Reference: February 2024 | Issue 2 | Vol 10 | Page 41
In January 2024, The National Institute for Health and Care Excellence (NICE) published its updated guideline for the diagnosis and management of early and locally advanced breast cancer. Several amendments have been made following a review of the best available evidence. The guideline aims to help healthcare professionals offer the right treatments to patients, taking into account the person’s individual preferences.
This article provides a summary of the updated document and identifies recommendations that remain unchanged as well as those that have been added or amended during the 2023/2024 review.
1.1 Preoperative assessment
1.1.1 For people having investigations for early and locally advanced invasive breast cancer, perform pretreatment ultrasound evaluation of the axilla, and if abnormal lymph nodes are identified, perform ultrasound-guided needle sampling. [2009]
1.1.2 Do not routinely use MRI of the breast as part of the preoperative assessment of people with biopsy-proven invasive breast cancer or ductal carcinoma in situ (DCIS). [2009]
1.1.3 Offer MRI of the breast as part of a preoperative assessment to people with invasive breast cancer if the extent of disease is not clear from clinical examination, mammography, and ultrasound assessment for planning treatment;if accurate mammographic assessment is difficult because of breast density;orto assess the tumour size if breast-conserving surgery is being considered for invasive lobular cancer. [2009]
1.1.4 Offer genetic testing for BRCA1 and BRCA2 mutations to women under 50 years with triple-negative breast cancer, including those with no family history of breast or ovarian cancer. [2017]
1.2 Providing information and psychological support
1.2.1 Ensure all people with breast cancer have a named clinical nurse specialist, or other specialist key worker with equivalent skills, to support them throughout diagnosis, treatment, and follow-up. [2009, amended 2018]
1.2.2 Offer all people with breast cancer prompt access to specialist psychological support and, where appropriate, psychiatric services. [2009]
1.2.3 Discuss opportunities for people with breast cancer to be involved in research, and encourage entry into clinical trials and other studies. [2018]
1.2.4 For guidance on fertility preservation, see the recommendations on people with cancer who wish to preserve fertility in the NICE guideline on fertility problems. [2018]
1.3 Surgery to the breast
1.3.1 Offer further surgery (re-excision or mastectomy, as appropriate) after breast-conserving surgery where invasive cancer or DCIS is present at the radial margins (‘tumour on ink’; 0mm). [2018]
Further surgery after breast-conserving surgery
1.3.2 Consider further surgery (re-excision or mastectomy, as appropriate) after breast-conserving surgery for invasive cancer with or without DCIS if tumour cells are present within 1mm of, but not at, the radial margins (greater than 0mm and less than 1mm). As part of the decision making, discuss the benefits and risks with the person, take into account the person’s circumstances, needs and preferences, any comorbidities, tumour characteristics, and potential treatments, including the use of radiotherapy and other adjuvant therapies. [2024]
1.3.3 Consider further surgery (re-excision or mastectomy, as appropriate) after breast-conserving surgery for DCIS without invasive cancer if tumour cells are present within 2mm of, but not at, the radial margins (greater than 0mm and less than 2mm). As part of the decision making, discuss the benefits and risks with the person.Take into account the person’s circumstances, needs and preferences,any comorbidities,tumour characteristics, and potential treatments, including the use of radiotherapy and other adjuvant therapies. [2024]
1.3.4 When discussing the benefits and risks of further surgery, follow the recommendations on enabling patients to actively participate in their care in NICE’s guideline on patient experience in adult NHS services, and communicating risks, benefits, and consequences in NICE’s guideline on shared decision making. [2024]
1.3.5 All breast units should audit
their local, regional, and distant recurrence rates after treatment, including systematically collecting data on radial margins and demographic information (such as socioeconomic status, age, and ethnicity). [2009, amended 2024]
Paget’s disease
1.3.6 Offer breast-conserving surgery with removal of the nipple–areolar complex as an alternative to mastectomy for people with Paget’s disease of the nipple that has been assessed as localised. Offer oncoplastic repair techniques to maximise cosmesis. [2009]
1.4 Surgery to the axilla
Invasive breast cancer
1.4.1 Perform surgery using sentinel lymph node biopsy (SLNB) rather than axillary lymph node clearance to stage the axilla for people with invasive breast cancer if they haveno evidence of lymph node involvement on ultrasound, ora negative ultrasound-guided needle biopsy. [2009, amended 2023]
