Lancet. 2009 Jan 10;373(9658):125-36. doi: 10.1016/S0140-6736(08)61766-3. Epub 2008 Dec 16.
Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study.
Amos C, Blake P, Branson A, Buckley CH, Redman CW, Shepherd J, Dunn G, Heintz P, Yarnold J, Johnson P, Mason M, Rudd R, Badman P, Begum S, Chadwick N, Collins S, Goodall K, Jenkins J, Law K, Mook P, Sandercock J, Goldstein C, Uscinska B, Cruickshank M, Parkin DE, Crawford RA, Latimer J, Michel M, Clarke J, Dobbs S, McClelland RJ, Price JH, Chan KK, Mann C, Rand R, Fish A, Lamb M, Goodfellow C, Tahir S, Smith JR, Gornall R, Kerr-Wilson R, Swingler GR, Lavery BA, Chan KK, Kehoe S, Flavin A, Eddy J, Davies-Humphries J, Hocking M, Sant-Cassia LJ, Pearson S, Chapman RL, Hodgkins J, Scott I, Guthrie D, Persic M, Daniel FN, Yiannakis D, Alloub MI, Gilbert L, Heslip MR, Nordin A, Smart G, Cowie V, Katesmark M, Murray P, Eddy J, Gornall R, Swingler GR, Finn CB, Moloney M, Farthing A, Hanoch J, Mason PW, McIndoe A, Soutter WP, Tebbutt H, Morgan JS, Vasey D, Cruickshank DJ, Nevin J, Kehoe S, McKenzie IZ, Gie C, Davies Q, Ireland D, Kirwan P, Davies Q, Lamb M, Kingston R, Kirwan J, Herod J, Fiander A, Lim K, Head AC, Lynch CB, Browning AJ, Cox C, Murphy D, Duncan ID, Mckenzie C, Crocker S, Nieto J, Paterson ME, Tidy J, Duncan A, Chan S, Williamson KM, Weekes A, Adeyemi OA, Henry R, Laurence V, Dean S, Poole D, Lind MJ, Dealey R, Godfrey K, Hatem MM, Lopes A, Monaghan JM, Naik R, Evans J, Gillespie A, Paterson ME, Tidy J, Ind T, Lane J, Oates S, Redford D, Ford M, Fish A, Larsen-Disney P, Johnson N, Bolger A, Keating P, Martin-Hirsch P, Richardson L, Murdoch JB, Jeyarajah A, Lamb M, McWhinney N, Farthing A, Mason PW, Kitchener H, Beynon JL, Hogston P, Low EM, Woolas R, Anderson R, Murdoch JB, Niven PA, Kerr-Wilson R, Chin K, Flynn P, Freites O, Newman GH, McNally O, Cullimore J, Olaitan A, Mould T, Menon V, Redman CW, George M, Hatem MH, Evans A, Fiander A, Howells R, Lim K, Cawdell G, Warwick AP, Eustace D, Giles J, Leeson S, Nevin J, van Wijk AL, Karolewski K, Klimek M, Blecharz P, McConnell D.
Erratum in
- Lancet. 2009 May 23;373(9677):1764.
Abstract
BACKGROUND:
Hysterectomy and bilateral salpingo-oophorectomy (BSO) is the standard surgery for stage I endometrial cancer. Systematic pelvic lymphadenectomy has been used to establish whether there is extra-uterine disease and as a therapeutic procedure; however, randomised trials need to be done to assess therapeutic efficacy. The ASTEC surgical trial investigated whether pelvic lymphadenectomy could improve survival of women with endometrial cancer.
METHODS:
From 85 centres in four countries, 1408 women with histologically proven endometrial carcinoma thought preoperatively to be confined to the corpus were randomly allocated by a minimisation method to standard surgery (hysterectomy and BSO, peritoneal washings, and palpation of para-aortic nodes; n=704) or standard surgery plus lymphadenectomy (n=704). The primary outcome measure was overall survival. To control for postsurgical treatment, women with early-stage disease at intermediate or high risk of recurrence were randomised (independent of lymph-node status) into the ASTEC radiotherapy trial. Analysis was by intention to treat. This study is registered, number ISRCTN 16571884.
FINDINGS:
After a median follow-up of 37 months (IQR 24-58), 191 women (88 standard surgery group, 103 lymphadenectomy group) had died, with a hazard ratio (HR) of 1.16 (95% CI 0.87-1.54; p=0.31) in favour of standard surgery and an absolute difference in 5-year overall survival of 1% (95% CI -4 to 6). 251 women died or had recurrent disease (107 standard surgery group, 144 lymphadenectomy group), with an HR of 1.35 (1.06-1.73; p=0.017) in favour of standard surgery and an absolute difference in 5-year recurrence-free survival of 6% (1-12). With adjustment for baseline characteristics and pathology details, the HR for overall survival was 1.04 (0.74-1.45; p=0.83) and for recurrence-free survival was 1.25 (0.93-1.66; p=0.14).
INTERPRETATION:
Our results show no evidence of benefit in terms of overall or recurrence-free survival for pelvic lymphadenectomy in women with early endometrial cancer. Pelvic lymphadenectomy cannot be recommended as routine procedure for therapeutic purposes outside of clinical trials.
- PMID:
- 19070889
- [PubMed - indexed for MEDLINE]
- PMCID:
- PMC2646126
Free PMC ArticleFigure 1
Lancet. 2009 January 10; 2009 May 23;373(9658):125-136.
Figure 3
Overall survival (A), disease and treatment-related deaths (B), and recurrence-free survival (C) by treatment group
Lancet. 2009 January 10; 2009 May 23;373(9658):125-136.
Figure 5
Effect of lymphadenectomy on overall survival (A) and recurrence-free survival (B) in women in different risk groups of recurrence
O–E=observed minus expected. Outer bars show 99% CI, inner bars show 95% CI.
Lancet. 2009 January 10; 2009 May 23;373(9658):125-136.
Figure 2
Profile of ASTEC surgical trial
We did not collect logs of patients assessed for eligibility. TAH=total abdominal hysterectomy. BSO=bilateral salpingo-oophorectomy. H=hysterectomy.
Lancet. 2009 January 10; 2009 May 23;373(9658):125-136.
Figure 4
Kaplan-Meier plots for the two treatment groups for overall and recurrence-free survival together with the model curves from fitting the Royston-Parmar parametric model
A and B show Kaplan-Meier estimates, with Royston-Parmar parametric model fitted. C and D show the absolute difference over time (95% CI) in survival from Royston-Parmar parametric model.
Lancet. 2009 January 10; 2009 May 23;373(9658):125-136.
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