Surgery timing
Timing of surgery - After neoadjuvant therapy (Practice Point)
Perform surgery within 4-6 weeks after neoadjuvant systemic therapy, allowing for recovery from myelosuppression.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using an expert consensus process. The wording is informed by that contained in the Optimal Care Pathway for people with breast cancer (in draft 2020).
Timing of surgery - No neoadjuvant therapy (Practice Point)
Perform surgery within 1 month of a decision to treat with surgery among those patients who do not receive neoadjuvant therapy.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using an expert consensus process. The wording is informed by that contained in the Optimal Care Pathway for people with breast cancer (in draft 2020).
Breast-conserving surgery (BCS) and mastectomy
BCS or mastectomy - Decision-making (Recommendation)
In patients with breast cancer who are undergoing breast surgery, offer the choice of either breast-conserving surgery (if technically possible) followed by radiation therapy, or a mastectomy.
How this guidance was developed
This recommendation was adapted from the NCCP 2015 guidelines (Ireland). The source recommendation was based on a systematic review of the evidence conducted to September 2014 and was graded 'A' (using SIGN methods) by the source guideline authors. The source recommendation was adapted by expanding the patient population from ‘women’ to ‘all patients’. In addition, "if technically possible” was added to account for instances where breast-conserving surgery may not be possible, such as a large tumour in a small breast.
This recommendation aligns with the 2017 Cancer Australia Statement – Influencing best practice in breast cancer: Practice 4.
BCS or mastectomy - Information needs (Recommendation)
Inform patients with breast cancer who are undergoing breast surgery that radiation therapy is usually required following breast-conserving surgery and that further surgery may be required if the surgical margins are positive or close.
How this guidance was developed
This recommendation was adapted from the KCE 2013 guidelines (Belgium) and the NZGG 2009 guidelines (NZ). Two source recommendations (one from each of these guidelines) were merged. The source recommendation from KCE 2013 was based on a systematic review of the evidence conducted to January 2010 and was graded ‘strong’ (using GRADE methods) by the source guideline authors. The source recommendation from NZGG was based on a systematic review of the evidence (the date of the review was not reported) and was graded 'A' (using NZGG methods). The source recommendations were further adapted by using language applicable to the Australian health care context.
BCS or mastectomy - Patients with gene mutation (Recommendation)
In patients with breast cancer with a confirmed germline mutation (e.g. BRCA1/2), that predisposes to an increased risk of breast cancer discuss the options of breast-conserving surgery, mastectomy or bilateral mastectomy, noting that there is a higher risk of a second malignancy if the breast is conserved, but that this risk is reduced by adjuvant systemic therapy.
How this guidance was developed
This recommendation was adapted from two recommendations in the CA 2014 guidelines (Australia). Each source recommendation was based on a systematic review of the evidence conducted to April 2012 and each was graded 'C' (using NHMRC methods) by the source guideline authors. The source recommendations were adapted by merging them, by expanding the patient population from ‘women with germline mutations’ to ‘patients with germline mutations’, by including ‘bilateral mastectomy’ and removing reference to ipsilateral risk, and by replacing ‘inform’ with ‘discuss’. The importance of distinguishing between ipsilateral and contralateral risk, and age of the patient (for example the higher risk of contralateral breast cancer in younger women with breast cancer) in considering the various options should be noted.
Surgical specimen - Fixation (Practice Point)
Ensure optimal fixation (and labelling) of breast cancer specimens for accurate pathological examination and biomarker assessment.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using an expert consensus process. Development of the practice point was informed by the 2017 Cancer Australia Statement – Influencing best practice in breast cancer: Practice 2.
Surgical specimen - Imaging (Practice Point)
Conduct post-excisional specimen imaging of image-guided excisions. The specimen should be suitably labelled with sutures and clips to allow orientation and margin assessment. Imaging can be specimen mammogram or ultrasound, performed by either the radiologist or surgeon.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using an expert consensus process.