1.4.2 Perform SLNB using the dual technique with isotope and blue dye. [2009]
1.4.3 Breast units should audit their axillary recurrence rates. [2009]
DCIS
1.4.4 Do not routinely perform SLNB for women with a preoperative diagnosis of DCIS who are having breast-conserving surgery, unless they are considered to be at high risk of invasive disease. People at high risk of invasive disease include those with a palpable mass or extensive microcalcifications. [2009]
1.4.5 Offer SLNB to all people who are having a mastectomy for DCIS. [2009]
Evaluation and management of a positive axillary lymph node identified by a preoperative ultrasound-guided needle biopsy
1.4.6 Offer axillary node clearance to people with invasive breast cancer who have a preoperative ultrasound-guided needle biopsy with pathologically proven lymph node metastases. [2009, amended 2018]
Evaluation and management of a positive axillary lymph node identified by SLNB (in people with a normal preoperative ultrasound-guided needle biopsy)
1.4.7 Offer further axillary treatment (axillary node clearance or radiotherapy) after SLNB to people who have one or more sentinel lymph node macrometastases. [2018]
1.4.8 Discuss the benefits and risks of not having further axillary treatment after primary breast-conserving surgery (within clinical trials where available) with women whohave one or two sentinel lymph node macrometastases andhave been advised to have whole-breast radiotherapy with systemic therapy (which may be endocrine therapy). [2018]
1.4.9 Do not offer further axillary treatment to people who only have micrometastases in their sentinel lymph nodes after primary surgery for invasive breast cancer. [2018]
1.4.10 Do not offer further axillary treatment to people who have isolated tumour cells in their sentinel lymph nodes after primary surgery for invasive breast cancer. Classify this as lymph node-negative breast cancer. [2018]
1.5 Breast reconstruction
1.5.1 Offer breast reconstruction to people after they have had mastectomy for breast cancer. [2023]
1.5.2 Be aware that some people may prefer not to have breast reconstruction surgery. [2018]
1.5.3 Offer both breast reconstruction options to women (immediate reconstruction and delayed reconstruction), whether or not they are available locally. [2018]
1.5.4 Offer immediate breast reconstruction to women who have been advised to have a mastectomy, including those who may need radiotherapy, unless they have comorbidities that rule out reconstructive surgery. [2018, amended 2023]
1.5.5 Discuss the benefits and risks of immediate breast reconstruction and delayed breast reconstruction with women. Topics to discuss are outlined in the full guideline and include the timing of breast reconstruction surgery (at the same time as mastectomy or later),different breast reconstruction surgery options and what they involve, how the timing of breast reconstruction surgery affects the options available,the uncertainty over long-term outcomes in women having radiotherapy. [2018]
1.6 Diagnostic assessment and adjuvant therapy planning
Predictive factors
1.6.1 Assess the oestrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) status of all invasive breast cancers simultaneously at the time of initial histopathological diagnosis. [2018]
1.6.2 Assess the ER status of all invasive breast cancers using standardised and quality-assured immunohistochemical techniques, and report the results quantitatively. [2009]
1.6.3 Assess the PR status of all invasive breast cancers using standardised and quality-assured immunohistochemical techniques, and report the results quantitatively. [2018]
1.6.4 Assess the HER2 status of all invasive breast cancers using standardised and quality-assured techniques, and report the results quantitatively. [2009]
1.6.5 Ensure that the ER, PR, and HER2 statuses are available and recorded at the preoperative and postoperative multidisciplinary team meetings when systemic treatment is discussed. [2018]
Adjuvant therapy planning
1.6.6 Consider adjuvant therapy after surgery for people with invasive breast cancer, and ensure that recommendations are documented at the multidisciplinary team meeting. [2009]
1.6.7 Base recommendations about adjuvant therapy on multidisciplinary team assessment of the prognostic and predictive factors, and the possible risks and benefits of the treatment. Make decisions with the person after discussing these factors. [2009, amended 2018]
1.6.8 Use the PREDICT tool to estimate prognosis and the absolute benefits of adjuvant therapy for women with invasive breast cancer. [2018]
1.6.9 When using the PREDICT tool, be aware that it is less accurate for:
- Women under 30 with ER-positive breast cancer;
- Women aged 70 and over;
- Women with tumours larger than 50mm.
