Clinician reports of high-grade adverse events (AEs) often form the basis for interpreting pharmacologic toxicity, although how this approach links to patient quality of life (QOL) is unclear. A study published in the Journal of the National Comprehensive Cancer Network examined evaluations of AEs in regard to QOL for patients with metastatic castration-naïve prostate cancer.
Patients in this study were participants in the phase 3 GETUG-AFU 15 trial. Questionnaires regarding QOL were completed prior to a first treatment and at 3 and 6 months on treatment. Counts of AEs provided by patients and clinicians at 3 and 6 months were also used in this study, and researchers compared metrics of cumulative toxicity.
All-grade and high-grade AEs as reported by either patients or clinicians were counted and evaluated against the patient QOL reports. AEs were also weighted by severity, with counts of AEs multiplied by their grades, for another method of assessing cumulative toxicity vs QOL.
Complete data were available for 184 patients. Patient assessments of all-grade, high-grade, and severity-weighted AEs were associated with reduced global and physical QOL scores (P < .01 for each). Clinician assessments, however, showed negative associations with physical QOL only and only for all-grade (P < .01) and severity-weighted (P < .01) AEs, not for high-grade AEs.
The study authors concluded that analysis of all-grade AEs enabled a more accurate perspective on patient QOL than did consideration of only high-grade AEs, and they expressed a preference for considering patient assessments of cumulative toxicity in estimating patient QOL.
Schuurhuizen CSEW, Marino P, Braamse AMJ, et al. Impact of patient- and clinician-reported cumulative toxicity on quality of life in patients with metastatic castration-naïve prostate cancer. J Natl Compr Canc Netw. 2018;16(12):1481-1488.