-analysis used RCTs identified in PubMed, MEDLINE, Embase, and Scopus from database inception to June 1, 2021.
Study Selection:
A total of 2259 RCTs were identified that assessed ICIs as monotherapy or in combination with chemotherapy or combined with another ICI and/or targeted therapy vs control groups not containing immunotherapy in patients with advanced solid tumors. Studies were reviewed independently by 2 authors.
Data Extraction And Synthesis:
This meta-analysis followed the PRISMA guidelines and recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium.
Main Outcomes And Measures:
The coprimary aims of the meta-analysis were (1) pooled differences between treatment groups in the mean change of PRO score from baseline to 12 and 24 weeks of follow-up and (2) pooled differences between treatment groups in the time to deterioration of PRO score. For each end point, RCTs have been analyzed according to the type of treatment administered in the experimental group: ICIs given as monotherapy, ICIs combined with chemotherapy, or ICIs in association with another ICI and/or with targeted therapies.
Results:
Of the 2259 identified RCTs, 34 (18 709 patients) met the selection criteria and were analyzed. In the group of 19 RCTs testing ICIs as monotherapy, the pooled between-groups difference of mean change from baseline to 12 weeks of follow-up was 4.6 (95% CI, 2.8-6.4), and the mean change from baseline to 24 weeks of follow-up was 6.1 (95% CI, 4.2-8.1), significantly favoring ICIs. The pooled difference was 1.4 (95% CI, -0.4 to 3.2) at week 12 and 2.5 (95% CI, -0.8 to 5.9) at week 24 in the group of 8 RCTs testing ICIs combined with chemotherapy and 2.1 (95% CI, -0.8 to 5.0) at week 12 and 2.1 (95% CI, -0.4 to 4.5) at week 24 in the group of 8 RCTs testing other ICI-containing combinations. The time to deterioration was significantly longer in the immunotherapy-containing groups compared with control groups in all 3 groups of RCTs evaluated (hazard ratios of 0.80 [95% CI, 0.70-0.91] for ICIs as monotherapy, 0.89 [95% CI, 0.78-1.00] for ICIs plus chemotherapy, and 0.78 [95% CI, 0.63-0.96] for other ICI-containing combinations).
Conclusions And Relevance:
Immune checkpoint inhibitors as monotherapy appear to have a favorable association with patient-reported quality of life and can be combined with other classes of anticancer drugs without worsening this quality of life.
Insights
Immune checkpoint inhibitors (ICIs) show a positive impact on patient quality of life. Combining ICIs with other cancer drugs does not worsen quality of life, suggesting favorable outcomes for patients.
Area of Science:
- Oncology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- The impact of immune checkpoint inhibitors (ICIs) on patient quality of life (QoL) is not well understood.
- Evaluating patient-reported outcomes (PROs) in cancer treatment is crucial for comprehensive care.
Purpose of the Study:
- To systematically review and meta-analyze patient-reported outcomes (PROs) from randomized clinical trials (RCTs) involving immunotherapy-based treatments.
- To assess the association between ICIs and patient quality of life.
Main Methods:
- A systematic review and random-effects meta-analysis of RCTs identified in major databases (PubMed, MEDLINE, Embase, Scopus) up to June 1, 2021.
- Included RCTs assessed ICIs (monotherapy or combination) versus control groups without immunotherapy in advanced solid tumors.
- Analyzed pooled differences in PRO scores and time to deterioration, following PRISMA guidelines.
Main Results:
- 34 RCTs (18,709 patients) were analyzed.
- ICIs as monotherapy significantly favored PROs at 12 and 24 weeks (mean change differences: 4.6 and 6.1, respectively).
- Time to deterioration was significantly longer with ICI-containing regimens (HRs ranging from 0.78 to 0.89).
Conclusions:
- Immune checkpoint inhibitors, particularly as monotherapy, demonstrate a favorable association with patient-reported quality of life.
- Combining ICIs with chemotherapy or other targeted therapies does not appear to negatively impact quality of life.
- These findings support the use of ICIs in advanced solid tumors, considering their positive effect on patient well-being.
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