It has not been validated in men, and the validation may have under-represented some ethnic groups. [2018, amended 2023]
1.7 Endocrine therapy
1.7.1 Treat all people with invasive breast cancer with surgery and appropriate systemic therapy, rather than endocrine therapy alone, unless a significant comorbidity means surgery is not suitable for them. [2009]
Adjuvant endocrine therapy for invasive breast cancer
1.7.2 Offer tamoxifen as the initial adjuvant endocrine therapy for men and premenopausal women with ER-positive invasive breast cancer. [2009, amended 2018]
1.7.3 Offer an aromatase inhibitor as the initial adjuvant endocrine therapy for postmenopausal women with ER-positive invasive breast cancer who are at medium or high risk of disease recurrence. Offer tamoxifen to women who are at low risk of disease recurrence, or if aromatase inhibitors are not tolerated or are contraindicated. [2009, amended 2018]
Ovarian function suppression
1.7.4 Consider ovarian function suppression in addition to endocrine therapy for premenopausal women with ER-positive invasive breast cancer. [2018]
1.7.5 Discuss the benefits and risks of ovarian function suppression in addition to endocrine therapy with premenopausal women with ER-positive invasive breast cancer. Explain to women that ovarian function suppression may be most beneficial for those women who are at sufficient risk of disease recurrence to have been offered chemotherapy. [2018]
1.7.6 Discuss the benefits and risks of extended endocrine therapy with people who this treatment may be suitable for. [2018, amended 2023]
1.7.7 Offer extended endocrine therapy (past the five-year point) with an aromatase inhibitor for postmenopausal women with ER-positive invasive breast cancer who are at medium or high risk of disease recurrence and who have been taking tamoxifen for two-to-five years. Medium or high risk may include people who have lymph node-positive breast cancer, with tumours that are T2 or greater and higher grade. [2018]
1.7.8 Consider extended endocrine therapy (past the five-year point) with an aromatase inhibitor for postmenopausal women with ER-positive invasive breast cancer who are at low risk of disease recurrence and who have been taking tamoxifen for two-to-five years. Low risk may include people with lymph node-negative breast cancer, with smaller or lower-grade tumours. [2018]
1.7.9 Consider extending the duration of tamoxifen therapy for longer than five years for people with ER-positive invasive breast cancer. [2018]
Endocrine therapy for DCIS
1.7.10 Discuss the benefits and risks of endocrine therapy after breast-conserving surgery for women with ER-positive DCIS. [2018]
1.7.11 Offer endocrine therapy after breast-conserving surgery for women with ER-positive DCIS if radiotherapy is recommended but not received. [2018]
1.7.12 Consider endocrine therapy after breast-conserving surgery for women with ER-positive DCIS if radiotherapy is not recommended. [2018]
1.8 Adjuvant chemotherapy for invasive breast cancer
1.8.1 For people with breast cancer where chemotherapy is indicated, offer a regimen that contains both a taxane and an anthracycline. Refer to the summaries of product characteristics for individual taxanes and anthracyclines to check for differences in licensed indications. [2018, amended 2023]
1.8.2 Discuss with people the benefits and risks of adding a taxane to anthracycline-containing regimens. Topics to discuss include:
- The benefits of reduced cardiac toxicity and reduced nausea;
- The risks of additional side effects, including neuropathy, neutropenia and hypersensitivity;
- The different side effects and dosing frequencies of different docetaxel and paclitaxel regimens, and the additional clinic visits that may be needed;
- That absolute benefit is proportional to absolute risk of recurrence.
