PROs better for measuring toxicities than patient satisfaction
Click Here to Manage Email Alerts
New data suggest patient-reported outcomes, or PROs, may not always reflect the effects of cancer treatment and may be more indicative of treatment-related toxicities than patient happiness with cosmetic outcomes, according to a 1-year post radiation study presented at ASCO20 Virtual Scientific Program.
“What we found was that [PROs] didn't really have to do with the treatment as much as their mood coming into the actual treatment. Baseline levels of depression, independent of the treatment itself for their cancer, had a profound impact on whether or not they were happy with their overall breast cosmesis, during and even 1 year out from their radiation treatment,” Mylan Torres, MD associate professor of radiation oncology in breast cancer at Emory University and co-leader of the Cancer Prevention and Control Program at Winship Cancer Institute, told Healio.
Data from the poster included two prospective longitudinal studies of breast cosmesis patients using percentage breast retraction as an objective gauge of asymmetry in preradiation and 1 year post radiation.
Using identical time points, percentage breast retraction assessment (pBRA) was measured and compared with two different patient-reported outcomes rating cosmetic results on a 0-10 scale of happiness with cosmesis and perceived differences in the treated vs. untreated breast.
Both univariate and multivariate analysis was used to evaluate relationships between patient-reported outcomes, percentage breast retraction assessment, Depressive Symptomatology Self-Report scores, clinical, tumor and treatment characteristics.
Of 98 women, 65.3% were pleased (score > 8) with their cosmetic results at the end of 1 year, with 59.5% noting moderate to severe differences in treated vs untreated breast (score < 6). However, the mean pBRA increased from 7.20 in preradiation to 9.69, confirming additional breast asymmetry 1 year post-radiation.
Before receiving radiation, 23% of patients reported moderate-to-severe depression (IDS-SR scores > 26). Multivariate analyses showed 1 year PROs of happiness with cosmetic outcomes did not correlate with pBRA, but significantly correlated with pre- and post-radiation depression. At 1 year, patients with higher pBRA measurements were also more likely to perceive breast texture differences or asymmetry (ie, lower PRO symmetry ratings). However, in the multivariate analysis neither pre- nor post-radiation depression was associated with specific PRO ratings of breast asymmetry, according to the poster.
“It's important for future research to really evaluate what exactly a given patient-reported outcome is measuring, and to ensure that the most optimal measure for a given endpoint is being used. Studies that are using PROs as clinical endpoints need to also measure other factors that might be influencing a patient's perception of their endpoint.” McManus, second year masters of public health and biostatistics student at Emory University Rollins School of Public Health, told Healio.
- McManus, et al. Abstract 569. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.