Article type
Abstract
Objectives Management of patients with relapsed/refractory hematologic malignancies continues to be a huge challenge in clinical oncology. Chimeric antigen receptor T (CAR-T) cell therapy continues to be a suitable treatment option and has produced remarkable achievements in hematologic malignancies. However, few studies have evaluated patient-reported outcomes (PROs) in patients with hematologic malignancies receiving CAR-T cell therapy. We performed a systematic review and meta-analysis to evaluate the benefits of CAR-T cell therapies focused on PROs. We also evaluated whether the analysis results of PROs were clinically meaningful through application of minimal clinically important differences (MCID).
Methods We conducted a systematic literature search in PubMed, Cochrane, and the Web of Science databases from inception to January 01, 2024. Study selection and data extraction were conducted independently by two reviewers based on pre-specified criteria. The COSMIN Risk of Bias checklist was used to evaluate the methodological quality of the included studies. Data were extracted at baseline, one month, three months, and more than six months after therapy. The DerSimonian and Laird’s random-effects model was employed to calculate the combined effect and 95% CI. The results were presented as pooled analyses in forest plots. The existence of heterogeneity among effect sizes of individual studies was analyzed with the I2 statistic. We analyzed contour-enhanced funnel plots to evaluate publication bias.
Results We identified 15 studies assessed with 16 different PROMs were included in the meta-analysis. CAR-T cell therapy improved PROs in the six domains of general health status, pain, fatigue, depression, social function, and cognitive function. The most effective domain in which CAR-T cell therapy improved the PROs after six months was general health status (SMD: 0.57, 95% CI: 0.34 to 0.81), while the least effective domain was cognitive function (SMD: 0.25, 95% CI: 0.14 to 0.37).
Conclusion The current meta-analysis shows that CAR-T cell therapy produces clinically meaningful differences in PROs. These results suggest that the professional perspective and patient values and preferences should be weighed equally when considering CAR-T cell therapy for hematologic malignancies.
Methods We conducted a systematic literature search in PubMed, Cochrane, and the Web of Science databases from inception to January 01, 2024. Study selection and data extraction were conducted independently by two reviewers based on pre-specified criteria. The COSMIN Risk of Bias checklist was used to evaluate the methodological quality of the included studies. Data were extracted at baseline, one month, three months, and more than six months after therapy. The DerSimonian and Laird’s random-effects model was employed to calculate the combined effect and 95% CI. The results were presented as pooled analyses in forest plots. The existence of heterogeneity among effect sizes of individual studies was analyzed with the I2 statistic. We analyzed contour-enhanced funnel plots to evaluate publication bias.
Results We identified 15 studies assessed with 16 different PROMs were included in the meta-analysis. CAR-T cell therapy improved PROs in the six domains of general health status, pain, fatigue, depression, social function, and cognitive function. The most effective domain in which CAR-T cell therapy improved the PROs after six months was general health status (SMD: 0.57, 95% CI: 0.34 to 0.81), while the least effective domain was cognitive function (SMD: 0.25, 95% CI: 0.14 to 0.37).
Conclusion The current meta-analysis shows that CAR-T cell therapy produces clinically meaningful differences in PROs. These results suggest that the professional perspective and patient values and preferences should be weighed equally when considering CAR-T cell therapy for hematologic malignancies.