Refer to the summaries of product characteristics for individual taxanes and anthracyclines to check for differences in licensed indications. [2018]
1.8.3 Ensure weekly and fortnightly paclitaxel is available locally, as it is better tolerated than three-weekly docetaxel, particularly in people with comorbidities. [2018, amended 2023]
Biological therapy
1.8.4 Offer adjuvant trastuzumab for people with T1c and above HER2-positive invasive breast cancer. Give this at three-week intervals for one year in combination with surgery, chemotherapy, endocrine therapy, and radiotherapy, as appropriate. [2009, amended 2023]
1.8.5 Consider adjuvant trastuzumab for people with T1a/T1b HER2-positive invasive breast cancer, taking into account any comorbidities, prognostic features, possible toxicity of chemotherapy, and the person’s preferences. [2018]
1.8.6 Use trastuzumab with caution in people with HER2-positive invasive breast cancer if they have any of the following:
- A baseline left ventricular ejection fraction of 55 per cent or less;
- A history of, or current, congestive heart failure;
- A history of myocardial infarction;
- Angina pectoris needing medication;
- Cardiomyopathy;
- Cardiac arrhythmias needing medical treatment;
- Clinically significant valvular heart disease;
- Haemodynamic-effective pericardial effusion;
- Poorly controlled hypertension. [2009, amended 2018]
1.9 Bisphosphonate therapy
1.9.1 Offer bisphosphonates (zoledronic acid or sodium clodronate) as adjuvant therapy to postmenopausal women with node-positive invasive breast cancer. [2018]
1.9.2 Consider bisphosphonates (zoledronic acid or sodium clodronate) as adjuvant therapy for postmenopausal women with node-negative invasive breast cancer and a high risk of recurrence. [2018]
1.9.3 Discuss the benefits and risks of bisphosphonate treatment with women, particularly the risk of osteonecrosis of the jaw, atypical femoral fractures, and osteonecrosis of the external auditory canal. Follow the Medicines and Healthcare products Regulatory Agency/Commission on Human Medicines (MHRA/CHM) advice on bisphosphonates. [2018]
Bone health
1.9.4 Offer a baseline dual-energy x-ray absorptiometry (DEXA) scan to assess bone mineral density in women with invasive breast cancer who are not receiving bisphosphonates as adjuvant therapy and who are starting adjuvant aromatase inhibitor treatment, or have treatment-induced menopause, or are starting ovarian ablation/suppression therapy. [2009, amended 2018]
1.9.5 Do not offer a DEXA scan to people with invasive breast cancer who are receiving tamoxifen alone. [2009, amended 2023]
1.9.6 Offer bisphosphonates to women identified by algorithms 1 and 2 in the guidance for the management of breast cancer treatment-induced bone loss: A consensus position statement from a UK expert group (2008; this guidance is not NICE-accredited). [2009]
1.10 Radiotherapy
1.10.1 Use a radiotherapy technique that minimises the dose to the lung and heart. [2018]
1.10.2 Use a deep inspiratory breath-hold radiotherapy technique for people with left-sided breast cancer to reduce the dose to the heart. [2018]
Radiotherapy after breast-conserving surgery
1.10.3 Offer whole-breast radiotherapy to women with invasive breast cancer who have had breast-conserving surgery with clear margins. [2018]
1.10.4 Consider partial-breast radiotherapy as an alternative to whole-breast radiotherapy for women who have had breast-conserving surgery for invasive cancer (excluding lobular type) with clear margins and who have a low absolute risk of local recurrence (defined as women aged 50 and over with tumours that are 3cm or less, N0, ER-positive, HER2-negative, and grade 1-to-2), and have been advised to have adjuvant endocrine therapy for a minimum of five years. [2018]
1.10.5 If partial-breast radiotherapy (see recommendation 1.10.4) may be suitable for a woman, discuss the benefits and risks with them and reach a shared decision on its use. Topics to cover include that local recurrence with partial-breast radiotherapy at five years is equivalent to that with whole-breast radiotherapy; the risk of local recurrence beyond five years is not yet known; there is a potential reduction in late adverse effects. [2018, amended 2023]
1.10.6 When giving partial-breast radiotherapy, use external beam radiotherapy. [2018]
1.10.7 Consider not using radiotherapy for women who have had breast-conserving surgery for invasive breast cancer with clear margins, and have a very low absolute risk of local recurrence (defined as women aged 65 and over with tumours that are T1N0, ER-positive, HER2-negative and grade 1 to 2), and are willing to take adjuvant endocrine therapy for a minimum of five years. [2018]
1.10.8 When considering not using radiotherapy, discuss the benefits and risks with the woman and explain that:
Without radiotherapy, local recurrence occurs in about 50 women per 1,000 at five years, and with radiotherapy, occurs in about 10 women per 1,000 at five years.
