PPP04 Presentation Time: 10:57 AM

IF 1.7 4区医学 Q4 ONCOLOGY

Brachytherapy Pub Date : 2024-10-25 DOI:10.1016/j.brachy.2024.08.012

Iosif Strouthos MD, PhD , Efstratios Karagiannis MD, PhD , Nicole Zamba MD , Dimitris Sokratous MD , Artemis Christodoulou MD , Georgios Antorkas MSc , Yiannis Roussakis PhD, MSc , Alexis Vrachimis MD, PhD , Constantinos Zamboglou MD, PhD , Konstantinos Ferentinos MD, PhD

{"title":"PPP04 Presentation Time: 10:57 AM","authors":"Iosif Strouthos MD, PhD , Efstratios Karagiannis MD, PhD , Nicole Zamba MD , Dimitris Sokratous MD , Artemis Christodoulou MD , Georgios Antorkas MSc , Yiannis Roussakis PhD, MSc , Alexis Vrachimis MD, PhD , Constantinos Zamboglou MD, PhD , Konstantinos Ferentinos MD, PhD","doi":"10.1016/j.brachy.2024.08.012","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>To report acute and early late toxicity and impact on early quality of life (QoL) of a patient cohort staged with 18F-PSMA-PET/CT, treated with a combination of prostate high dose-rate brachytherapy (HDR-BT) and prostate/seminal vesicle external beam radiation therapy (EBRT) for intermediate and high-risk prostate cancer in a phase II prospective trial (NCT05003752).</div></div><div><h3>Materials and Methods</h3><div>In this prospective phase II trial, a total of 41 patients with intermediate (IR), high (HR) and very high risk (VHR) prostate cancer, were recruited to receive a combination of hypofractionated EBRT to the prostate/seminal vesicles of 36 Gy (12 fractions of 3 Gy each) delivered in consecutive days, followed by single fraction real time HDR-BT of 14 Gy. Patients also received short-term (3-6 months) or long-term (>6 months) androgen deprivation therapy (ADT). All patients were both conventionally staged with prostate multi-parametric MRI (mpMRI), abdomen/pelvis CT and bone scintigraphy, with additional PSMA-PET/CT prior to their study inclusion. Acute, as well as early late genito-urinary (GU) and gastro-intestinal (GI) toxicity was assessed according to Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) questionnaires. Patient QoL was evaluated through Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaires. Erectile function was assessed by International Index for Erectile Function -5 (IIEF-5) questionnaire.</div></div><div><h3>Results</h3><div>Fourty-one patients (NCCN 48.8% UIR, 43.9% HR and 7.3% VHR) completed treatment and reached at least 14 months of follow-up (FU) at the time of the current analysis. Median FU was 20 months (IQ range 14-28). Median age was 72 years, median PSA before treatment was 11.0 ng/mL (5.0-28.3) and median volume of the prostate was 36.5 cc (14.9-68.2). Short-term ADT was administered to 43.9% of patients whereas 48.8% received long-term ADT, the rest of the patients did not receive hormonal therapy. No severe (i.e. Grade 2-4) acute events were recorded. The most common acute GU symptoms were nocturia and dysuria (29% and 20% respectively), whereas the most common acute GI events were increased bowel movements and pain during defecation (10% and 5% respectively). A significant decline from baseline compared to 3 months post treatment was observed both in hormonal and sexual domains, with high severity exhibited as a worsening from 12% to 38% and from 0% to 5%, respectively. No other domains exhibited any significant decline (urinary, and bowel).</div></div><div><h3>Conclusions</h3><div>The evaluation of the primary results of the presented prospective phase II trial suggests that the proposed hypofractionated combined radiotherapeutic scheme is a well-tolerated, presenting no acute or early late severe adverse events. Moreover, patient reported outcomes confirm these results, since no significant decline in any domain from baseline values was recorded.</div></div>","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Brachytherapy","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S153847212400148X","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose

To report acute and early late toxicity and impact on early quality of life (QoL) of a patient cohort staged with 18F-PSMA-PET/CT, treated with a combination of prostate high dose-rate brachytherapy (HDR-BT) and prostate/seminal vesicle external beam radiation therapy (EBRT) for intermediate and high-risk prostate cancer in a phase II prospective trial (NCT05003752).

Materials and Methods

In this prospective phase II trial, a total of 41 patients with intermediate (IR), high (HR) and very high risk (VHR) prostate cancer, were recruited to receive a combination of hypofractionated EBRT to the prostate/seminal vesicles of 36 Gy (12 fractions of 3 Gy each) delivered in consecutive days, followed by single fraction real time HDR-BT of 14 Gy. Patients also received short-term (3-6 months) or long-term (>6 months) androgen deprivation therapy (ADT). All patients were both conventionally staged with prostate multi-parametric MRI (mpMRI), abdomen/pelvis CT and bone scintigraphy, with additional PSMA-PET/CT prior to their study inclusion. Acute, as well as early late genito-urinary (GU) and gastro-intestinal (GI) toxicity was assessed according to Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) questionnaires. Patient QoL was evaluated through Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaires. Erectile function was assessed by International Index for Erectile Function -5 (IIEF-5) questionnaire.

