NOTTINGHAM UNIVERSITY NHS TRUST BREAST INSTITUTE GUIDELINE NEOADJUVANT CHEMOTHERAPY (NACT) FOR BREAST CANCER

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1 NOTTINGHAM UNIVERSITY NHS TRUST BREAST INSTITUTE GUIDELINE NEOADJUVANT CHEMOTHERAPY (NACT) FOR BREAST CANCER Definitions: NACT is recommended initial treatment for inflammatory breast cancer and inoperable breast cancers. NACT is an option for large operable primary breast tumours and /or those involving the skin or chest wall and / or those with extensive lymphadenopathies (stage IIIB & IIIC). It can be considered for all women who are known to require chemotherapy as part of their overall treatment (e.g. Her-2 +ve or ER-ve tumours). In locally advanced and large operable cancers, primary systemic therapy is used for achieving operability and increasing the choice of surgery for example to enable breast conservation. NACT has not yet shown improved disease-free survival (DFS) or overall survival (OS) compared with adjuvant chemotherapy. However, it is equivalent to adjuvant chemotherapy in terms of survival. N.B. Historic evidence suggesting increased LRR with NACT in patients downstaged from mastectomy to breast conservation surgery,is based on a cohort of patients that did not receive full treatment regimens. There is no evidence to support increased LRR after NACT in patients who receive appropriate surgery and adjuvant treatments. Work-up: Axilla Ultrasound axilla before chemotherapy with biopsy as appropriate Staging Indicated for those with locally advanced breast cancer patients: >5cm and/or those involving the skin or chest wall and / or those with extensive lymphadenopathies (stage IIIB & IIIC). - Lab tests ( FBC, U&E, LFTs, alkaline phosphatase, bone profile, CA15.3/CEA) - CT scan: chest, abdomen and pelvis: to exclude metastatic breast cancer outside the breast and regional lymph nodes. - Staging not required for women having NACT who do not have locally advanced breast cancer.

2 MRI: Breast MRI is indicated for the following: 1) Evaluating the extent of disease in known cancer patients for surgical planning: - Multifocal and multicentric disease - Pectoralis and chest wall involvement - Contralateral breast cancer 2) Evaluating response to neoadjuvant chemotherapy for the calculation of Nottingham Post Neoadjuvant Response Index (NPRI) 3) Repeat MRI after cycle 6 of NACT ready for booking for surgery date and to finalize surgical options. Clips: A small metal clip is placed into the biopsy site under ultrasound guidance to mark the centre of the tumour before chemotherapy. This aims to localize the initial tumour foot-print after chemotherapy (to guide surgery), especially if the tumour completely regresses after chemotherapy. It also targets selection of tissue for detailed histological examination for assessment of chemotherapy response and the calculation of NPRI. Genetics All triple negative patients <50 years of age should have genetic screening discussed and consideration of blood storage before commencing chemotherapy. Fertility Urgent referral to Mr Hopkisson for all women of childbearing age who have not completed their family before chemotherapy. Mr Hopkisson will counsel women about their fertility options.

3 Chemotherapy: It is recommended to maintain dose intensity of NACT to achieve the maximum probability of pcr. For the same reason in HER-2 +ve breast cancer Trastuzumab should be started in the neoadjuvant setting in association with the Taxane as part of the chemotherapy regime. Standard Chemotherapy: FEC+T x 8 FEC (Flurouracil 600mg/m2, Epirubicin 75 to 100mg m2 and Cyclophosphamide 600mg m2) every three weeks for 4 cycles followed by Docetaxel 75 to 100mg/ m2 every three weeks for 4 cycles (with Herceptin in HER-2 Positive). Non-anthracycline, Taxane-based regime (TCH or TC) is offered in selected patients (e.g. for those patients who are at risk of cardiac complications). Use of GCSF should be considered in high risk patients. HER-2 directed therapy Herceptin is administered 3 weekly for one year (x 17 cycles). Combination with Taxane is safe and has been demonstrated to be more effective than sequential treatment. Dose: Herceptin 600mg subcutaneously every 3 weeks for a total period of one year (MRI heart as baseline to assess satisfactory ejection fraction and 4 monthly assessment until the course of Herceptin is complete).

4 Management of Axilla Patients with nodal metastasis on histology will have axillary node clearance post chemotherapy. Patients with normal axillary node, Pre-NACT chemotherapy will have SLNB after chemotherapy. (N.B. SLNB has reduced sensitivity post-chemotherapy and therefore consider additional sampling retrieving up to 4 nodes in total). Adjuvant Endocrine therapy is per departmental protocol. Adjuvant Radiotherapy: Indication for adjuvant chemotherapy & radiotherapy will be discussed after surgery based on NPRI Neoadjuvant Radiotherapy: Can be discussed at MDT in selected cases planned for breast reconstruction, and in cases where radiotherapy is necessary to facilitate resectability of the whole tumour. Follow-up and long-term implications: AIM; To detect early local or distant recurrence or contralateral breast cancer. To evaluate and treat therapy related complications To provide psychological support and information No randomized data exists to support any particular follow-up protocol. Locally advanced disease (as defined above) It is recommend to have regular visits every 6 months (Clinic code: BRCNS) in the first 2 years, then annually to 5 years at the Specialist Nursing Practioner s clinic (Clinic code: PBC32) before discharge. Mammography every year for 5 years or until reach screening age. Non- Locally advanced disease Normal follow-up as per routine follow up protocol. May 15

5 Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Author: Contact Name and Job Title Directorate & Speciality Neo-Adjuvant Chemotherapy (NACT) for Breast Cancer Dr S Chan Consultant Oncologist CAS Breast Date of submission May 2015 Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) Breast Cancer Patients Requiring Neo-Adjuvant Chemotherapy Version If this version supersedes another clinical guideline please be explicit about which guideline it replaces including version number. Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-6) 1 NICE Guidance, Royal College Guideline, SIGN (please state which source). 2a 2b 3a meta analysis of randomised controlled trials at least one randomised controlled trial at least one well-designed controlled study without randomisation 3b at least one other type of well-designed quasi-experimental study 4 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 5 expert committee reports or opinions and / or clinical experiences of respected authorities 6 recommended best practise based on the clinical experience of the guideline developer Consultation Process Ratified by: Date: Multidisciplinary Team Multidisciplinary Team May 2015 Target audience Review Date: (to be applied by the Integrated Governance Team) May 2020 A review date of 5 years will be applied by the Trust. Directorates can choose to apply a shorter review date, however this must be managed through Directorate Governance processes. This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date.

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