Hippokratia 2013, 17(3):288
Department of surgical oncology, Theageneio Anticancer Hospital, Thessaloniki, Greece
Key words: Sentinel lymph node biopsy, lymphadenectomy, primary melanoma.
Corresponding author: Gavriilidis Paschalis, 2 A Simeonidi STR, 54007, Thessaloniki, Greece,
tel: +306977826253 e-mail: firstname.lastname@example.org
Until today there is no explicit and evidence based answer, about the superiority of sentinel lymph node biopsy (SLNB)over the nodal observation, in patients with primary melanoma.
An interesting debate flared-up after the publication on the 28th of September 2006 in NEJM by Morton DL, et al1. The multicentre selective lymphadenectomy trial-1 group (MSLT-1) evaluated the usefulness of SLNB over the nodal observation in patients with primary melanoma. They concluded that in cases with primary melanoma that are 1.2 to 3.5 mm in thickness, SLNB should be preferred to observation. However, reputable melanoma centres comparing the overall disease-free survival and melanoma specific survival of the SLNB group and observational one, found that there is no essential profit for the SLNB group.
MSLT-1 group promised further analyses of the data (results expected around 2008-2011) that would have solved the question of usefulness once and for all, but the results have not yet published.
Because of unexplained delay for publishing their new results, on 7th Jan 2013 the Editor of the BMJ declared: ‘This is not the only case in which clinical trial data have been published late or not at all. In addition to the well documented suppression of data by drug companies there are clear examples of delayed or non-publication in non-industry sponsored trials’2.
In England the National Institute for Health and clinical Excellence (NICE) recommends that SLNB should be performed only in centres with expertise and in context of clinical trials. However, it is reported that was carried out, in at least 19 hospitals, only 2 of which were involved in clinical trials3.
Therefore we can see that there are alternate interpretations that refute the published results of MSLT-1. Do we need another randomized control trial or do we need a new interpretation of the results of the MSLT-1 by a common group of the funders of the trial and its refuters?
1. Morton DL, Thompson JF, Cochran AJ, Mozzilo N, Elashoff R, Essner R, et al. Sentinel node biopsy or nodal observation in melanoma. N Engl J Med. 2006; 355: 1307-1317.
2. Godlee F. Timely publication of all trial results may mean less overtreatment. BMJ 2013; 346: 159.
3. Torjesen I. Sentinel node biopsy for melanoma: unnecessary treatment? BMJ 2013; 346: e8645.