Rationale and impact

These sections briefly explain why the committee made the recommendations and how they might affect practice. They link to details of the evidence and a full description of the committee's discussion.

Providing information and psychological support

Recommendations 1.2.3 and 1.2.4

Why the committee made the recommendations

The committee agreed, based on their clinical expertise, that continued improvement in breast cancer survival as well as post-diagnosis quality of life needs ongoing research into new or refined treatment options to allow further optimisation of care.

People having treatment for breast cancer should be advised about options for preserving their fertility, so the existing NICE guideline on this topic was cross-referred to.

How the recommendations might affect practice

Recruitment into clinical trials wherever possible is already standard practice, so the recommendation is unlikely to result in a change in practice.

Discussion of fertility options is already standard practice, so the recommendation is unlikely to result in a change in practice.

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Surgery to the breast

Recommendation 1.3.1

Why the committee made the recommendation

There was some evidence that there was a reduced risk of ductal carcinoma in situ (DCIS) local recurrence if tissue margins were greater than 0 mm, so the committee recommended further surgery (re-excision or mastectomy) to extend the margins if needed. Although there was no consistent evidence about tissue margins for invasive breast cancer, the committee agreed that further surgery should be offered.

The committee agreed that complete excision of the tumour with clear margins was essential for the high-quality care of people with DCIS or invasive breast cancer.

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. So, the committee agreed that this was an important topic for further research and made a recommendation for research on the optimum tumour‑free margin width after surgery to the breast.

How the recommendation might affect practice

The rates of further surgery currently vary across the country. Although the committee noted that the recommendation will reinforce current best practice, there may be some centres that will need to amend their practice in order to follow this recommendation.

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Further surgery after breast-conserving surgery

Recommendations 1.3.2 to 1.3.5

Why the committee made the recommendations

The committee agreed that the best choice for radial margin size would be a balance between the need for further surgery (to reduce the risk of local recurrence and maximise overall survival) and maintaining good levels of patient satisfaction. This balance also needs to take into account the potential harms of further surgery, and possible need for other treatments to take priority over further surgery. Because of the way the evidence was reported in the included studies, the committee discussed the evidence on radial margins after breast-conserving surgery separately for people who had invasive breast cancer with or without DCIS and for people who had DCIS only. Most of the data was for local recurrence, with some for distant recurrence and very limited data for overall survival or breast-cancer-specific survival. There was no evidence on patient-reported outcomes or quality of life. Therefore, the committee based most of their discussion on the evidence for local recurrence, and used their personal and clinical experience to consider the perspectives and preferences of people who have breast cancer.

The committee discussions focused on whether a radial margin of 1 mm or 2 mm should be the cut-off for further surgery. The committee agreed that when the tumour is at 0 mm, this balance is strongly in favour of further surgery to try to ensure the full tumour is removed, so the existing recommendation to offer further surgery was retained without reviewing the evidence. For people with invasive breast cancer with or without DCIS, the evidence showed that the risk of local recurrence was higher with radial margins of greater than 0 mm to less than 1 mm compared with greater than or equal to 1 mm. This was also the case for local recurrence when radial margins of greater than 0 mm to 2 mm were compared with greater than 2 mm. However, the evidence could not differentiate between greater than 1 mm to 2 mm compared with greater than 2 mm. The committee also noted that the incidence of local recurrence has decreased because of advances in breast cancer care.

Taking this into account with the evidence for local recurrence, the committee did not think that recommending a margin of 1 mm, rather than 2 mm, would lead to a substantially increased risk of local recurrence. Additionally, they agreed that for many people, a margin of 1 mm is likely to be preferable over a more cautious approach with a margin of 2 mm because the smaller margin is likely to achieve better breast preservation and result in fewer additional surgeries. They noted that repeated surgeries negatively affect breast appearance, and this can have a negative effect on the person's self-esteem and view of themselves. They are also traumatic for the person involved and can lead to stress, infections, pain, complications associated with recovery from the anaesthetic and operation, and negatively affect their everyday life. As a result, the committee agreed that further surgery should be considered for people who had breast-conserving surgery for invasive breast cancer with or without DCIS if tumour cells are present within 1 mm of the radial margins.

For DCIS only, the limited evidence was of very low quality, and it was not possible to combine the findings from the studies that were available in a meta-analysis. Therefore, the committee was not confident of the differences between a margin of less than, or greater than, 2 mm on local or distant recurrence. As a result, they decided to retain the threshold of 2 mm from the existing recommendation when considering further surgery for this population. The committee did not make a recommendation for research for this group because they were aware of new studies already underway that could inform this decision in the future.

As well as thinking about the potential clinical benefits of further surgery, the committee acknowledged the importance of taking the person's circumstances, needs and preferences into account as part of the decision-making process. This is intended to help ensure that any barriers to particular treatment options are considered and addressed where possible. They recommended that there should be a discussion with the person about the benefits of surgery, such as reducing the risk of recurrence, as well as risks, such as infection and complications. The committee also agreed other clinical factors, such as tumour characteristics and potential treatments, should be taken into account. They referred to the NICE guidelines on shared decision making and patient experience to help inform these discussions.

