@inbook{37bfdb4318f94892931f673df1341bed,
title = "Symptoms as patient-reported outcomes in cancer patients undergoing immunotherapies",
abstract = "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{\textquoteright}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.",
keywords = "Cancer, Immunotherapy, Patient-reported outcomes, Symptoms",
author = "Mendoza, {Tito R.}",
note = "Funding Information: The use of PROs continues to increase over the years for several reasons. First, the National Institutes of Health (NIH), as part of its Roadmap Program, has made a significant investment in the development of a measurement system called the Patient-Reported Outcomes Measurement Information System to increase the measurement precision of patient self-report questionnaires [1]. Second, the US Food and Drug Administration (FDA) has issued guidance for the pharmaceutical industry entitled patient-reported outcome measures: use in medical product development to support labeling claims, which provides guidance on how self-report measures are to be used for making claims about the effectiveness of agents for which approval is being sought [2]. Third, the National Cancer Institute realized the shortcomings of their Common Terminology Criteria for Adverse Events (CTCAE) and therefore commissioned contract work to develop a patient-reported outcome version of the CTCAE coined as the PRO-CTCAE [3]. Publisher Copyright: {\textcopyright} Springer Nature Switzerland AG 2018.",
year = "2018",
doi = "10.1007/978-3-030-02505-2_9",
language = "English (US)",
series = "Advances in Experimental Medicine and Biology",
publisher = "Springer New York LLC",
pages = "165--182",
booktitle = "Advances in Experimental Medicine and Biology",
}