Indications for mastectomy

1. Tumour factors

· multi-centric disease

· multi-focal disease (possible exception –foci in same quadrant)

· extensive DCIS ( guideline >4cm, depends on size of breast)

· inflammatory breast cancer

· local recurrence after previous BCS with XRT

· failure of BCS (margins involved/ re-excision margins involved)

· Failure of primary “downstaging”

2. Patients factors

· patient choice

· Unable to have XRT ( previous Mantle XRT ( e.g. Hodgkins), scleroderma, Lupus, Morphoea, complications of small vessel disease (e.g. rheumatoid or diabetes). In certain circumstances the chest wall or breast shape are likely to increase the risk of underlying lung injury from XRT, check with oncology

· Breast would be significantly distorted by the volume to be removed by BCS (consider primary “down-staging” with chemotherapy or endocrine)

· BRCA abnormality or other significant inherited risk factor

 

Indications for BCS

1. Tumour factors

· Unifocal or uniquadrant disease

· Small tumour volume/breast volume ratio

· Feasible, safe oncoplastic technique of volume replacement or displacement

· Successful “downstaging”

2. Patients factors

· Suitable for adjuvant XRT if appropriate. For non-invasive disease, will need breast XRT for high grade DCIS, but not usually for intermediate and low grade DCIS, depending on Van Nuys score (3,4 or 5 = low risk, 6 or 7 = intermediate risk, give XRT, 8 or 9 = high risk, consider mastectomy not XRT)

· Amenable to mammoplasty approaches (additional scarring)

 

 

Indications for SNB / ANC

· Proven invasive breast cancer with normal axillary nodes on USS, SNB at time of surgical removal of breast cancer.

· SNB prior to the actual breast cancer operation, e.g. mastectomy with immediate breast reconstruction, or if having primary chemo or endocrine therapy.

· ANC is the current recommended management of the axilla when the nodes are known to be positive either on core biopsy at diagnosis or if positive on SNB. The risks of the procedure and the risks of not clearing the positive axilla should be discussed with the patient. NB POSNOC trial recruitment

 

Indications for primary chemotherapy

· Downsizing fro BCS

· Inflammatory Ca breast

· Cancer > 10 cm

· T4 lesion

· Fixed axillary nodes

 

Day case vs in patient procedure

All BCS, ANC or mastectomy are potentially day cases. If patient having combination/ bilateral surgery then consider if day case feasible but might require IP bed. Immediate reconstruction Inserting implants might require overnight stay but could be day case if Braxon (ADM) technique used and patient on a.m. list. Generally mastectomy with reconstruction needs overnight stay

See trust guidelines for eligibility for day case surgery

 

Risk reduction surgery requests

Women sometimes seek what they feel is greater risk reduction surgery when diagnosed with cancer e.g. mastectomy when BCS would seem reasonable or contralateral mastectomy at time of ipsilateral cancer diagnosis. The establishment of the real degree of risk as opposed to the perceived risk needs to be clear. Unless they have a pre-existing known proven BRCA abnormality and/or other evidence of clinical planning of risk reduction surgery prior to diagnosis of cancer, immediate risk reduction is not appropriate.

 

Family History

· 3 generation family history with ages at diagnosis, bilateral breast cancer, (bilateral mastectomy does not mean bilateral disease).

· Relevant cancers - Ovarian, prostate, pancreatic, male breast cancer, sarcoma, melanoma

· Use the IBIS risk calculator with caution, if risk identified on both sides of the family, only the greatest-risk side is relevant,

· Risk assessment – if normal, reassure and discharge

· Near normal risk – lifetime risk < 16%, if> 35 consider baseline mammograms and discharge with lifestyle advice

· Moderate risk - lifetime risk 16-25%, if >35 baseline mammo, then annually 40-50, lifestyle advice

· High risk – lifetime risk >25%, refer genetics, genetic testing if a living affected relative then possibly eligible genetic testing, MRI surveillance (see NICE guidance algorithm)