The committee noted that, in their experience, the existing recommendation about auditing recurrence is not uniformly applied and that the information recorded does not necessarily include the radial margin. They therefore expanded the recommendation to highlight factors that they thought should be recorded in addition to recurrence. The committee was also aware of a new National Audit of Primary Breast Cancer that may improve recording of this information.

The committee noted that there was no evidence for people receiving neoadjuvant hormone therapy or biological treatments and very little evidence for people receiving neoadjuvant chemotherapy, and that the quality of this evidence was very low. Therefore, they could not make a specific recommendation for this group. However, they agreed that the evidence for people who did not have neoadjuvant therapy could be extrapolated to this group and that the recommendation for people with invasive breast cancer with or without DCIS could apply to them as well.

How the recommendations might affect practice

It is not expected that the recommendation for people with invasive breast cancer will increase resource use since it is likely that fewer people will have further surgery given the reduction in margin size. The recommendations should also encourage standardisation of practice in relation to radial margins for invasive breast cancer with or without DCIS across the UK. The recommendations for DCIS retain the existing radial margins and are therefore not expected to change practice or resource use.

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Evaluation and management of a positive axillary lymph node

Recommendations 1.4.7 to 1.4.10

Why the committee made the recommendations

There was no new evidence that led the committee to change from the existing recommended practice (as recommended in the previous NICE guideline CG80) of:

  • offering axillary clearance to people with preoperatively pathologically proven involvement of the axillary lymph nodes

  • not offering axillary treatment after primary surgery to people with isolated tumour cells in their sentinel lymph nodes.

The committee agreed that current evidence shows that further axillary treatment after primary surgery does not improve survival for people with micrometastases and there are risks such as lymphoedema, so further treatment should not be offered to this population. There were unclear benefits and risks of further axillary treatment after primary surgery in people with only 1 or 2 sentinel lymph node macrometastases who have had breast-conserving surgery and have been advised to have whole-breast radiotherapy and systemic therapy, so the committee agreed that the risks and benefits of further treatment should be discussed with this group.

Studies of neoadjuvant therapy were excluded from the evidence review.

How the recommendations might affect practice

The committee agreed that the recommendations will result in a minor change in practice because some centres currently use mainly surgery and may not use radiotherapy. In addition, more time may need to be factored in to plan and deliver radiotherapy treatment.

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Breast reconstruction

Recommendations 1.5.2 to 1.5.5

Why the committee made the recommendations

There was not much good evidence, but the committee agreed that the main benefits of immediate breast reconstruction compared with delayed reconstruction are improved aesthetic satisfaction, improved symmetry, improved health-related quality of life, lower overall rates of complications and a reduced need for further surgery. The committee agreed that in some circumstances, there are advantages to delayed reconstruction compared with immediate reconstruction (for example, reduced mastectomy flap loss and capsular contracture). Therefore, delayed reconstruction should also be an option for women who wish to have a reconstruction after mastectomy. The committee also agreed that the option of no reconstruction should also be discussed, because this may be the preferred option for some women.

In addition, although radiotherapy can impact on outcomes after breast reconstruction, there was no consistent evidence for worse outcomes between radiotherapy delivered after immediate reconstructions compared with radiotherapy before delayed reconstructions. Therefore, the committee agreed that immediate reconstruction should be offered regardless of plans for chest-wall radiotherapy.

There is little evidence regarding longer-term outcomes and different types of reconstruction. Because of this, the committee agreed that more research is needed to understand whether immediate breast reconstruction or delayed breast reconstruction is better in women who may need postmastectomy radiotherapy. So, they made a recommendation for research on long‑term outcomes for breast reconstruction in women having radiotherapy to the chest wall.

How the recommendations might affect practice

The recommendations may result in a substantial change in practice because many centres do not routinely offer immediate breast reconstruction to all women (especially those who have been advised to have radiotherapy). The impact will depend on how many immediate reconstructions are already carried out. In addition, the uptake of immediate breast reconstruction will also depend on women's preferences. There may be cost savings associated with immediate reconstructions because fewer surgical procedures are needed (reconstruction is done at the same time as mastectomy and there are lower rates of additional symmetrisation surgery).

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Predictive factors

Recommendations 1.6.1, 1.6.3 and 1.6.5

Why the committee made the recommendations

There was not enough good evidence, so the committee agreed, using a formal consensus scoring system and their knowledge and experience, that progesterone receptor (PR) status should be assessed for all invasive breast cancers because:

  • it will help when tailoring adjuvant therapy

  • it will reduce delays in starting treatment

  • if people are already having testing at this stage, their PR status can be assessed without them having to wait for additional test results.

The committee also agreed that oestrogen receptor (ER), PR and human epidermal growth factor receptor 2 (HER2) status assessments should be requested simultaneously at the time of initial diagnosis to ensure that results are available at the initial preoperative multidisciplinary team meeting (as well as the postoperative meeting). This will avoid delays and the need for additional discussions.

How the recommendations might affect practice

Most people with invasive breast cancer have PR testing in current practice, although it is not always performed at diagnosis. The recommendations should reduce variation in practice and delays in starting treatment, and the need for pathology results to be discussed at more than 1 multidisciplinary meeting, so may lead to a small cost saving.