Surgical margins - Indications for further surgery #1 (Recommendation)
Offer further surgery (re-excision or mastectomy, as appropriate) after breast-conserving surgery where invasive cancer and/or DCIS is present at the radial margins (as defined by tumour on ink, 0 mm).
How this guidance was developed
This recommendation was adopted from the NICE 2018 guidelines (UK). The source recommendation was based on a systematic review of the evidence conducted to September 2017 and used wording ('Offer') indicative of a strong recommendation (using GRADE methods) by the source guideline authors. The source recommendation was accepted with minor stylistic changes, but with no changes to the meaning or tone of the source recommendation.
Surgical margins - Indications for further surgery #2 (Recommendation)
Consider further surgery (re-excision or mastectomy, as appropriate) after breast-conserving surgery where there is invasive cancer and/or DCIS within 2mm of but not at the radial margins (>0mm and <2 mm).
How this guidance was developed
This recommendation was adapted from the NICE 2018 guidelines (UK). The source recommendation was based on a systematic review of the evidence conducted to September 2017 used wording ('Discuss') indicative of the need for shared decision-making by the source guideline authors. The source recommendation was adapted by making it more directive by replacing 'discuss' with 'consider' and simplifying it by removing the specific points for discussion. The NICE committee indicated that there was not enough evidence to clearly define an optimum margin width between 0 mm and 2 mm to minimise local recurrence rates and minimise further surgery, and the committee agreed this was an important topic for further research.
Paget’s disease of the nipple - Imaging (Practice Point)
In patients with Paget’s disease of the nipple, perform breast imaging prior to surgery to exclude underlying breast malignancy.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using an expert consensus process.
Paget’s disease of the nipple - BCS or mastectomy (Recommendation)
In patients with Paget’s disease of the nipple with or without underlying breast cancer, offer breast-conserving surgery with removal of the nipple/areolar complex followed by whole breast radiation therapy, as an alternative to mastectomy.
How this guidance was developed
This recommendation was adapted from the KCE 2013 guideline (Belgium). The source recommendation was based on a systematic review of the evidence conducted to January 2010 and was graded ‘weak' (using GRADE methods) by the source guideline authors. The recommendation was adapted by expanding the patient population to include patients with Paget's disease with underlying invasive breast cancer.
Paget's disease of the nipple – Nipple reconstruction (Recommendation)
In patients with Paget’s disease of the nipple treated with breast-conserving surgery with removal of the nipple/areolar complex, offer nipple reconstruction, based on the individual patient’s preferences.
How this guidance was developed
This recommendation was adopted from the KCE 2013 guidelines (Belgium). The source recommendation was based on a systematic review of the evidence conducted to January 2010 and was graded ‘strong’ (using GRADE methods) by the source guideline authors. The source recommendation was accepted with minor stylistic changes, but with no changes to the meaning or tone of the source recommendation.
Breast reconstruction
Breast reconstruction – Surgery timing and technique options (Recommendation)
Before a mastectomy is performed, discuss the benefits and risks of all reconstruction options with reference to timing (immediate or delayed), technique (implant-based or tissue-based reconstruction) and breast symmetrising procedures, regardless of whether these procedures are available locally, and implications for future surveillance. Be aware that some patients may prefer not to have breast reconstruction surgery, and some may prefer to discuss reconstruction later.
How this guidance was developed
This recommendation was adapted from the NICE 2018 guidelines (UK). Two source recommendations were merged by the EWG. Both source recommendations were based on a systematic review conducted to September 2017 with one using wording (‘Offer’) indicative of a strong recommendation and one using wording (‘Discuss’) indicative of a conditional recommendation (using GRADE methods) by the source guideline authors. The source recommendation was adapted by making it less directive, by replacing 'offer' with 'discuss', and by expanding the population from 'women' to 'all patients’.
This recommendation aligns with the 2017 Cancer Australia Statement – Influencing best practice in breast cancer: Practice 11.