 

 

Protocol once breast cancer confirmed

· Introduction of BCN, Information leaflets, explain function MDT

· Complete and fax (blue) proforma to GP same day

· Gatekeeper/booking form completed to initiate pre-op process and ensure any implants or ADM is then requested, that anticioagulation or other medication that needs stopping for surgery is highlighted, dialysis patients referred to Arrowe Park. Latex and other significant allergies should be noted on this form. Gatekeeper form given to BCN/ secretary for faxing to admissions

· Date for first treatment will be within 4 weeks but no definite date for surgery till diaries checked (weekly). Enter in appropriate diary if possible, or await MDT for date confirmation. Date only to be confirmed to patient once MDT agrees (weekly)

· Request SNB isotope injection for day of surgery (20MBq nanocoll) if late a.m. or p.m. list, or evening before (40MBq nanocoll) if a.m. list (request on Meditech)

· Request USS or stereo wire or skin mark as agreed by MDT, as well as specimen x-ray (on Meditech)

· Cancer operation patients should be booked into pre-op clinic Wednesdays run by the BCN (non-cancer operations have preop in any other pre-op clinic, not Wednesday)

· Consider if patient needs anaesthetic assessment, eg if has pacemaker, sever COPD, difficult airway, then write to lead anaesthetist for pre-op assessment (Dr Herod)

· Consider any trial information relevant to pre-op patients (e.g. 100K Genome project, LORIS, POSNOC) and offer to patient

 

Pre-op assessment for breast cancer

· For all new diagnoses – fax gatekeeper/booking form to admissions if date known. The pre-op appointment is initiated by the gatekeeper / booking form

· Pre-op clinic is usually run by the BCN (for cancer procedures) but, if not available, the consent process should be started in clinic by breast team as other pre-op nurses (for non-cancer procedures) cannot do consent

· Tests should include bloods (FBC UE LFT bone profile,) Vit D measurement (if postmenopausal) and swabs per trust protocol

· For patients having implant based surgery, implant registry forms to be issued

· Patients undergoing image-guided cancer resection or SNB need to have these procedures requested via Meditech as soon as possible to avoid cancellation of procedure on the day.

· ECG according to Trust protocol

· Echocardiogram if planning left sided mastectomy with reconstruction

· Any medications that need to be stopped prior to operation should be identified and dates patient omits them to be clarified to patient

· Pre-op CHO load for cancer patients having issued with instructions tailored to patients intended operating time

· Refer to anaesthetist (Dr Herod or colleague) if issues arise regarding anaesthetic risk

Staging

· CXR not routinely needed

· CT scan if: advanced breast cancer requiring primary chemotherapy

if inoperable

abnormal bloods

suspicious symptoms

if for chemo for downstaging but with proven positive nodes

· Post-operative staging, - 4+ positive nodes,< 4 nodes with extensive VI, <4 nodes ECS nodes see below under post-operative staging

 

MRI

There is no role for the routine use of MRI in imaging breast tissue. The indications are

• assessing a breast cancer prior to primary chemotherapy to downsize the tumour when the surgical intention is breast conservation. The MRI should be repeated at the end of primary chemotherapy to ensure the planned surgical conservation is feasible (to reduce the need for multiple operations for involved margins). If, on clinical grounds, the breast cancer has failed to reduce sufficiently after primary chemotherapy and conservation was not going to be attempted, then the second MRI will not be necessary.

• assessing a breast lump in a woman with a breast implant in situ (augmentation or reconstruction) that cannot be clearly demonstrated on USS or mammogram

• assessing a woman recently diagnosed with lobular invasive breast cancer that appears on mammogram and USS to be a single focus and amenable to breast conservation. This type of cancer is often multifocal or more extensive within the breast than clinically or mammographically apparent. MRI will more often demonstrate the occult disease that will then help plan surgery for the woman

MRI in these circumstances should be performed with gadolinium contrast and the washout curves assessed for distinguishing profiles between benign and malignant disease.