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Adjuvant therapy planning

Recommendations 1.6.8 and 1.6.9

Why the committee made the recommendations

Good evidence showed that the prognostic tool PREDICT is an accurate tool to estimate prognosis and the benefits of treatment in most people.

How the recommendations might affect practice

The committee agreed that most healthcare professionals already use the PREDICT tool, so this recommendation will not mean a big change in practice.

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Ovarian function suppression

Recommendations 1.7.4 and 1.7.5

Why the committee made the recommendations

There was evidence that ovarian function suppression increased overall survival when combined with tamoxifen, and that women who have had chemotherapy benefited more. However, ovarian function suppression did not improve disease-free survival. In addition, it induces a temporary menopause and can worsen the menopausal symptoms seen with tamoxifen.

Given the limited evidence of benefits and the side effects of the treatment, the committee agreed that healthcare professionals should discuss the potential benefits and risks with women. This will help women decide which treatment is right for them.

How the recommendations might affect practice

There is variation among centres in the use of ovarian function suppression, so the recommendations should lead to greater consistency and improve access to the treatment, even though not all women will wish to have it. There will be an increase in required resources for centres that do not currently provide ovarian function suppression because additional appointments will be needed to administer the medication and monitor side effects. However, this was not anticipated to be a substantial cost increase because of the number of centres already offering ovarian function suppression. Further, increased costs will be at least partially offset by improvements in survival outcomes.

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Extended endocrine therapy

Recommendations 1.7.6 to 1.7.9

Why the committee made the recommendations

Good evidence showed that switching to an aromatase inhibitor after 5 years of tamoxifen improved disease-free survival compared with postmenopausal women who had only received tamoxifen for 5 years, with the benefits being greater in those women who had a greater risk of disease recurrence.

The evidence showed no benefit in terms of disease-free survival or overall survival from continuing tamoxifen beyond 5 years. However, some of the studies on tamoxifen were conducted in the 1980s and may not be relevant to current practice. In the committee's experience, continuing tamoxifen can be beneficial for some women.

However, evidence showed that being on endocrine therapy for more than 5 years can increase the risk of problems such as endometrial cancer, osteoporosis, toxicity and phlebitis. The committee agreed that people will often prioritise survival even if this means they will have a reduced quality of life, but that people need to be informed about the possible benefits and risks so they can make a choice.

Because of the risk of problems with taking endocrine therapy for more than 5 years, the committee agreed that healthcare professionals should discuss the potential benefits and risks with women to help them make an informed choice about treatment, based on their own risk factors.

How the recommendations might affect practice

Some centres already review treatment at 5 years and continue endocrine therapy with tamoxifen or an aromatase inhibitor when it could benefit women. Because a large number of women will be affected by these recommendations, the resource impact will be large for centres that are not currently providing treatment after 5 years.

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Endocrine therapy for ductal carcinoma in situ

Recommendations 1.7.10 to 1.7.12

Why the committee made the recommendations

There was good evidence that tamoxifen after breast-conserving surgery for ER-positive DCIS improved disease-free survival and reduced rates of local recurrence in women who did not have radiotherapy. Because of their concerns about over-treatment, the committee agreed that women who were at higher risk (those who should have had radiotherapy, but who did not receive it) would benefit more. There was no evidence available for aromatase inhibitors; however, the committee agreed they would likely produce similar improvements in disease-free survival and reductions in local recurrence as tamoxifen. Therefore, the committee recommended endocrine therapy, rather than specifically tamoxifen.

The committee agreed that the benefits and risks of endocrine therapy should be discussed with the woman because of the potential treatment-related complications, such as menopausal symptoms, and the impact on family planning.

How the recommendations might affect practice

Offering endocrine therapy after initial treatment of DCIS will be a change of practice because it is not currently routinely offered to these women. However, because of the small number of people with DCIS who will not receive radiotherapy, and the low cost of the medicines, the committee agreed that the impact will not be significant.

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Adjuvant chemotherapy for invasive breast cancer

Recommendations 1.8.1 to 1.8.3

Why the committee made the recommendations

There was good evidence of improved survival when taxanes are added to anthracycline-based chemotherapy in people with node-positive and node-negative breast cancer. In both groups, the benefits and risks of treatment should be discussed because of the potential side effects associated with taxanes. Three-weekly docetaxel was identified as a regimen with potentially more toxicity than weekly or fortnightly paclitaxel.

How the recommendations might affect practice

These recommendations may result in a substantial change in practice because of increased taxane use, particularly for people with node-negative breast cancer and comorbidities.

In addition, there will be an increase in weekly and fortnightly chemotherapy regimens being offered (for people who cannot tolerate 3‑weekly regimens). These regimens have a higher cost because they are more resource intensive, and may affect capacity in chemotherapy services.

