Frailty Assessments Indicate Severe AE Probability in Prostate Cancer

When the BMI index was 23, the serum albumin was 4.0 g/dL, and the G8 score was 12, there was a 73% chance of experiencing a severe AE.

Frailty assessments may be a viable tool for detecting which patients with metastatic hormone-sensitive prostate cancer may have less tolerability for treatment with upfront docetaxel, according to a multicenter retrospective study presented at the 2025 American Urological Association (AUA) Annual Meeting.

Of the 32 patients included in the data analysis, 18 (56%) experienced at least 1 severe adverse event (AE). There were significant differences in body mass index (BMI; P = .011), serum albumin (P = .046), and G8 screening tool readings (P <.001) in patients with and without severe AEs. The relation between age (P = .458), ECOG performance status (P = .238), and hemoglobin (P = .123) was not as significant.

Additionally, the receiver operating characteristic curve showed that the area under the curve (AUC) was 0.762 for BMI, 0.706 for serum albumin, and 0.850 for G8 screening tool readings. The cutoff for these values was 23 for BMI, 3.9 g/dL for serum albumin, and 14 for G8. The factors were implemented into a nomogram that exhibited a greater AUC of 0.857.

When the BMI index was 23 and serum albumin was 4.0 g/dL, the probability of experiencing a severe AE was 10% when the G8 screening tool showed a score of 17 points, 43% when the G8 score was 14 points, 59% when the G8 score was 13 points, and 73% when the G8 score was 12 points.

“Patients with less tolerability for upfront docetaxel might be estimated by the frailty assessment. The G8 could be a useful tool when evaluating the safety of docetaxel,” wrote lead study author Sosuke Omizo, in the Department of Urology at Hirosaki University Graduate School of Medicine in Hirosaki, Japan, and fellow authors, in the poster. “Further study is needed to evaluate whether the treatment intensity needs to be modified based on the risk classification.”

The trial initially examined 68 patients in the study’s database who were treated with upfront docetaxel or a triplet between January 2014 and April 2024, of whom 32 patients had a frailty evaluation with the G8 screening tool.

A severe AE was defined as an AE of grade 3 or higher.

In patients who experienced at least 1 AE of grade 3 or higher (n = 18) and in those that did not (n = 14), the age was 70.5 years (64 ~ 84) and 71 years (54 ~ 81), respectively (P <.458), and the average G8 score was 11.75 (5 ~ 75) and 15 (11.5 ~ 17), respectively (P = .001). The ECOG performance status was 0 (0 ~ 4) and 0 (0 ~ 0; P = .238), the BMI index was 21.9 (17.5 ~ 29.1) and 24.2 (20.0 ~ 34.0; P = .011), the serum albumin was 3.85 (2.6 ~ 4.4) and 4.2 (3.7 ~ 4.5; P = .046), and the hemoglobin was 13.5 (6.6 ~ 17.2) and 14.7 (11.8 ~ 16.7; P = .123).

The primary objective of this study was to evaluate the ability of frailty to predict the incidence of severe AEs in patients with metastatic hormone-sensitive prostate cancer who were treated with androgen deprivation therapy (ADT) plus upfront docetaxel, or ADT with darolutamide (Nubeqa) plus docetaxel.

The study authors noted that low G8 scores were indicative of the occurrence of severe docetaxel AEs, and that additional research is needed to assess if this risk classification will require alterations to treatment intensity.

Reference

Omizo S, Mikami J, Fukushima T, et al. Utility of frailty in predicting severe AEs in mHSPC treated with upfront docetaxel or darolutamide plus docetaxel: a multicenter retrospective study. Presented at the 2025 American Urological Association Annual Meeting. April 26-29, 2025; Las Vegas, NV. Poster GG02-28.