Trial reports simplified treatment for endometrial cancer
15 December 2008
MRC/58/08
A clinical trial looking at the surgical treatment of endometrial cancer – the most common type of womb cancer – showed a full hysterectomy was just as effective in preventing the cancer coming back as more extensive surgery. It also showed that further surgery to remove lymph nodes around the womb did not increase the chances of long term survival. The Medical Research Council (MRC) ASTEC (A Study in the Treatment of Endometrial Cancer) trial was funded by the MRC and the National Cancer Research Network. The results of ASTEC are published in the Lancet.
Since 1988, the International Federation of Gynaecology and Obstetrics (FIGO) has required that endometrial cancer be surgically treated not only by removing the womb, fallopian tubes and ovaries (hysterectomy + bilateral salpingo-oophorectomy), but also the surrounding lymph nodes (pelvic lymphadenectomy) for analysis. Some suggested that if no disease was found in the nodes, radiotherapy could be avoided. However, evidence for this approach was scarce and came primarily from non-randomised studies and case studies.
ASTEC now provides clear evidence that there are no overall or recurrence-free survival benefits from the more extensive surgery. Over 1,400 women were recruited into the trial from 85 centres in four countries, all with histologically proven endometrial cancer which was thought to be confined to the uterus. The women in the study had hysterectomies and removal of the fallopian tubes and ovaries. Women with endometrial cancer recruited to the trial had very good outcomes with 80% of women surviving for 5 years after diagnosis and 79% in the standard surgery arm alive and free from disease recurrence after 5 years.
Professor Henry Kitchener, who was the Chief Investigator for the trial, said:
“ASTEC has important implications for clinical practice and future trials. Removing the lymph nodes increases the length of the surgery by 50 percent, and poses extra risks. However small, these cannot be justified in the absence of benefits, and the procedure should not be carried out as routine.”
Dr Ann Marie Swart who led the trial for the MRC Clinical Trials Unit said:
“ASTEC is the largest trial ever looking at surgical treatment of endometrial cancer. It shows how important it is to assess surgical treatments in randomised trials. Unfortunately, compared to drug trials, very few trials of surgical interventions are ever done.”
A second part of ASTEC included an assessment of the impact of adjuvant radiotherapy (External Beam Radiotherapy, EBRT) on disease recurrence and survival in women at high and intermediate risk of disease recurrence. The radiotherapy findings, combined with a similar trial performed in Canada (the National Cancer Institute of Canada Clinical Trials Group EN.5 trial) and results from other similar trials are also published in the Lancet. These results showed that the addition of external beam radiotherapy did not improve overall survival.
Original paper: Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC Trial): a randomised study is published online in the Lancet.
Notes to Editors:
- Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC Trial): a randomised study is published online in the Lancet on Saturday 13 December.
- Endometrial cancer is the most common type of womb cancer (uterine cancer or cancer of the uterus). It refers to several types of malignancy which arise from the endometrium, or lining of the uterus. Womb cancer is the fourth most common cancer found in women in the UK. 6,400 women are diagnosed with womb cancer each year in the UK.
- In the ASTEC surgical trial, after a median follow up of 37 months, 191 women had died (88 standard surgery group, 103 lymphadenectomy group). The hazard ratio (HR) for overall survival was 1.16 (95% confidence interval 0.87-1.54; p=0.31 in favour of standard surgery. 251 women died or had recurrent disease (107 standard surgery group, 144 lymphadenectomy group), HR 1.35 (1.06-1.73; p=0.017) in favour of standard surgery.
- In the ASTEC and EN.5 trials, after a median follow up of 58 months, 135 women (68 observation, 67 external beam radiotherapy) had died. Hazard ratio for overall survival was 1.05 (95% CI 0.75-1.48;p=0.77). Together with results from other similar trials, including over 2000 patients, an absolute benefit of more than a 3% improvement in overall survival at 5 years can be excluded.
- The EN.5 trial was coordinated by the National Cancer Institute of Canada Clinical Trials Group, which is funded by the Canadian Cancer Society and based at Queen’s University in Kingston, Ont.
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