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Biological therapy

Recommendation 1.8.5

Why the committee made the recommendation

There was evidence that adjuvant trastuzumab can improve disease-free survival and overall survival in some people with T1a and T1b HER2-positive invasive breast cancer who were treated with adjuvant trastuzumab and chemotherapy. However, only a small number of people will benefit from this treatment and, because trastuzumab can cause heart problems, it is important to avoid offering it to people who do not need it. Because of this, the committee agreed that adjuvant trastuzumab should be an option for women with T1a and T1b tumours rather than a standard treatment.

Combined chemotherapy and trastuzumab was not found to be cost effective when compared with chemotherapy alone. However, the committee agreed that it was more appropriate to compare combined chemotherapy and trastuzumab with no treatment because these are the strategies that are likely to be used in clinical practice. Because it is the HER2 positivity that increases risk of recurrence for people with small (T1a and T1b) tumours, it does not make sense from a clinical perspective to not treat the component that is increasing risk (that is, trastuzumab treatment for HER2 positivity). Further, the effect of chemotherapy alone in the economic model may be overestimated because the data may not fully reflect the population under consideration.

How the recommendation might affect practice

Currently, T1 tumours are not routinely treated with adjuvant trastuzumab, so this recommendation will lead to a change in practice. However, the committee agreed that the number of additional people having treatment would be small, so the impact on current practice would be minor and unlikely to require a substantial increase in resources.

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Adjuvant bisphosphonate therapy

Recommendations 1.9.1 to 1.9.3

Why the committee made the recommendations

There was good evidence that treatment with sodium clodronate and zoledronic acid improved disease-free and overall survival in postmenopausal women with node-positive invasive breast cancer.

There was little evidence of benefit for other bisphosphonates. The committee recommended considering zoledronic acid or sodium clodronate treatment for other high-risk populations (such as postmenopausal women with node-negative invasive breast cancer and a high risk of recurrence), based on the evidence that sodium clodronate has overall survival benefits in mixed populations.

Although there is evidence that intravenous (IV) bisphosphonates have a higher risk of osteonecrosis of the jaw, oral bisphosphonates have a higher risk of gastrointestinal problems. There is also a risk of atypical femoral fractures and osteonecrosis of the external auditory canal with bisphosphonates. Because each drug and regimen has different risks, the potential benefits and risks should be discussed with women to help them make an informed choice.

There was little evidence on survival, particularly for premenopausal women on ovarian suppression, those with node-positive or node-negative disease, and those with positive or negative oestrogen or progestogen statuses. There was not enough evidence to make a recommendation relating to the use of adjuvant bisphosphonates in premenopausal women. The committee agreed that further research is needed to determine the long-term survival benefits and the groups of people most likely to benefit from adjuvant bisphosphonates. So, they made a recommendation for research on groups of people who would benefit from the use of adjuvant bisphosphonates.

The committee did not look at the evidence relating to the use of bisphosphonates for bone health or for the use of baseline dual-energy X-ray absorptiometry (DEXA) scanning, so did not make any new recommendations.

How the recommendations might affect practice

Bisphosphonates are not consistently offered as adjuvant treatment, so this recommendation may lead to an increase in prescribing.

GPs may need to monitor people taking oral bisphosphonates, but this is likely to be an annual review so would not have a large workload impact. However, people may make more GP visits if they have side effects from bisphosphonate treatment.

The committee agreed that IV bisphosphonates would usually be administered at the same time as chemotherapy drugs for the first 6 months of treatment, so this would not result in extra hospital visits for this period. After that, extra visits for administration and monitoring may be needed.

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Radiotherapy techniques

Recommendations 1.10.1 and 1.10.2

Why the committee made the recommendations

There was good evidence that radiotherapy to the internal mammary nodes reduced locoregional recurrence and improved survival. However, the committee took into account the potential for lung and heart toxicity, so recommended using a radiotherapy technique that minimises this risk.

There was evidence that deep inspiratory breath-hold radiotherapy techniques reduce the mean radiotherapy heart dose for adults with left-sided invasive breast cancer receiving whole-breast radiotherapy. The committee did not identify any harms. There was also evidence that deep inspiration breath-hold radiotherapy techniques did not reduce the target coverage of whole-breast radiotherapy.

There was no evidence about the use of deep inspiration breath-hold radiotherapy techniques for people with right-sided breast cancer, so the committee did not make separate recommendations for this subgroup.

How the recommendations might affect practice

Using a radiotherapy technique that minimises the dose to the lung and heart is likely to need a change in practice for many centres. There will be some impact on resources in order to implement this recommendation because additional training will be needed, and local protocols will need developing. However, the long-term impact on resources will be minimal: some additional planning time will be needed but there is no impact on the length or number of radiotherapy sessions.

Currently, deep inspiratory breath-hold radiotherapy techniques are not routinely offered to people with invasive breast cancer having whole-breast radiotherapy. However, the committee noted that the Royal College of Radiologists has produced consensus statements that advise using this technique, and that many centres already offer it. The recommendation will ensure consistent practice and ensure that people can access the best care.

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Radiotherapy after breast-conserving surgery

Recommendations 1.10.3 to 1.10.8

Why the committee made the recommendations

There is evidence that whole-breast radiotherapy after breast-conserving surgery reduces the risk of recurrence and increases overall survival. It also decreases rates of depression and anxiety.

