Hyperthermic isolated limb perfusion for extremity soft tissue sarcomas: systematic review of clinical efficacy and quality assessment of reported trials.

BACKGROUND AND OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSION 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.