A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis.

Autor: Ridner SH; Vanderbilt University School of Nursing, Vanderbilt University, Nashville, TN, USA. sheila.ridner@vanderbilt.edu., Dietrich MS; Vanderbilt University School of Nursing, Vanderbilt University, Nashville, TN, USA.; Department of Biostatistics, Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA., Cowher MS; Department of Surgery, Alleghany General Hospital, Pittsburgh, PA, USA., Taback B; Division of Breast Surgery, Department of Surgery, Columbia University Medical Center, New York, NY, USA., McLaughlin S; Section of Surgical Oncology, Mayo Clinic, Jacksonville, FL, USA., Ajkay N; Department of Surgery, University of Louisville, Louisville, KY, USA., Boyages J; Faculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW, Australia., Koelmeyer L; Faculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW, Australia., DeSnyder SM; Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Wagner J; University of Kansas Medical Center, Westwood, KS, USA., Abramson V; Ingram Cancer Center, Vanderbilt Medical Center, Nashville, TN, USA., Moore A; Southeast Health Southeast Cancer Center, Cape Girardeau, MO, USA., Shah C; Department of Radiation Oncology, Cleveland Clinic, Taussig Cancer Institute, Cleveland, OH, USA.
Jazyk: angličtina
Zdroj: Annals of surgical oncology [Ann Surg Oncol] 2019 Oct; Vol. 26 (10), pp. 3250-3259. Date of Electronic Publication: 2019 May 03.
DOI: 10.1245/s10434-019-07344-5
Abstrakt: Background: Breast cancer-related lymphedema (BCRL) represents a major source of morbidity among breast cancer survivors. Increasing data support early detection of subclinical BCRL followed by early intervention. A randomized controlled trial is being conducted comparing lymphedema progression rates using volume measurements calculated from the circumference using a tape measure (TM) or bioimpedance spectroscopy (BIS).
Methods: Patients were enrolled and randomized to either TM or BIS surveillance. Patients requiring early intervention were prescribed a compression sleeve and gauntlet for 4 weeks and then re-evaluated. The primary endpoint of the trial was the rate of progression to clinical lymphedema requiring complex decongestive physiotherapy (CDP), with progression defined as a TM volume change in the at-risk arm ≥ 10% above the presurgical baseline. This prespecified interim analysis was performed when at least 500 trial participants had ≥ 12 months of follow-up.
Results: A total of 508 patients were included in this analysis, with 109 (21.9%) patients triggering prethreshold interventions. Compared with TM, BIS had a lower rate of trigger (15.8% vs. 28.5%, p < 0.001) and longer times to trigger (9.5 vs. 2.8 months, p = 0.002). Twelve triggering patients progressed to CDP (10 in the TM group [14.7%] and 2 in the BIS group [4.9%]), representing a 67% relative reduction and a 9.8% absolute reduction (p = 0.130).
Conclusions: Interim results demonstrated that post-treatment surveillance with BIS reduced the absolute rates of progression of BCRL requiring CDP by approximately 10%, a clinically meaningful improvement. These results support the concept of post-treatment surveillance with BIS to detect subclinical BCRL and initiate early intervention.
Databáze: MEDLINE
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