钯-103前列腺近距离放射治疗联合补充外照射放疗的前瞻性评估：44/20/0试验的长期结果
Prospective Evaluation of Supplemental External Beam Radiation Therapy With Palladium-103 Prostate Brachytherapy: Long-Term Results of the 44/20/0 Trials.
作者信息
King Martin T, Merrick Gregory S, Galbreath Robert W, Fiano Ryan, Butler Wayne M, Wallner Kent E, Orio Peter F
机构信息
Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts.
Urologic Research Institute, Sarasota, Florida; Bethany College, Bethany, West Virginia.
出版信息
Pract Radiat Oncol. 2025 May-Jun;15(3):e276-e285. doi: 10.1016/j.prro.2024.10.005. Epub 2024 Oct 22.
PURPOSE
The 44/20 and 20/0 randomized trials evaluated whether different external beam radiation therapy (EBRT) dosing regimens prior to brachytherapy affected biochemical failure (BF). We report long-term outcomes of both trials and evaluate whether biological equivalent dose (BED) was associated with reduced BF in the combined trial cohort.
METHODS AND MATERIALS
Both trials enrolled patients with clinical T1c to T2b, Gleason scores 7 to 9, and/or a pretreatment prostate-specific antigen (PSA) 10 to 20 ng/mL disease. The 44/20 trial randomized patients to 44 Gy EBRT with 90 Gy palladium (Pd)-103 versus 20 Gy EBRT with 115 Gy Pd-103. The subsequent 20/0 trial randomized patients to the 20 Gy arm versus monotherapeutic 125 Gy Pd-103. For each trial, univariate Fine-Gray analysis evaluated whether the treatment arm was associated with BF for the entire cohort and the unfavorable intermediate-risk (UIR) subgroup. For the combined trial cohort, multivariate Fine-Gray analysis evaluated whether BED was associated with BF while adjusting for clinical factors.
RESULTS
There were 247 analyzable patients in the 44/20 trial. At a median follow-up of 13.7 years, there were no differences in BF for the entire cohort (subdistribution hazard ratio [sHR] 0.99; 95% CI, 0.43, 2.276; P = .97) or the UIR subgroup (sHR 0.72; 95% CI, 0.25, 2.08; P = .55). There were 383 analyzable patients in the 20/0 trial. At a median follow-up of 10.4 years, there were no differences in BF for the entire cohort (sHR 0.42; 95% CI, 0.13-1.80; P = .15) or the UIR subgroup (sHR 0.81; 95% CI, 0.16-4.03; P = .80). For the combined cohort (630 patients), BED was not associated with BF (1.00; 95% CI, 0.98-1.02; P = .88) on multivariate analyses while adjusting for androgen deprivation therapy utilization, 4-tiered National Comprehensive Cancer Network category, and year of treatment.
CONCLUSIONS
Brachytherapy monotherapy should be a standard-of-care treatment for clinically localized, intermediate-risk prostate cancer, including UIR disease.
目的
44/20和20/0随机试验评估了近距离放射治疗前不同的外照射放疗（EBRT）给药方案是否会影响生化失败（BF）。我们报告了两项试验的长期结果，并评估了联合试验队列中生物等效剂量（BED）是否与BF降低相关。
方法和材料
两项试验均纳入临床T1c至T2b、Gleason评分7至9和/或治疗前前列腺特异性抗原（PSA）为10至20 ng/mL疾病的患者。44/20试验将患者随机分为接受44 Gy EBRT联合90 Gy钯（Pd）-103组与接受20 Gy EBRT联合115 Gy Pd-103组。随后的20/0试验将患者随机分为20 Gy组与单纯125 Gy Pd-103组。对于每项试验，单变量Fine-Gray分析评估治疗组是否与整个队列以及不良中危（UIR）亚组的BF相关。对于联合试验队列，多变量Fine-Gray分析在调整临床因素的同时评估BED是否与BF相关。
结果
44/20试验中有247例可分析患者。在中位随访13.7年时，整个队列（亚分布风险比[sHR] 0.99；95% CI，0.43，2.276；P = 0.97）或UIR亚组（sHR 0.72；95% CI，0.25，2.08；P = 0.55）的BF无差异。20/0试验中有383例可分析患者。在中位随访10.4年时，整个队列（sHR 0.42；95% CI，0.13 - 1.80；P = 0.15）或UIR亚组（sHR 0.81；95% CI，0.16 - 4.03；P = 0.80）的BF无差异。对于联合队列（630例患者），在多变量分析中，调整雄激素剥夺治疗的使用、4级国家综合癌症网络分类和治疗年份后，BED与BF无关（1.00；95% CI，0.98 - 1.02；P = 0.88）。
结论
近距离放射治疗单药治疗应成为临床局限性、中危前列腺癌（包括UIR疾病）的标准治疗方法。
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