Levonorgestrel intrauterine system for endometrial protection in women with breast cancer on adjuvant tamoxifen

Sally Dominick; Martha Hickey; Jason Chin; H Irene Su

doi:10.1002/14651858.CD007245.pub3

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Figure 1

Study flow diagram

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Figure 2

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 3

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

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Figure 4

Forest plot of comparison: 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, outcome: 1.1 Endometrial Polyps.

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Figure 5

Forest plot of comparison: 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, outcome: 1.2 Endometrial Hyperplasia.

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Figure 6

Forest plot of comparison: 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, outcome: 1.4 Fibroids.

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Figure 7

Forest plot of comparison: 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, outcome: 1.5 Abnormal Vaginal Bleeding or Spotting.

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Figure 8

Forest plot of comparison: 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, outcome: 1.6 Breast Cancer Recurrence.

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Figure 9

Forest plot of comparison: 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, outcome: 1.7 Breast Cancer‐related Death.

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Analysis 1.1

Comparison 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, Outcome 1 Endometrial Polyps.

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Analysis 1.2

Comparison 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, Outcome 2 Endometrial Hyperplasia.

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Analysis 1.3

Comparison 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, Outcome 3 Endometrial Cancer.

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Analysis 1.4

Comparison 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, Outcome 4 Fibroids.

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Analysis 1.5

Comparison 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, Outcome 5 Abnormal Vaginal Bleeding or Spotting.

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Analysis 1.6

Comparison 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, Outcome 6 Breast Cancer Recurrence.

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Analysis 1.7

Comparison 1 LNG‐IUS with endometrial surveillance versus endometrial surveillance alone, Outcome 7 Breast Cancer‐related Death.

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Summary of findings for the main comparison. The LNG‐IUS with endometrial surveillance compared to endometrial surveillance alone for endometrial protection in women with breast cancer on adjuvant tamoxifen

The LNG‐IUS with endometrial surveillance compared to endometrial surveillance alone for endometrial protection in women with breast cancer on adjuvant tamoxifen
Patient or population: endometrial protection in women with breast cancer on adjuvant tamoxifen Setting: hospital, outpatient clinic Intervention: LNG‐IUS with endometrial surveillance Comparison: endometrial surveillance alone
Outcomes	*Illustrated comparative risks^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed Risk	Corresponding Riks
	Endometrial surveillance alone	LNG‐IUS with endometrial surveillance
Endometrial Polyps follow up: range 24 months to 60 months	Moderate		OR 0.22 (0.13 to 0.39)	417 (4 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	235 per 1000	63 per 1000 (38 to 107)
Endometrial Hyperplasia follow up: range 24 months to 60 months	Moderate		OR 0.13 (0.03 to 0.67)	417 (4 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	28 per 1000	4 per 1000 (1 to 19)
Endometrial Cancer follow up: range 24 months to 60 months	Moderate		not estimable	154 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	0 per 1000	0 per 1000 (0 to 0)
Fibroids follow up: range 12 months to 24 months	Moderate		OR 0.48 (0.16 to 1.46)	314 (3 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	58 per 1000	29 per 1000 (10 to 82)
Abnormal Vaginal Bleeding or Spotting follow up: 12 months	Moderate		OR 7.26 (3.37 to 15.66)	376 (3 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	17 per 1000	113 per 1000 (56 to 215)
Abnormal Vaginal Bleeding or Spotting follow up: 24 months	Moderate		OR 2.72 (1.04 to 7.10)	233 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	42 per 1000	107 per 1000 (44 to 239)
Abnormal Vaginal Bleeding or Spotting follow up: 60 months	Moderate		not estimable	94 (1 RCT)	⊕⊕⊕⊝ MODERATE ¹
	0 per 1000	0 per 1000 (0 to 0)
Breast Cancer Recurrence follow up: range 24 months to 60 months	Moderate		OR 1.74 (0.64 to 4.74)	154 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	80 per 1000	131 per 1000 (53 to 291)
Breast Cancer‐related Death follow up: range 12 months to 60 months	Moderate		OR 1.02 (0.36 to 2.84)	277 (3 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	69 per 1000	70 per 1000 (26 to 174)
The basis for the assumed risk* is the median control group risk across studies. The corresponding risk (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; OR: Odds 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
¹ limited sample size and low event rate

