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The HSE’s National Cancer Control Programme (NCCP) is developing national evidence-based clinical guidelines for the diagnosis, staging and treatment of common cancers, through its Guideline Development Groups. The guidelines are being developed to improve the standard and consistency of clinical practice in line with the best and most recent scientific evidence available.
In conjunction with the National Clinical Effectiveness Committee (NCEC), the NCCP has created a National Guideline on Breast Cancer. This guideline focuses on the diagnosis, staging and treatment of patients with breast cancer and focuses on areas of clinical practice known to be controversial or uncertain; where there is identifiable variation in practice; where there is new or emerging evidence; and where guidelines have potential to have the most impact.
Patients that are covered by this guideline are adults (18 years or older) with newly diagnosed early and locally advanced breast cancer. The scope of this guideline does not include patients with metastatic disease or breast cancer recurrence.
This guideline is intended for all health professionals involved in the diagnosis, staging and treatment of patients with breast cancer. The NCCP has also developed GP referral guidelines, standardised GP referral forms, and GP electronic referral for patients with breast cancer.
A multidisciplinary clinical team is responsible for the implementation of the guideline recommendations and a lead clinician for breast cancer has been nominated in each breast unit in the designated cancer centres.
Recommendations have been divided into the key clinical areas of radiology, surgery, medical oncology, radiation oncology and palliative care.
For all patients being investigated for invasive breast cancer, pre-treatment ultrasound evaluation of the axilla should be performed and, if morphologically abnormal lymph nodes are identified, ultrasound-guided needle sampling should be offered.
Ultrasound-guided lymph node sampling (fine needle aspiration/core needle biopsy) is recommended in patients with breast cancer where ultrasound demonstrates lymph nodes of cortical thickness of ≥3mm or if the node demonstrates abnormal morphological features.
In patients with a clinically suspicious examination and normal imaging (mammography and ultrasound), clinically guided core biopsy should be performed.
The routine use of MRI of the breast is not recommended in the preoperative assessment of patients with biopsy-proven invasive breast cancer or ductal carcinoma in situ.
Offer MRI of the breast to patients with invasive breast cancer, if there is discrepancy regarding the extent of disease from clinical examination, mammography and ultrasound assessment for planning treatment, or if breast density precludes accurate size assessment.
In patients with invasive lobular cancer, MRI can be considered to assess tumour size, if breast conserving surgery is a treatment option.
Breast MRI is indicated in the clinical setting of occult primary breast cancer (typically, axillary lymphadenopathy) and following negative clinical breast examination and negative conventional imaging.
In the setting of negative conventional imaging, MRI can facilitate treatment planning for patients with Paget’s disease.
In newly diagnosed patients with breast cancer who have symptoms suggestive of metastases, appropriate imaging investigations should be performed, regardless of tumour stage.
In newly diagnosed asymptomatic patients with breast cancer, evidence does not support the use of routine imaging for metastatic disease in pathological stage I and II disease.
In newly diagnosed asymptomatic patients with breast cancer, use of staging imaging for metastatic disease is recommended for stage III and IV disease.
In patients with newly diagnosed breast cancer who require staging, contrast enhanced CT chest, abdomen and pelvis and whole body isotope bone scan are recommended. PET-CT is not routinely recommended. However, it may be considered in specific cases.
Women with ductal carcinoma in situ who are undergoing breast surgery should be offered the choice of breast conserving surgery and radiotherapy or mastectomy.
Women with ductal carcinoma in situ may be offered breast conserving surgery and radiotherapy except where there are indications for mastectomy and sentinel lymph node biopsy.
Women with invasive breast cancer who are undergoing breast surgery should be offered the choice of breast conserving surgery and radiotherapy or mastectomy.
In the general population, there is no evidence that a contralateral risk-reducing mastectomy improves a patient’s prognosis. However, a contralateral risk-reducing mastectomy may be undertaken to address specific patient concerns if it is discussed at a multidisciplinary team meeting and the benefits, risks and alternatives have been discussed with the patient.
There are subsets of patients who may benefit from a contralateral risk-reducing mastectomy, such as genetic mutation carriers.
A discussion regarding breast reconstruction should be undertaken with all patients undergoing mastectomy for breast cancer.
Patients with operable (invasive) breast cancer with no clinical or radiological evidence of axillary lymph nodes metastases at initial diagnosis should be considered for sentinel node biopsy.
Patients with isolated tumour cells and micrometastases do not require an axillary clearance.
In patients undergoing breast conserving surgery and radiotherapy who are clinically and radiological node negative at presentation and have one or two macrometastatic sentinel lymph nodes in a sentinel lymph node biopsy, the avoidance of axillary lymph node dissection may be considered following a discussion at a multidisciplinary team meeting and with the patient.
For all patients treated with breast conserving surgery and radiotherapy for ductal carcinoma in situ, a minimum of 2mm radial margin of excision is recommended.
