1.5TMR 引导下的每日自适应 SBRT 治疗前列腺癌：可行性、初步临床耐受性、治疗期间的生活质量和患者报告的结果。

1.5 T MR-guided and daily adapted SBRT for prostate cancer: feasibility, preliminary clinical tolerability, quality of life and patient-reported outcomes during treatment.

机构信息

Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Cancer Care Center, Don Calabria, Negrar di Valpolicella, 37024, Verona, Italy.

University of Brescia, Brescia, Italy.

出版信息

Radiat Oncol. 2020 Mar 23;15(1):69. doi: 10.1186/s13014-020-01510-w.

DOI:10.1186/s13014-020-01510-w

PMID:32248826

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7092497/

Abstract

BACKGROUND

Unity Elekta is a unique magnetic resonance (MR)-linac that conjugates a 1.5 Tesla MR unit with a 7 MV flattening filter free accelerator.A prospective observational study for the clinical use of Elekta Unity is currently ongoing in our department. Herein, we present our preliminary report on the feasibility, quality of life, and patient-reported outcomes measures (PROMs) for localized prostate cancer (PC) treated with stereotactic body radiotherapy (SBRT).

METHODS

The SBRT protocol consisted of a 35 Gy schedule delivered in 5 fractions within 2 weeks. Toxicity and quality of life (QoL) were assessed at baseline and after treatment using the Common Terminology Criteria for Adverse Events v5.0, International Prostatic Symptoms Score (IPSS), ICIQ-SF, IIEF-5, and EORTC-QLQ-C30 and PR-25 questionnaires.

RESULTS

Between October 2019 and January 2020, 25 patients with localized PC were recruited. The median age was 68 years (range, 54-82); 4 were low risk, 11 favorable intermediate risk (IR) and 10 unfavorable IR. Median iPSA was 6.8 ng/ml (range, 1-19), and 9 of these patients (36%) received concurrent androgen deprivation therapy. Median prostate volume was 36 cc (range, 20-61); median baseline IPSS was 5 (range, 0-10). Median time for fraction was 53 min (range, 34-86); adaptive strategy with daily critical structure and target re-contouring and daily replanning (adapt to shape) was performed in all cases. No grade ≥ 3 adverse event was observed, three patients (12%) reported grade 2 acute genitourinary toxicity (urinary frequency, urinary tract pain and urinary retention), while only one patient reported mild rectal pain. No relevant deteriorations were reported in PROMs.

CONCLUSION

To the best of our knowledge, this is the first experience reporting feasibility, clinician-reported outcome measurements, and PROMs for 1.5 T MR-guided adaptive SBRT for localized prostate cancer. The preliminary data collected here report optimal safety and excellent tolerability, as also confirmed by PROMs questionnaires. Moreover, the data on technical feasibility and timing of online daily adapted planning and delivery are promising. More mature data are warranted.

TRIAL REGISTRATION

Date of approval April 2019 and numbered MRI/LINAC n°23,748.

摘要

背景

Unity Elekta 是一种独特的磁共振（MR）-直线加速器，它将 1.5T MR 单元与 7MV 无均整滤过加速器相结合。目前，我们科室正在进行 Elekta Unity 临床应用的前瞻性观察研究。在此，我们报告了使用立体定向体部放疗（SBRT）治疗局限性前列腺癌（PC）的可行性、生活质量和患者报告的结果测量（PROMs）的初步结果。

方法

SBRT 方案包括 35Gy 剂量，在 2 周内分 5 次给予。使用通用不良事件术语标准 v5.0、国际前列腺症状评分（IPSS）、ICIQ-SF、IIEF-5、EORTC-QLQ-C30 和 PR-25 问卷在基线和治疗后评估毒性和生活质量（QoL）。

结果

2019 年 10 月至 2020 年 1 月期间，共招募了 25 例局限性 PC 患者。中位年龄为 68 岁（范围 54-82 岁）；4 例为低危，11 例为中危（IR），10 例为高危（IR）。中位 iPSA 为 6.8ng/ml（范围 1-19），其中 9 例（36%）接受了同期雄激素剥夺治疗。中位前列腺体积为 36cc（范围 20-61）；中位基线 IPSS 为 5（范围 0-10）。分次时间中位数为 53 分钟（范围 34-86）；所有病例均采用每日关键结构和靶区再轮廓、每日重新计划（自适应形状）的自适应策略。未观察到任何等级≥3 的不良事件，3 例（12%）患者报告有急性泌尿生殖系统毒性（尿频、尿路疼痛和尿潴留），1 例患者报告有轻度直肠疼痛。PROMs 未见明显恶化。

结论

据我们所知，这是首次报道使用 1.5T MR 引导自适应 SBRT 治疗局限性前列腺癌的可行性、临床医生报告的结果测量和 PROMs。这里收集的初步数据报告了最佳的安全性和极好的耐受性，这也得到了 PROMs 问卷的证实。此外，关于在线每日自适应计划和交付的技术可行性和时间的数据很有希望。需要更成熟的数据。