However, because the risk of breast cancer recurring at 5 years is very low and there are harms associated with radiotherapy, the benefits of radiotherapy for women with a very low risk of recurrence are less certain. For these women, the committee agreed that healthcare professionals should fully discuss the benefits and risks with women before a decision is made.

Good evidence showed that partial-breast radiotherapy led to similar results to whole-breast radiotherapy after breast-conserving surgery in women with a low risk of local recurrence. In addition, it may have fewer treatment-related adverse effects. There was evidence for multicatheter interstitial brachytherapy, but this was not recommended because it is not currently available in England.

How the recommendations might affect practice

Most women are already offered radiotherapy after breast-conserving surgery so this reflects current practice, but more time may be needed to discuss the balance of benefits and risks with women.

The committee was aware that current practice for external beam partial-breast radiotherapy after breast-conserving surgery is based on the Royal College of Radiologists' 2016 consensus statement, so there would be no change to recommended practice.

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Radiotherapy after mastectomy

Recommendations 1.10.10 to 1.10.12

Why the committee made the recommendations

The committee agreed that adjuvant postmastectomy radiotherapy should be offered to people who have macroscopically node-positive invasive breast cancer or have involved resection margins. This is because the evidence showed a beneficial effect on survival and local recurrence. Although the evidence was limited and the committee acknowledged that radiotherapy is associated with lung and cardiac morbidity, they concluded that for this group of women, the benefits of radiotherapy outweigh the harms.

There was evidence of a beneficial effect of postmastectomy radiotherapy on local recurrence and overall survival for people with node-negative invasive breast cancer. However, the committee agreed that there was a risk of over-treatment if all people with node-negative invasive breast cancer received postmastectomy radiotherapy. Therefore, the committee recommended that adjuvant postmastectomy radiotherapy should be considered for people with node-negative T3 or T4 invasive breast cancer. There was no evidence for this specific subgroup, but they would be considered at increased risk of recurrence and mortality relative to smaller, node-negative invasive breast cancers because of the size of the tumour.

The committee agreed that radiotherapy after mastectomy should not be offered to women with early invasive breast cancer who are at low risk of local recurrence (for example, most women who are lymph node-negative) because the evidence showed limited benefit in survival and local recurrence.

How the recommendations might affect practice

The committee agreed that the recommendations will reinforce current practice, so there would be little change in practice.

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Dose fractionation of external beam radiotherapy

Recommendations 1.10.13 to 1.10.16

Why the committee made the recommendations

The committee noted that most centres use regimens of either 40 Gy in 15 fractions or 26 Gy in 5 fractions. However, there was variation between centres in which external beam hypofractionation regimen they used.

The evidence compared a number of different external beam hypofractionation regimens, but the committee focused on the evidence from 2 randomised controlled trials (RCTs) that compared clinical effectiveness and safety, and a cost-effectiveness analysis, of the 2 hypofractionation regimens that are established in current practice (40 Gy in 15 fractions over 3 weeks and 26 Gy in 5 fractions over 1 week). High-quality to very low-quality evidence showed that the effects of both external beam hypofractionation regimens were comparable, with no clinically important differences between treatment arms for all-cause mortality, breast cancer-related mortality or disease recurrence. Economic evidence showed the 26 Gy in 5 fractions as an effective use of NHS resources compared with 40 Gy in 15 fractions and supported its use in current practice. In addition, the committee noted that in their experience, most people preferred to attend radiotherapy appointments over the course of 1 week rather than over 3 weeks for practical reasons related to fewer trips to the hospital (for example, reduced travelling time and costs, less time off work or from caring responsibilities). The committee recognised how the COVID-19 pandemic had also impacted current practice and had accelerated the change to implement the shorter 26 Gy in 5 fractions regimen.

The evidence showed that there was a higher incidence of outcomes related to clinician-assessed adverse events at 5 years and quality-of-life measurements (related to harder or firmer breasts) for people who were given 26 Gy in 5 fractions compared with 40 Gy in 15 fractions. However, with the exception of a quality-of-life outcome related to swollen breasts, the differences in effect between the 2 regimens were not clinically significant. The committee agreed that in their experience, 26 Gy in 5 fractions is widely accepted by people, despite the small risk of increased adverse events. After taking into account the benefits of a shorter regimen and the impact of the adverse events, the committee recommended the use of 26 Gy in 5 fractions for people having partial-breast, whole-breast or chest-wall radiotherapy, without nodal irradiation, after breast-conserving surgery or mastectomy.

The committee noted that the evidence presented was from populations who were receiving whole-breast radiotherapy. There was no evidence for people who are at lower risk of disease recurrence than those included in the evidence base and who are offered partial-breast radiotherapy because of their reduced risk. However, the committee agreed that, considering the already lower risk for this population, the findings of 26 Gy in 5 fractions in the higher-risk population could be extrapolated to also cover the lower-risk population. The committee also noted that the decision over whether someone has partial-breast or whole-breast radiotherapy can change based on clinical judgement and assessment of the treatment area. As such, the committee agreed that if partial-breast radiotherapy were excluded, the recommendations would not be in line with current practice and may disadvantage a large group of people.

