Management of breast cancer in women A national clinical guideline 1 Introduction 1 2 Diagnosis, referral and investigation 2 3 Surgery 7 4 Radiotherapy 13 5 Systemic therapy 16 6 Psychological care 24 7 Follow up 29 8 Information for discussion with patients and carers 31 9 Development of the guideline 35 10 Implementation and audit 38 Abbreviations 40 Annexes 41 References 44 December 2005 84 COPIES OF ALL SIGN GUIDELINES ARE AVAILABLE ONLINE AT WWW.SIGN.AC.UK 84 Scottish Intercollegiate Guidelines Network S I G N KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS LEVELS OF EVIDENCE 1 ++ High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1 + Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1 - Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2 ++ High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2 + Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2 - Case control or cohort studies with a high risk of confounding or bias andasignicantriskthattherelationshipisnotcausal 3 Non-analytic studies, eg case reports, case series 4 Expert opinion GRADES OF RECOMMENDATION Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reect the clinical importance of the recommendation. A At least one meta-analysis, systematic review of RCTs, or RCT rated as 1 ++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1 + , directly applicable to the target population, and demonstrating overall consistency of results B A body of evidence including studies rated as 2 ++ , directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1 ++ or 1 + C A body of evidence including studies rated as 2 + , directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2 ++ D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2 + Verbatim extract from SIGN 29 published in 1998. This material covers areas that were not updated in the current version of the guideline. GOOD PRACTICE POINTS Recommended best practice based on the clinical experience of the guideline development group This document is produced from elemental chlorine-free material and is sourced from sustainable forests © Scottish Intercollegiate Guidelines Network ISBN 1 899893 34 2 First published 2005 SIGN consents to the photocopying of this guideline for the purpose of implementation in NHSScotland Scottish Intercollegiate Guidelines Network, 28 Thistle Street, Edinburgh EH2 1EN • www.sign.ac.uk 11 1 INTRODUCTION 1 Introduction 1.1 THE NEED FOR A GUIDELINE 1 1.2 REMIT OF THE GUIDELINE 2 (see section 1.5) 1.3 KEY QUESTIONS 1.4 STATEMENT OF INTENT 1.5 REVIEW AND UPDATING www.sign.ac.uk Older recommendations taken directly from SIGN 29 are clearly marked with a SIGN 29 symbol and a green font. It should be remembered that these older recommendations have not been developed with the rigour of current SIGN methodology and the evidence on which they are based may have been superseded. 2 MANAGEMENT OF BREAST CANCER IN WOMEN 1 + 2 Diagnosis, referral and investigation 2.1 INTRODUCTION (section 2.2.1); (section 2.2.2) (section 2.3). 4 6 10 C Women should be encouraged to become aware of the feel and shape of their breasts, so that they are familiar with what is normal for them. C Women should be encouraged to report any change from normal to their general practitioner. Radiographers Radiologists 11 11 12 16 4 2 DIAGNOSIS, REFERRAL AND INVESTIGATION 2.2 DIAGNOSING BREAST CANCER 20 18 (see Table 1). Table 1: Scottish Cancer Group Referral Guideline Source of problem Who to refer Who to manage in primary care LUMP PAIN NIPPLE SYMPTOM retraction SKIN CHANGES 4 MANAGEMENT OF BREAST CANCER IN WOMEN 2 ++ 2 ++ 4 1 + 21 2.3 INVESTIGATION OF SYMPTOMATIC BREAST CANCER 22 B All patients should have a full clinical examination. B Where a localised abnormality is present, patients should have imaging usually followed byneneedleaspiratecytology or core biopsy. B A lesion considered malignant following clinical examination, imaging or cytology alone should,wherepossible,havehistopathologicalconrmationofmalignancybeforeany denitivesurgicalproceduretakesplace (eg mastectomy or axillary clearance). D Patients should be seen at a one-stop, multidisciplinary clinic involving breast clinicians, radiologists and cytology. 24 C Clear lines of communication should be maintained between the primary care team and staff in the breast unit. C The GP should be made aware of the information given to the patient and relatives. 26 A Psychological support should be available to women diagnosed with breast cancer at the clinic. 