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Referencias

References to studies included in this review

Ir a:

Barakat 2006 {published data only}

Barakat RR, Bundy BN, Spirtos NM, Bell J, Mannel RS, Gynecologic Oncology Group Study. Randomized double‐blind trial of estrogen replacement therapy versus placebo in stage I or II endometrial cancer: a Gynecologic Oncology Group Study. Journal of Clinical Oncology 2006;24(4):587‐92. CENTRAL

References to studies excluded from this review

Ir a:

Ayhan 2006 {published data only}

Ayhan A, Taskiran C, Simsek S, Sever A. Does immediate hormone replacement therapy affect the oncologic outcome in endometrial cancer survivors?. International Journal Gynecological Cancer 2006;16(2):805‐8. CENTRAL

Chapman 1996 {published data only}

Chapman JA, DiSaia PJ, Osann K, Roth PD, Gillotte DL, Berman ML. Estrogen replacement in surgical stage I and II endometrial cancer survivors. American Journal of Obstetrics and Gynecology 1996;175(5):1195‐200. CENTRAL

Creasman 1986 {published data only}

Creasman WT, Henderson D, Hinshaw W, Clarke‐Pearson DL. Estrogen replacement therapy in the patient treated for endometrial cancer. Obstetrics and Gynecology 1986;67(3):326‐30. CENTRAL

Lee 1990 {published data only}

Lee RB, Burke TW, Park RC. Estrogen replacement therapy following treatment for stage I endometrial carcinoma. Gynecologic Oncology 1990;36(2):189‐91. CENTRAL

Shim 2014 {published data only}

Shim SH, Lee SJ, Kin SN. Effect of hormone replacement therapy on the rate of recurrence in endometrial cancer survivors: a meta‐analysis. European Journal of Cancer 2014;50(9):1628‐37. CENTRAL

Suriano 2001 {published data only}

Suriano KA, McHale M, McLaren CE, Li KT, Re A, DiSaia PJ. Estrogen replacement therapy in endometrial cancer patients. Obstetrics and Gynecology 2001;97(4):555‐60. CENTRAL

Additional references

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Amant 2005

Amant F, Moerman P, Neven P, Timmerman D, van Limbergen E, Vergote I. Endometrial cancer. Lancet 2005;366(9484):491‐505.

ASTEC/EN5 Study Group 2009

ASTEC/EN5 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.

Beresford 1997

Beresford SAA, Weiss NS, Voight LF, McKnight B. Risk of endometrial cancer in relation to oestrogen combined with cyclic progestagen therapy in postmenopausal women. Lancet 1997;349(9050):458‐61.

Bokhman 1983

Bokhman JV. Two pathogenetic types of endometrial carcinoma. Gynecologic Oncology 1983;15(1):10‐7.

Chlebowski 2015

Chlebowski RT, Anderson GL, Sarto GE, Haque R, Runowicz CD, Aragaki AK, et al. Continuous combined estrogen plus progestin and endometrial cancer: the Women's Health Initiative Randomized Trial. Journal of the National Cancer Institute 2015;108(3):pii.

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Feeley 2001

Feeley KM, Wells M. Hormone replacement therapy and the endometrium. Journal of Clinical Pathology 2001;54(6):435‐40.

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Galaal 2014

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Gelfand 1989

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Hammond 1979

Hammond CB, Jelovsek FR, Lee KL, Creasman WT, Parker RT. Effects of long term estrogen replacement therapy. II. Neoplasia. American Journal of Obstetrics and Gynecology 1979;133(5):537‐47.

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Hickey M, Szabo RA, Hunter MS. Non‐hormonal treatments for menopausal symptoms. BMJ 2017;359:j5101.

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Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.

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Kurman RJ, Zaino RJ, Norris HJ. Endometrial carcinoma. In: Kurman RJ editor(s). Blaustein’s Pathology of the Female Genital Tract. 4th Edition. New York (NY): Springer, 1994:439‐86.

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Kyrgiou M, Swart AM, Qian W, Warwick J. A comparison of outcomes following laparoscopic and open hysterectomy with or without lymphadenectomy for presumed early‐stage endometrial cancer: Results from the Medical Research Council ASTEC Trial. International Journal of Gynaecological Cancer 2015;25(8):1424‐36.

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MacLennan AH. HRT in difficult circumstances: are there any absolute contraindications?. Climacteric 2011;14(4):409‐17.

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Mørch LS, Kjaer SK, Keiding N, Løkkegaard E, Lidegaard Ø. The influence of hormone therapies on type I and II endometrial cancer: a nationwide cohort study. International Journal of Cancer 2015;138(6):1506‐15.