The committee recognised that there may be circumstances when 40 Gy in 15 fractions would be more suitable than 26 Gy in 5 fractions. For example, the committee noted that, in their clinical experience, some groups of people, such as those with a high BMI or fibromyalgia, may experience a greater number of acute adverse events from the 5-fraction regimen (for example, skin reactions, breast oedema or pain). Therefore, some people may prefer the 15-fraction regimen. The committee also noted that the number of people in the studies who had undergone breast reconstruction surgery was small, and it was difficult to determine the most effective hypofractionation regimen for this group. The 15-fraction regimen may also be used for those whose dosimetry is outside that used in the FAST-Forward trial. The committee highlighted the importance of shared decision making for these groups and ensuring that people are aware of the benefits and risks of each treatment option. As such, the committee made a recommendation that 40 Gy in 15 fractions over 3 weeks should be considered for some groups of people, and that its use should be agreed between the person and their care team.

The committee discussed the eligibility criteria for some of the trials in the evidence and noted that people who received nodal radiotherapy were excluded from the main study populations. They highlighted that there are particular concerns around adverse effects such as lymphoedema for people who received regional lymph node irradiation. The committee acknowledged that future trials and the FAST-Forward nodal sub-study results may address some of these concerns, but until further evidence is available the 40 Gy in 15 fractions regimen should continue to be used for this group.

There was limited evidence comparing the 2 hypofractionation regimens in people having breast reconstruction or having regional lymph node irradiation. As such, the committee developed recommendations for research on people having breast reconstruction (including autologous breast reconstruction, but particularly implant-based reconstruction) and people having regional lymph node irradiation. These should provide clinicians with an increased understanding of how effective the 26 Gy in 5 fractions regimen is for these groups in future.

How the recommendations might affect practice

The recommendations may reduce variation in practice, with most people being offered 26 Gy in 5 fractions rather than 40 Gy in 15 fractions. This is already current practice in many centres and will not have a major impact for those centres. In those centres where 26 Gy in 5 fractions is not yet current practice, there will be significant cost savings and capacity will be released for more appointments. For places where 40 Gy in 15 fractions is used more routinely, these recommendations may increase the number of people who are offered 26 Gy over 5 fractions. This will reduce the treatment duration and the costs associated with treatment.

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Radiotherapy to nodal areas

Recommendation 1.10.23

Why the committee made the recommendation

There was good evidence that radiotherapy to the internal mammary nodes reduced locoregional recurrence and improved survival. However, the committee took into account the potential for lung and heart toxicity, and agreed the importance of using a radiotherapy technique that minimises this risk.

How the recommendation might affect practice

This recommendation is likely to need a change in practice for many centres. There will be some impact on resources in order to implement this recommendation because additional training will be needed, and local protocols will need developing. However, the long-term impact on resources will be minimal: some additional planning time will be needed but there is no impact on the length or number of radiotherapy sessions.

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Neoadjuvant chemotherapy

Recommendations 1.11.1 to 1.11.3

Why the committee made the recommendations

There was good evidence to say that having chemotherapy before surgery (neoadjuvant chemotherapy) enables some women to have breast-conserving surgery who would otherwise have had total removal of their breast. The committee agreed that the response to neoadjuvant therapy could help guide the choice of subsequent adjuvant therapy.

How the recommendations might affect practice

The committee agreed that the recommendations would not result in a major change in practice because neoadjuvant chemotherapy is already offered in many centres. These recommendations will help improve consistency in practice.

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Neoadjuvant chemotherapy regimens

Recommendations 1.11.4 and 1.11.5

Why the committee made the recommendations

There was evidence that platinum-containing neoadjuvant chemotherapy regimens can improve pathological complete response rate and breast conservation rate in people with triple-negative invasive breast cancer. However, the committee took into account that platinum-containing regimens can cause anaemia, thrombocytopenia, neutropenia and febrile neutropenia, as well as bone marrow problems and renal problems in older people. The committee agreed that healthcare professionals should have a full discussion with people about the benefits and risks of these regimens.

There was no evidence on people with the BRCA germline mutation, so the committee did not make separate recommendations for this subgroup.

How the recommendations might affect practice

Currently, platinum-containing neoadjuvant chemotherapy is not routinely offered to people with triple-negative early and locally advanced breast cancer, although the committee was aware that some centres may offer it. The recommendations will therefore bring a change in practice and will make practice more consistent across the NHS. The committee estimated that approximately 30% to 40% of people receiving neoadjuvant chemotherapy may be affected by the recommendations.

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Neoadjuvant endocrine therapy

Recommendations 1.11.6 to 1.11.8

Why the committee made the recommendations

For postmenopausal women, there was some evidence that breast conservation rates, changes in tumour size and overall survival are the same with neoadjuvant endocrine therapy and neoadjuvant chemotherapy. Endocrine therapy is safer and has fewer side effects than chemotherapy, but there was not enough evidence to recommend endocrine therapy over chemotherapy for every woman. The committee agreed that healthcare professionals should discuss the potential benefits and risks with women to help them decide which treatment is right for them and that more research is needed to say whether neoadjuvant endocrine therapy is as effective as neoadjuvant chemotherapy.