For patients receiving breast-conserving surgery and post-operative radiotherapy for invasive breast cancer, the excision should have a clear margin; the tumour should not be touching ink.
Adjuvant chemotherapy should be considered for all patients with breast cancer whose disease is at moderate-/high-risk of recurrence.
Adjuvant trastuzumab should be considered in all patients with HER2-positive breast cancer who receive adjuvant chemotherapy.
The standard duration of treatment with adjuvant trastuzumab is one year.
Adjuvant trastuzumab should preferably be given concurrently with taxane-based regimens. It should not be given concurrently with anthracyclines.
Premenopausal women with hormone receptor-positive breast cancer should be treated with tamoxifen. The standard duration of treatment with tamoxifen for premenopausal women with hormone receptor-positive breast cancer is at least five years, but there is evidence to support up to 10 years of use.
Currently, the routine use of adjuvant ovarian ablation/suppression is not considered standard practice.
Postmenopausal women with hormone receptor-positive breast cancer should be treated with hormonal therapy for at least five years. The options include:
Tamoxifen for five years followed by five years of an aromatase inhibitor.
An aromatase inhibitor as initial adjuvant therapy for five years.
Tamoxifen for two to three years followed by an aromatase inhibitor to complete five years of adjuvant endocrine therapy or tamoxifen for two to three years followed by five years of adjuvant endocrine therapy.
In postmenopausal women, the use of tamoxifen alone for five years can be considered for those who decline, have a contraindication to, or are intolerant of aromatase inhibitors.
Any patient who is a candidate for adjuvant systemic therapy can be considered for neoadjuvant systemic therapy.
Neoadjuvant chemotherapy can be considered as part of a multimodal treatment approach for patients with stage IIa, IIb, and III breast cancer.
For patients with locally advanced or inflammatory breast cancer preoperative chemotherapy is the preferred option.
Patients with HER2-positive breast cancer, receiving neoadjuvant chemotherapy, should receive trastuzumab.
Neoadjuvant endocrine therapy is an option for patients with oestrogen receptor-positive breast cancer considered unsuitable for neoadjuvant chemotherapy or primary surgery.
Post-mastectomy radiotherapy should be recommended in patients with lymph node-positive breast cancer if they have high risk of recurrence (≥4 positive lymph nodes and/or T3/T4 primary tumour).
Post-mastectomy radiotherapy should be considered in patients with intermediate risk of recurrence (one to three nodes) and individual patients should be discussed at multidisciplinary team meeting.
All patients with ductal carcinoma in situ having breast conserving surgery should be considered for adjuvant radiotherapy.
Radiotherapy is recommended for all patients undergoing breast conserving surgery for early breast cancer.
Hypofractionation schedules are recommended for patients with early breast cancer.
In patients who have undergone breast conserving surgery for early breast cancer, adjuvant radiotherapy shows a benefit in all subpopulations.
In patients who have breast conserving surgery, radiotherapy boost is recommended for patients aged 50 or under at diagnosis.
Radiotherapy boost should be considered in patients >50 who have risk factors (eg, high-grade invasive cancers).
Women who have undergone surgery for breast cancer should receive local breast irradiation as soon as possible following wound healing. A safe interval between surgery and the start of radiotherapy is unknown, but it is reasonable to start breast irradiation within 12 weeks of definitive surgery.
Recommend adjuvant radiation to the supraclavicular fossa in patients with four or more positive axillary nodes.
Consider adjuvant radiation to the supraclavicular fossa in selected patients with one to three positive axillary nodes.
Consider irradiation to the internal mammary chain in patients with positive axillary nodes and/or inner quadrant tumours.
Consider adjuvant radiation to the axilla in patients with positive axillary nodes who have not had an axillary dissection.
For patients with cancer, early provision of palliative care can improve patient outcomes. Assessment of palliative care needs should be an ongoing process throughout the course of a patient’s cancer illness and services provided on the basis of identified need.
The full guideline (Diagnosis, staging and treatment of patients with breast cancer: National Clinical Guideline No. 7) can be accessed here: http://www.hse.ie/eng/services/list/5/cancer/profinfo/guidelines/breast/
Breast cancer trends in Ireland
Breast cancer is the most common malignant tumour diagnosed in Irish women, with 2,883 cases diagnosed each year on average during 2011-2013, according to the latest data from the National Cancer Registry Ireland (NCRI). This represents almost one-third of all major malignancies diagnosed in women. The incidence rate increased significantly between 1994 and 2013, by circa 1.5 per cent annually. The trend has been influenced somewhat by the introduction of screening (BreastCheck programme) from 2000 onwards, notes the NCRI.
Although survival from breast cancer is high (currently 82 per cent five-year survival), it is the second most common cause of cancer death in women (after lung cancer). On average, 690 deaths per year were attributed to breast cancer during 2011-2012, accounting for 17 per cent of all cancer deaths in Irish women. Nevertheless, the mortality rate has declined significantly by about 2 per cent per year since 1994.