Patient-reported quality-of-life outcomes in immune checkpoint inhibitor therapy: addressing gaps, capturing patient experience, and advancing the field.
Immune checkpoint inhibitors (ICIs) have transformed cancer care, extending survival across multiple malignancies. Yet quality-of-life (QoL) outcomes remain underreported and inconsistently integrated into research and practice. Standard frameworks and instruments do not fully capture immune-related adverse events (irAEs) and may overlook the experiences of racially, socioeconomically, linguistically, and digitally marginalized groups.
This review examines how methodological limitations, and systemic inequities constrain the assessment of QoL in immune checkpoint inhibitor (ICI) therapy. It evaluates existing QoL instruments and frameworks guiding patient-reported outcomes (PROs) and identifies opportunities for advancing equity-centered, patient-informed approaches.
This narrative review synthesized evidence identified through literature searches and reference screening across oncology, regulatory science, digital health, equity, and community-engaged research. QoL assessment domains analyzed included methodological rigor, trial design, digital integration, intersectionality, literacy, and social determinants of health.
Quality-of-life reporting in ICI trials remains limited, with only about 14% of trials publishing PRO results and fewer than 12% including them in the primary publication. Existing tools inadequately capture irAEs, while trial designs neglect long-term survivorship and diverse populations. Frameworks such as SPIRIT-PRO and CONSORT-PRO improve methodological rigor, but provide limited guidance on equity, cultural adaptation, or caregiver perspectives. Barriers, including digital exclusion, linguistic gaps, and underrepresentation of racial and age groups, further bias QoL evidence.
Quality of life should be recognized as a core clinical endpoint and an indicator of equity in ICI therapy evaluation. Future research must integrate culturally validated instruments, inclusive digital strategies, and community-engaged approaches to ensure survivorship outcomes reflect the realities of all patients. By moving beyond survival, QoL assessment can anchor cancer care in equity and patient-centered lived experience.
This review examines how methodological limitations, and systemic inequities constrain the assessment of QoL in immune checkpoint inhibitor (ICI) therapy. It evaluates existing QoL instruments and frameworks guiding patient-reported outcomes (PROs) and identifies opportunities for advancing equity-centered, patient-informed approaches.
This narrative review synthesized evidence identified through literature searches and reference screening across oncology, regulatory science, digital health, equity, and community-engaged research. QoL assessment domains analyzed included methodological rigor, trial design, digital integration, intersectionality, literacy, and social determinants of health.
Quality-of-life reporting in ICI trials remains limited, with only about 14% of trials publishing PRO results and fewer than 12% including them in the primary publication. Existing tools inadequately capture irAEs, while trial designs neglect long-term survivorship and diverse populations. Frameworks such as SPIRIT-PRO and CONSORT-PRO improve methodological rigor, but provide limited guidance on equity, cultural adaptation, or caregiver perspectives. Barriers, including digital exclusion, linguistic gaps, and underrepresentation of racial and age groups, further bias QoL evidence.
Quality of life should be recognized as a core clinical endpoint and an indicator of equity in ICI therapy evaluation. Future research must integrate culturally validated instruments, inclusive digital strategies, and community-engaged approaches to ensure survivorship outcomes reflect the realities of all patients. By moving beyond survival, QoL assessment can anchor cancer care in equity and patient-centered lived experience.