BMJ raises concerns over effectiveness of costly melanoma
procedure and witheld clinical trial data
11 January 2012
As part of its ongoing campaign to highlight the unethical
practice of witholding important clinical research data, the BMJ has
published a special report this week that finds that thousands of
melanoma patients around the world are undergoing an unnecessary
expensive and invasive procedure called sentinel node biopsy. The BMJ
claims that there is a lack of clear evidence for the procedure and has
concerns that it may do more harm than good.
Although not recommended for routine use in England, it has
become the standard care for melanoma patients in several countries
including the United States, where it was estimated to cost over
$686m in 2012.
Melanoma is the fifth most common cancer in the UK, affecting one
in 60 people. In the US it affects one in 50 people and, of the
seven most common cancers, is the only one that is increasing.
Sentinel node biopsy was developed in the US in the early 1990s to
detect the early spread of cancer cells in patients with melanoma.
It involves taking a small sample of the lymph node (gland) nearest
to the melanoma for testing. If cancer cells are found, patients are
advised to have surgery to remove some of the surrounding lymph
In 2006, a major trial (known as MSLT-I) published in the New
England Journal of Medicine found that sentinel node biopsy did not
improve overall survival after five years, yet the researchers
claimed that disease-free survival was significantly higher in the
The results proved controversial, but further analyses of the
data (expected around 2008 and 2011) that would have settled the
question of effectiveness once and for all have not yet been
In 2007, the US National Cancer Institute, which funded the
trial, accepted that it remained open to debate whether sentinel
node biopsy should be standard care, but there has been no
correction or clarification issued by the researchers or the
journal. Nor has there been any public explanation about the delay
in publishing the further analyses.
And when the BMJ contacted the lead researcher, he gave no
timescale for when publication of the results could be expected.
Meanwhile, large numbers of patients are being exposed to
unnecessary and potentially harmful surgery. It is thought that as
many as 96% of patients who have sentinel node biopsy will have
unnecessary surgery, which carries a risk of complications such as
lymphoedema (severe swelling of the limbs), cellulitis (deep skin
infection) and scarring.
In England, guidance from the National Institute for Health and
Clinical Excellence (NICE) states that sentinel node biopsy should
be performed only in centres with expertise in the context of
clinical trials. Yet data obtained by the BMJ show that at least 19
trusts across England carried out sentinel node biopsy procedures on
melanoma patients between 2006 and 2011.
The figures also suggest that in 2010-11, over 1,100 sentinel
node biopsies could have been conducted at an estimated cost to the
NHS of £7.6m. Given only two trials of sentinel node biopsy in
melanoma are ongoing, this is likely to account for only a fraction
of these biopsies.
The report concludes: “The full and final results of MSLT-I would
clarify whether sentinel node biopsy is beneficial, and what, if
any, its role in melanoma should be. It is time for the funders of
MSLT-1 and those responsible for overseeing research to demand
prompt publication of the full and final results of MSLT-I.”
Commenting on the report, BMJ Editor Dr Fiona Godlee, says the
evidence that much research goes unreported is overwhelming, putting
patients at risk and wasting healthcare resources. She calls on both
industry and academia to clean up their act, and invites BMJ readers
to sign up to www.alltrials.net – a campaign launched this week to
ensure that all trials are registered and their results published.