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Faries MB, et al. Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma. The New England journal of medicine. 2017;376:2211-2222. PMID 28591523

One-paragraph summary

MSLT-II randomised patients with sentinel-node metastases — detected either by standard pathological assessment or by a multimarker molecular assay — to immediate completion lymph-node dissection or to nodal observation with ultrasonography. The primary endpoint was melanoma-specific survival, with disease-free survival and the cumulative rate of non-sentinel-node metastasis as secondary endpoints. Immediate completion dissection was not associated with increased melanoma-specific survival among 1,934 patients in the intention-to-treat analysis or among 1,755 in the per-protocol analysis (NCT00297895).

Key findings

  • 3-year melanoma-specific survival was 86 ± 1.3% with dissection and 86 ± 1.2% with observation (P = .42) at a median follow-up of 43 months.
  • 3-year disease-free survival was slightly higher with dissection (68 ± 1.7% vs 63 ± 1.7%, P = .05), attributable to better regional nodal control (92 ± 1.0% vs 77 ± 1.5%, P < .001) — a result the authors say must be interpreted with caution.
  • Non-sentinel-node metastases were found in 11.5% of dissected patients and were a strong independent prognostic factor for recurrence (HR 1.78, P = .005).
  • Lymphoedema occurred in 24.1% of dissected patients.
  • DeCOG-SLT reached the same conclusion independently in 483 randomised patients at a median 72 months: 5-year distant-metastasis-free survival 67.6% (observation) versus 64.9% (dissection) (Leiter 2019, PMID 31557067).

Limitations

  • Median follow-up at publication was 43 months; melanoma-specific survival curves can separate later.
  • The comparison is dissection versus observation after a positive sentinel node; it does not test whether the sentinel node biopsy itself is beneficial — that was MSLT-I's question, and MSLT-I's design and analysis have been formally challenged (Thomas 2009, PMID 19246272).
  • Observation included protocol ultrasound surveillance, which is more intensive than routine care in many settings.
  • The trial predates effective adjuvant systemic therapy, so the counterfactual for a patient with residual nodal disease today is different.
  • The subsequent analysis of the observation arm suggesting the biopsy may itself be therapeutic in some patients is single-arm and hypothesis-generating (PMID 35921122).

Why it matters

MSLT-II removed a routine operation from melanoma practice on a negative primary endpoint, and it did so with a morbidity figure — 24.1% lymphoedema — that made the risk side of the calculation concrete. Its second-order consequence is the more interesting one: sentinel-node status was adopted partly on an assumed therapeutic action of early lymphadenectomy, and that action has now been withdrawn, yet sentinel-node status remains the AJCC 8th-edition stage III determinant and the eligibility gate for every modern adjuvant and neoadjuvant trial. Nobody has re-derived those eligibility rules from the post-MSLT-II evidence base, which is the junction recorded as OQ-2 and D2 in OPEN-QUESTIONS.md.

Cited by wiki pages

  • sentinel node and nodal management
  • staging
  • overview
  • surveillance and survivorship
  • guidelines
  • clinical trials landscape
  • red flags and safety concerns