The recommendation is also supported by several more recent recommendations in the ESMO (2019) clinical practice guidelines for early breast cancer.
Breast reconstruction – Chemotherapy timing (Practice Point)
Inform patients that chemotherapy may be delayed if complications arise from reconstructive surgery.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using an expert consensus process.
Breast reconstruction – Risk-reducing mastectomy (Recommendation)
Skin-sparing mastectomy or nipple-sparing mastectomy with immediate breast reconstruction can be offered to patients undergoing risk-reducing mastectomy.
How this guidance was developed
This recommendation was adapted from the CCO 2016 guidelines (Canada). The source recommendation was based on a systematic review of the evidence conducted to 13 May 2014 and was not graded by the source guideline authors. The source recommendation was adapted by removing reference to nipple-sparing mastectomy and areola-sparing mastectomy.
Breast reconstruction – Tissue-based reconstruction (Practice Point)
For patients who are contemplating delayed breast reconstruction, and who have had chest wall radiation therapy, tissue-based reconstruction is preferred.
How this guidance was developed
This practice point was developed using an expert consensus process. A potentially relevant ungraded source recommendation was identified from the CCO 2016 guidelines (Canada) that discussed autologous tissue-based versus implant-based reconstruction. The CCO recommendation was not adopted or adapted because tissue-based reconstruction was considered the preferred option in the Australian health care context.
Breast reconstruction – Implant-based reconstruction (Recommendation)
For patients undergoing implant-based breast reconstruction, no recommendations can be made for or against the use of specific collagen-based or non-biological matrices.
How this guidance was developed
This recommendation was adapted from the CCO 2016 guidelines (Canada). The source recommendation was based on a systematic review of the evidence conducted to 13 May 2014 and was not graded by the source guideline authors. The source recommendation was adapted by broadening the scope to include the use of 'specific collagen-based or non-biological matrices' instead of 'acellular dermal matrix' only.
Breast reconstruction – Autologous fat grafting (Recommendation)
For patients undergoing breast reconstruction, no recommendations can be made for or against the routine use of autologous fat grafting for aesthetic purposes, noting that its use should be based on clinical need.
How this guidance was developed
This recommendation was adapted from the CCO 2016 guidelines (Canada). The source recommendation was based on a systematic review of the evidence conducted to 13 May 2014 and was not graded by the source guideline authors. The source recommendation was adapted by removing the wording ‘with the shortage of high-quality studies’ and adding that use of autologous fat grafting should be based on clinical need.
Breast reconstruction – Nipple-sparing mastectomy (Practice Point)
Consider nipple-sparing mastectomy for all patients without clinical or radiological nipple involvement but be cautious for patients with the following clinical features: extensive DCIS, significant ptosis (unless staging procedure considered), invasive cancer close to the nipple, large breasts, or the presence of risk factors for skin flap ischaemia (such as smoking, diabetes, or general poor health).
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using an expert consensus process.
Breast reconstruction – Inflammatory breast cancer (Recommendation)
Nipple-sparing mastectomy and areolar-sparing mastectomy are not recommended in inflammatory breast cancer or where the cancer involves the nipple/areolar complex.
How this guidance was developed
This recommendation was adapted from the CCO 2016 guidelines (Canada). The source recommendation was based on a systematic review of the evidence conducted to 13 May 2014 and was not graded by the source guideline authors. The source recommendation was adapted by removing ‘skin-sparing mastectomy’ as an intervention and removing 'inflammatory breast cancer or locally advanced breast cancer who will require postoperative radiation therapy' from the description of the patient population.
Sentinel node biopsy (SNB) and axilla management
Sentinel node biopsy - Indications #1 (Recommendation)
Offer sentinel node biopsy to breast cancer patients with no clinical or radiological evidence of axillary lymph node metastases at initial diagnosis.
How this guidance was developed
This recommendation was adopted from the NCCP 2015 guidelines (Ireland). The source recommendation was based on a systematic review of the evidence conducted to September 2014 and was graded ‘A’ (using SIGN methods) by the source guideline authors. The source recommendation was accepted with minor stylistic changes, but with no changes to the meaning or tone of the source recommendation.