The evidence for premenopausal women showed that neoadjuvant chemotherapy was more effective than endocrine therapy, but that endocrine therapy may be effective in some women. However, some women may prefer endocrine therapy because it is safer and has fewer side effects. Because of this, the committee agreed that healthcare professionals should discuss the potential benefits and risks with women to help them decide which treatment is right for them. The committee agreed that more research is needed on the long-term safety of neoadjuvant endocrine therapy, and to identify which premenopausal women will benefit from it. So, they made recommendations for research on the safety of neoadjuvant endocrine therapy in premenopausal women and postmenopausal women with early breast cancer.

How the recommendations might affect practice

Neoadjuvant endocrine therapy is already being used, although there may be an increase in the number of people being offered it.

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Radiotherapy after neoadjuvant chemotherapy

Recommendations 1.11.10 to 1.11.13

Why the committee made the recommendations

There was not enough evidence to recommend subgroups of women in whom postmastectomy radiotherapy could be safely omitted after neoadjuvant chemotherapy. Therefore, the committee agreed that the recommendations for postmastectomy radiotherapy among people who have not received neoadjuvant chemotherapy applied to this population.

People with node-negative T4 cancer were not included in this review because they are covered by the recommendation from the previous guideline which has been retained.

Women who respond well to neoadjuvant chemotherapy may derive less benefit from radiotherapy, but the committee agreed that further research was required to determine if the risks of radiotherapy outweighed the benefits in some women. So, they made a recommendation for research on the indications for postmastectomy radiotherapy after neoadjuvant chemotherapy.

How the recommendations might affect practice

The committee noted that decisions about postmastectomy radiotherapy after neoadjuvant chemotherapy are currently based on pretreatment investigations, so there will be no change to practice.

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Lymphoedema

Recommendation 1.12.2

Why the committee made the recommendation

Good evidence showed that there is no increased risk of lymphoedema associated with maintaining exercise levels after axillary intervention, so the committee agreed that people should not restrict or avoid physical activity.

Although the evidence was limited and mixed, the committee concluded that there is no consistent evidence of increased risk of lymphoedema associated with air travel, travel to hot countries, manicures, hot-tub use, sports injuries, or medical procedures on the treated side.

How the recommendation might affect practice

Advice about preventing lymphoedema is already being provided as part of routine care, so there is unlikely to be much change in practice. However, the recommendation will lead to greater consistency in the advice offered. It should also reduce inequality and improve the quality of standard care if people who have had axillary treatment need immunisations or elective procedures.

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Arm and shoulder mobility

Recommendations 1.12.5 to 1.12.12

Why the committee made the recommendations

The committee noted there was very little high-quality evidence for any of the outcomes, and most of the evidence was low to very low quality. The committee agreed that they did not feel confident in making recommendations based on low-quality evidence from mainly single studies. Therefore, they used their clinical knowledge and experience alongside high-quality evidence from 1 UK-based RCT to support their decision making. This evidence showed improved outcomes with a physiotherapy-led structured supervised exercise programme in addition to usual care for reduction of pain, quality-of-life improvement and adherence to arm and shoulder exercises in people with a higher risk of developing shoulder problems. The trial provided all participants with information leaflets about exercises to help with arm and shoulder mobility after breast cancer surgery. This reflects standard practice in the UK, and the committee agreed it was important to reflect this advice in the recommendations. The recommendations also highlight that instructions on upper limb exercises and information should be discussed, explained and clarified with the person before radiotherapy begins, as the exercises should have been well established before starting treatment. The committee recommended that this should also happen before surgery.

The committee were aware that instructions on upper limb exercises are not always given out by someone who is a specialist in physiotherapy (for example, breast care nurses), so they also recommended that breast care units have documented local guidelines in place that include details about who and how to deliver this information effectively. They thought it was important that the information included details on when the exercises should be started. For most people, this will be the day after surgery, but it may be later for others, such as those who have certain surgical procedures (for example, free flap reconstruction or implant reconstruction) where exercising the day after surgery could interfere with their recovery. Exercises should be tailored to each person based on their needs (for example, comorbidities and side effects of cancer treatment), but for the majority of patients, a standard programme of upper limb exercises will be suitable. The committee also agreed it was important that instructions on upper limb exercises should be available in other formats to be accessible to people with different needs (for example, video or large print and various languages). There are already recommendations on communication in the NICE guideline on patient experience in adult NHS services, so a link to this was included as part of the recommendation.

Based on the effectiveness of the intervention in the UK-based trial, the committee agreed that people who met the same criteria as those included in the trial should be identified as being at higher risk of developing shoulder problems. These people should then be offered supervised support to apply the exercises. The baseline shoulder identification of someone as high risk of developing shoulder problems could be done by a member of the clinical team (for example, a clinical nurse specialist) and could be done by looking at a person's medical history and asking the person if they have experienced any of the issues listed in the recommendation (for example, asking if they have stiffness of their shoulder or if the function of their shoulder is reduced). The evidence did not specify that these risk factors were only relevant to the affected side and the committee noted that people should be considered at high risk if they have any of the pre-existing shoulder conditions in the contralateral side. It was also highlighted that for most people radiotherapy to the axilla or supraclavicular nodes is decided before surgery. However, for some people this may be decided after postoperative pathology review. For this reason, they recommended that people who are identified as needing radiotherapy to the axilla or supraclavicular nodes after surgery should also be considered as being at higher risk of developing shoulder problems. This ensures that people would not miss out from supervised support if the need for radiotherapy was not identified before surgery.

