ImpediMed Limited (ASX.IPD) is pleased to announce the PREVENT Trial successfully met its primary endpoint. This study, which provides level I evidence, demonstrated that intervention in patients with early detection of cancer-related lymphoedema using ImpediMed’s L-Dex® technology resulted in a lower rate of progression to chronic disease than patients with early detection from volume measurements using a tape measure, a result that is statistically significant. These findings, available as a preprint on medRxiv.org, were based on 1,200 patients followed for up to 3 years across 13 hospitals in the US and Australia.
The results are as follows:
• The trial met its primary endpoint.
• In patients with early detection using L-Dex, intervention resulted in a 7.9% rate of chronic lymphoedema compared to a 19.2% rate of chronic lymphoedema in patients with early detection using tape measure (p=0.016).
• This represents an absolute reduction of 11.3% and relative reduction of 59%.
• 92% of patients with early detection of cancer-related lymphoedema using L-Dex and intervention did not progress to chronic lymphoedema.
The paper concludes the following:
• These statistically significant results demonstrate that bioimpedance spectroscopy (BIS) screening should be a standard approach for prospective breast cancer-related lymphoedema (BCRL) surveillance.
• BIS is more specific for lymphoedema detection than tape measure (TM), as it had fewer triggers and longer times to intervention trigger.
• While the BIS protocol can be easily replicated in clinical settings, the rigor of the TM protocol for this study exceeded what is practical in most clinics. Thus, BIS may offer even more benefit across clinical settings than what was demonstrated in this study.
• BIS, as compared to TM, provides a more precise identification of patients likely to benefit from an early compression intervention.
The PREVENT trial is a pivotal study, the largest randomised controlled trial to assess lymphoedema prevention. The study enrolled 1,200 patients across 10 trial sites in the US and Australia, involving 13 hospitals, including Vanderbilt University, Mayo Clinic and MD Anderson. The trial was conducted over six and a half years and patients were followed for up to three years, with the primary aim to determine if early intervention in patients with subclinical detection of extracellular fluid accumulation via bioimpedance spectroscopy results in a lower rate of lymphoedema progression versus the rate when tape measure is used for subclinical detection.
The Company believes these results, combined with previously published data, will give clinicians the information they need to begin early intervention on their patients at a stage when it’s possible to keep the lymphoedema from advancing. There is strong support for the prospective surveillance model for early intervention with the National Comprehensive Cancer Network® (NCCN®) clinical practice guidelines supporting the need for pre-treatment and on-going measurement of patients at risk for lymphoedema and that better patient outcomes are reached with early detection. When the peerreviewed paper is published, these results will provide all clinicians addressing lymphoedema in breast cancer patients clear scientific data regarding the optimal measurement and sound evidence to switch from using tape measurements.
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