Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Iridium Netwerk, GZA Ziekenhuizen, Antwerp, Belgium.
EJ Whitten Prostate Cancer Centre, Melbourne, Australia; ICON Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
Eur Urol Oncol. 2024 Jun;7(3):462-468. doi: 10.1016/j.euo.2023.09.007. Epub 2023 Oct 9.
BACKGROUND: Treatment recommendations for patients with limited nodal recurrences are lacking, and different locoregional treatment approaches are currently being used. OBJECTIVE: The aim of this trial is to compare metastasis-directed therapy (MDT) with or without elective nodal pelvic radiotherapy (ENRT). DESIGN, SETTING, AND PARTICIPANTS: PEACE V-Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM) is an international, phase 2, open-label, randomized, superiority trial (ClinicalTrials.gov identifier: NCT03569241). Patients diagnosed with positron emission tomography-detected pelvic nodal oligorecurrence (five or fewer nodes) following radical local treatment for prostate cancer were randomized in a 1:1 ratio between arm A (MDT and 6 mo of androgen deprivation therapy [ADT]) and arm B (ENRT [25 × 1.8 Gy] with MDT and 6 mo of ADT). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We report the secondary endpoint acute toxicity, defined as worst grade ≥2 Common Terminology Criteria for Adverse Events v4.0 gastrointestinal (GI) or genitourinary (GU) toxicity within 3 mo of treatment. The chi-square test was used to compare toxicity between treatment arms. We also compare the quality of life (QoL) using the European Organisation for Research and Treatment of Cancer QLQ C30 and PR25 questionnaires. RESULTS AND LIMITATIONS: Between June 2018 and April 2021, 196 patients were assigned randomly to MDT or ENRT. Ninety-seven of 99 patients allocated to MDT and 93 of 97 allocated to ENRT received per-protocol treatment. Worst acute GI toxicity proportions were as follows: grade ≥2 events in three (3%) in the MDT group versus four (4%) in the ENRT group (p = 0.11). Worst acute GU toxicity proportions were as follows: grade ≥2 events in eight (8%) in the MDT group versus 12 (13%) in the ENRT group (p = 0.95). We observed no significant difference between the study groups in the proportion of patients with a clinically significant QoL reduction from baseline for any subdomain score area. CONCLUSIONS: No clinically meaningful differences were observed in worst grade ≥2 acute GI or GU toxicity or in QoL subdomains between MDT and ENRT. PATIENT SUMMARY: We found no evidence of differential acute bowel or urinary side effects using metastasis-directed therapy and elective nodal radiotherapy for the treatment of patients with a pelvic lymph node recurrence.
背景：对于局部淋巴结复发患者的治疗推荐方案尚缺乏，目前正在采用不同的局部区域治疗方法。 目的：本试验旨在比较针对转移灶的治疗（MDT）联合或不联合选择性盆腔淋巴结放疗（ENRT）。 设计、地点和参与者：PEACE V-Salvage 治疗寡复发局部淋巴结前列腺癌转移（STORM）是一项国际性的 2 期开放标签随机优效性试验（ClinicalTrials.gov 标识符：NCT03569241）。患者在根治性局部治疗前列腺癌后，经正电子发射断层扫描（PET）检测到盆腔淋巴结寡复发（5 个或更少的淋巴结），按 1:1 比例随机分配到 A 组（MDT 和 6 个月的雄激素剥夺治疗[ADT]）和 B 组（ENRT[25×1.8 Gy]联合 MDT 和 6 个月 ADT）。 主要结局测量和统计分析：我们报告了次要终点急性毒性，定义为治疗后 3 个月内最严重的≥2 级通用不良事件术语标准 4.0（CTCAE v4.0）胃肠道（GI）或泌尿生殖系统（GU）毒性。采用卡方检验比较治疗组之间的毒性。我们还使用欧洲癌症研究和治疗组织（EORTC）QLQ C30 和 PR25 问卷比较生活质量（QoL）。 结果和局限性：2018 年 6 月至 2021 年 4 月期间，196 名患者被随机分配至 MDT 或 ENRT。99 名按计划接受 MDT 治疗的患者中，97 名接受了治疗；97 名按计划接受 ENRT 治疗的患者中，93 名接受了治疗。最严重的急性 GI 毒性比例如下：MDT 组有 3 名（3%）患者出现≥2 级事件，ENRT 组有 4 名（4%）患者出现（p=0.11）。最严重的急性 GU 毒性比例如下：MDT 组有 8 名（8%）患者出现≥2 级事件，ENRT 组有 12 名（13%）患者出现（p=0.95）。在任何亚域评分区域的基线临床 QoL 下降比例方面，研究组之间未观察到 QoL 方面有统计学意义的差异。 结论：MDT 和 ENRT 治疗盆腔淋巴结复发患者，在最严重的≥2 级急性 GI 或 GU 毒性或 QoL 亚域方面，未观察到有临床意义的差异。 患者总结：我们未发现针对转移灶的治疗和选择性盆腔淋巴结放疗在治疗盆腔淋巴结复发患者时，在急性肠道或泌尿系统副作用方面存在差异。
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