Overall survival at 10 years is the same with or without radiotherapy.
There is no increase in serious late effects if radiotherapy is given (for example, congestive cardiac failure, myocardial infarction, or secondary cancer). [2018]
1.10.9 Consider adjuvant radiotherapy for women with DCIS following breast-conserving surgery with clear margins. Discuss the possible benefits and risks of radiotherapy and make a shared decision about its use. [2009]
Radiotherapy after mastectomy
1.10.10 Offer adjuvant postmastectomy radiotherapy to people with node-positive (macrometastases) invasive breast cancer or involved resection margins. [2018]
1.10.11 Consider adjuvant postmastectomy radiotherapy for people with node-negative T3 or T4 invasive breast cancer. [2018]
1.10.12 Do not offer radiotherapy following mastectomy to people with invasive breast cancer who are at low risk of local recurrence (for example, most people who have lymph node-negative breast cancer). [2018, amended 2023]
Dose fractionation for external beam radiotherapy
1.10.13 Offer 26 Gy in five fractions over one week for people with invasive breast cancer having partial-breast, whole-breast or chest-wall radiotherapy, without regional lymph node irradiation, after breast-conserving surgery or mastectomy. [2023]
1.10.14 Consider 40 Gy in 15 fractions over three weeks for people with invasive breast cancer having partial-breast, whole-breast or chest-wall radiotherapy, without regional lymph node irradiation, after breast-conserving surgery or mastectomy when they have a diagnosis that increases sensitivity to radiotherapy, or have had implant-based reconstruction, or have any other factor that could mean having radiotherapy over three weeks is more acceptable (such as high body mass index or fibromyalgia). [2023]
1.10.15 When discussing the benefits and risks of the two regimens, follow the recommendations on enabling patients to actively participate in their care in the NICE guideline on patient experience in adult NHS services, and communicating risks, benefits, and consequences in the NICE guideline on shared decision making. [2023]
1.10.16 Offer 40 Gy in 15 fractions over three weeks for people with invasive breast cancer having regional lymph node irradiation, with or without whole-breast or chest-wall radiotherapy, after breast-conserving treatment or mastectomy. [2023]
Breast boost following breast-conserving surgery
1.10.17 Offer an external beam boost to the tumour bed for women with invasive breast cancer and a high risk of local recurrence, following whole-breast radiotherapy. [2009, amended 2018]
1.10.18 Inform women of the risk of side effects associated with an external beam boost to the tumour bed following whole-breast radiotherapy. [2009, amended 2018]
Radiotherapy to nodal areas
1.10.19 Do not offer adjuvant radiotherapy to regional lymph nodes to people with invasive breast cancer who have histologically lymph node-negative breast cancer. [2009, amended 2018]
1.10.20 Do not offer people with invasive breast cancer adjuvant radiotherapy to the axilla after axillary clearance. [2009, amended 2023]
1.10.21 Offer adjuvant radiotherapy to the supraclavicular fossa to people with invasive breast cancer and four or more involved axillary lymph nodes. [2009]
1.10.22 Offer adjuvant radiotherapy to the supraclavicular fossa to people with invasive breast cancer and one-to-three positive lymph nodes if they have other poor prognostic factors (for example, T3 and/or histological grade 3 tumours) and good performance status. [2009]
1.10.23 Consider including the internal mammary chain within the nodal radiotherapy target for people with node-positive (macrometastases) invasive breast cancer. [2018]
Intraoperative radiotherapy
1.10.24 For guidance on intraoperative radiotherapy, see the NICE technology appraisal guidance on the intrabeam radiotherapy system for adjuvant treatment of early breast cancer. [2018]
1.11 Primary systemic therapy
Neoadjuvant chemotherapy
