Abstract PD4-02: A study to determine the optimal method of detection and threshold for lymphoedema intervention: A multi-centre prospective study

Abstract

Abstract Introduction Lymphoedema, a complication of nodal surgery in 30-40% of patients, reduces quality of life for sufferers. This prospective, multi-centre study compared multi-frequency bioimpedance spectroscopy (BIS, ImpediMed) with a validated perometer method to determine which test is more sensitive for detecting lymphoedema after axillary clearance and identify the factors predicting lymphoedema development. Material and methods Participants (n = 629) undergoing axillary clearance at 9 UK centres underwent pre-operative and arm volume measurements post-surgery (1, 3, 6, 9 & 12 months, then 6 monthly) by arm perometry, BIS measurements (L-Dex) and recorded self-reported symptoms via questionnaires. Follow-up was a minimum of two years from surgery. Change in arm volume was calculated using relative arm volume change (RAVC) with >10% increase defined as lymphoedema. The predictors of lymphoedema development and optimal method for its detection were assessed using Cox Regression, Log Rank and Kaplan-Meier survival analyses. Results In total, 629 women underwent axillary surgery, with a median age of 56 (range 22 to 90) years; 80% were ER positive and received endocrine therapy, 78% received radiotherapy and 65% received chemotherapy. Lymphoedema was detected by 24 months in 124 (20%) women by perometry. Using the LDex >10 cut-off score, bioimpedance sensitivity was 71% and specificity was 89% (PPV 47%) compared to RAVC changes. Women who had an RAVC >5%-<10% at six months developed lymphoedema in 44% of cases by two years, whereas those who had less than 3% RAVC developed lymphoedema in 9% of cases (p=>0.000001). Twenty-six per cent of ER negative patients developed lymphoedema compared to 19% ER positive cancer patients. The type (taxane versus no taxane) and whether chemotherapy was neo-adjuvant or adjuvant did not predict lymphoedema development. Univariate analysis revealed BMI (p=0.003), ER negativity (p=<0.010), absence of endocrine therapy (p=0.034), number of nodes involved (p=0.001) and an increase in RAVC >5%-<10% (p<0.005) all predicted lymphoedema development by two years. On multivariate analysis, RAVC >5%-<10% after six months (HR 5.51 95% CI 3.05 – 9.94) along with number of nodes involved (HR 1.06 95% CI 1.03 – 1.09) and BMI HR 1.04 (1.04 – 1.09) were included in the model for predicting lymphoedema development at two years. Conclusions This is the first report; ER negative cancer is associated with an increased risk of lymphoedema after axillary node clearance. Arm measurements should be taken from baseline in all patients undergoing axillary surgery and increases greater than 3% should lead to further surveillance to prevent lymphoedema development. Perometer measurement is the optimal technique for measuring and predicting the development of lymphoedema. A threshold RAVC of >5%-<10% after six months predicts lymphoedema in 44% of patients by two years. (Funded by NIHR Programme Grant). Citation Format: Bundred NJ, Ashton S, Riches K, Ashcroft L, Evans A, Todd C, Bramley M, Hodgkiss T, Purushotham A, Keeley V. A study to determine the optimal method of detection and threshold for lymphoedema intervention: A multi-centre prospective study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr PD4-02.