1,200
BREAST CANCER PATIENTS
Stopping Lymphedema Starts with PREVENT
“[L-Dex] screening should be a standard approach for prospective breast cancer-related lymphedema surveillance.” –
The PREVENT Trial
THE PREVENT TRIAL
The results are in. And they’re conclusive.
92% of patients with early detection using L-Dex® and intervention did not progress to chronic lymphedema.
PREVENT is The Largest Randomized Trial to Assess Lymphedema Prevention
Robust Trial Design
Randomization
Newly diagnosed breast cancer patients with planned surgery received informed consent and baseline measurements using L-Dex and tape measure. Following surgery, patients were randomized to lymphedema follow-up using either L-Dex or tape measure.
Testing
Measurements were taken at 3, 6, 12, 15, 18, 21, 24, 30, 36 months with the 15 and 21 month visits at investigator discretion.
Trigger
An L-Dex increase of 6.5 or more from baseline was a trigger for intervention in the L-Dex group. A tape measure volume increase between 5% and 10% from baseline was a trigger for intervention in the tape measure group.
Intervention
Intervention was a 23-32 mmHG compression sleeve and gauntlet worn for 4 weeks, 12 hours a day.
Progression
Progression to complete decongestive physiotherapy (CDP) was the same for both groups: a tape measure volume increase of 10% or more from baseline.
PRIMARY ENDPOINT RESULT
Significantly Lower Progression to Chronic Lymphedema
with early detection using L-Dex and intervention versus using tape measure.
Lymphedema Detection Methods
L-Dex
- Bioimpedance spectroscopy (BIS) uses mild electric current passed through the body to accurately measure fluid in the body.
- The impedance to the current is measured at 256 frequencies and a sophisticated mathematical analysis converts the information into the L-Dex score.
- The L-Dex score is 80% sensitive and 90% specific in identifying lymphedema at the subclinical stage2.
Tape Measure
- Optimal guidelines ensured reliable volume measurements using tape measure.
- Circumference measurements were taken every 10 cm with a minimum of 5 measurements per arm.
- Each tape measure in the study was fitted with a tension spring for consistent tension during every measurement.
- Each tape measure visit took at least 20 minutes and clinical trial sites were trained annually.
THE PREVENT TRIAL
L-Dex More Precise and Reliable than Tape Measure
“[L-Dex] is more specific for lymphedema detection than tape measure.”
“[L-Dex], as compared to tape measure, provides a more precise identification of patients likely to benefit from an early compression intervention.”
Thank You to the PREVENT Patients and Investigators
Thank you to the patients and to the PREVENT investigators. Your contributions are advancing the science of lymphedema care so that cancer patients and survivors can access early detection and intervention of lymphedema.
PREVENT Publications
Final 3-Year Primary Endpoint Results
- 92% of patients with early detection using L-Dex and intervention did not progress to chronic lymphedema
- Significantly lower progression to chronic lymphedema with early detection using L-Dex and intervention versus using tape measure
- L-Dex more precise and reliable than tape measure
Kaplan–Meier Analysis
- The Kaplan–Meier analysis shows that patients with early detection using L-Dex and intervention have statistically significant higher rates of lymphedema progression free survival through three years compared to using tape measure
- This reinforces the importance of monitoring patients for three years, since progression to chronic lymphedema occurred throughout the three-year follow up period
PREVENT Secondary Aims
- Early detection and intervention of breast cancer-related lymphedema reduces the burden of chronic lymphedema on patients
- L-Dex testing is more effective than tape measure at identifying the optimal time to intervene to stop lymphedema progression
PREVENT Secondary Aims
- Early detection and intervention of breast cancer-related lymphedema reduces the burden of chronic lymphedema on patients
- L-Dex testing is more effective than tape measure at identifying the optimal time to intervene to stop lymphedema progression
BCRL Risk Factor Analysis
- The results confirm known BCRL risk factors such as axillary lymph node dissection, taxane-based chemotherapy, regional nodal irradiation, and obesity
- The analysis provides novel data on the increased risk of BCRL in patients living in a rural areas as well as no increased risk from air travel
Radiation Analysis
- BIS demonstrated better discrimination than tape measure for the risk of subclinical lymphedema in patients receiving radiation for post-treatment surveillance to detect subclinical lymphedema and initiate early intervention
- The risk of subclinical lymphedema increased with more extensive axillary radiation treatment
- Patients having axillary lymph node dissection or extensive radiation require close surveillance
RE-AIM Framework
- The prospective surveillance model for lymphedema in BC can be successfully implemented using the RE-AIM framework applied retrospectively
- The implementation of the PSM used in the RCT has assisted in changing clinical practices and improving the quality and effectiveness of the health care system
2-Year Trajectory
- Data supports the need for long-term (24 months) prospective surveillance with frequent assessments (every 3 months) at least 15 months after surgery
- Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema
1-Year Interim Analysis
- Initial data favorable to L-Dex
- More patients progressed following intervention triggered by tape measure than L-Dex
- L-Dex arm did not trigger interventions above expectations
L-Dex Trigger Analysis
- Recommend that an L-Dex change from baseline ≥6.5, rather than ≥10, be considered to best capture subclinical lymphedema
- Aggressive measurement with L-Dex at a frequency greater than every 6 months, that is, every 3 months, especially during the first 6–12 months post-surgery, is recommended to facilitate identification of subclinical lymphedema and support early diagnosis of clinical lymphedema
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References
- Ridner SH, et al. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphatic Research and Biology 2022.
- Fu MR, et al. L-Dex ratio in detecting breast cancer-related lymphedema: reliability, sensitivity, and specificity. Lymphology 2013;46:85-96.