CLINICAL NEWS UPDATE:
The PREVENT Trial
Letter from the Chief Medical Officer
I am pleased to report that the PREVENT Randomized Controlled Trial (RCT) met its primary endpoint. The final three-year results published in Lymphatic Research and Biology showed that L-Dex® is more effective in reducing the rate of chronic cancer-related lymphedema with early detection and intervention compared to tape measure. These results are practice-changing and establish L-Dex as the new standard of care in the prevention of chronic cancer-related lymphedema.
PREVENT Key Findings:
- Significantly fewer patients progressed to need complete decongestive physiotherapy using early detection with L-Dex and intervention compared to tape measure (primary endpoint result)
- Tape measure: 19.2% (23/120) vs. L-Dex: 7.9% (7/89), p = 0.016
- Significantly fewer patients triggered for intervention with L-Dex than with tape measure
- Tape measure: 27.5% (120/437) vs. L-Dex 20.1% (89/442), p=0.011
- A risk-adjusted analysis showed a benefit for L-Dex compared to tape measure for all groups at high risk for lymphedema
The authors concluded, “L-Dex screening should be a standard approach for prospective breast cancer-related lymphedema surveillance”
The PREVENT trial is the largest RCT assessing lymphedema prevention. Enrollment began in 2014 and patients were followed for three years. 1,200 breast cancer patients with planned surgical treatment were enrolled at 10 participating sites in the United States and Australia. A patient’s breast cancer treatment must have included one or any combination of total mastectomy, axillary dissection, sentinel node biopsy of more than 6 nodes, radiation therapy to chest wall/breast or nodes, and/or taxane-based chemotherapy to be eligible for inclusion in the trial. In this way, the study included a broad range of patients at higher risk for breast cancer-related lymphedema.
We want to thank the patients and investigators involved in PREVENT. Importantly, we want to thank Dr. Sheila Ridner for her leadership and dedication to conducting a high-quality study with practice changing impact for clinicians and patients alike.
Frank Vicini, MD
Chief Medical Officer, ImpediMed