Stopping Lymphedema Starts with PREVENT

Stopping Lymphedema Starts with PREVENT

The Prevent Trial

Stopping
Lymphedema
Starts with
Prevent

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“[L-Dex] screening should be a standard approach for
prospective breast cancer-related lymphedema surveillance.”

– The PREVENT Trial

92%
of patients
with early detection using L-Dex® and intervention did not progress to chronic lymphedema.

The results are in.
And they’re conclusive.

See the Study

PREVENT is the largest randomized trial to assess lymphedema prevention

1,200

Breast Cancer
Patients

10

Centers

including 6 NCCN/NCI centers
across US and AUS

1:1

Randomization

L-Dex vs. Tape Measure

Robust Trial Design

Robust Trial Design Graphic
Robust Trial Design Graphic

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.

Significantly Lower Progression to Chronic Lymphedema

with early detection using L-Dex and intervention versus using tape measure.

Primary Endpoint Result

Significantly Lower Progression to Chronic Lymphedema

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Lymphedema Detection Methods

L-Dex Score History Chart

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.
Lymphedema Detection Methods - Tape Measure

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.

L-Dex® more precise and reliable than tape measure

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.”

— The PREVENT Trial

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.

Vanderbilt University Mayo Clinic Southeast Health MD Anderson Center Columbia University University of Louisville McQuarie University University of Kansas Cancer Center Cleveland Clinic Massey Cancer Center Allegheny Health Network

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

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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Letter From Our CMO

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References

  1. 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.
  2. Fu MR, et al. L-Dex ratio in detecting breast cancer-related lymphedema: reliability, sensitivity, and specificity. Lymphology 2013;46:85-96.