This recommendation aligns with a more recent source recommendation in ESMO (2019) early breast cancer clinical practice guidelines which indicates that ‘SLNB, rather than full nodal clearance, is the standard of care for axillary staging in early, clinically-node negative breast cancer ('A')'.
This aligns with the NICE (2009) guidance on this topic based on a systematic review of the evidence (not updated in 2018) which indicates that SNB is the preferred technique in patients with no evidence of lymph node involvement on ultrasound or a negative ultrasound-guided needle biopsy.
Sentinel node biopsy – Indications #2 (Practice Point)
Perform sentinel node biopsy (SNB) in clinically node negative T1 tumours. SNB can be performed in node negative T2/T3 or multicentric/multifocal cancer, noting that SNB is associated with a higher false negative rate in these cancers.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using a consensus process.
Sentinel node biopsy – Risk-reducing mastectomy (Practice Point)
Sentinel node biopsy is not required when performing risk-reducing mastectomy, provided the patient has had adequate preoperative imaging.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. The practice point was developed using an expert consensus process
Sentinel node biopsy – Inflammatory breast cancer (Recommendation)
Sentinel node biopsy should not be performed in patients who have inflammatory breast cancer.
How this guidance was developed
This recommendation was adopted from the ASCO 2017 guidelines (US). The source recommendation was based on a systematic review of the evidence conducted to July 2016 and was graded ‘weak’ (using SIGN methods) by the source guideline authors. The source recommendation was accepted with minor stylistic changes, but with no changes to the meaning or tone of the source recommendation.
Sentinel node biopsy – Pregnant women (Practice Point)
In pregnant women with breast cancer with no clinical or radiological evidence of axillary lymph node metastases at initial diagnosis, consider the use of radioactive tracers but do not use Patent Blue dye if undertaking sentinel node biopsy.
How this guidance was developed
This practice point was developed using an expert consensus process. A potentially relevant ‘weak’ (using ASCO methods) source recommendation was identified from the ASCO 2017 guidelines (US) that recommends against sentinel node biopsy (SNB). The ASCO recommendation was not adopted or adapted because it was considered that SNB can be contemplated depending on the technique used. This practice point was developed to address safety concerns about the potential of Patent Blue dye to cause anaphylaxis, which is of particular concern in pregnant women.
Sentinel node biopsy – Lymphatic mapping #1 (Practice Point)
Where possible, lymphatic mapping with preoperative lymphoscintigraphy in combination with intraoperative use of the gamma probe and Patent Blue dye should be used to locate the sentinel node(s), noting that the theatre team and anaesthetist must be aware of the potential for Patent Blue dye to cause anaphylaxis.
How this guidance was developed
This practice point was adopted from the CA 2008a guidelines (Australia). The source recommendation was based on a systematic review of the evidence conducted to July 2007 and was not graded by the source guideline authors. The recommendation in the NICE 2018 (UK) guidelines is noted that supports use of the dual technique. This recommendation was based on a review of the evidence in July 2008. Importance of awareness of the potential anaphylaxis risk with Patent Blue dye by the theatre team and anaesthetist was specifically added. The CA 2008 guidelines further indicate that, in the event of an adverse reaction, agreed protocols should be in place. The source recommendation was accepted as a practice point, given the time elapsed since the systematic review.
Sentinel node biopsy – Lymphatic mapping #2 (Practice Point)
Where combination technique is not available or suitable, the use of radioisotope alone or Patent Blue dye alone (where no nuclear facilities are available) may be considered, noting that the theatre team and anaesthetist must be aware of the potential for Patent Blue dye to cause anaphylaxis.
