ASCENDE-RT 生存终点的更新分析。
An Updated Analysis of the Survival Endpoints of ASCENDE-RT.
机构信息
Department of Radiation Oncology, BC Cancer - Vancouver, Vancouver, British Columbia, Canada; Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Department of Radiation Oncology, BC Cancer - Vancouver, Vancouver, British Columbia, Canada; Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
出版信息
Int J Radiat Oncol Biol Phys. 2023 Apr 1;115(5):1061-1070. doi: 10.1016/j.ijrobp.2022.11.005. Epub 2022 Dec 15.
PURPOSE
Using the primary endpoint of time to biochemical progression (TTP), Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (ASCENDE-RT) randomized National Comprehensive Cancer Network patients with intermediate and high-risk prostate cancer to low-dose-rate brachytherapy boost (LDR-PB) or dose-escalated external beam boost (DE-EBRT). Randomization to the LDR-PB arm resulted in a 2-fold reduction in biochemical progression compared with the DE-EBRT group at a median follow-up of 6.5 years (P < .001). Herein, the primary endpoint and secondary survival endpoints of the ASCENDE-RT trial are updated at a 10-year median follow-up.
METHODS
Patients were randomly assigned to either the LDR-PB or the DE-EBRT arm (1:1). All patients received 1 year of androgen deprivation therapy and 46 Gy in 23 fractions of pelvic RT. Patients in the DE-EBRT arm received an additional 32 Gy in 16 fractions, and those in the LDR-PB arm received an I implant prescribed to a minimum peripheral dose of 115 Gy. Two hundred patients were randomized to the DE-EBRT arm and 198 to the LDR-PB arm.
RESULTS
The 10-year Kaplan-Meier TTP estimate was 85% ± 5% for LDR-PB compared with 67% ± 7% for DE-EBRT (log rank P < .001). Ten-year time to distant metastasis (DM) was 88% ± 5% for the LDR-PB arm and 86% ± 6% for the DE-EBRT arm (P = .56). There were 117 (29%) deaths. Ten-year overall survival (OS) estimates were 80% ± 6% for the LDR-PB arm and 75% ± 7% for the DE-EBRT arm (P = .51). There were 30 (8%) patients who died of prostate cancer: 12 (6%) in the LDR-PB arm, including 2 treatment-related deaths, and 18 (9%) in the DE-EBRT arm.
CONCLUSIONS
Men randomized to the LDR-PB boost arm of the ASCENDE-RT trial continue to experience a large advantage in TTP compared with those randomized to the DE-EBRT arm. ASCENDE-RT was not powered to detect differences in its secondary survival endpoints (OS, DM, and time to prostate cancer-specific death) and none are apparent.
目的
使用生化进展时间（TTP）作为主要终点，雄激素抑制联合选择性淋巴结和剂量递增放疗（ASCENDE-RT）将美国国家综合癌症网络（NCCN）中中高危前列腺癌患者随机分为低剂量率近距离放射治疗（LDR-PB）或剂量递增外照射（DE-EBRT）。在中位随访 6.5 年时，与 DE-EBRT 组相比，LDR-PB 组的生化进展率降低了 2 倍（P<0.001）。在此，ASCENDE-RT 试验的主要终点和次要生存终点在中位随访 10 年时进行了更新。
方法
患者被随机分配到 LDR-PB 或 DE-EBRT 组（1:1）。所有患者均接受 1 年雄激素剥夺治疗和 46 Gy/23 次盆腔放疗。DE-EBRT 组患者额外接受 32 Gy/16 次，LDR-PB 组患者接受 I 植入物治疗，处方至最小外周剂量 115 Gy。200 例患者被随机分配至 DE-EBRT 组，198 例患者被随机分配至 LDR-PB 组。
结果
LDR-PB 的 10 年 Kaplan-Meier TTP 估计值为 85%±5%，而 DE-EBRT 为 67%±7%（对数秩检验 P<0.001）。LDR-PB 组 10 年远处转移（DM）时间为 88%±5%，DE-EBRT 组为 86%±6%（P=0.56）。有 117 例（29%）死亡。LDR-PB 组 10 年总生存率（OS）估计值为 80%±6%，DE-EBRT 组为 75%±7%（P=0.51）。有 30 例（8%）患者死于前列腺癌：LDR-PB 组 12 例（6%），包括 2 例与治疗相关的死亡，DE-EBRT 组 18 例（9%）。
结论
与随机分配到 DE-EBRT 组的患者相比，随机分配到 LDR-PB 组的 ASCENDE-RT 试验患者的 TTP 继续有显著优势。ASCENDE-RT 没有足够的效力来检测次要生存终点（OS、DM 和前列腺癌特异性死亡时间）的差异，目前也没有明显差异。
Zotero 插件