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Meta-Analysis
. 2012 Oct 17;10(10):CD007847.
doi: 10.1002/14651858.CD007847.pub2.

Postoperative tamoxifen for ductal carcinoma in situ

Helen Staley  1 , Iain McCallum, Julie Bruce
Affiliations
Meta-Analysis

Postoperative tamoxifen for ductal carcinoma in situ

Helen Staley et al. Cochrane Database Syst Rev. .

Abstract

Background: Ductal carcinoma in situ (DCIS) is a non-invasive carcinoma of the breast. The incidence of DCIS has increased substantially over the last twenty years, largely as a result of the introduction of population-based mammographic screening. The treatment of DCIS tumours involves surgery with or without radiotherapy to prevent recurrent DCIS and invasive carcinoma. However, there is clinical uncertainty as to whether postoperative hormonal treatment (tamoxifen) after surgery confers benefit in overall survival and incidence of recurrent carcinoma.

Objectives: To assess the effects of postoperative tamoxifen in women having local surgical resection of DCIS.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), the Cochrane Breast Cancer Group's Specialised Register, and the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) on 16 August 2011.

Selection criteria: Published and unpublished randomised controlled trials (RCTs) and quasi-randomised controlled trials comparing tamoxifen after surgery for DCIS (regardless of oestrogen receptor status), with or without adjuvant radiotherapy.

Data collection and analysis: Two authors independently assessed trial quality and extracted data. Statistical analyses were performed using the fixed-effect model and the results were expressed as relative risks (RRs) or hazard ratios (HRs) with 95% confidence intervals (CIs).

Main results: We included two RCTs involving 3375 women. Tamoxifen after surgery for DCIS reduced recurrence of both ipsilateral (same side) DCIS (HR 0.75; 95% CI 0.61 to 0.92) and contralateral (opposite side) DCIS (RR 0.50; 95% CI 0.28 to 0.87). There was a trend towards decreased ipsilateral invasive cancer (HR 0.79; 95% CI 0.62 to 1.01) and reduced contralateral invasive cancer (RR 0.57; 95% CI 0.39 to 0.83). The number needed to treat in order for tamoxifen to have a protective effect against all breast events is 15. There was no evidence of a difference detected in all cause mortality (RR 1.11; 95% CI 0.89 to 1.39). Only one study, involving 1799 participants followed-up for 163 months (median) reported on adverse events (i.e. toxicity, mood changes, deep vein thrombosis, pulmonary embolism, endometrial cancer) with no significant difference between tamoxifen and placebo groups, but there was a non-significant trend towards more endometrial cancer in the tamoxifen group.

Authors' conclusions: While tamoxifen after local excision for DCIS (with or without adjuvant radiotherapy) reduced the risk of recurrent DCIS (in the ipsi- and contralateral breast), it did not reduce the risk of overall mortality.

PubMed Disclaimer

Conflict of interest statement

No authors have any conflict of interest relating to this review.

Figures

1
1
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Forest plot of comparison: Outcome: 1.1 DCIS ipsilateral.
4
4
Forest plot of comparison: Outcome 1.2 DCIS contralateral
5
5
Forest plot of comparison: Outcome: 1.3 Invasive, ipsilateral breast cancer
6
6
Forest plot of comparison: Outcome 1.4 Invasive, contralateral breast cancer
1.1
1.1. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 1 DCIS ipsilateral.
1.2
1.2. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 2 DCIS contralateral.
1.3
1.3. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 3 Invasive, ipsilateral breast cancer.
1.4
1.4. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 4 Invasive contralateral breast cancer.
1.5
1.5. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 5 Local, regional and distant invasive breast cancer.
1.6
1.6. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 6 Mortality rate.
1.7
1.7. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 7 Endometrial cancer.
1.8
1.8. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 8 All breast events.
1.9
1.9. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 9 DCIS ipsilateral (radiated patients only).
1.10
1.10. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 10 DCIS contralateral (radiated patients only).
1.11
1.11. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 11 Invasive ipsilateral breast cancer (radiated patients only).
1.12
1.12. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 12 Invasive contralateral breast cancer (radiated patients only).
1.13
1.13. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 13 All breast events (radiated patients only).
1.14
1.14. Analysis
Comparison 1 Tamoxifen versus no tamoxifen, Outcome 14 Mortality rate (radiated patients only).
See this image and copyright information in PMC

Comment in

References

References to studies included in this review

NSABP B‐24 Trial 2011 {published data only}
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Garcia {unpublished data only}
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