How this guidance was developed
This practice point was adapted from the CA 2008a guidelines (Australia). The source recommendation was based on a systematic review of the evidence conducted in July 2007 and was not graded by the source guideline authors. The source recommendation was adapted by making the recommendation less directive, by highlighting the reason for caution, and by removing the information on audit measures. Importance of awareness of the potential anaphylaxis risk with Patent Blue dye by the theatre team and anaesthetist was specifically added. The CA 2008 guidelines further indicate that, in the event of an adverse reaction, agreed protocols should be in place. The source recommendation was accepted as a practice point, given the time elapsed since the systematic review.
Sentinel node biopsy – Excision (Practice Point)
Excise all identified sentinel nodes, including internal mammary nodes, where access is possible.
How this guidance was developed
This practice point was adapted from the CA 2008a guidelines (Australia). The source recommendation was based on a systematic review of the evidence conducted in July 2007 and was not graded by the source guideline authors. The source recommendation was adapted by adding 'including internal mammary nodes' and removing 'non-axillary sentinel nodes’.
Sentinel node biopsy – Intraoperative assessment (Practice Point)
Do not routinely perform intraoperative assessment of the sentinel node.
How this guidance was developed
This practice point was developed using an expert consensus process. A potentially relevant ungraded source recommendation was identified from the CA 2008a guidelines (Australia) that recommends intraoperative assessment of the sentinel node. The CA recommendation was not adopted or adapted because it was considered no longer relevant, given that practice has changed since 2008 for this aspect of care
Sentinel node biopsy – Pathological assessment (Recommendation)
In order to allow staging as per American Joint Committee on Cancer (AJCC) criteria, sentinel lymph nodes must be examined pathologically by a method which ensures detection of all clinically significant metastases (i.e. 2 mm or greater). All lymph node tissue should be processed. Immunohistochemistry can be used selectively.
How this guidance was developed
This recommendation was based on the current American Joint Committee on Cancer (AJCC) Staging manual (eighth edition 2017). Although not developed as a clinical practice guideline, the AJCC Staging Manual was based on a comprehensive systematic review of the evidence. Because of the importance of this aspect of care and the strong evidentiary basis of the AJCC Staging Manual, it was agreed that this guidance should be a recommendation rather than a practice point. The guidance from the AJCC Staging Manual was simplified.
Management of the axilla – Indications for axillary node clearance (Recommendation)
Offer axillary node clearance to patients with breast cancer who have a preoperative ultrasound-guided needle biopsy with pathologically proven lymph node metastases.
How this guidance was developed
This recommendation was adopted from the NICE 2018 guidelines (UK). The source recommendation was based on a systematic review of the evidence conducted to September 2017 and used wording ('Offer') indicative of a strong recommendation (using GRADE methods) by the source guideline authors. The source recommendation was accepted with minor stylistic changes, but with no changes to the meaning or tone of the source recommendation.
Management of the axilla – Indications for further axillary treatment #1 (Recommendation)
Discuss further axillary treatment (axillary node clearance or radiation therapy) in patients who have more than two macrometastases.
How this guidance was developed
This recommendation was adapted from the NICE 2018 guidelines (UK) under the heading ‘Evaluation and management of a positive axillary lymph node identified by a sentinel lymph node biopsy (in people with a normal preoperative ultrasound-guided needle biopsy’. The source recommendation was based on a systematic review of the evidence conducted to September 2017 and used wording ('Offer') indicative of a strong recommendation (using GRADE methods) by the source guideline authors. The wording was made less directive as the adapted wording reflected a ‘narrower situation’ than that described in the source recommendation.
This recommendation is also supported by a source recommendation from the ESMO (2019) early breast cancer guidelines (Europe), graded 'A' (using adapted Infectious Diseases Society of America-United States Public Health Service Grading System) which indicates that further axillary surgery is not required for the converse scenario, i.e. low axillary disease burden.
Management of the axilla – Indications for further axillary treatment #2 (Recommendation)
Discuss the benefits and risks of having no further axillary treatment after mastectomy or after breast-conserving surgery in patients who have one or two sentinel lymph node macrometastases and have been advised to have radiation therapy and adjuvant systemic therapy.
