NEW YORK (Reuters Health), Dec 15 - Pelvic lymphadenectomy and adjuvant external-beam radiotherapy do not improve survival in women with early endometrial cancer, according to two reports appearing in the December 13 online issue of the Lancet.
Using data from the ASTEC surgical trial, Dr. Ann Marie Swart, from the Medical Research Council Clinical Trials Unit, London, and colleagues assessed the outcomes of 1,408 women with endometrial carcinoma thought to be confined to the corpus who were randomized to undergo standard surgery (hysterectomy and bilateral salpingo-oophorectomy) with pelvic lymphadenectomy or without.
Following surgery, patients at intermediate or high risk of disease recurrence were entered in the ASTEC radiotherapy trial and randomized to receive observation only or radiotherapy.
During a median follow-up period of 37 months, 88 patients in the standard surgery group had died compared with 103 in the lymphadenectomy group. This translates into a 16% reduced risk of death with standard surgery, although the difference was not statistically significant. Moreover, at five years, the absolute difference in overall survival was just 1%.
Standard surgery was associated with a significant 35% reduced risk of disease recurrence (p = 0.017). The absolute difference in recurrence-free survival at five years was 6%.
On multivariate analysis, no significant differences were seen between the surgical approaches in overall or recurrence-free survival.
The second study, also conducted by Swart and colleagues, involved a meta-analysis of data from the ASTEC radiotherapy trial and from the National Cancer Institute of Canada Clinical Trials Group EN.5 trial. Included were 905 women with intermediate- or high-risk early-stage disease drawn from 112 centers in seven countries.
During a median follow-up period of 58 months, 68 patients in the observation group and 67 treated with radiotherapy died. Five-year overall survival was identical in each group: 84%.
"For the currently available supplementary treatments 'less may be more' for most patients with early-stage endometrial cancer," Dr. Michael Hockel and Dr. Nadja Dornhofer, from the University of Leipzig, Germany, write in a related editorial. "Appropriate studies need to explore whether locoregional tumor control can be improved and distant metastases prevented by better surgery and different systemic therapies."
Lancet 2008.
Last Updated: 2008-12-12 18:30:24 -0400 (Reuters Health)
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