Patient-reported outcomes version of the common terminology criteria for adverse events and quality-of-life linear analogue self-assessment in breast cancer patients receiving radiation therapy: single-institution prospective registry

R S Bhangoo,W W Wong,C E Vargas,M A Golafshar,C S Thorpe,L A Mcgee,S R Keole,T Z Vern-Gross,M Y Halyard,T A Dewees

doi:10.1186/s41687-021-00408-9

Abstract

Purpose/objectivesWe sought to investigate the impact of patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) on overall quality-of-life (QOL) employing linear analogue self-assessment (LASA) in breast cancer (BC) patients undergoing radiation therapy (RT).Materials/methodsAll patients treated with RT for BC with curative intent from 2015 to 2019 at our institution were included. Breast specific PRO-CTCAE and overall QOL LASA questionnaires were administered at baseline, end-of-treatment, 3, 6, 12 months, and then annually. Minimal clinically important difference in overall QOL was a 10-point change in LASA. Hypofractionation was any treatment > 2 Gy per fraction. Mixed models for repeated measures were used to determine the association of PRO-CTCAE and overall QOL LASA.ResultsThree hundred thirty-one (331) patients with a median follow-up of 3.1 years (range 0.4–4.9) were included. Average overall QOL LASA scores were 78.5 at baseline, 79.8 at end-of-treatment, 79.8 at 3 months, 77.1 at 6 months, 79.4 at 12 months, and 79.7 at 24 months. On univariate analysis, patients reporting a grade ≥ 3 PRO-CTCAE had, on average, a 10.4-point reduction in overall LASA QOL (p < 0.0001). On multivariate analysis, not being treated with hypofractionation and higher BMI were predictive for worse overall LASA QOL with a 10-point reduction in LASA for patients reporting a grade ≥ 3 PRO-CTCAE (p < 0.0001).ConclusionsPatients reporting a grade ≥ 3 PRO-CTCAE experienced statistically significant and clinically meaningful deterioration in overall QOL LASA. Hypofractionation improved QOL while higher BMI predicted for worse QOL. PRO-CTCAE should be integrated into future clinical trials.

Highlights

Adverse events during cancer treatment are recorded using the US National Cancer Institute’s (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [1]
Not being treated with hypofractionation and higher Body mass index (BMI) were predictive for worse overall linear analogue selfassessment (LASA) QOL with a 10-point reduction in LASA for patients reporting a grade ≥ 3 Patient-reported outcome (PRO)-CTCAE (p < 0.0001)
Hypofractionation improved QOL while higher BMI predicted for worse QOL

Summary

Introduction

Adverse events during cancer treatment are recorded using the US National Cancer Institute’s (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [1]. There are numerous tools to measure PROs including the NCI’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [8]. This was developed by a multidisciplinary group of investigators who identified 78 symptomatic adverse events (AEs) in CTCAE that were deemed to be appropriate for patient reporting for patients undergoing cancer treatment including surgery, chemotherapy, and/or radiation therapy [8]. Each of the items was assessed to determine the applicability to rate according to frequency, severity, and/or activity interference for the patient This resulted in 124 items in the PRO-CTCAE each graded on a 5-point scale corresponding to the CTCAE scale [8]. PRO-CTCAE has proven to be valid and reliable compared to other measures [9]

Methods

Results

Conclusion