Elsevier

The Lancet

Volume 351, Issue 9105, 14 March 1998, Pages 793-796
The Lancet

Articles
Immediate or delayed dissection of regional nodes in patients with melanoma of the trunk: a randomised trial

https://doi.org/10.1016/S0140-6736(97)08260-3Get rights and content

Summary

Background

The use of elective regional node dissection in patients with cutaneous melanoma without any clinical evidence of metastatic spread is still debated. Our aim was to evaluate the efficacy of immediate node dissection in patients with melanoma of the trunk and without clinical evidence of regional node and distant metastases.

Methods

An international multicentre randomised trial was carried out by the WHO Melanoma Programme from 1982 to 1989. The trial included only patients with a trunk melanoma 1·5 mm or more in thickness. After wide excision of primary melanoma, patients were randomised to either immediate regiona node dissection or a regional node dissection delayed until appearance of regional-node metastases.

Findings

Of the 252 patients entered, 240 (95%) were eligible and evaluable for analysis. 122 of these were randomised to immediate node dissection. 5-year survival observed in patients who had delayed node dissection was 51·3% (95% CI 41·7–60·1) compared with 61·7% (52·0–70·1) of patients who had immediate node dissection (p=0·09). 5-year survival rate in patients with occult regional node metastases was 48·2% (28·0–65·8) and 26·6% (13·4–41·8, p=0·04) in patients in whom the regional node dissection was delayed until the time of appearance of regional node metastases. Multivariate analysis showed that routine use of immediate node dissection had no impact on survival (hazard ratio 0·72, 95% CI 0·5–1·02), whilst the status of regional nodes affected survival significantly (p=0·007). The patients with regional nodes that became clinically and histologically positive during follow-up had the poorest prognosis.

Interpretation

Node dissection offers increased survival in patients with node metastases only. Sentinel node biopsy may become a tool to identify patients with occult node metastases, who could then undergo node dissection.

Introduction

Elective node dissection in patients with cutaneous melanoma with no clinically detectable node metastases has been long debated. Until the report of the Melanoma Intergroup Committee randomised trial,1 the benefit from elective node dissection in these patients had not been shown.2, 3, 4, 5 The Intergroup trial showed that a subgroup of patients aged 60 or younger, with a primary melanoma of maximum thickness between 1 and 4 mm, benefited from elective regional node dissection even though the same evaluation on the whole series treated was negative. These results confirm that not all stage I and stage II patients benefit from elective node dissection.6 We report a randomised clinical trial (WHO Clinical Trial #14) that was designed to evaluate the efficacy of elective dissection of regional nodes in patients with a primary melanoma on the trunk at a tumour thickness of 1·5 mm or greater.

Section snippets

Patient and methods

Eligible patients were aged 65 or younger, with a primary melanoma on the trunk with no evidence of regional node or distant metastases, and Breslow thickness of 1·5 mm or greater. The patients had to be either previously treated or have had a biopsy within 6 weeks of final surgical treatment. Patients with a history of previous cancer (excluding basal cell carcinoma of the skin and non-invasive cancer of the uterine cervix) were excluded, as were patients with clinically positive nodes. The

Results

252 patients entered the study between 1982 and 1989; 240 (95%) were evaluable. The mean follow-up was 132 months. 12 patients were excluded from analysis, six in each arm. Reasons for exclusion were: treatment not in accordance with randomisation (seven patients), diagnosis of melanoma not confirmed by the pathologists' panel (three), site of origin outside the trunk (one), and lack of pathological documentation (one). 62 additional patients did not enter into the study: 59 because primary

Discussion

Our results from this randomised trial confirm the inefficacy of elective regional node dissection as routine treatment in all melanoma patients with a primary melanoma of the trunk thicker than 1·5 mm (p=0·09). Comparison with the Intergroup results1 is not possible because the length of follow-up was longer in our patients, patients in our study had on average thicker melanomas, and we dealt with trunk melanoma only. In addition, our sample size did not allow subgroup analysis.

The secondary

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