• assessing a breast implant that has become distorted in a patient who has had breast augmentation whose USS / mammogram does not demonstrate a lesion and where there is no clinical mass to suggest breast cancer. No gadolinium needed in this situation.

 

MRI requests should be discussed with radiology / MDT

 

Antiendocrine therapy for breast cancer

For ER positive patients, if PR positive alone discuss at MD

Given as SET (no surgery planned), PET (downstaging) or adjuvant therapy following surgery

Peri-menopausal (< 50, LMP within 2 years, unless had oophorectomy, or > 50 with LMP within 12 months)

If on hormone based contraception and amenorrhoeic, treat as premenopausal

Lab results of hormone status are unreliable.

1. Pre-menopausal - Tam 20mg daily 5 years minimum for low risk, consider extend to 10 years of still premenopausal at end of 5 years. If postmenopausal after first 5 years, then extend treatment with 5 years AI. If High risk, continue Tam if still premenopausal or switch to Letrozole of post menopausal

2. Postmenopausal - AI x 5 years, - high risk, consider extending to 10 years (if bone health good) or switch to tam if not contraindicated or bone health poor.

or Tam x 5 years then AI x 5 years (low risk)–

or Tam x 10 years, depending on contraindications

In general 10 years is better than 5 years treatment for all but lowest risk group, discussion at diagnosis and again at 5 years as evidence evolves.

Risks of adjuvant anti-endocrine therapy

Tam – endometrial hyperplasia and atypia, endometrial cancer, VTE/DVT and PE. Contraindications are proven previous VTE, endometrial cancer. Side effect profile can be managed depending on symptoms

AI – osteoporosis, premature fractures, musculoskeletal pains and stiffness. Contraindications are proven osteoporosis with fractures despite treatment bisphosphonates

Interactions with their other medications

Tam – anticoagulants, SSRI (citalopram & venlafaxine have low potential for affecting CYP2D6, Duloxetine is a moderate inhibitor of CYP2D6, but avoid fluoxetine, paroxetine as they potently inhibit the enzyme reducing conversion of tamoxifen to its active metabolite) BMJ paper [Ref ] (excess of deaths in tamoxifen users co-prescribed paroxetine). Using venlafaxine is best choice SSRI for tamoxifen related hot flushes. Change to AI if patient can only take paroxetine or fluoxetine for depression.

AI – don’t appear to interact with other medications

 

Bone Health

Bone density assessments (DEXA) should be performed within six months of starting AI, and again about 3 years later during the 5 years course of treatment.

Patients on AI and bispohosphonate for osteoporosis should have DEXA q 24 monthly

Postmenopausal patients diagnosed since July 2016 should be having zoledronic acid anyway and don’t need DEXA scans

Commencement of ZA requires a normal Vit D level and completed treatment from any dental infection, (see draft algorithm from Clatterbridge Cancer Centre)

 

Advice leaflets

A variety of patient advice leaflets are provided in the clinic and stored either at the nurses station or in the beast care nurses office/store cupboard. Relevant advice leaflets should be offered to all patients. Lifestyle advice about diet exercises smoking cessation alcohol consumption and weight control with respect to cancer risk should be offered where relevant.

 

Primary down-staging to achieve BCS

· Requires the woman to be having systemic therapy as part of her treatment (i.e. chemotherapy or anti-endocrine therapy). MDT discussion.

· Intention – to reduce risk of needing mastectomy

· If using chemotherapy, it must be established that she would be likely to benefit from chemotherapy as part of her treatment prior to agreeing this plan.

· If using endocrine therapy it will take 8-12 months to achieve effect

· Down-staging with systemic chemotherapy or endocrine therapy might not achieve the intended aim, and mastectomy will still then be needed, patient should be advised of this at outset.

Protocol

· MDT discussion to agree plan

· Establish axillary node stage (USS +/- core biopsy, or SNB) prior to starting systemic treatment.

· Gel marker placement into lesion under USS guidance at start of primary medical therapy.