Results

Fourty-one patients (NCCN 48.8% UIR, 43.9% HR and 7.3% VHR) completed treatment and reached at least 14 months of follow-up (FU) at the time of the current analysis. Median FU was 20 months (IQ range 14-28). Median age was 72 years, median PSA before treatment was 11.0 ng/mL (5.0-28.3) and median volume of the prostate was 36.5 cc (14.9-68.2). Short-term ADT was administered to 43.9% of patients whereas 48.8% received long-term ADT, the rest of the patients did not receive hormonal therapy. No severe (i.e. Grade 2-4) acute events were recorded. The most common acute GU symptoms were nocturia and dysuria (29% and 20% respectively), whereas the most common acute GI events were increased bowel movements and pain during defecation (10% and 5% respectively). A significant decline from baseline compared to 3 months post treatment was observed both in hormonal and sexual domains, with high severity exhibited as a worsening from 12% to 38% and from 0% to 5%, respectively. No other domains exhibited any significant decline (urinary, and bowel).

Conclusions

The evaluation of the primary results of the presented prospective phase II trial suggests that the proposed hypofractionated combined radiotherapeutic scheme is a well-tolerated, presenting no acute or early late severe adverse events. Moreover, patient reported outcomes confirm these results, since no significant decline in any domain from baseline values was recorded.

查看原文本刊更多论文

PPP04 演讲时间：上午 10:57

目的在一项II期前瞻性试验（NCT05003752）中，对接受前列腺高剂量率近距离放射治疗（HDR-BT）和前列腺/精囊外照射放射治疗（EBRT）联合治疗的中危和高危前列腺癌患者群进行18F-PSMA-PET/CT分期，报告其急性和早期晚期毒性以及对早期生活质量（QoL）的影响。材料与方法在这项前瞻性 II 期试验中，共招募了 41 名中度（IR）、高度（HR）和极高度（VHR）前列腺癌患者，让他们在连续几天内接受前列腺/精囊低分次 EBRT 组合治疗，每次 36 Gy（12 次，每次 3 Gy），然后再接受单次实时 HDR-BT 治疗，每次 14 Gy。患者还接受了短期（3-6 个月）或长期（6 个月）雄激素剥夺疗法（ADT）。在纳入研究之前，所有患者都接受了前列腺多参数磁共振成像（mpMRI）、腹部/骨盆 CT 和骨闪烁扫描的常规分期，并进行了 PSMA-PET/CT 检查。根据放射治疗肿瘤学组（RTOG）和欧洲癌症研究与治疗组织（EORTC）的调查问卷对急性、早期晚期泌尿生殖系统（GU）和胃肠道（GI）毒性进行评估。患者的生活质量通过前列腺癌临床实践扩展指数综合问卷（EPIC-CP）进行评估。结果41名患者（NCCN 48.8% UIR、43.9% HR和7.3% VHR）完成了治疗，并在本次分析时完成了至少14个月的随访（FU）。中位随访时间为 20 个月（IQ 范围为 14-28 个月）。中位年龄为 72 岁，治疗前 PSA 中位值为 11.0 ng/mL (5.0-28.3)，前列腺体积中位值为 36.5 cc (14.9-68.2)。43.9%的患者接受了短期ADT治疗，48.8%的患者接受了长期ADT治疗，其余患者未接受激素治疗。没有严重（即 2-4 级）急性事件的记录。最常见的急性胃肠道症状是夜尿和排尿困难（分别占29%和20%），而最常见的急性消化道症状是排便次数增多和排便时疼痛（分别占10%和5%）。与治疗后 3 个月的基线相比，荷尔蒙和性功能领域均出现明显下降，严重程度分别从 12% 恶化到 38%，从 0% 恶化到 5%。结论对所提交的前瞻性 II 期试验主要结果的评估表明，所提出的低分次联合放射治疗方案耐受性良好，没有出现急性或早期晚期严重不良反应。此外，患者报告的结果也证实了这些结果，因为与基线值相比，任何方面都没有显著下降。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Brachytherapy 医学-核医学

CiteScore

3.40

自引率

21.10%

发文量

119

审稿时长

9.1 weeks

期刊介绍： Brachytherapy is an international and multidisciplinary journal that publishes original peer-reviewed articles and selected reviews on the techniques and clinical applications of interstitial and intracavitary radiation in the management of cancers. Laboratory and experimental research relevant to clinical practice is also included. Related disciplines include medical physics, medical oncology, and radiation oncology and radiology. Brachytherapy publishes technical advances, original articles, reviews, and point/counterpoint on controversial issues. Original articles that address any aspect of brachytherapy are invited. Letters to the Editor-in-Chief are encouraged.