2 + 4 C Centres and units should develop an integrated network of cancer care using common clinical guidelines, management protocols and strategies of care. Table 2: Summary of investigations Investigation 40 B In patients with symptomatic disease two-view mammography should be performed as part of triple assessment (clinical assessment, imaging and tissue sampling) in a designated breast clinic. B Mammography is not recommended in women under the age of 35 years unless there is a strong suspicion of carcinoma. C Magneticresonanceimagingshouldbeconsideredinspecicclinicalsituationswhere other imaging modalities are not reliable, or have been inconclusive, and where there are indications that MRI is useful. 2 DIAGNOSIS, REFERRAL AND INVESTIGATION 6 MANAGEMENT OF BREAST CANCER IN WOMEN see annex 2 41 4 1 ++ 1 ++ 1 ++ 1 + 3 Surgery 3.1 CONSERVATION SURGERY VERSUS MASTECTOMY (see section 3.3). 42 44 compared 46 48 3 SURGERY 8 MANAGEMENT OF BREAST CANCER IN WOMEN 2 + A All women with early stage invasive breast cancer who are candidates for breast conserving surgery should be offered the choice of breast conserving surgery (excision of tumour with clear margins)ormodiedradicalmastectomy. A The choice of surgery must be tailored to the individual patient, who should be fully informed of the options and who should be aware that breast irradiation is required following conservation and that further surgery may be required if the margins are positive. C Breast conserving surgery is contraindicated if: the ratio of the size of the tumour to the size of the breast would not result in acceptable cosmesis there is multifocal disease or extensive malignant microcalcification on mammogram there is a contraindication to local radiotherapy (eg previous radiotherapy at this site, connective tissue disease, severe heart and lung disease, pregnancy). C Central situation of the tumour is not a contraindication to conservation, although it may require excision of the nipple and areola, which may compromise cosmesis. 3.2 BREAST RECONSTRUCTION AFTER MASTECTOMY C The possibility of breast reconstruction should be discussed with all patients prior to mastectomy. 3.3 SURGICAL MANAGEMENT OF THE AXILLA [...]... shown that the use of anthracycline based chemotherapy in advanced disease is associated with a modest survival advantage.117 A 1++ 4 Anthracyclines should be prescribed in preference to non-anthracycline regimens in the adjuvant setting, as they offer additional benefits Epirubicin may be preferred as it causes less cardiac adverse effects 17 MANAGEMENT OF BREAST CANCER IN WOMEN Taxanes A meta-analysis... radiotherapy did not reduce all-cause mortality or breast cancer mortality after mastectomy alone or mastectomy plus axillary clearance Radiotherapy did reduce all cause mortality and breast cancer mortality after mastectomy plus axillary sampling.73 In the review, radiotherapy may have been associated with late adverse effects, which are rare, including pneumonitis, pericarditis, arm oedema, brachial... IMC is conflicting Two trials showed no improvement in survival in patients who underwent internal mammary node dissection in addition to standard radical mastectomy.82 ,83 1+ A trial of 150 patients with internal mammary node involvement randomised individuals to either radical resection of the internal mammary supraclavicular chain, irradiation of the supraclavicular and internal mammary nodes, or... data that they offer additional survival benefits over optimal anthracyclines regimens 1+ 5.3.1 advanced disease Epirubicin Randomised controlled trials in advanced breast cancer have shown that epirubicin and doxorubicin have equivalent efficacy when measured by response rates or survival In a pooled analysis of six trials comparing equal doses of these drugs, alone or as part of combination therapy,... removal of the first draining nodes 3.3.1 summary of existing surgical guidelines Several guidelines and RCTs have considered the relative merits of the different surgical approaches to the axilla The Cancer Care Ontario guideline recommends axillary dissection (level 1 and 2 with pathological examination) as the standard of care in women with stage 1 and 2 breast cancer. 42 The guideline reports that... that postoperative radiotherapy significantly decreased the annual risk of isolated local recurrence compared with no postoperative radiotherapy (OR 0.32; p . Management of breast cancer in women A national clinical guideline 1 Introduction 1 2 Diagnosis, referral and investigation 2 3 Surgery 7 4 Radiotherapy. SURGERY 8 MANAGEMENT OF BREAST CANCER IN WOMEN 2 + A All women with early stage invasive breast cancer who are candidates for breast conserving surgery