· Request Echocardiogram if for primary chemotherapy

· Patient review midway through systemic treatment to assess response so far and to plan likely date for surgery

· Patient review approx. 4 weeks before op date to finalise plan, book further imaging if needed

· If lesion no longer palpable at end of systemic treatment do check mammogram of the ipsilateral breast for surgery planning e.g. for localisation

· Lesion might need image guided localisation for successful BCS

· Staging CT only needed if primary therapy needed for advanced disease or inflammatory cancer, not for down-staging – see staging above.

 

Breast reconstruction

All women undergoing mastectomy should have a discussion about reconstruction. All women undergoing wide excision should have a discussion about the anticipated effect of the operation and, where relevant, a discussion about volume replacement or displacement techniques.

Reasons for not undergoing reconstruction should be documented:

· Patient choice – offer delayed reconstruction as well

· Comorbidity – will need further operations, serious undertaking if ASA3+, should be PS 0 or 1

· Body habitus – poor result from implant based recon if bmi>35, consider contralat reduction to make prosthesis fitting more practical

· Post-primary chemotherapy for inflammatory breast cancer/T4 tumour (higher risk local recurrence and complications, offer delayed reconstruction

Implant based

Implant with ADM, tissue expander or implants combined with autologous techniques – see Breast reconstruction booklet (Macmillan Cancer Care). As an immediate or delayed procedure

Autologous techniques

Pedicled flaps (LD and muscle sparing LD) performed at COCH, free flaps referred to Whiston. Neither usually performed as immediate procedure unless there is no chance that the patient will need postoperative chemotherapy or XRT, e.g. DCIS, small node negative cancers (pre-op SNB), small local recurrences after previous BCS with XRT

Lipofill and nipple reconstruction

Performed at COCH

 

Consultation requires adequate time for discussion of all advantages and disadvantages, review of in-house portfolio of photographs, offer advice booklet from Macmillan, referral to breast care nurse for further discussion as needed. Establishment of patient expectations as far as can be determined is essential to avoid miscommunication. Pre-existing medical problems might prevent any technique being safe.

 

Post-operative management

All patients must be discussed at MDT prior to receiving results in surgery/oncology joint results clinic. (weekly on Wednesday)

MDT

Weekly meeting of all team members to agree results of investigations and plan for therapy

England registered patients referred to Clatterbridge onclogists

Wales registered patients referred to Glan Clwd oncologists

Identify patients suitable for trials

Identify trials open for recruitment

Reason for mastectomy to be recorded

Reason for primary chemotherapy to be recorded

CSOD coding recorded

Check wound, assess any complications

From the MDT –is further surgery required ?

wider margins (2mm for DCIS, 10mm for DCIS to potentially avoid XRT, 1mm form invasive) mastectomy – extensive DCIS, unexpected multifocality (consider reconstruction) completion ANC – consider POSNOC, if low node involvement woman might decline with full information

further surgery might be deferred until after chemotherapy/trastuzamab completed. This should be agreed by MDT and a follow up surgical clinic arranged to ensure further surgery is scheduled at the end of chemotherapy

From the MDT –if no further surgery needed

Predict nhs/prognosis discussion/ offer printout

Medication review form to ask GP to initiate antiendocrine therapy if not for oncology review. Info leaflets about anti endocrine therapy

All postmenopausal women with invasive disease should be offered ZA by oncology, advise patients to ensure dental issues addressed, check Vit D result, BCN to refer to oncology for ZA service

If chemotherapy and / or XRT is required, refer to oncology and arrange Echo for chemo

Staging CT needed if:

4+ nodes affected

Extensive LVI and node positive

Following MDT discussion

Follow-up

Surgical follow-up - 4 months following diagnosis for those having surgery as first treatment then annually on the diagnosis of breast cancer with annual mammogram. For those having primary chemotherapy, they are reviewed 1-2 times during chemotherapy, then after surgery then annually on the diagnosis of breast cancer.