小柯机器人

美国埃默里大学温希普癌症研究所Ashesh B Jani团队比较了¹⁸F-fluciclovine-PET/CT显像与单纯常规显像指导前列腺癌术后挽救性放疗对患者预后的影响。2021年5月7日，《柳叶刀》杂志发表了该成果。

分子成像越来越多地用于指导前列腺癌的治疗决策和计划。为了评估¹⁸F-fluciclovine-PET/CT与常规影像（骨扫描和CT或MRI）相比，在挽救性前列腺切除术后放疗中改善癌症控制的作用，研究组进行了一项单中心、开放标签、临床2/3期、随机对照试验，招募前列腺切除术后前列腺特异性抗原（PSA）可检测且常规显像阴性（无盆腔外或骨发现）的前列腺癌患者。

将这些患者按1：1随机分组，分别接受单纯常规显像指导的放疗，或常规显像加¹⁸F-fluciclovine-PET/CT指导的放疗。在¹⁸F-fluciclovine-PET/CT组中，放疗严格根据PET结果来决定，PET结果也用于靶区划定。主要终点为3年无事件生存率，通过对接受放疗的患者进行单变量和多变量分析，将事件定义为生化或临床复发或进展，或开始全身治疗。

2012年9月18日到2019年3月4日，研究组共随机分配了165名患者，中位随访时间为3.52年。¹⁸F-fluciclovine-PET/CT组中的PET结果显示4例患者放疗失败，将其排除在生存分析之外。常规显像组中有33%的患者未达到中位生存期，¹⁸F-fluciclovine-PET/CT组中有20%，常规显像组的3年无事件生存率为63.0%，¹⁸F-fluciclovine-PET/CT组中为75.5%，组间差异显著。

在校正分析中，研究组与无事件生存率显著相关。两个研究组的毒性相似，最常见的不良反应是尿频或尿急（常规显像组发生率为46%，¹⁸F-fluciclovine-PET/CT组为41%）和急性腹泻（常规显像组发生率为14%，¹⁸F-fluciclovine-PET/CT组为21%）。

研究结果表明，在前列腺切除术后放疗决策和计划中联合使用¹⁸F-fluciclovine-PET/CT可显著提高无生化复发或持续的生存率。

附：英文原文

Title: 18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial

Author: Ashesh B Jani, Eduard Schreibmann, Subir Goyal, Raghuveer Halkar, Bruce Hershatter, Peter J Rossi, Joseph W Shelton, Pretesh R Patel, Karen M Xu, Mark Goodman, Viraj A Master, Shreyas S Joshi, Omer Kucuk, Bradley C Carthon, Mehmet A Bilen, Olayinka A Abiodun-Ojo, Akinyemi A Akintayo, Vishal R Dhere, David M Schuster

Issue&Volume: 2021-05-07

Abstract:

Background

Molecular imaging is increasingly used to guide treatment decisions and planning in prostate cancer. We aimed to evaluate the role of 18F-fluciclovine-PET/CT in improving cancer control compared with conventional imaging (bone scan and either CT or MRI) alone for salvage postprostatectomy radiotherapy.

Methods

In EMPIRE-1, a single-centre, open-label, phase 2/3 randomised controlled trial, patients with prostate cancer with detectable PSA after prostatectomy and negative conventional imaging (no extrapelvic or bone findings) were randomly assigned in a 1:1 ratio to radiotherapy directed by conventional imaging alone or to conventional imaging plus 18F-fluciclovine-PET/CT. Computer-generated randomisation was stratified by PSA concentration, adverse pathology indicators, and androgen deprivation therapy intent. In the 18F-fluciclovine-PET/CT group, radiotherapy decisions were rigidly determined by PET findings, which were also used for target delineation. The primary endpoint was 3 year event-free survival, with events defined as biochemical or clinical recurrence or progression, or initiation of systemic therapy, using univariate and multivariable analyses in patients who received radiotherapy. This trial is registered with ClinicalTrials.gov, NCT01666808 and is closed to new participants.

Findings

From Sept 18, 2012, to March 4, 2019, 165 patients were randomly assigned, with median follow-up of 3·52 years (95% CI 2·98–3·95). PET findings resulted in four patients in the 18F-fluciclovine-PET/CT group having radiotherapy aborted; these patients were excluded from survival analyses. Median survival was not reached (95% CI 35·2–not reached; 33% of 81 patients had events) in the conventional imaging group compared with not reached (95% CI not reached–not reached; 20% of 76 patients) in the 18F-fluciclovine-PET/CT group, and 3 year event-free survival was 63·0% (95% CI 49·2–74·0) in the conventional imaging group versus 75·5% (95% CI 62·5–84·6) for 18F-fluciclovine-PET/CT (difference 12·5; 95% CI 4·3–20·8; p=0·0028). In adjusted analyses, study group (hazard ratio 2·04 [95% CI 1·06–3·93], p=0·0327) was significantly associated with event-free survival. Toxicity was similar in both study groups, with the most common adverse events being late urinary frequency or urgency (37 [46%] of 81 patients in the conventional imaging group and 31 [41%] of 76 in the PET group), and acute diarrhoea (11 [14%] in the conventional imaging group and 16 [21%] in the PET group).

Interpretation

Inclusion of 18F-fluciclovine-PET into postprostatectomy radiotherapy decision making and planning significantly improved survival free from biochemical recurrence or persistence. Integration of novel PET radiotracers into radiotherapy decisions and planning for prostate cancer patients warrants further study.

DOI: 10.1016/S0140-6736(21)00581-X

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00581-X/fulltext

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