How this guidance was developed
This recommendation was adopted from the NICE 2018 guidelines (UK). The source recommendation was based on a systematic review of the evidence conducted to September 2017 and used wording ('Discuss') indicative of the need for shared decision-making by the source guideline authors. The information on clinical trials was removed as this aspect of care is covered in a separate recommendation, and in the key principles.
Management of the axilla – Indications for further axillary treatment #3 (Recommendation)
Do not offer further axillary treatment after breast-conserving surgery and breast radiation therapy or mastectomy to patients who have only micrometastases (0.2 - ≤2 mm) in their sentinel lymph nodes, or who have only isolated tumour cells (0.2 mm) in their sentinel lymph nodes.
How this guidance was developed
This recommendation was adapted from the NICE 2018 guidelines (UK). Two source recommendations based on a systematic review of the evidence conducted to September 2017 and which used wording ('Do not offer') indicative of a strong recommendation (using SIGN methods) by the source guideline authors were merged. The source recommendation was adapted by replacing the word ‘people’ with ‘patients’ and by including ‘0.2 - ≤2 mm’ after the word ‘micrometastases’ to add further specificity to this recommendation.
Management of the axilla – After neoadjuvant systemic therapy (Practice Point)
Management of an axilla that becomes sentinel node negative after neoadjuvant systemic therapy is an emerging aspect of care and no definitive guidance can currently be given.
How this guidance was developed
No evidence-based source recommendation was identified for this topic, which was considered an important aspect of care. This practice point was developed using an expert consensus process.
It is supported by recent guidance from the Association of Breast Surgery, Faculty of Clinical Oncology of the Royal College of Radiologists, UK Breast Cancer Group, National Coordinating Committee for Breast Pathology and British Society of Breast Radiology (2019).
Risk-reducing strategies
Risk-reducing strategies #1 (Recommendation)
In patients with breast cancer with a population risk of contralateral breast cancer (that is, no genetic predisposition) do not routinely offer risk-reducing mastectomy for the contralateral breast.
How this guidance was developed
This recommendation was adapted from the NCCP 2015 guidelines (Ireland). The source recommendation was based on a systematic review of the evidence conducted to September 2014 and was graded 'B' (using SIGN methods) by the source guideline authors. The source recommendation was adapted by removing 'if it is discussed at a multidisciplinary team meeting' as this does not always happen in practice. The recommendation was made more directive by adding ‘do not routinely offer’.
Risk-reducing strategies #2 (Recommendation)
In premenopausal women with breast cancer with a confirmed germline mutation (e.g. BRCA 1/2) that predisposes to an increased risk of breast cancer, discuss risk-reducing strategies (e.g. contralateral risk-reducing mastectomy or endocrine therapy/ risk-reducing medication).
How this guidance was developed
This recommendation was adapted from the CA 2014 guidelines (Australia). The source recommendation was based on a systematic review of the evidence conducted to April 2012 and was graded 'B' (using NHMRC methods) by the source guideline authors. The source recommendation was adapted by removing the specification of BRCA1/2 mutations, specification of gender in the patient population, and the focus on young women and contralateral risk-reducing strategies.
Risk-reducing strategies #3 (Recommendation)
In women with breast cancer with a confirmed germline mutation (e.g. BRCA 1/2) that predisposes to an increased risk of ovarian/fallopian tube cancer, refer to a gynaecological oncologist for discussion of the benefits and risks of bilateral salpingo-oophorectomy (BSO).
How this guidance was developed
This recommendation was adapted from the CA 2014 guidelines (Australia). The source recommendation was based on a systematic review of the evidence conducted to April 2012 and was graded 'B' (using NHMRC methods) by the source guideline authors. The source recommendation was adapted by removing the specification of age and gender in the patient population. The lack of certainty of the evidence regarding BSO among women with breast cancer who are BRCA1/2 mutation carriers and reduced risk of breast cancer and reduced breast cancer mortality was noted.
