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Randomized Controlled Trial
. 2023 Oct 1;278(4):630-637.
doi: 10.1097/SLA.0000000000005952. Epub 2023 Jun 14.

Efficacy of Immediate Lymphatic Reconstruction to Decrease Incidence of Breast Cancer-related Lymphedema: Preliminary Results of Randomized Controlled Trial

Michelle Coriddi  1 , Joseph Dayan  1 , Emily Bloomfield  1 , Leslie McGrath  1 , Richard Diwan  1 , Jasmine Monge  1 , Julia Gutierrez  1 , Stav Brown  1 , Lillian Boe  2 , Babak Mehrara  1
Affiliations
Randomized Controlled Trial

Efficacy of Immediate Lymphatic Reconstruction to Decrease Incidence of Breast Cancer-related Lymphedema: Preliminary Results of Randomized Controlled Trial

Michelle Coriddi et al. Ann Surg. .

Abstract

Objective: To conduct a randomized controlled trial (RCT) on the efficacy of immediate lymphatic reconstruction (ILR) for decreasing the incidence of breast cancer-related lymphedema (BCRL) after axillary lymph node dissection (ALND).

Background: Despite encouraging results in small studies, an appropriately powered RCT on ILR has not been performed.

Methods: Women undergoing ALND for breast cancer were randomized in the operating room 1:1 to either ILR, if technically feasible, or no ILR (control). The ILR group underwent lymphatic anastomosis to a regional vein using microsurgical techniques; control group had no repair and cut lymphatics were ligated. Relative volume change (RVC), bioimpedance, quality of life (QoL), and compression use were evaluated at baseline and every 6 months postoperatively up to 24 months. Indocyanine green (ICG) lymphography was performed at baseline and 12 and 24 months postoperatively. The primary outcome was the incidence of BCRL, defined as ≥10% RVC from baseline in the affected extremity at 12-, 18-, or 24-month follow-up.

Results: Of 72 patients randomized to ILR and 72 to control from January 2020 to March 2023, our preliminary analysis includes 99 patients with 12-month follow-up, 70 with 18-month follow-up, and 40 with 24-month follow-up. The cumulative incidence of BCRL was 9.5% in the ILR group and 32% in the control group ( P =0.014). The ILR group had lower bioimpedance values, decreased compression usage, better lymphatic function on ICG lymphography, and better QoL than the control group.

Conclusions: Preliminary results of our RCT show that ILR after ALND decreases BCRL incidence. Our goal is to finish the accrual of 174 patients with 24-month follow-up.

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Conflict of interest statement

B.M. is the recipient of investigator-initiated research awards from Regeneron Corp and Pfizer and royalty payments from PureTech and is a consultant with Mediflix Corp. J.D. is an advisor to Stryker Corporation, is on the board of Welwaze Medical LLC, and has a royalty agreement with Springer publishers for the book, Multimodal Treatment of Upper and Lower Extremity Lymphedema. The remaining authors report no conflicts of interest.

Figures

FIGURE 1:
FIGURE 1:
CONSORT Flow
FIGURE 2:
FIGURE 2:
Cumulative Incidence of Breast Cancer-Related Lymphedema
FIGURE 3:
FIGURE 3:
Compression Use Over Time by Treatment Arm
FIGURE 4:
FIGURE 4:
Changes in PROM from Baseline to Follow-Up at 12, 18, and 24 Months
See this image and copyright information in PMC

Comment in

References

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