ARTICLE IN PRESS

Evidence-Based Healthcare & Public Health (2005) 9, 77–78

KEYWORDBreast canElderly woRadiotheraTamoxifenOlder womRandomisecontrolled

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EVIDENCE-BASED CLINICAL PRACTICE

Radiotherapy plus tamoxifen reduces localrecurrence rates in older women with early breastcancer compared with tamoxifen alone$

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from: Fyles AW, McCreaarly breast cancer. N E

Question: How does tamoxifen plus breast irradiation affect survival and localrelapse in older women with breast cancer compared with tamoxifen alone?

Study design: Randomised controlled trial.

Main results: At 5 years, there were no significant differences in overall survivalbetween groups (tamoxifen plus irradiation v tamoxifen alone: 92.8% v 93.2%;p ¼ 0:83). At 5 years, tamoxifen plus irradiation significantly reduced localrecurrence compared with tamoxifen alone (local recurrence rate: 0.6% v 7.7%;hazard ratio 8.3, 95% CI 3.3 to 21.2). Tamoxifen plus irradiation significantly reducedaxillary relapse compared with tamoxifen alone (0.5% v 2.5%; p ¼ 0:049). Tamoxifenplus irradiation significantly improved disease-free survival rates compared withtamoxifen alone at 5 years (91% v 84%; hazard ratio 1.7, 95% CI 1.2 to 2.5). Therewere no significant differences between groups in distant relapse rates (tamoxifenplus irradiation v tamoxifen alone: 4.5% v 4%; p ¼ 0:69). In a planned sub-groupanalysis of women with T1, receptor positive tumours, tamoxifen plus irradiationsignificantly reduced local relapse compared with tamoxifen alone (0.4% v 5.9%;po0:001).

Authors’ conclusions: Adding breast irradiation to a tamoxifen regimen significantlyreduces recurrence of cancer in the breast and axillary nodes, and improves 5-yeardisease-free survival rates in older women with early breast cancer.& 2005 Published by Elsevier Ltd.

Further details

Setting

Toronto, Vancouver and Victoria, Canada; December 1992 to June 2000.

Published by Elsevier Ltd.

dy DR, Manchul LA et al. Tamoxifen with or without breast irradiation in women 50 years of agengl J Med 2004; 351: 963–970.

ARTICLE IN PRESS

EVIDENCE-BASED CLINICAL PRACTICE78

Participants

769 women (aged over 50 years; median 68 years) who had undergone breast-conserving surgery for stageT1 or T2 breast cancer (tumour diameter p5 cm; median 1.4 cm). Exclusions: a history of cancer (otherthan non-melanoma skin cancer or carcinoma of the cervix), a previous episode of breast cancer, orunsuitability for radiotherapy.

Intervention

All women received tamoxifen (20mg daily for 5 years). Within 12 weeks of surgery, women randomised toadditional breast irradiation received 40 Gy in 16 daily fractions over 3 to 4 weeks to the breast and chestwall, then 12.5 Gy in five daily fractions to the primary site.

Main outcomes

Disease-free survival, defined as time from randomisation to treatment failure (cancer in the same breast,axillary nodes or at a distant location) or death; incidence of relapse in the breast or axillary nodes, andoverall survival. Women were seen every 3 months in years 1-3, every 6 months in years 4-5 and yearlyafterwards (mean follow-up 5.6 years). Participants received a mammogram yearly and chest radiographyevery 2 years.

Notes

Randomisation was stratified according to: tumour size, oestrogen receptor status, method of determiningstatus of axillary lymph nodes in older participants and treatment centre.Analysis was done on an intention-to-treat basis; 551/769 (71.7%) participants completed follow-up.

Sources of funding: Ministry of Health and Long-Term Care, Province of Ontario; Canadian Breast CancerFoundation British Columbia and Yukon Chapter; Princess Margaret Hospital Foundation.

Abstract provided by Bazian Ltd, London