Department of Clinical Epidemiology, McGill University, Montreal, Canada.
J Surg Oncol. 2012 Dec;106(8):921-8. doi: 10.1002/jso.23200. Epub 2012 Jul 17.
Extremity soft tissue sarcomas (STS) are managed with radiotherapy and limb-sparing surgery however aggressive or recurrent cases require amputation. Hyperthermic isolated limb perfusion (HILP) has been proposed as an alternative. Our aim was to systematically review phase II HILP trials, assess tumor response, limb salvage (LS), and quality of scientific publications on this technique.
We conducted a literature search of electronic databases (MEDLINE, EMBASE, Scopus, Cochrane Library) and clinical trial registries for phase II HILP trials on non-resectable extremity STS. Outcomes of interest were complete response (CR), partial response (PR), and LS rates. Quality of published trials was assessed using a quality checklist.
Of 518 patients across 12 studies, 408 had some response (CR or PR), and 428 had the limb spared. Median CR, PR, and LS rates were 31%, 53.5%, and 82.5%, respectively. Median Wieberdink loco-regional toxicity rates were 3.8%, 45.5%, 17%, 1%, and 0% for levels 1-5, respectively. No trial fulfilled either all ideal or essential quality criteria. Seven trials did not include statistical methodology.
HILP seems effective in treating advanced extremity STS. However, poor publication quality hinders results validity. Technical and methodological standardization, well-designed, multi-institutional trials are warranted.
肢体软组织肉瘤（STS）采用放疗和保肢手术治疗，但侵袭性或复发性病例需要截肢。高温隔离肢体灌注（HILP）已被提议作为一种替代方法。我们的目的是系统地回顾 HILP 的 II 期临床试验，评估肿瘤反应、保肢（LS）以及该技术的科学出版物的质量。
我们对电子数据库（MEDLINE、EMBASE、Scopus、Cochrane 图书馆）和非可切除肢体 STS 的 II 期 HILP 临床试验进行了文献检索。感兴趣的结果是完全缓解（CR）、部分缓解（PR）和 LS 率。使用质量检查表评估已发表试验的质量。
在 12 项研究的 518 名患者中，408 名患者有一定的反应（CR 或 PR），428 名患者保留了肢体。中位 CR、PR 和 LS 率分别为 31%、53.5%和 82.5%。中位 Wieberdink 局部区域毒性发生率分别为 1-5 级的 3.8%、45.5%、17%、1%和 0%。没有一个试验同时满足所有理想或基本的质量标准。有 7 个试验没有包括统计方法学。
HILP 似乎对治疗晚期肢体 STS 有效。然而，较差的发表质量阻碍了结果的有效性。需要进行技术和方法学标准化、精心设计、多机构试验。
