ASTEC
Needs reviewEfficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study
Phase 3N = 1,408NCT00003749
- Population
- Women with histologically proven endometrial carcinoma thought preoperatively to be confined to the corpus
- Design
- Randomised trial from 85 centres in four countries (UK, South Africa, Poland, New Zealand) between 1 July 1998 and 31 March 2005. 1,408 women with histologically proven endometrial carcinoma thought preoperatively to be confined to the corpus were allocated by minimisation to standard surgery (hysterectomy and bilateral salpingo-oophorectomy, peritoneal washings and palpation of para-aortic nodes; n = 704) or standard surgery plus lymphadenectomy (n = 704). The primary outcome measure was overall survival; analysis was by intention to treat. 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. Registered as ISRCTN 16571884; ClinicalTrials.gov NCT00003749 is the combined MRC protocol for lymphadenectomy and adjuvant radiotherapy and lists an estimated enrolment of 2300.
- Primary endpoint
- OS
- Arms
- Standard surgery (control, n = 704): Hysterectomy and bilateral salpingo-oophorectomy, peritoneal washings and palpation of para-aortic nodes
- Standard surgery plus lymphadenectomy (experimental, n = 704): Standard surgery plus systematic pelvic lymphadenectomy
- People
- ASTEC study group, MRC ASTEC
OSHR 1.16 (95% CI 0.87–1.54)RFSHR 1.35 (95% CI 1.06–1.73)
Show the numbers
| Endpoint | Analysis | Standard surgery plus lymphadenectomy | Standard surgery | Effect |
|---|---|---|---|---|
| OS | primarymedian follow-up 37 monthsASTEC 2009 | — | — | HR 1.16 (95% CI 0.87–1.54)P=0.31Hazard ratio for lymphadenectomy vs standard surgery; a value above 1 is in favour of standard surgery. 191 deaths (88 standard surgery, 103 lymphadenectomy); absolute difference in 5-year overall survival 1% (95% CI -4 to 6). Median follow-up 37 months (IQR 24-58). Adjusted for baseline characteristics and pathology details: HR 1.04 (0.74-1.45), p=0.83. |
| RFSDeath or recurrent disease | primarymedian follow-up 37 monthsASTEC 2009 | — | — | HR 1.35 (95% CI 1.06–1.73)P=0.017Hazard ratio for lymphadenectomy vs standard surgery; a value above 1 is in favour of standard surgery. 251 women died or had recurrent disease (107 standard surgery, 144 lymphadenectomy); absolute difference in 5-year recurrence-free survival 6% (95% CI 1-12). Adjusted for baseline characteristics and pathology details: HR 1.25 (0.93-1.66), p=0.14. |
| Endpoint | Analysis | Standard surgery plus lymphadenectomy | Standard surgery | Effect |
|---|---|---|---|---|
| OS | primarymedian follow-up 37 monthsASTEC 2009 | — | — | HR 1.16 (95% CI 0.87–1.54)P=0.31Hazard ratio for lymphadenectomy vs standard surgery; a value above 1 is in favour of standard surgery. 191 deaths (88 standard surgery, 103 lymphadenectomy); absolute difference in 5-year overall survival 1% (95% CI -4 to 6). Median follow-up 37 months (IQR 24-58). Adjusted for baseline characteristics and pathology details: HR 1.04 (0.74-1.45), p=0.83. |
| RFSDeath or recurrent disease | primarymedian follow-up 37 monthsASTEC 2009 | — | — | HR 1.35 (95% CI 1.06–1.73)P=0.017Hazard ratio for lymphadenectomy vs standard surgery; a value above 1 is in favour of standard surgery. 251 women died or had recurrent disease (107 standard surgery, 144 lymphadenectomy); absolute difference in 5-year recurrence-free survival 6% (95% CI 1-12). Adjusted for baseline characteristics and pathology details: HR 1.25 (0.93-1.66), p=0.14. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 1.16 | 0.87–1.54 |
| RFS | 1.35 | 1.06–1.73 |