At 12 months, men in the HRT group saw a larger decline in bowel outcomes than those in the CRT group [mean score, −7.5 vs −3.7, a mean 3.8-point greater decline for bowel symptoms; P <.001].1 But the difference did not reach the study’s predesignated threshold for clinical significance.“In this study, there was no clinically meaningful difference between [study] arms in mental health status defined by anxiety or depression.
“Clinical significance is an important metric when assessing the issue of interpretability of patient-reported outcomes,” they noted. “It helps us understand what changes in scores correspond to small, moderate, or large patient benefit or decrement. For example, if a person improves by 5 points on a 100-point scale on sexual function, will he be more satisfied with his sexual experiences or perceived as having better sexual function by his partner? In this context, the present study shows that the single time point the bowel score was statistically significantly worse in the HRT arm was of small consequence as perceived by the patient.”
The researchers cautioned that the study did not specify a predetermined single time point for the primary quality of life EPIC end point.1
“Therapy that has no more adverse events for a course of 5.6 weeks compared with 8.2 weeks would have obvious implications for patient decision making and resource savings,” the researchers reported. “It should be noted that most patients who qualified for this trial would also be eligible for active surveillance, and thus better quality of life than radiotherapy or surgery, yet many men choose treatment.”
Given the study’s findings regarding quality of life outcomes (described as “the last lingering concern of HRT”) and noting an estimated $7700 cost saving per patient treated with HRT instead of conventional radiotherapy, there should be “no deterrents to its adoption,” they concluded.
1. Bruner DW, Pugh SL, Lee WR, et al. Quality of life in patients with low-risk prostate cancer treated with hypofractionated vs conventional radiotherapy: a phase 3 randomized clinical trial. JAMA Oncology. 2019;5(5):664-670.