ASTEC Study

Efficacy of Systematic Pelvic Lymphadenectomy in Endometrial Cancer (MRC ASTEC Trial): A Randomised Study

Disease site

Uterine 

Publication month/year

January 2009

Study question

Can pelvic lymphadenectomy improve survival of women with early endometrial cancer independent of the effect of adjuvant therapy

Type of study

Randomised controlled trial (RCT)

Interventions compared

Hysterectomy and bllateral salpingoopherectomy (Standard surgery) alone vs. Standard surgery with pelvic lymphadenectomy

Experimental arm (Intervention)

Standard surgery, peritoneal washings and palpation of para-aortic lymph nodes with systematic lymphadenectomy (iliac and obturator nodes)

Control arm

Standard surgery, peritoneal washings and lymph node palpation

Primary outcome

Overall survival (OS)

Secondary outcome
  • Recurrence free survival – interval from time of randomisation to first recurrence of endometrial cancer or death from any cause
  • Disease specific survival – interval from time of randomisation to death from endometrial cancer or death due to treatment (including all cases within 30 days of surgery) as classified by the (blinded) Chief Investigator
  • Adverse effects from treatment
Inclusion criteria
  • Histologically proven endometrial carcinoma preoperatively confined to the corpus
  • Those who were able to undergo both systematic lymphadenectomy and external beam radiotherapy
  • Women who had CT/MRI suggestion of node enlargement were not excluded
Exclusion criteria

Nil defined

Results
Standard surgery Lymphadenectomy group
Randomised(n) 704 704
Overall survival(OS) 87.5% 85.4%
total death(n) 88 103
Recurrence free survival (recurrence + death) 107 144
5 years recurrence free survival 79% 73%
Treatment related morbidity (moderate/severe) 12% 17%
  • In the lymphadenectomy group, 58 (8%) women had no nodes removed
  • In the lymphadenectomy group, 72 (12%) had one to four nodes removed and 396 (65%) women had ten or more removed (median 12 nodes)
  • 9% of patients were found to have lymph node
  • Similar proportions received adjuvant treatment (radiotherapy, chemotherapy and progestogens)
Conclusions

This study found no evidence of benefit regarding overall/recurrence free/disease specific survival for systematic pelvic lymphadenectomy in women with early stage endometrial cancer. 

Study limitations
  • Suspicious nodes sampled in control arm (5%) if surgeon believed this to be in the patients best interests
  • Dissection not completed in lymphadenectomy cases (8%)
  • Para-aortic node sampling performed at surgical discretion
  • Minor morbidity may have been under-reported
  • Protocol specification of lymphadenectomy not comprehensive regarding pelvic/para-aortic node dissection
Additional resources

ASTEC/EN.5 radiotherapy trial for post surgical treatment of women with early stage disease at intermediate or high risk of disease recurrence – randomisation independent of lymph node status. Study demonstrated a small reduction in risk of isolated pelvic recurrence by 2.9%, however found no evidence of affect in overall or disease specific survival (https://pubmed.ncbi.nlm.nih.gov/19070891/) 

 

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