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Table 1. Chan 2007 & Wong 2013

	Treatment Group	Control	P value
6 months follow‐up
Randomised	64	65
Completed	55	58

Abnormal vaginal bleeding or spotting	20	1	<0.001

12 months follow‐up
Completed	55	58

Abnormal vaginal bleeding or spotting	6	1	0.06
Endometrial polyps	1	9	0.02
Endometrial hyperplasia	0	0
Fibroids	1	2	1.0

24 months follow‐up
Completed	55	57

Abnormal vaginal bleeding or spotting	6	3	0.45

45 months follow‐up
Completed	48	52

Abnormal vaginal bleeding or spotting	0	0

60 months follow‐up
Completed	46	48

Abnormal vaginal bleeding or spotting	0	0
Endometrial polyps	2	16	< 0.001
Endometrial hyperplasia	0	1	1.0
Endometrial cancer	0	0
Fibroids	1	2	1.0
Breast cancer recurrence	10	6	0.25
Breast cancer‐related deaths	6	5	0.71

Table 1. Chan 2007 & Wong 2013

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Table 2. Gardner 2000 & 2009

	Treatment Group	Control	P value
12 months follow‐up
Randomised	64	58
Completed	47	52

Endometrial polyps	1	4	0.4
Endometrial hyperplasia	0	1
Fibroids	1	3	0.2

Final follow‐up (24, 36, or 48 months)
Completed at 24 months	31	29
Completed at 36 months	19	20
Completed at 48 months	6	9

Endometrial polyps	3	8
Endometrial hyperplasia	0	1
Endometrial cancer	0	0
Breast cancer recurrence	1	1
Breast cancer‐related deaths	2	2

Table 2. Gardner 2000 & 2009

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Table 3. Kesim 2008

	Treatment Group	Control	P value
5 months follow‐up
Randomised	70	72
Completed	70	72

Abnormal vaginal bleeding or spotting	7	0

12 months follow‐up
Randomised	70	72
Completed	70	72

Abnormal vaginal bleeding or spotting	0	0

36 months follow‐up
Randomised	70	72
Completed	70	72

Endometrial polyps	4	14	< 0.05
Endometrial hyperplasia	0	4	< 0.05

Table 3. Kesim 2008

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Table 4. Omar 2010

	Treatment Group	Control	P value
12 months follow‐up
Randomised	75	75
Completed	60	63

Abnormal vaginal bleeding or spotting	22	2	<0.001
Breast cancer‐related deaths	0	1

24 months follow‐up
Completed	59	62

Abnormal vaginal bleeding or spotting	7	2	0.08
Endometrial polyps	1	10	0.02
Endometrial hyperplasia	0	0
Fibroids	2	4	1.0

Table 4. Omar 2010

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Comparison 1. LNG‐IUS with endometrial surveillance versus endometrial surveillance alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Endometrial Polyps Show forest plot	4		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only

1.1 Short term follow‐up (12 months)	2	212	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.22 [0.08, 0.64]
1.2 Long term follow‐up (24 to 60 months)	4	417	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.22 [0.13, 0.39]
2 Endometrial Hyperplasia Show forest plot	4	417	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.13 [0.03, 0.67]

3 Endometrial Cancer Show forest plot	2	154	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]

4 Fibroids Show forest plot	3	314	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.48 [0.16, 1.46]

5 Abnormal Vaginal Bleeding or Spotting Show forest plot	3		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only

5.1 12 months	3	376	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.26 [3.37, 15.66]
5.2 24 months	2	233	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.72 [1.04, 7.10]
5.3 45 months	1	100	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.4 60 months	1	94	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Breast Cancer Recurrence Show forest plot	2	154	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.74 [0.64, 4.74]

7 Breast Cancer‐related Death Show forest plot	3	277	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.02 [0.36, 2.84]

Comparison 1. LNG‐IUS with endometrial surveillance versus endometrial surveillance alone

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