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Muka T, Oliver‐Williams C, Kunutsor S, Laven JS, Fauser BC, Chowdhury R, et al. Association of age at onset of menopause and time since onset of menopause with cardiovascular outcomes, intermediate vascular traits, and all‐cause mortality: a systematic review and meta‐analysis. JAMA Cardiology 2016;1(7):767‐76.

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Pike MC, Peters RK, Cozen W, Probst‐Hensch NM, Felix JC, Wan PC, et al. Estrogen‐progestin replacement therapy and endometrial cancer. Journal of the National Cancer Institute 1997;89(15):1110‐6.

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

Barakat 2006

Methods

Randomised controlled trial. Randomisation was stratified across 3 strata (FIGO stage 1A, IB/IC and II endometrial cancer).

Median follow‐up: 35.7 months.

Participants

1236 participants with surgically staged FIGO IA, IB, IC or occult stage II endometrial cancer.

Inclusion criteria: indication for treatment with HRT due to symptomatic hypo‐oestrogenic state or as prophylaxis in the presence of increased cardiovascular or osteoporotic risk

Exclusion criteria: liver dysfunction, history of thromboembolic disease or other cancer within 5 years, with the exception of non‐melanoma of the skin

Interventions

Intervention: oestrogen replacement therapy (unspecified formulation)

Control: placebo

Outcomes

Tumour recurrence (2.3% of participants in the HRT arm versus 1.9% of participants in the placebo arm

Time to recurrence: not reported.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information given regarding the method of random sequence generation.

Allocation concealment (selection bias)

Unclear risk

No information given regarding the measures undertaken to ensure allocation concealment.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Blinding was reported, though with minimal detail. However, outcomes were unlikely to have been significantly affected by deficiencies in the blinding of participants and personnel.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Blinding was reported, though with minimal detail. However, outcomes were unlikely to have been significantly affected by deficiencies in the blinding of participants and personnel.

Incomplete outcome data (attrition bias)
All outcomes

High risk

There was significant departure from the assigned treatment with very poor compliance (41.1%) among participants in the treatment arm.

Selective reporting (reporting bias)

High risk

The trial could not report all relevant oncological outcomes due to premature closure.

Other bias

High risk

The trial was closed prior to achievement of its accrual goal.

FIGO: International Federation of Gynecology and Obstetrics; HRT: hormone replacement therapy.

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

Ayhan 2006

Non‐randomised study

Chapman 1996

Non‐randomised study

Creasman 1986

Non‐randomised study

Lee 1990

Non‐randomised study

Shim 2014

Review

Suriano 2001

Non‐randomised study

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 1

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Study flow diagram.
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Figure 3

Study flow diagram.

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Summary of findings for the main comparison. Oestrogen replacement therapy compared to placebo for women previously treated for endometrial cancer

Oestrogen replacement therapy compared to placebo for women previously treated for endometrial cancer

Patient or population: women previously treated for endometrial cancer
Setting: oncology follow‐up
Intervention: oestrogen replacement therapy
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty (quality) of the evidence
(GRADE)

Comments

Risk with placebo

Risk with oestrogen replacement therapy

Rate of symptom relief

—

—

—

—

—

—

Rate of tumour recurrence
follow‐up: median 36 months

Study population

RR 1.17

(0.54 to 2.50)

1236
(1 RCT)

⊕⊝⊝⊝
Very low1,2,3

—

19 per 1000

14 per 1000
(9 to 40)

Rate of appearance of a new malignancy
follow‐up: median 36 months

Study population

RR 0.80 (0.32 to 2.01)

1236
(1 RCT)

⊕⊝⊝⊝
Very low1,2,3

—

16 per 1000

13 per 1000
(5 to 33)

Rate of survival: overall survival

—

—

—

—

—

The single study did not report overall survival of control and intervention groups individually, though it did report the percentage of participants alive at the end of follow‐up (median follow‐up: 35.7 months; 94.3% in the HRT group and 95.6% in the placebo group).

Rate of survival: progression‐free survival

—

—

—

—

—

The study did not report progression‐free survival of control and intervention groups individually, though it did report the percentage of participants alive, with no evidence of disease at the end of follow‐up (median follow‐up: 35.7 months; 95.8% in the HRT group and 96.9% in the placebo group).

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

1Downgraded one level as the single RCT was closed prior to achieving its accrual goal. This was a serious departure from the study design and a serious risk of bias.

2Downgraded one level as there were insufficient data with respect to allocation concealment and description of the intervention, along with a significant risk of attrition bias.

3Downgraded one level for imprecision, as the single included study was underpowered to detect significant differences in the primary outcomes.

Figuras y tablas -
Summary of findings for the main comparison. Oestrogen replacement therapy compared to placebo for women previously treated for endometrial cancer
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