(HealthDay News) — Despite considerable controversy surrounding the third interim results of the Multicenter Selective Lymphadenectomy Trial (MSLT-I), which indicate a benefit of sentinel lymph node biopsy (SLNB) on disease-free survival in melanoma, the procedure is carried out routinely, according to a report published online Jan. 8 in BMJ.
Noting that results from the MSLT-I third interim analysis generated considerable controversy, Ingrid Torjesen, a freelance journalist based in London, discusses issues surrounding the use of SLNB in melanoma.
According to the report, the fourth and fifth analyses of the MSLT-I data, expected around 2008 and 2011, should have settled the question of the effectiveness of SLNB. Although all final 10-year data should have been collected by June 2012, these results have not yet been published and no timescale has been offered for their publication. While awaiting these results, SLNB is promoted by researchers and pharmaceutical and biotechnology companies. The procedure has become standard of care in the United States and is in routine clinical practice in the United Kingdom, despite 2006 guidelines from the National Institute for Health and Clinical Excellence cautioning against this. Many patients are being exposed to sentinel node and regional lymphadenectomy for unknown benefit, in spite of known harms of potentially unnecessary surgery. The procedure is estimated to cost a patient between $10,096 and $15,223 in the United States.
“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,” Torjesen concludes. “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.”