ABSTRACT
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.
Subject(s)
Inguinal Canal , Lymph Node Excision , Lymphedema , Melanoma , Skin Neoplasms , Humans , Melanoma/surgery , Melanoma/pathology , Lymphedema/etiology , Lymph Node Excision/adverse effects , Female , Male , Prospective Studies , Middle Aged , Follow-Up Studies , Skin Neoplasms/surgery , Skin Neoplasms/pathology , Inguinal Canal/surgery , Inguinal Canal/pathology , Prognosis , Survival Rate , Leg , Aged , Adult , Postoperative Complications/etiology , Neoplasm StagingABSTRACT
Merkel cell carcinoma (MCC) is a rare aggressive cutaneous neuroendocrine malignancy that frequently metastasizes to the regional lymphatic basin. Pathological assessment of regional lymph nodes with sentinel lymph node biopsy (SLNB) in patients without clinical involvement has permitted more accurate staging and more appropriate management. Nonetheless, concerns have been raised regarding the accuracy of this technique and its prognostic implications. We conducted a review of previously published data analysing the positive and false negative rates of SLNB in MCC. A search of the Medline and Embase databases to April 2015 identified 36 published studies between 1997 and 2015 comprising 692 patients. With the addition of 29 patients treated at our own institution, we conducted an analysis of 721 patients. Among this cumulative cohort, SLNBs were performed from 736 regional sites with 29·6% recorded as positive. Regional metastasis occurred in 45 cases following a negative SLNB, for a false negative rate of 17·1%. Adjuvant regional radiotherapy in the setting of a negative SLNB did not affect regional recurrence (P = 0·31), providing credence to emerging evidence that regional therapy can be safely omitted in the setting of a negative SLNB. Distant relapse was noted far more frequently following a positive rather than negative SLNB (17·6% vs. 7·3%, P < 0·001).
