Symptoms as Patient-Reported Outcomes in Cancer Patients Undergoing Immunotherapies

Cancer therapies are toxic. Newer oncological treatments such as immunotherapy produce unconventional adverse events that are collectively referred to as immune-related adverse events (irAEs). These irAEs are clinician-rated and typically reported via tabulation of adverse events from the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). However, the symptomatic effects of treatment and the severity of disease are best reported by the patient themselves. Although many pivotal trials for immunotherapeutic agents include health-related quality-of-life measures, symptom-focused assessments are more proximal to the effects of treatment and disease burden. This chapter discusses how best to measure symptoms, describes the desirable properties of a psychometrically valid symptom assessment tool, reviews available symptom assessment tools, provides methods to assist in the interpretation of PRO data, elucidates the feasibility and benefit of incorporating PRO in several cancer cohorts, describes the current use of PROs in immunotherapy, and identifies areas where further research are needed to enhance the use of PROs in cancer patients undergoing immunotherapy.