Integrating the patient (pt) voice with clinician reports to identify cancer-specific subsets of symptomatic adverse events (SymAE).
155 Background: The Pt-Reported Outcomes Version of the Common Terminology Criteria for AE (PRO-CTCAE) was developed for pts to report on the frequency, severity, and interference of SymAE. A study was conducted to identify a hepatocellular carcinoma (HCC)-relevant subset of the PRO-CTCAE's 124 items to enhance evaluation of SymAE in HCC trials and long-term effects in survivorship. Methods: Qualitative and quantitative data were collected from medical oncologists specializing in HCC and pts diagnosed with HCC stratified by Child-Pugh class and treatment. Oncologists were asked about HCC diagnosis, treatment, and SymAE and provided ratings (ranging from 0 = unimportant to 10 = very important) of the following: 1) importance to pts of 34 prevalent SymAE from past HCC trials (all phases); 2) importance to pts of each PRO-CTCAE item; and 3) their own perceived importance of each PRO-CTCAE item with regard to tolerability. Pts were asked about their diagnosis, treatment, and experience of SymAE after which they completed the PRO-CTCAE and were debriefed on the importance of each item. Results: Four medical oncologists from Spain, Taiwan, Korea, and Hong Kong with ≥ 20 years of experience completed interviews. SymAE from prior trials rated highly important to pts (mean rating across oncologists ≥ 7) included hand-foot syndrome, diarrhea, fatigue, decreased appetite, rash, vomiting, and weight loss. PRO-CTCAE items rated highly important to pts included diarrhea, vomiting, shivering or shaking chills, hand-foot syndrome, rash, fatigue, difficulty swallowing, and loss of control of bowel movements. Items rated highly for tolerability included diarrhea, shivering or shaking chills, and hand-foot syndrome. Pt interviews (planned up to 24) are ongoing. Conclusions: Oncologists identified 10 clinically relevant items from sponsor SymAE data and the PRO-CTCAE for use in HCC trials. Findings from pt interviews will compare provider and pt perspectives about SymAE and strengthen the set of selected items. Combining clinician and pt ratings with clinical trial data may be a promising method for identifying cancer-specific PRO-CTCAE item sets for use throughout the cancer care continuum.