Intensive ADT therapy did not negatively affect health-related quality of life in patients with biochemically recurrent prostate cancer丨ASCO 2024
Editor's note: Patients with prostate cancer with biochemical recurrence after radical prostatectomy have a shorter prostate-specific antigen doubling time and a higher incidence of distant metastasis and prostate-specific death. Previous PRESTO studies have shown that intensive androgen deprivation therapy can prolong biochemical progression-free survival (bPFS) in these patients with prostate cancer. At this year's ASCO Congress, a study of the enhanced ADT regimen in the PRESTO study was analyzed for health-related quality of life.
摘要号（报告类型）：5006（Oral Abstract Session）
英文题目：Health-related quality of life (HRQOL) results from PRESTO (AFT-19), a phase 3 randomized trial of intensification of androgen blockade in patients with high-risk biochemically relapsed castration sensitive prostate cancer.
Chinese title: Health-related quality of life (HRQOL) results of the PRESTO (AFT-19) study, a phase III randomized trial of intensive androgen deprivation therapy in patients with high-risk biochemical relapsed castration-sensitive prostate cancer
Background:
The PRESTO trial (NCT03009981) showed that in patients with prostate cancer who had undergone radical prostatectomy with biochemical recurrence, PSA doubling time of ≤ 9 months and no evidence of metastatic disease on routine imaging showed that 52 weeks of intensive ADT therapy was associated with prostate disease without androgen deprivation therapy (ADT) alone, with a PSA-PFS of 24.9 months compared with apalutamide in combination with apalutamide, compared with 20.3 months in the control group, HR=0.52;The PSA-PFS of ADT combined with apalutamide and abiraterone acetate and prednisone was 26.0 months, higher than that of the control group (20.0 months), HR=0.48. This study further analysed the patient's healthy quality of life (HRQOL) outcomes.
Way:
HRQOL measures included the Hot Flashes-Related Daily Disturbance Scale (HFRDIS), the Extended Prostate Cancer Composite Index (EPIC)-26 Sexual Function Domain, the PROMIS Fatigue Short Scale, and the EQ-5D-5L, and assessed the overall quality of life of 504 patients. The published thresholds for least clinically important differences in these HRQOL measures were: HFRDIS score 1.66, EPIC sexual function 10-12, PROMIS fatigue 3-5, and EQ-5D-5L 0.06, respectively. A general linear mixed model was used to estimate the mean difference in HRQOL between groups based on intention-to-treat approach.
Outcome:
Patient baseline characteristics remained balanced between groups.
There was no significant difference between groups for the EPIC Sexual Function Score, nor did it exceed the threshold for clinically important differences.
In terms of EPIC hormones, there was no significant difference between the same groups, nor did it exceed the threshold of clinically important differences.
For HFRDIS, there were no significant differences between groups; However, compared with the ADT alone group, the ADT plus apalutamide and abiraterone group exceeded the threshold of clinically important differences.
For the PROMIS fatigue score, the threshold for clinically important differences was not exceeded between groups.
Similarly, there was no statistically significant difference in EQ-5D-5L index scores between groups, and the threshold for clinically important differences was not exceeded.
Overall, no statistically significant difference was reported in any HRQOL measurement between intensive ADT treatment (group B, group C) and ADT alone (group A).
Conclusion:
Intensive ADT treatment with ADT in combination with apalutamide, or ADT in combination with apalutamide and abiraterone acetate and prednisone up to 52 weeks, improved PSA progression-free survival but did not negatively affect HRQOL. These HRQOL results further support intensive ADT therapy for patients with high-risk biochemically recurrent prostate cancer.
Bibliography:
Ronald C. Chen, Gina L. Mazza, Briant Fruth, et al. Health-related quality of life (HRQOL) results from PRESTO (AFT-19), a phase 3 randomized trial of intensification of androgen blockade in patients with high-risk biochemically relapsed castration sensitive prostate cancer. J Clin Oncol 42, 2024 (suppl 16; abstr 5006)