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P39. A Randomized Controlled Trial Comparing Inguinal to Ilio-inguinal Lymphadenectomy for Inguinal Metastatic Melanoma with Negative Pelvic Nodes on PET / CT Scan (The EAGLE FM Study): Final Results

Thursday, March 5, 2026
2:11 PM - 2:18 PM MST
Location: 301D
Introduction:

The EAGLE FM study was designed to determine the best surgical option for patients with metastatic melanoma in the inguinal lymph nodes (LNs) but no evidence of pelvic LN or distant spread on staging PET/CT scan and brain scan. At the time the study was designed there was wide variation between institutions performing inguinal lymphadenectomy (IL) or ilio-inguinal lymphadenectomy (I-IL).


Methods: Investigator led, international phase III, non-inferiority, prospective randomized controlled trial (RCT) of IL versus I-IL. The aim was to accrue 580 patients over 5 years. Patients were eligible with macroscopic or sentinel node (SN) detected inguinal LN, with known or unknown primary melanoma. The primary endpoint was disease free survival (DFS) 5 years after randomisation. Secondary endpoints were overall survival (OS), regional recurrence free survival (RRFS), and distant metastasis free survival (DMFS) and surgical morbidity


Results:

Recruitment commenced 2/03/2015 but was suspended on 16/12/2019 on the advice of the DSMC with investigators advised to complete follow up. There were 96 patients randomized across 16 sites with Australia recruiting 34.4%, Brazil 18.8% and UK / Europe 46.9%. Mean age was 56 years, 45.8% were male, 55.2% were macroscopic LN and 44.8% SN detected.  The DFS at 5 years was 50.5% for IL and 47.4% for I-IL (NS). At 5 years the OS was 80.8% for IL and 62.9% for I-IL (p=0.074), RRFS was 63.1% for IL and 56.3% for I-IL (NS) and DMFS 64.7% for IL and 52.7% for I-IL (NS). All 5-year survival outcomes numerically favored IL. Surgical morbidity was similar in the 2 groups, but chronic pain was non-significantly greater in the I-IL group (p 0.09).


Conclusions:

EAGLE FM is the only RCT investigating IL vs I-IL in patients with negative pelvic nodes on PET / CT. The study commenced at a time of rapid changes in melanoma management with DeCOG SLT and MSLT II confirming no benefit from completion lymphadenectomy and the rapid uptake of nascent effective systemic therapy drugs from stage 4 and unresectable stage 3 melanoma into the earlier settings impacting recruitment and DFS. Nevertheless, these data show no significant benefit in terms of DFS, OS, RRFS or DMFS from having an I-IL, which is a larger, minimally more morbid surgery. The results of this study support recommending IL for patients with this clinical scenario and should be considered when deciding on management in more contemporary settings.

Learning Objectives:

  • Understand the preferred surgical management of metastatic melanoma to the inguinal lymph nodes
  • Understand the relative survival outcomes and morbidity of inguinal vs ilio-inguinal dissection
  • See how international melanoma surgical units collaborate on clinical trials and understand the challenges of undertaking surgical trials during a period of rapid change in disease management.