Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study

By H. Kitchener, A. Swart, Q. Qian, Chris Amos, Mkb Parmar. The Lancet, 2009

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Summary 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. Funding Medical Research Council and National Cancer Research Network.

Subfields: Epidemiology, Obstetrics and Gynecology

View Paper: https://www.semanticscholar.org/paper/8b6310941cb7408c1b629556b9e5c6ce528882eb

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Citations in the corpus

Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome (2013, methodology): “Examples of RMST in analysis of several trials We compare RMST and Cox/logrank analysis in a further four MRC cancer trials: ASTEC in endometrial cancer [16] (surgery vs.”
ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer (2015, methodology): “Similarly, the ASTEC trial, which included 1408 patients with stage I endometrial cancer who were randomised to receive surgical staging with or without pelvic lymphadenectomy, failed to show a beneficial effect of lymphadenectomy.(96) Although these trials represent the best data available, controv”
Post operative radiation therapy in endometrial carcinoma : reducing overtreatment and improving quality of life (2013, result): “Two recent large randomised trials allocated patients to TAH-BSO with or without lymphadenectomy and found no benefit in overall and disease free survival, nor differences in rates and sites of recurrence, while lymphadenectomy was associated with higher rates of treatment related morbidity, especia”
ESMO-ESGO-ESTRO consensus conference on endometrial cancer: Diagnosis, treatment and follow-up. (2015, methodology): “Although the 1988 FIGO staging system included surgical staging, two large randomised trials have since found no benefit of routine lymphadenectomy for nodal staging purposes in low- and intermediate-risk endometrial cancer [95,96].”