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前列腺切除术后患者接受 18F-氟柳氯胺指导的前列腺床仅放疗的生化无复发生存:前瞻性随机试验的事后分析。

Biochemical Relapse-Free Survival in Postprostatectomy Patients Receiving 18F-Fluciclovine-Guided Prostate Bed-Only Radiation: Post Hoc Analysis of a Prospective Randomized Trial.

机构信息

Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.

Department of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia.

出版信息

Pract Radiat Oncol. 2024 Nov-Dec;14(6):e492-e499. doi: 10.1016/j.prro.2024.05.011. Epub 2024 Jul 20.

Abstract

PURPOSE

Whole-pelvis (WP) radiation therapy (radiation) improved biochemical relapse-free survival (bRFS) compared with prostate bed (PB)-only radiation in the Radiation Therapy Oncology Group 0534, but was performed in an era prior to positron emission tomography (PET) staging. Separately, 18F-fluciclovine PET/CT-guided postprostatectomy radiation improved 3-year bRFS versus radiation guided by conventional imaging alone. We hypothesized that patients who were changed from WP to PB-only radiation after PET would have bRFS that was: (a) no higher than patients initially planned for PB-only radiation; and (b) lower than patients planned for WP radiation without PET guidance.

METHODS AND MATERIALS

We conducted a post hoc analysis of a prospective, randomized trial comparing conventional (arm 1) versus PET-guided (arm 2) postprostatectomy radiation. In arm 2, pre-PET treatment field decisions were recorded and post-PET fields were defined per protocol; pathologic node negative (pN0) without pelvic or extrapelvic PET uptake received PB-only radiation. Three-year bRFS was compared in patients planned for WP with change to PB-only radiation (arm 2 [WP:PB]) vs arm 2 patients planned for PB-only with final radiation to PB-only (arm 2 [PB:PB]) and arm 1 pN0 patients treated with WP radiation (arm 1 [WP]) using the Z test and log-rank test. Demographics were compared using the chi-square test, Fisher exact test, or analysis of variance, as appropriate.

RESULTS

We identified 10 arm 2 (WP:PB), 31 arm 2 (PB:PB) and 11 arm 1 (WP) patients. Androgen deprivation was used in 50.0% of arm 2 (WP:PB) and 3.2% of arm 2 (PB:PB) patients, P < .01. Median preradiation prostate-specific antigen was higher in arm 2 (WP:PB) vs arm 2 (PB:PB) patients (0.4 vs 0.2 ng/mL, P = .03); however, there were no significant differences in T stage, Gleason score, or margin positivity. Three-year bRFS was 80% in arm 2 (WP:PB) vs 87.4% in arm 2 (PB:PB), P = .47, respectively. Arm 1(WP) patients had significantly worse 3-year (23%) bRFS vs arm 2 (WP:PB), P < .01.

CONCLUSIONS

Patients initially planned for WP radiation with field decision change to PB-only radiation after PET showed (1) no significant difference in 3-year bRFS compared with patients initially planned for PB-only radiation; and (2) improved bRFS compared with patients receiving WP radiation without PET guidance. PET-guided volume de-escalation in selected patients may be 1 approach to mitigating toxicity without compromising outcomes.

摘要

目的

放射治疗肿瘤组 0534 的研究表明,全骨盆(WP)放射治疗(放疗)相较于单纯前列腺床(PB)放疗可改善生化无复发生存率(bRFS),但这项研究是在正电子发射断层扫描(PET)分期之前进行的。此外,18F-氟丁氨酸 PET/CT 引导的前列腺癌根治术后放疗可提高 3 年 bRFS,与单纯使用常规影像学引导的放疗相比。我们假设,在 PET 检查后,从 WP 改为单纯 PB 放疗的患者的 bRFS 为:(a)不比最初计划单纯 PB 放疗的患者高;(b)比没有 PET 指导的 WP 放疗患者低。

方法和材料

我们对一项前瞻性、随机试验进行了事后分析,比较了常规治疗(臂 1)与 PET 引导治疗(臂 2)。在臂 2 中,记录了治疗前的治疗野决策,并按照方案定义了治疗后野;无盆腔或盆外 PET 摄取的病理淋巴结阴性(pN0)患者接受单纯 PB 放疗。采用 Z 检验和对数秩检验,比较 WP 计划改变为单纯 PB 放疗(臂 2[WP:PB])的患者与单纯 PB 计划的患者(臂 2[PB:PB]),以及臂 1 pN0 患者(臂 1[WP])的 3 年 bRFS。使用卡方检验、Fisher 确切检验或方差分析,根据情况比较了患者的人口统计学特征。

结果

我们确定了 10 名臂 2(WP:PB)、31 名臂 2(PB:PB)和 11 名臂 1(WP)患者。50.0%的臂 2(WP:PB)和 3.2%的臂 2(PB:PB)患者接受了雄激素剥夺治疗,P<.01。与臂 2(PB:PB)患者相比,臂 2(WP:PB)患者的治疗前前列腺特异性抗原中位数更高(0.4 与 0.2ng/ml,P=0.03);然而,T 分期、Gleason 评分或切缘阳性率没有显著差异。臂 2(WP:PB)患者的 3 年 bRFS 为 80%,臂 2(PB:PB)患者为 87.4%,P=0.47。与臂 2(WP:PB)患者相比,臂 1(WP)患者的 3 年 bRFS(23%)显著更差,P<.01。

结论

在 PET 检查后,将最初计划 WP 放疗的患者的治疗野改为单纯 PB 放疗,患者(1)3 年 bRFS 无显著差异,与最初计划单纯 PB 放疗的患者相比;(2)与未接受 PET 指导的 WP 放疗患者相比,bRFS 有所改善。在选定的患者中,通过 PET 引导进行体积缩小可能是减轻毒性而不影响疗效的一种方法。

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