Brachytherapy as the sole method of adjuvant radiotherapy for breast cancer after local excision (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Brachytherapy as the sole method of adjuvant radiotherapy for breast cancer after local excision
| Treatment for breast cancer usually involves surgery to remove part or all of the breast. This is sometimes followed by radiotherapy, particularly if only part of the breast has been removed. Brachytherapy is a type of radiotherapy in which the source of radiation is placed in or close to the area being treated. It can be used as an additional treatment (known as adjuvant) after surgery. It typically involves the insertion of radioactive implants into the space in the breast where tissue has been removed. The implants are usually in place for 1 to 5 days. The aim of the procedure is to minimise the chance of the cancer recurring. |
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The National Institute for Health and Clinical Excellence is examining brachytherapy as the sole method of adjuvant radiotherapy for breast cancer after local excision and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about brachytherapy as the sole method of adjuvant radiotherapy for breast cancer after local excision.
Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation. The process that the Institute will follow after the consultation period ends is as follows.
For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprocessmanual). NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and how it might be improved. Closing date for comments: 24 April 2008 |
| Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation. |
| 1 | Provisional recommendations |
| 1.1 | Current evidence on brachytherapy as the sole method of adjuvant radiotherapy for breast cancer after local excision (referred to hereafter as 'brachytherapy') raises no major safety concerns. Current evidence on its efficacy is limited in quantity and there is little information on long-term outcomes (5 years or more). Therefore, this procedure should be used only in the context of research, which should address control of local disease with a minimum of 5 years of follow-up. The Institute may review the procedure upon publication of further evidence. |
| 2 | The procedure | ||
| 2.1 | Indications and current treatments | ||
| 2.1.1 | Breast cancer in men is rare: all the evidence on which this guidance was based is derived from treatment of breast cancer in women. | ||
| 2.1.2 | Treatment of breast cancer depends on its type, stage and grade. Surgery is usually the first option and may involve removing all (mastectomy) or part (local excision) of the breast. In order to reduce the risk of local cancer recurrence, adjuvant treatment with chemotherapy or hormone therapy can be used. | ||
| 2.2 | Outline of the procedure | ||
| 2.2.1 | Brachytherapy can be delivered either as an interstitial or a balloon technique and is performed under local or general anaesthesia. In interstitial brachytherapy, a number of catheters are inserted into the breast tissue surrounding the area where the tumour was removed. Wires with radioactive implants are then inserted through the catheters where they are left in place for a few hours (high dose rate) or a few days (low dose rate). After this, the catheters and implants are removed. In balloon brachytherapy, a balloon device attached to a catheter is inserted, through a small incision, into the area where the tumour was removed. The balloon is inflated allowing the surrounding breast tissue to come into close contact with it. A small portion of the catheter is connected to a computer-controlled high dose rate radiotherapy machine which inserts a radioactive implant. Balloon brachytherapy requires a number of treatment sessions over several days. After each session the implant is removed and the catheter disconnected. | ||
| Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more details, refer to the sources of evidence (see appendix). | |||
| 2.3 | Efficacy | ||
| 2.3.1 | In a randomised controlled trial of 258 patients treated with interstitial brachytherapy or whole-breast external beam radiotherapy, 5-year actuarial rates of local recurrence were 5% (6/128) and 3% (4/130), respectively (p = 0.50). There were no statistically significant differences in 5-year overall survival (95% versus 92%) or cancer-specific survival (98% versus 96%) (absolute numbers not given). | ||
| 2.3.2 | In a non-randomised controlled trial of 398 patients, there was no statistically significant difference in 5-year actuarial rates of ipsilateral breast tumour recurrence between patients treated with interstitial brachytherapy and those who had external beam radiotherapy (1% in both groups, p = 0.65; absolute numbers not given). In this trial 5-year overall actuarial survival rates were also similar (87% for interstitial brachytherapy and 93% for external beam radiotherapy, p = 0.23; absolute numbers not given). A second non-randomised controlled trial of 144 patients reported local or regional recurrence in 8% (8/51) of tumours in the brachytherapy group compared with 5% (5/94) in the external beam radiotherapy group after a median follow-up of 75 months (p = 0.23). Disease-free survival at final follow-up (median 75 months) was 88% in the brachytherapy group and 92% in the external beam group (p value not stated; absolute numbers not given). | ||
| 2.3.3 | The Specialist Advisers considered key efficacy outcomes to include local and regional recurrence rates, cancer-specific mortality, cosmetic outcome and quality-of-life outcomes. | ||
| 2.4 | Safety | ||
| 2.4.1 | The case series of 103 patients reported that 17% of the 75 patients treated with interstitial brachytherapy had grade 1 and 5% had higher grades of skin erythema, compared with 43% and 0%, respectively, of the 28 patients treated with balloon brachytherapy (p = 0.01 and 0.06, respectively). In the same study, subcutaneous fibrosis was reported in 32% of patients treated with interstitial brachytherapy and 11% of patients treated with balloon brachytherapy (p = 0.04). There was no statistically significant difference in symptomatic fat necrosis (12% for interstitial brachytherapy compared with 7% for balloon brachytherapy, p = 0.73) (absolute numbers not given). | ||
| 2.4.2 | Complications of interstitial and balloon brachytherapy reported by the studies included: fat necrosis in 4% (2/51) and 16% (8/50) of patients; fibrosis in 10% (5/50) and 19% 53/274) of patients; telangiectasia in 2% (1/50) and 13% (35/274) of patients; breast pain in 3% (3/89) and 7% (20/274) of patients; and infection in 3% (9/274), 8% (92/1140) and 9% (4/43) of patients. A case series of 70 patients specified that two cases of infection were severe (one case of mastitis and one abscess). | ||
| 2.4.3 | The Specialist Advisers considered adverse events to include erythema, infections, seroma formation, breast fibrosis, fat necrosis, skin telangiectasias, breast pain, breast oedema and hyperpigmentation. | ||
| 2.5 | Other comments | ||
| 2.5.1 | The Committee's recommendations were influenced by their view that any procedure for the treatment of early breast cancer should be supported by good quality evidence from large numbers of patients. | ||
| 3 | Further information | ||
| 3.1 | The Institute is developing clinical guidelines on early and advanced breast cancer and has published an update to the manual 'Improving outcomes in breast cancer'. The Institute has published interventional procedures guidance on interstitial laser therapy for breast cancer, low dose rate brachytherapy for localised prostate cancer, pre-operative high dose rate brachytherapy for rectal cancer, high dose rate brachytherapy for carcinoma of the cervix and prostate cancer. For more information go to www.nice.org.uk. | ||
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
March 2008
| Appendix: | Sources of evidence |
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The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.
Available from: www.nice.org.uk/ip694overview. |
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This page was last updated: 31 January 2011