News Release

Less invasive lymph-node biopsy could prevent unnecessary surgery for patients with early stage endometrial cancer

Peer-Reviewed Publication

The Lancet_DELETED

Sentinel-lymph-node (SLN) biopsy can accurately diagnose lymph node status in patients with early stage endometrial cancer and provide vital information on the most effective adjuvant (additional) treatment without the need for complete lymphadenectomy (removal of all the pelvic lymph nodes), thereby reducing the risk of surgical complications. These findings published Online First in The Lancet Oncology, suggest that this minimally invasive procedure is a safe and effective alternative to more extensive lymph node removal.

Accurately determining how far cancer has spread, a process known as staging, is used to plan the most effective treatment for patients. Traditional surgery (lymphadenectomy), involving the removal of all the pelvic lymph nodes, is associated with an increased risk of complications including lymphocysts and lymphoedema (swelling caused by excess fluid build-up), and has shown little benefit in patients with early stage endometrial cancer.

A few small retrospective studies have suggested that doctors could evaluate endometrial cancer using SLN biopsy, a less invasive procedure involving the excision of just a few nodes instead of all regional lymph nodes*.

The SENTI-ENDO trial was designed to investigate the performance of SLN biopsy at predicting lymph node status in patients with early stage endometrial cancer. Between July, 2007, and August, 2009, 133 patients with early stage endometrial cancer from nine centres across France underwent SLN biopsy followed by complete lymphadenectomy.

SLN was successful in 77% of cases in the right hemipelvis and 76% in the left hemipelvis, with an overall detection rate of 98%.

No false negative cases were recorded in 100% of hemipelvises, so all healthy lymph nodes were correctly identified. Using the patient as the unit of analysis, the less invasive technique produced a negative predictive value (probability that patients who test negative result are correctly diagnosed) of 97% and sensitivity (rate of true positives) of 84%.

No complications were reported during SLN biopsy.

The authors say: "The SLN procedure provides data to tailor adjuvant therapy without increasing the risk of intraoperative and early postoperative complications. Therefore, the SLN procedure alone could be recommended for low-risk and intermediate-risk endometrial cancer."

They conclude: "Further studies are needed to evaluate the cost-effectiveness of systemic lymphadenectomy compared with lymphoscintigraphy and the SLN procedure, and the effect of the SLN procedure on adjuvant therapies and quality of life."

In a Comment, Henry Kitchener from The University of Manchester, Manchester, UK suggests that SLN biopsy can now be considered standard care: "The procedure seems feasible (almost 90% of women had detectable SLNs), and it seems reliable in terms of negative predictive value and sensitivity when ultrastaging of SLNs is implemented."

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Professor Emile Daraï, Tenon University Hospital, Paris, France. T) +33 1 56 01 73 18) emile.darai@tnn.aphp.fr

Professor Henry Kitchener, The University of Manchester, Manchester, UK. T) +44 (0) 161 276 6421 E) henry.c.kitchener@manchester.ac.uk

Notes to editors:

*During the SLN biopsy, a radioactive colloid and/or blue dye are injected pericervically and follow the path that tumour cells are most likely to take from the tumour to the lymph nodes. The first(s) node(s) to absorb the dye and/or radiocolloid, the sentinel node(s), is removed and biopsied.

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