1.11.1 Offer neoadjuvant chemotherapy to people with ER-negative invasive breast cancer as an option to reduce tumour size. [2018]
1.11.2 Offer neoadjuvant chemotherapy to people with HER2-positive invasive breast cancer in line with the NICE technology appraisal guidance on pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer. [2018]
1.11.3 Consider neoadjuvant chemotherapy for people with ER-positive invasive breast cancer as an option to reduce tumour size if chemotherapy is indicated. [2018]
1.11.4 For people with ER/PR/HER2-negative (triple-negative) invasive breast cancer, consider a neoadjuvant chemotherapy regimen that contains both a platinum and an anthracycline. [2018]
1.11.5 Discuss the benefits and risks of adding a platinum to an anthracycline-containing neoadjuvant chemotherapy regimen, and in particular the risk of increased toxicity. [2018]
Neoadjuvant endocrine therapy
1.11.6 Consider neoadjuvant endocrine therapy for postmenopausal women with ER-positive invasive breast cancer as an option to reduce tumour size if there is no definite indication for chemotherapy. [2018]
1.11.7 Advise premenopausal women that neoadjuvant chemotherapy may be more likely to produce a clinical response than neoadjuvant endocrine therapy, but that some tumours do respond to neoadjuvant endocrine therapy. [2018]
1.11.8 Discuss with women the benefits and risks of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy. [2018]
Radiotherapy after neoadjuvant chemotherapy
1.11.9 Offer local treatment with mastectomy (or, in exceptional cases, breast-conserving surgery) followed by radiotherapy to people with locally advanced or inflammatory breast cancer that has been treated with neoadjuvant chemotherapy. [2009]
1.11.10 Offer postmastectomy radiotherapy after neoadjuvant chemotherapy if post-treatment histology shows node-positive (macrometastases) breast cancer or involved resection margins. [2018]
1.11.11 Offer postmastectomy radiotherapy after neoadjuvant chemotherapy if pretreatment investigations show node-positive (macrometastases) breast cancer. [2018]
1.11.12 Consider postmastectomy radiotherapy after neoadjuvant chemotherapy if post-treatment histology shows node-negative T3 breast cancer. [2018]
1.11.13 Consider postmastectomy radiotherapy after neoadjuvant chemotherapy if pretreatment investigations show node-negative T3 breast cancer. [2018]
1.12 Complications of local treatment and menopausal symptoms
Lymphoedema
1.12.1 Inform people with breast cancer about lymphoedema and their risk of developing it after treatment with surgery and radiotherapy (see recommendation 1.12.2). Give them relevant written information before treatment to take away and refer back to. [2009]
1.12.2 When informing people with breast cancer about the risk of developing lymphoedema, advise them that:
- Lymphoedema can occur in the arm, breast or chest wall;
- They do not need to restrict their physical activity;
- There is no consistent evidence of increased risk of lymphoedema associated with air travel, travel to hot countries, manicures, hot-tub use or sports injuries;
- There is no consistent evidence of increased risk of lymphoedema associated with medical procedures (for example, blood tests, injections, intravenous medicines and blood pressure measurement) on the treated side, and the decision to perform medical procedures using the arm on the treated side should depend on clinical need and the possibility of alternatives. [2018, amended 2023]
1.12.3 Give people who have had treatment for breast cancer advice on how to reduce the risk of infection that may cause or exacerbate lymphoedema. [2009]
1.12.4 Ensure that people with breast cancer who develop lymphoedema have prompt access to a specialist lymphoedema service. [2009]
The full NICE guideline for ‘early and locally advanced breast cancer: Diagnosis and management’ (NG101) can be accessed at www.nice.org.uk/guidance/ng101.
Leave a Reply
You must be logged in to post a comment.