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
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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
+
, 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
©
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on which they are based may have been superseded.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
practitioner.
Radiographers
Radiologists
11
11
12
16
PAIN
NIPPLE
SYMPTOM
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.
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
1
++
1
+
3 Surgery
3.1 CONSERVATION SURGERY VERSUS MASTECTOMY
(see section 3.3).
42
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
3.3 SURGICAL MANAGEMENT OF THE AXILLA
1
++
1
++
4
4
4
3 SURGERY
A Axillary surgery should be performed in all patients with invasive breast cancer.
42
10
MANAGEMENT OF BREAST CANCER IN WOMEN
4
2
+
2
++
in some patients
B Women with ductal carcinoma in situ who are candidates for breast surgery should be
offered the choice of lumpectomy or mastectomy.
11
1
++
1
++
1
+
4
2
+
A Women who have undergone breast conserving surgery should be offered postoperative
breast irradiation.
3 SURGERY
12
MANAGEMENT OF BREAST CANCER IN WOMEN
1
+
4
1
+
++
1
+
1
+
v
vs
A Radiotherapy should be given following mastectomy or breast conserving surgery to reduce
localrecurrencewherethebenettotheindividualislikelytooutweighrisksofradiation
related morbidity.
4.3 SELECTING THE APPROPRIATE SITE
+
1
+
1
+
4
4
1
+
4
84
4.5 DOSE FRACTIONATION
4 RADIOTHERAPY
16
MANAGEMENT OF BREAST CANCER IN WOMEN
1
++
1
++
1
++
1
+
1
+
5 Systemic therapy
5.1 ADJUVANT CHEMOTHERAPY
100
A All women under the age of 70 years, with early breast cancer should be considered for
adjuvant chemotherapy.
101
104
110
111
A Neoadjuvant chemotherapy should be considered for women with large cancers as it
improves the rate of breast conservation and is not detrimental to long term
outcome.
5.3 ANTHRACYCLINE AND TAXANE THERAPY
112
114
Epirubicin
+
2
+
1
+
Taxanes
118
A Taxanes should be considered in patients with advanced disease.
5.4 BIOLOGICAL THERAPIES
121
124
1
+
1
+
2
+
128
A Combination therapy of trastuzumab with a taxane is recommended in women with
metastatic breast cancer.
5 SYSTEMIC THERAPY
20
MANAGEMENT OF BREAST CANCER IN WOMEN
1
+
1
+
5.5 VINORELBINE AND CAPECITABINE THERAPY
142
A Either capecitabine or vinorelbine should be considered for patients with advanced breast
cancer.
21
1
+
1
+
4
1
+
1
++
1
+
148
148
A Bisphosphonates should be routinely used in combination with other systemic therapy in
patients with metastatic breast cancer with symptomatic bone metastases. The choice of
agent for an individual patient depends on individual circumstances.
5.7 ENDOCRINE THERAPY
Adjuvant therapy
Neo-adjuvant therapy
+
1
++
1
+
4
160
161
C All treatments for patients with early breast cancer should be started as soon as is practical.
Youngwomenwithoestrogenreceptornegativetumoursmaybenetparticularlyfrom
early initiation of chemotherapy following surgery.
5.9 MANAGEMENT OF MENOPAUSAL SYMPTOMS
162