Short-Term ADT Plus High-Dose Radiotherapy Improves Outcomes in Localized Prostate Cancer
核心洞察
A phase 3 trial (GETUG 14) reveals that combining short-term androgen deprivation therapy (搜索) (ADT) with high-dose radiotherapy improves disease-free survival in localized prostate cancer (搜索) patients.
The addition of ADT significantly reduces the risk of biochemical failure but does not significantly impact metastasis failure or overall survival.
Patients with intermediate-risk prostate cancer (搜索) showed a notable improvement in 5-year disease-free survival with the combined therapy compared to radiotherapy alone.
Combining short-term androgen deprivation therapy (搜索) (ADT) with high-dose radiotherapy improves disease-free survival (DFS) in patients with localized prostate cancer (搜索), according to the GETUG 14 trial presented at the 2024 ASTRO Annual Meeting. The study, a phase 3 randomized trial, found that the addition of ADT to high-dose radiotherapy prolonged DFS and reduced biochemical failure, marking a significant advancement in treating intermediate- and high-risk localized prostate cancer.
GETUG 14 Trial Details
The GETUG 14 trial (NCT00104741) enrolled 376 patients with localized prostate cancer (搜索), randomizing them to either high-dose radiotherapy alone (n=191) or short-term ADT plus high-dose radiotherapy (n=179). Both arms received a radiotherapy dose of 80 Gy. The ADT regimen consisted of monthly triptorelin and daily flutamide for 4 months, initiated 2 months before radiotherapy. The primary endpoint was disease-free survival, with secondary endpoints including overall survival, biochemical failure, metastasis failure, toxicity, and patient-reported quality of life.
Key Findings
After a median follow-up of 84 months, the 5-year DFS rate was 84% in the ADT-radiotherapy arm compared to 76% in the radiotherapy-alone arm (HR, 0.64; 95% CI, 0.43-0.94; P = .02). Specifically, among patients with intermediate-risk disease, the 5-year DFS rate was 87% in the ADT-radiotherapy arm and 74% in the radiotherapy-alone arm (HR, 0.55; 95% CI, 0.33-0.90; P = .02). However, for high-risk disease, the 5-year DFS rates were 79% and 75%, respectively (HR, 0.76; 95% CI, 0.40-1.47; P = .40), indicating no significant difference in this subgroup.
The rate of biochemical failure at 5 years was significantly lower in the ADT-radiotherapy arm (10%) compared to the radiotherapy-alone arm (21%), with an HR of 0.45 (95% CI, 0.28-0.72; P = .001). However, the trial did not find a significant difference between the two arms regarding metastasis failure or overall survival.
Toxicity Profile
Regarding toxicity, the study reported no significant differences between the ADT-radiotherapy arm and the radiotherapy-alone arm in grade 2 or higher early/late genitourinary toxicities, early/late gastrointestinal toxicities, or late erectile dysfunction. Specifically:
- Grade 2 or higher early genitourinary toxicities: 42% (ADT-radiotherapy) vs 39% (radiotherapy-alone)
- Grade 2 or higher late genitourinary toxicities: 27% vs 30%
- Grade 2 or higher early gastrointestinal toxicities: 26% in both arms
- Grade 2 or higher late gastrointestinal toxicities: 23% vs 21%
- Grade 2 or higher late erectile dysfunction: 63% vs 61%
Notably, the rate of grade 2 or higher early erectile dysfunction was significantly higher in the ADT-radiotherapy arm (31%) compared to the radiotherapy-alone arm (6%; P < .001).
Expert Commentary
Dr. Nicolas Demogeot, MD, of Institut de Cancerologie de Lorraine, stated, "Short-term ADT improves disease-free survival in intermediate- and high-risk prostate cancer (搜索) patients receiving high-dose radiotherapy without increasing gastrointestinal and genitourinary toxicities." He emphasized that high-dose radiotherapy should be combined with short-term ADT to enhance outcomes in intermediate- and high-risk localized prostate cancer.