Extensive lymph node surgery may not be necessary for some patients with melanoma
Prof Claus Garbe - University of Tübingen, Tübingen, Germany
You’ve been looking at sentinel lymph node biopsy positive patients with melanoma. Why were you looking at them, what did you want to find out?
The recommendation today is that sentinel lymph node positive patients should receive a complete lymphadenectomy which is major surgery and also has adverse events like a rather high rate of permanent lymphedema. So our question was do these patients benefit in respect to survival from the complete lymphadenectomy? And in order to answer that we conducted a randomised trial within the German Dermatological Co-operative Oncology Group, forty centres.
You had the revolutionary idea that maybe not doing anything might be a good idea.
Yes, and so indeed we needed nine years in order to enrol 483 patients. Two-thirds of the patients refused to participate in this trial because they wanted not to be randomised either to surgery or to observation but they wanted to decide on their own.
They wanted action which people often do want action. But what happened?
So the outcome is that we do not find a survival benefit. So in terms of distant metastasis free survival we have only a difference of 0.3% after three years. Similarly, for the melanoma specific overall survival the curves overlap completely and this is also true for the recurrence free survival. The only difference is we have a higher local control in the lymph node basin after performing a complete lymphadenectomy. But the difference is not large, 14% recurrences in the lymph node basin in the observation group and 8% recurrences in the lymphadenectomy group, so it’s a question whether this is clinically meaningful.
What are the clear clinical implications coming from this then?
I think we have to really think whether we can recommend our patients the complete lymphadenectomy when they have a positive sentinel node. I guess the answer in Europe will be no and in the US probably they want to wait until their study shows the same results.
Now, this is a phase III study so what do you think, then, is the bottom line coming out of this?
Probably we will decide in Germany not to recommend the complete lymphadenectomy in positive sentinel lymph node patients. And I expect that we will have this in our guidelines soon.