Assessment of early and late symptom toxicity in a real-world cancer treatment population using the PRO-CTCAE.

Abstract

e18663 Background: The FDA’s Draft Guidance for Core Patient-Reported Outcomes (PROs) in Cancer Clinical Trials, recommends assessment of disease-related symptoms, symptomatic adverse events, overall side effect impact, physical function, and role function. This guidance also recommends that core PROs be assessed more frequently within the first few treatment cycles. The NCI’s PRO Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a system to evaluate symptomatic toxicity. The objective of this study is to assess the utility of frequent assessment early in treatment, using PRO-CTCAE measures for symptom monitoring. Methods: The patient cohort (n = 248) was derived from users of PROmpt®, an application for remote patient reporting and provider symptom management, employed in routine care in 30+ integrated cancer treatment centers. Patients were enrolled (9/20-10/21) at treatment initiation. Baseline characteristics were assessed by survey and review of patient EMR records. PRO-CTCAE derived surveys of 14 core symptoms (pain, shortness-of-breath, nausea, diarrhea, sadness, anxiety, constipation, fever, neuropathy, insomnia, urinary problems, decreased appetite, fatigue and mouth sores) were administered weekly. Patients who completed surveys in weeks 1 – 3 AND weeks 9 – 11 were selected for analysis (n = 75), with weekly incidences calculated for these windows. Differences were tested using dependent measures T-test. Exploratory analysis of differences by gender, frailty status, and tumor type were also performed. Results: Overall cohort was predominantly female (86.7%), with mean age 59.6 yrs. Subjects with baseline multi-dimensional geriatric assessments (MGA), were 73% fit, 24.3% intermediate and 2.7% frail. The majority of symptoms (11 of 14) showed directional decline over time, with 6 trending towards significance (p < / = 0.10). Increases, however, were statistically significant for neuropathy(p = 0.01) and directional for shortness-of-breath (p = 0.10) and mouth sores (p = 0.32). Conclusions: Findings support recommendations for frequent, early assessment, with weekly surveys showing higher symptom incidence for most items compared with later assessment. Observation of late symptom increases support continued, regular monitoring for timely management of emerging symptoms with continued treatment.