Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma
- Study type
- Clinical trial
- Study name
- MSLT-II
- Phase
- Phase 3
- Design
- International randomised trial (immediate completion lymph node dissection versus nodal observation with ultrasound)
- Sample size
- 1934 patients evaluable in the intention-to-treat analysis; 1755 patients in the per-protocol analysis
- Source
- N Engl J Med · 2017
- Trial registration
- NCT00297895
In plain words
In patients with melanoma whose sentinel lymph node (the first node the cancer drains to) contained cancer cells, removing the rest of the lymph nodes in that area straight away did not improve the chance of surviving melanoma compared with regular check-ups with ultrasound scans. Removing the nodes did prevent the cancer from coming back in that lymph node area, but it made lymphoedema (swelling caused by build-up of lymph fluid) much more common. Decisions about further treatment should be made with the treating doctor, based on each patient's situation.
Key results
Treatment arms and regimens
Immediate completion dissection of the regional lymph nodes of the sentinel node basin; follow-up with clinical examination every 4 months in the first 2 years, every 6 months in years 3 to 5 and annually thereafter, without mandatory nodal ultrasound. The intervention is surgical and there is no protocol drug regimen.
Observation: clinical examination every 4 months in the first 2 years, every 6 months in years 3 to 5 and annually thereafter, with ultrasound of the sentinel node basin at each visit in the first 5 years; dissection only if a detectable nodal recurrence occurred. No protocol drug regimen.
Source of the regimen details: Full text of the paper (PMC5548388); surgical trial with no protocol drug regimen
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients aged 18 to 75 years with clinically localised cutaneous melanoma, ECOG 0 or 1, a life expectancy unrelated to melanoma of 10 years or more, and sentinel lymph node metastasis detected by standard pathological assessment or a multimarker molecular assay (RT-PCR). Patients were enrolled at screening before sentinel node biopsy (3531 patients, December 2004 to March 2014), and 1939 were randomised (1:1; stratified by Breslow thickness, ulceration, method of metastasis detection and centre). Adjuvant therapy was reported in 8.1% of the dissection group and 6.5% of the observation group.
Endpoints
Primary endpoint: melanoma-specific survival (survival until death from melanoma).
Secondary endpoints: disease-free survival and the cumulative rate of non-sentinel node metastasis.
Safety and side effects
Complications were more frequent after completion dissection. By the last follow-up (30 April 2016), lymphoedema had occurred in 24.1% of patients in the dissection group and 6.3% in the observation group (P<0.001); lymphoedema was mild in 64% of cases, moderate in 33% and severe in 3%. The main paper reports only lymphoedema rates and describes other surgical complications as more frequent and mostly transient.
Clinical significance and place in guidelines
Based on this abstract, immediate completion dissection in patients with sentinel node metastasis did not improve melanoma-specific survival, but increased regional disease control and was associated with a substantial increase in lymphoedema. The findings support careful observation with ultrasound as an alternative. The trial's status in current guidelines and its effect on clinical practice are not reported in the abstract and should be checked against current guidelines.
Limitations
The abstract stresses that the disease-free survival and regional disease control results should be interpreted with caution. The primary analysis of melanoma-specific survival was done at a median follow-up of 43 months. Other limitations are discussed in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.