Removal of pelvic lymph nodes or radiotherapy cannot be recommended as routine treatments

December 12, 2008

Two Articles published Online first and in an upcoming edition of The Lancet show that two common adjuvant treatments for women with early endometrial cancer -- removing the pelvic lymph nodes or external beam radiotherapy -- should not be part of routine care. The Articles were written by Dr Ann Marie Swart, Medical Research Council (MRC) Clinical Trials Unit, London, UK, and Professor Henry Kitchener, University of Manchester, UK, and colleagues on behalf of the ASTEC study group and the ASTEC/EN.5 writing committee.

The first Article examined the benefits of removal of the pelvic lymph nodes (pelvic lymphadenectomy), in addition to the standard treatments of hysterectomy and removal of both ovaries and both fallopian tubes (bilateral salpingo-oophorectomy/BSO). Removal of the pelvic lymph nodes has been used to establish whether or not there is disease outside the uterus and is also a therapeutic procedure. In this randomised trial, the researchers analysed 1408 women from 85 centres in four countries* with endometrial cancer believed to be localised. Of these, 704 were randomly assigned to standard surgery (hysterectomy and BSO, peritoneal washing, and palpation of para-aortic nodes**; while the other 704 were assigned to standard surgery plus pelvic lymphadenectomy. The primary outcome was overall survival.

The researchers found that, after a median follow-up of just over three years, 88 women in the standard surgery died compared with 103 in the lymphadenectomy group - meaning women in the lymphadenectomy group were actually 16% more likely to die in the lymphadenectomy group. When looking at the combined chances of death or recurrent disease, 144 women in the lymphadenectomy group experienced one or the other, compared with 107 in the standard group -- an increased risk of 35% for women having their pelvic lymph nodes removed.

The authors conclude: "This randomised trial has shown no evidence of a benefit for systematic lymphadenectomy for endometrial cancer in terms of overall, disease-specific, and recurrence-free survival. This study is one of the largest reported surgical gynaecological cancer trials...Pelvic lymphadenectomy cannot be recommended as routine procedure for therapeutic purposes outside of clinical trials."

In the second Article, the effects of external beam radiotherapy (EBR) are examined. EBR has been offered to women who have had successful surgery (hysterectomy/BSO) for early endometrial cancer, but are considered to have an increased risk of recurrence due to their particular cancer pathology. This Article analyses 789 women from the ASTEC study plus a further 116 from the EN.5 study, from 112 centres in seven countries***. The patients were randomly assigned after surgery to observation (453 women) or to EBR (452). EBR was delivered in 20-25 daily fractions up to the target dose. Again the primary outcome was overall survival.

The researchers found that, after a median follow-up of 58 months, 68 women in the observation group had died, compared with 67 in the EBR group. There was no evidence that overall survival was higher in the EBR group, and 5-year overall survival was 84% in both groups. When combined in a meta-analysis with other trials, these results again showed no benefit for overall survival for EBR. With brachytherapy (placement of a small radioactive pellet near to the cancer site) used in 53% of women in the trial, the local recurrence rate in the observation group at 5 years was 6%.

The authors conclude: "The ASTEC/EN.5 trial has shown no evidence of a benefit for external beam radiotherapy for early endometrial cancer at intermediate or high risk of recurrence, in terms of overall, disease-specific, and disease-specific recurrence-free survival. Combining these findings with data from other trials, we can exclude even a very small benefit of radiotherapy on overall survival... Adjuvant external beam radiotherapy cannot be recommended as part of routine treatment to improve survival for women with early endometrial cancer at intermediate or high risk of recurrence, and brachytherapy might be preferred for local control."

In an accompanying Comment, Dr Michael Höckel and Dr Nadja Dornhöfer, Department of Obstetrics and Gynaecology, Women's and Children's Centre, University of Leipzig, Germany, say: "For the currently available supplementary treatments 'less may be more' for most patients with early-stage endometrial cancer and 'different may be better' for the patients with high-risk tumours."
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For both Dr Ann Marie Swart, Medical Research Council (MRC) Clinical Trials Unit, London, UK and Professor Henry Kitchener, University of Manchester, UK please contact the MRC press office T) +44 (0) 207 670 5139 / +44 (0) 7818 428 297 E) press.office@headoffice.mrc.ac.uk / ams@ctu.mrc.ac.uk / henry.c.kitchener@manchester.ac.uk

Dr Michael Höckel, Department of Obstetrics and Gynaecology, Women's and Children's Centre, University of Leipzig, Germany contact by e-mail E) michael.hoeckel@uni-klinik.leipzig.de

Notes to editors: *Four countries: UK, Poland, South Africa, New Zealand

**palpation= feeling of the para aortic nodes, which if abnormal would be removed, and, if found to contain cancer would mean that the patient was not eligible for the radiotherapy trial.

***Seven countries: UK, Canada, Poland, Norway, New Zealand, Australia, USA

For full Article and Comment: http://press.thelancet.com/astecfinal.pdf

Lancet

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