The committee also agreed that, in their experience, other people having surgery for breast cancer who did not meet the high-risk criteria in the recommendations could benefit from supervised support. This includes, for example, people with learning or sensory disabilities, which could adversely affect their ability to carry out exercises without supervision and make them more likely to develop shoulder problems as a result. It also includes people having breast cancer surgery who have side effects from additional cancer treatments or who have other commonly performed adjunct surgeries in addition to breast cancer surgery, as well as people who are having radiotherapy without surgery.

Based on their experience, the committee recommended that supervised support should be delivered by a physiotherapy staff member or other appropriately trained allied health professional (for example, an occupational therapist). This should include checking the performance of the exercises and correcting them as needed. The committee agreed that people may not feel confident in translating written exercise instructions into physical movement, so would benefit from having advice on whether they are doing them correctly. This support also allows people who might be experiencing difficulties with both the exercises and with shoulder function to be identified early after radiotherapy or surgery. It will also ensure that people are able to receive the full benefit from the exercises, and may increase adherence if someone is confident they are doing the exercises correctly.

The committee also agreed supervised exercises and physiotherapy support should be available in different formats (for example, virtual or group sessions), and be tailored to individual circumstances and needs (for example, mental health and learning needs) to help with adherence. There was no evidence about interventions delivered virtually, but the committee agreed to recommend this option as it may help to reduce health inequalities and address access options for people where other interventions are not locally available. The committee were aware that some people may not be able to access virtual services for a range of reasons, such as a lack of access to suitable devices, living in areas of poor connectivity and difficulties with using the technology. However, including virtual services in the recommendations should not provide barriers to these people accessing support, as they can be given the option of face-to-face sessions. The committee also highlighted that face-to-face physiotherapy may be more beneficial for people with complex needs or those at higher risk (for example, people from minority ethnic family backgrounds, people with disabilities, neurodiverse people, those who experience physical difficulties with recovery or rehabilitation) because they might need specific instructions and feedback.

The committee were mindful that, while their experience shows that virtual interventions are beneficial, there is a lack of evidence for this and that there was no evidence on whether the format of the intervention (individual, group, virtual, and face to face) impacted adherence or satisfaction. Therefore, the committee took this into account when making recommendations for research to cover this gap in the evidence.

There was limited, low-quality evidence on long-term outcomes and no evidence on outcomes for different population subgroups, such as people from minority ethnic family backgrounds, disabled people and neurodiverse people. The committee also noted that lower-quality evidence comparing interventions was not conclusive. The committee discussed the importance of understanding the most effective and cost-effective way of delivering the intervention (for example, type of physiotherapy or exercise, mode of delivery, number of sessions) and the acceptability of such intervention for different populations, and made a recommendation for research on the most effective and cost-effective way of delivering the intervention to address this gap in the evidence.

The committee also recommended that people should be referred to the physiotherapy department if they report a persistent reduction in arm and shoulder mobility after breast cancer treatment. This allows people to continue to seek support if it is needed. The committee noted that the recommendation for research into adherence to, and satisfaction with, different intervention formats will gather evidence about the long-term effects of strategies to reduce arm and shoulder problems, and this may reduce the number of people who have to be referred to the physiotherapy department in future.

How the recommendations might affect practice

There may be an increase in the number of people having supervised exercise or physiotherapy support after breast cancer surgery or before radiotherapy. However, if this could be delivered virtually (individual or group), it is likely to have a lower impact on NHS resources than in‑person 1‑to‑1 sessions and could free up resources for face-to-face interventions for those for whom virtual services are not appropriate or if there are barriers to them accessing virtual services.

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Lifestyle

Recommendations 1.14.1 and 1.14.2

Why the committee made the recommendations

There was evidence that both dietary changes (reducing fat intake and maintaining a healthy weight) and physical activity increase survival in people with invasive breast cancer.

There was some evidence that cancer recurrence is more likely in people who drink more than 3 or 4 alcoholic drinks per week or 6 g of alcohol per day. This equates to approximately 5 units of alcohol per week.

There was no evidence that smoking cessation reduces recurrence of breast cancer, although the view of the committee was that smoking cessation should always be recommended to people with breast cancer.

How the recommendations might affect practice

The committee discussed that many NHS services would already be advising people with breast cancer about the importance of a healthy lifestyle, and how they can make lifestyle changes to reduce the risk of recurrence. The committee agreed that these recommendations will help to direct conversations towards effective lifestyle changes. There will be no impact on resources because these discussions were already happening, and most of the lifestyle changes will be 'self-care' and implemented by patients themselves.

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  • National Institute for Health and Care Excellence (NICE)