Astec trial

It recruited women who had had surgery to remove womb cancer that was stage 1 or 2. All the women were considered to be at intermediate or high risk of the cancer coming back.

Just over half the women in each of these 2 groups had internal radiotherapy brachytherapy at some point after their surgery. There was no significant difference between the groups. The researchers analysed the results together with results of a similar trial that took place in Canada at the same time. When they looked at the results of both trials, they found that external radiotherapy did not help women who had surgery to remove womb cancer at intermediate or high risk of coming back, and it caused side effects.

So, they came to the conclusion that it should not be part of standard treatment. We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists peer reviewed and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves. Dr Sarah Louise Smyth.

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The writing committee had full access to all the data in the study, and the trial management group had final responsibility for the decision to submit for publication. Patient characteristics at randomisation including details of surgery and local pathology are shown in table 2.

Pretreatment characteristics, surgery received, and local pathology details reported at randomisation. Details of radiotherapy received are summarised in table 3. Pretreatment characteristics of women who did and did not receive brachytherapy are shown in the webtable. Adjuvant treatment for endometrial cancer before disease recurrence was given to a small proportion of women. Reported toxicity is summarised in table 4.

A summary of events is shown in table 5 and a summary of the primary comparisons with 5 year rates in table 6. Kaplan-Meier plots for the two treatment groups are shown in figure 2. A proportion of women did not die from endometrial cancer and had no disease recurrence before death. At the time of analysis, women 67 observation, 62 external beam radiotherapy had disease recurrence or had died from endometrial cancer.

Kaplan-Meier plots for disease-specific recurrence-free survival are shown in figure 2C. Site of recurrence is shown in table 5. The cumulative incidence of isolated vaginal or pelvic initial recurrence curves are shown in figure 3.

We also did analyses of overall survival, disease-specific survival, and disease-specific recurrence-free survival, adjusting for baseline characteristics using the Cox model table 6.

The results were similar to the unadjusted analysis. For the analyses of risk group interactions, exploratory analyses on overall survival and disease-specific survival are shown in figure 4. Disease-specific recurrence-free survival chosen as the most sensitive because of number of events, and least confounded by deaths from causes other than endometrial cancer was used to explore outcomes in women defined as high and intermediate risk. The effect of risk group on this outcome measure is shown in the webfigure.

Exploratory interaction analyses of the effect of external beam radiotherapy in groups defined as intermediate or high risk, and in those women who had lymphadenectomy or no lymphadenectomy as part of primary surgery, are shown in figure 4.

Effect of external beam radiotherapy on subgroups defined as at high and intermediate risk of recurrence and on women who had lymphadenectomy or no lymphadenectomy as part of initial surgery. No further trials have been identified. The main aim of updating the published review figure 5 was to assess the effect of radiotherapy in intermediate-risk and high-risk early-stage disease. The Aalders trial 2 was excluded because it was undertaken between and , before the introduction of FIGO staging.

The Soderini trial was excluded because it was published in abstract form only with no definitive time-to-event data. Combining these findings with data from other trials, we can exclude even a very small benefit of radiotherapy on overall survival. The small reduction in isolated local recurrence does not translate into an effect on overall or recurrence-free survival.

However, all pathologists in participating centres were given guidance to ensure that there was consistency across centres in the determination of high-risk pathology. All pathology reports were reviewed centrally to ensure that the histological description matched the diagnosis. The first trial of external beam radiotherapy in early endometrial cancer included all stage I women. All women in the GOG99 trial had surgical staging, and women with positive lymph nodes were excluded.

Although there is no standard definition of intermediate-risk or high-risk endometrial cancer, a consensus has emerged that women with papillary serous or clear cell endometrial cancer, and women with all other histological subtypes who are stage IC with high-grade tumours, are at high risk of recurrence.

Therefore, drawing firm conclusions about any possible interaction of lymphadenectomy and postoperative adjuvant external radiotherapy is difficult. A consensus could not be reached between all collaborating centres as to the use of such treatment, and a third patient randomisation to brachytherapy versus no brachytherapy was felt to be impracticable.

Therefore centres were asked to state their brachytherapy policy for all trial participants. Previous meta-analyses have attempted to use pooled data to investigate the effect of radiotherapy on different subgroups in trials whose entry criteria included intermediate-risk and high-risk women. Using published data, we could not undertake detailed subgroup analyses on the effect of treatment by subtype and risk category; this could only be done in a meta-analysis with individual patient data.

The ASTEC surgical trial investigated whether pelvic lymphadenectomy could improve survival of women with endometrial cancer. The primary outcome measure was overall survival.