Preliminary outcomes of a randomized controlled trial evaluating immediate lymphatic reconstruction after axillary lymph node dissection for treatment of breast cancer
Michelle Coriddi*, Joseph Dayan, Leslie McGrath, Emily Bloomfield, Richard Diwan, Jasmine Monge, Julia Gutierrez, Babak J. Mehrara
Memorial Sloan Kettering Cancer Center, New York , NY
Introduction: Lymphedema can occur after axillary lymph node dissection (ALND) for breast cancer treatment in 24-49% of patients. Treatment is palliative and lifelong, usually requiring compression garments and physiotherapy. Immediate lymphatic reconstruction (ILR) is a procedure that aims to decrease the incidence of lymphedema by anastomosing the transected lymphatics draining the arm to a regional vein at the time of ALND. Prior prospective studies with a small number of patients and retrospective studies reporting the efficacy of ILR have been promising. However, an appropriately powered randomized controlled trial has not been performed.
Methods: A randomized controlled trial was conducted evaluating the rate of lymphedema after ALND in patients who had ILR versus control. Patients were seen pre-operatively to obtain baseline arm volume measurements, calculated based on the truncated cone formula using arm circumference measurements compared to the contralateral arm. Bioimpedance and quality of life (QoL) surveys (LYMQOL, ULL27, BAI, CESD) were also obtained. A baseline indocyanine green (ICG) lymphography was performed at the time of surgery to evaluate lymphatic drainage. Patients were randomized to either ILR or control after ALND. ILR was performed in standard fashion. Patients were evaluated at 6, 12, 18 and 24 months post-operatively. Arm volume, bioimpedance, QoL surveys and compression usage data were obtained at each visit. ICG lymphography was also performed at 12 and 24 months. A 10% relative arm volume change at either the 12, 18 or 24 month follow-up visits was diagnostic of lymphedema.
Results: 137 of 176 patients have been randomized to either ILR (67) or control (70). There were no differences in terms of age, BMI, neo-adjuvant chemotherapy or adjuvant radiation between groups. In total 81 patients completed 12-month follow-up, 59 patients completed 18-month follow-up, and 33 patients completed 24-month follow-up. The overall rate of lymphedema in control group was 24.4% and in ILR group was 5.0% (p=0.026). There was no significant difference in bioimpedance between groups. There was less compression use in the ILR group versus the control group at 24 months, but this was not significant (29.4% versus 43.8%, p=0.5). ICG lymphography showed significantly better lymphatic function with less dermal backflow indicative of lymphatic fluid accumulation in the skin in the ILR group compared to controls at 12 months (p=0.05). There were no significant findings regarding QoL data, however there was a trend toward better function in patients in the ILR group compared to controls at 12 and 18 months on the LYMQOL function dimension (p=0.07, 0.1).
Conclusion: Preliminary results of our randomized controlled trial evaluating ILR after ALND show a decreased rate of lymphedema and a trend toward better quality of life. However, enrollment is ongoing and more patients with longer term follow up will be needed to confirm these early results.
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