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ASTEC/EN.5

Adjuvant external beam radiotherapy in the treatment of endometrial cancer: pooled MRC ASTEC and NCIC CTG EN.5 randomised trials

N = 905NCT00002807

Population
Women with intermediate-risk or high-risk early-stage endometrial cancer, randomised after surgery
Design
Pooled report of two randomised trials of observation versus external beam radiotherapy after surgery (905 women: 789 from ASTEC and 116 from EN.5; 112 centres in seven countries; 1996 to 2005). Target radiotherapy dose 40 to 46 Gy in 20 to 25 fractions to the pelvis. Primary outcome measure overall survival; all analyses by intention to treat. Median follow-up 58 months. ASTEC is registered as ISRCTN16571884 and EN.5 as NCT00002807.
Primary endpoint
OS
Arms
  • Observation (control, n = 453): Observation after surgery
  • External beam radiotherapy (experimental, n = 452): Pelvic external beam radiotherapy, target 40 to 46 Gy in 20 to 25 fractions
People
ASTEC/EN.5 Study Group, ASTEC/EN.5 Study Group
OSHR 1.05 (95% CI 0.75–1.48)Δ 60-month OS0 points
Show the numbers
Results reported for ASTEC/EN.5
EndpointAnalysisExternal beam radiotherapyObservationEffect
OSOverall survival; 5-year estimatesprimarymedian follow-up 58 monthsASTEC/EN.5 200984% at 5 y84% at 5 yHR 1.05 (95% CI 0.75–1.48)P=0.77135 women had died (68 observation, 67 external beam radiotherapy). The abstract also reports a meta-analysis of trials that combined ASTEC and EN.5 data, with an overall survival hazard ratio of 1.04 (95% CI 0.84-1.29); which other trials were included is not stated in the abstract.
Local recurrenceObservation groupLocal recurrence rate at 5 years in the observation group only; brachytherapy was used in 53% of women in ASTEC/EN.5primaryASTEC/EN.5 2009—6.1% at 5 yThe abstract gives this rate for the observation group only, not for the radiotherapy group.
Results reported for ASTEC/EN.5
EndpointAnalysisExternal beam radiotherapyObservationEffect
OSOverall survival; 5-year estimatesprimarymedian follow-up 58 monthsASTEC/EN.5 200984% at 5 y84% at 5 yHR 1.05 (95% CI 0.75–1.48)P=0.77135 women had died (68 observation, 67 external beam radiotherapy). The abstract also reports a meta-analysis of trials that combined ASTEC and EN.5 data, with an overall survival hazard ratio of 1.04 (95% CI 0.84-1.29); which other trials were included is not stated in the abstract.
Local recurrenceObservation groupLocal recurrence rate at 5 years in the observation group only; brachytherapy was used in 53% of women in ASTEC/EN.5primaryASTEC/EN.5 2009—6.1% at 5 yThe abstract gives this rate for the observation group only, not for the radiotherapy group.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.050.75–1.48
Primary publication: ASTEC/EN.5 Study Group, Blake P, Swart AM, Orton J, Kitchener H, Whelan T, Lukka H, et al. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet. 2009;373(9658):137-46. PubMedDOI

Appears in

Sources

  1. ASTEC/EN.5 Study Group, Blake P, Swart AM, Orton J, Kitchener H, Whelan T, Lukka H, et al. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet. 2009;373(9658):137-46.

    PubMedDOI