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镓-PSMA PET/CT引导下机器人辅助挽救性淋巴结清扫术的初步多中心经验:安全性可接受,但肿瘤学获益似乎有限。

Initial multicentre experience of gallium-PSMA PET/CT guided robot-assisted salvage lymphadenectomy: acceptable safety profile but oncological benefit appears limited.

作者信息

Siriwardana Amila, Thompson James, van Leeuwen Pim J, Doig Shaela, Kalsbeek Anton, Emmett Louise, Delprado Warick, Wong David, Samaratunga Hemamali, Haynes Anne-Maree, Coughlin Geoff, Stricker Phillip

机构信息

St Vincent's Prostate Cancer Centre, St Vincent's Clinic, Sydney, NSW, Australia.

Garvan Institute of Medical Research, Kinghorn Cancer Centre, Sydney, NSW, Australia.

出版信息

BJU Int. 2017 Nov;120(5):673-681. doi: 10.1111/bju.13919. Epub 2017 Jun 20.

Abstract

OBJECTIVES

To evaluate the safety and short-term oncological outcomes of gallium-labelled prostate-specific membrane antigen ( Ga-PSMA) positron-emission tomography (PET)/computed tomography (CT)-directed robot-assisted salvage node dissection (RASND) for prostate cancer oligometastatic nodal recurrence.

MATERIALS AND METHODS

Between February 2014 and April 2016, 35 patients across two centres underwent RASND for Ga-PSMA PET/CT-detected oligometastatic nodal recurrence. RASND was performed using targeted pelvic dissection, unilateral extended pelvic template or bilateral extended pelvic template dissection, depending on previous pelvic treatment and extent/location of nodal disease. Complications were reported using the Clavien-Dindo classification system. Definitions of prostate-specific antigen (PSA) treatment response to RASND were defined as 6-week PSA <0.2 ng/mL (broad definition) or PSA <0.05 ng/mL (strict definition) in those who had undergone primary prostatectomy, and 6-week PSA level < post-radiotherapy nadir in those who had undergone primary radiotherapy. Biochemical recurrence (BCR) after RASND was defined as a PSA >0.2 ng/mL or PSA > nadir, for those who had undergone primary prostatectomy and primary radiotherapy, respectively. Predictors of treatment response were analysed using univariate binary logistic regression.

RESULTS

A total of 58 lesions suspicious for lymph node metastases (LNM) in 35 patients were detected on Ga-PSMA imaging. A total of 32 patients (91%) had histopathologically proven LNM at RASND, with a total of 87 LNM and a median (interquartile range) of 2 (1-3) LNM per patient. In all, eight patients (23%) experienced complications, all Clavien-Dindo grade ≤2. Treatment response was seen in 15 (43%) and 11 patients (31%), using the broad and strict definitions, respectively. BCR-free survival and clinical recurrence-free survival at a median follow-up of 12 months were 23% and 66%, respectively, for the entire cohort. Bilateral template dissection was the only significant univariate predictor of treatment response in our cohort.

CONCLUSIONS

Although RASND appears safe and feasible, less than half of our cohort had a treatment response, and less than a quarter experienced BCR-free survival at 12-month median follow-up. Ga-PSMA imaging underestimates micro-metastatic disease, therefore RASND will rarely be curative. Strict patient selection and restricting RASND to clinical trials is recommended. Long-term follow-up from such trials is required to further assess potential quality of life and mortality benefits.

摘要

目的

评估镓标记的前列腺特异性膜抗原(Ga-PSMA)正电子发射断层扫描(PET)/计算机断层扫描(CT)引导下的机器人辅助挽救性淋巴结清扫术(RASND)治疗前列腺癌寡转移淋巴结复发的安全性和短期肿瘤学结局。

材料与方法

2014年2月至2016年4月期间,两个中心的35例患者因Ga-PSMA PET/CT检测到寡转移淋巴结复发而接受了RASND。根据先前的盆腔治疗情况以及淋巴结疾病的范围/位置,采用靶向盆腔清扫、单侧扩大盆腔模板或双侧扩大盆腔模板清扫进行RASND。使用Clavien-Dindo分类系统报告并发症。RASND治疗反应的前列腺特异性抗原(PSA)定义为:接受过前列腺根治术的患者6周PSA<0.2 ng/mL(宽泛定义)或PSA<0.05 ng/mL(严格定义);接受过根治性放疗的患者6周PSA水平<放疗后最低点。RASND后生化复发(BCR)定义为:接受过前列腺根治术和根治性放疗的患者,PSA分别>0.2 ng/mL或PSA>最低点。使用单变量二元逻辑回归分析治疗反应的预测因素。

结果

在Ga-PSMA成像上共检测到35例患者的58个可疑淋巴结转移(LNM)病灶。共有32例患者(91%)在RASND时经组织病理学证实有LNM,共87个LNM,每位患者的LNM中位数(四分位间距)为2(1-3)个。总共有8例患者(23%)出现并发症,均为Clavien-Dindo≤2级。分别采用宽泛和严格定义时,治疗反应在15例(43%)和11例患者(31%)中可见。整个队列在中位随访12个月时的无BCR生存率和无临床复发生存率分别为23%和66%。双侧模板清扫是我们队列中唯一显著的单变量治疗反应预测因素。

结论

尽管RASND看起来安全可行,但我们队列中不到一半的患者有治疗反应,在中位随访12个月时不到四分之一的患者无BCR生存。Ga-PSMA成像低估了微转移疾病,因此RASND很少能治愈。建议严格选择患者并将RASND限制在临床试验中。需要对这类试验进行长期随访,以进一步评估潜在的生活质量和死亡率益处。

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