Leg Lymphoedema After Inguinal and Ilio-Inguinal Lymphadenectomy for Melanoma: Results from a Prospective, Randomised Trial

• Published in: Annals of surgical oncology Vol. 31; no. 6; pp. 4061 - 4070
• Main Authors: Lee, T. S., Li, I., Peric, B., Saw, R. P. M., Duprat, J. P., Bertolli, E., Spillane, J. B., van Leeuwen, B. L., Moncrieff, M., Sommariva, A., Allan, C. P., de Wilt, J. H. W., Jones, R. Pritchard, Geh, J. L. C., Howle, J. R., Spillane, A. J.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.06.2024; Springer Nature B.V
• Subjects: Adult; Aged; Female; Follow-Up Studies; Humans; Inguinal Canal - pathology; Inguinal Canal - surgery; Leg; Lymph Node Excision - adverse effects; Lymphedema; Lymphedema - etiology; Male; Medicine; Medicine & Public Health; Melanoma; Melanoma - pathology; Melanoma - surgery; Metastases; Middle Aged; Neoplasm Staging; Oncology; Patients; Postoperative Complications - etiology; Prognosis; Prospective Studies; Radiation therapy; Skin Neoplasms - pathology; Skin Neoplasms - surgery; Statistics; Surgery; Surgical Oncology; Survival Rate; Wound infection
• ISSN: 1068-9265; 1534-4681; 1534-4681
• DOI: 10.1245/s10434-024-15149-4

Background The Evaluation of Groin Lymphadenectomy Extent for Melanoma (EAGLE FM) study sought to address the question of whether to perform inguinal (IL) or ilio-inguinal lymphadenectomy (I-IL) for patients with inguinal nodal metastatic melanoma who have no clinical or imaging evidence of pelvic disease. Primary outcome measure was disease-free survival at 5 years, and secondary endpoints included lymphoedema. Methods EAGLE FM was designed to recruit 634 patients but closed with 88 patients randomised because of slow recruitment and changes in melanoma management. Lymphoedema assessments occurred preoperatively and at 6, 12, 18, and 24 months postoperatively. Lymphoedema was defined as Inter-Limb Volume Difference (ILVD) > 10%, Lymphoedema Index (L-Dex ® ) > 10 or change of L-Dex ®  > 10 from baseline. Results Prevalence of leg lymphoedema between the two groups was similar but numerically higher for I-IL at all time points in the first 24 months of follow-up; highest at 6 months (45.9% IL [CI 29.9–62.0%], 54.1% I-IL [CI 38.0–70.1%]) and lowest at 18 months (18.8% IL [CI 5.2–32.3%], 41.4% I-IL [CI 23.5–59.3%]). Median ILVD at 24 months for those affected by lymphoedema was 14.5% (IQR 10.6–18.7%) and L-Dex ® was 12.6 (IQR 9.0–17.2). There was not enough statistical evidence to support associations between lymphoedema and extent of surgery, radiotherapy, or wound infection. Conclusions Despite a trend for patients who had I-IL to have greater lymphoedema prevalence than IL in the first 24 months after surgery, our study’s small sample did not have the statistical evidence to support an overall difference between the surgical groups.