National Cancer Grid Breast Cancer Management Guidelines – Sept 2019
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National Cancer Grid Breast Cancer management guidelines – Sept 2019 Disclaimer: These are general guidelines and must be considered with value judgements for individual patients. Essential: mandatory Preferred /Desirable / Optimal: cost effective with evidence of efficacy Optional: can be considered, minimal evidence, cost is an issue Page 1 of 18 National Cancer Grid Breast Cancer management guidelines – Sept 2019 Formatted: Indent: Left: 0 cm, First line: 0 cm Evaluation of a breast Lump All women with a breast lump should undergo a TRIPLE TEST which comprising of 1. Clinical Examination by an experienced clinician preferably a breast surgeon 2. Bilateral imaging: a bilateral mammogram and/or Ultrasound/ MRI as appropriate## 3. Histopathology** (Core biopsy preferred or FNAC) # Incisional biopsy may be considered in exceptional cases Type of lesion Suspicious looking solid mass (includes Benign looking Cyst* Benign looking (confirmed on Breast complex cystic and solid mass) solid mass Ultrasound) Biopsy Biopsy for Histopathology confirmation *** hemorrhagic contents / rapid filling or refilling/ residual solid component Aspirate Malignant Benign Biopsy *** (image-guided if needed) Watery, Observe/ Excise yellow, green Benign Malignant Follow relevant algorithm Discharge patient (follow up if clinical concern) *Solitary and multiple simple cysts can be observed and do not need to be aspirated. ***Core Biopsy is preferred in cases where neo-adjuvant therapy is planned (for grading and receptor status) and for guided non palpable-lesions and if MRM considered. FNAC is acceptable if patient cannot afford Core Biopsy. IHC evaluation is mandatory prior to neo adjuvant therapy. Histo/cyto pathology confirmation is a MUST before initiating cancer directed treatment (surgery/ chemotherapy/ other systemic treatment). Exception: in case where frozen section is required for primary diagnosis Page 2 of 18 National Cancer Grid Breast Cancer management guidelines – Sept 2019 Primary diagnostic procedure should not be Excision Biospy prior to failure of routine procedures. *** Histo/cyto pathology confirmation is a MUST before initiating cancer directed treatment (surgery/ chemotherapy/ other systemic treatment #: In cases of discordance in triple test, further evaluation must be considered. ## MRI breast may be considered in cases with extremely dense breast with clinical or imaging based suspicion of multiple tumors, high risk women with dense breast. Page 3 of 18 National Cancer Grid Breast Cancer management guidelines – Sept 2019 Management Schema for Operable breast cancer (Tis,T1-2, N0-1, M0) Clinical diagnosis of operable breast cancer Histopathological confirmation; breast and axilla imaging as appropriate ( if for NACT : core biopsy) Staging investigations not indicated in cT1-2, N0-1, M0, unless specific symptoms suspicious of metastases Wants BCS but not eligible presently (large Wishes for and is eligible for BCS T size or inadequate breast vs tumor ratio) Not eligible*** or doesn’t want BCS NACT not indicated Tis Neoadjuvant chemotherapy # (Re-asses with clinical evaluation after every cycle confirming maximal response) 1,2 Eligible Not eligible Breast conserving surgery/ BCS mastectomy +/- Whole +/- Oncoplasty breast reconstruction **** Adjuvant chemotherapy , radiotherapy, hormone therapy or targeted therapy as indicated Approach to axilla Clinically node negative axilla Clinically node positive axilla (no palpable nodes/ no enlarged nodes on MMG/US) Upfront surgery Post NACT Sentinel lymph node biopsy@/low Clinically N0 axillary sampling, send for frozen&& section&& Node negative Node Positive Complete Axillary Dissection. (Sentinel lymph node biopsy/low axillary sampling Complete axillary T1/T2 – stop at sampling Complete axillary 3,4 7 directed management of axilla clearance or SLN clearance ( Level I to III) 8 may be done if criteria met) * Number of cycles should be based on tumor response/ institutional practice Final paraffin section 5,6 node positive Page 4 of 18 National Cancer Grid Breast Cancer management guidelines – Sept 2019 # Tailoring treatment based on IHC , to be able to consider post NACT adjuvant therapy to non responders can be discussed with patients ***: Contraindications to BCS include: diffuse microcalcification, EIC+ with margin positive, poor patient compliance, previous chest or breast radiation, relative contraindication is multicentricity. Contra-indications to radiotherapy e.g. collagen vascular diseases. 3: SNB can be performed either using dual dye- radiocolloid and blue dye (preferred method) OR using blue dye alone. 1 to 2 ml peri-tumoral and/or sub-areolar injection / sub-dermal injection of patent blue dye or 2% methylene blue 10 minutes prior to the surgical incision and 40 MBq in 0.5ml of 99m-technetium–labeled sulphur/ antimony colloid peri-tumoral and/or sub-areolar injection / sub-dermal injection 2 to 12 hours prior to surgery. 5: If the Patient and Tumor characteristics meet the ACOZOG Z-11 ( T1 , micro metastasis in node , Low grade tumor, ER /PR positive, BCS done, whole breast RT using tangential fields planned) and 1-2 SLN positive, no further axillary surgery may be considered. ****Breast reconstruction may be be performed by surgeons in motivated and suitable patients following mastectomy . Implant or autologous flap reconstruction can be performed based on patients suitability and choice of surgeon . 7.If cN0 prior to NACT or an OBC with cN1 post chemotherapy cN): can be considered for SLN/ Low axillary sampling &&: if FS not available: LAS and final HPR or ALND (level II if no gross enlarged nodes) Margins in BCS : negative margin defined as no tumor on inked surface. In case of positive margins, should be revised . In case of persistent positive margins, MRM to be considered In patients with family history of cancer, younger than 40 years, male breast cancer or patients with synchronous and metachronous breast cancer, can be referred for genetic counselling and those who are willing may be considered for testing to rule-out presence of germline pathogenic variant. Screen detected Low grade DCIS undergoing lumpectomy may not require axillary assessment. Page 5 of 18 National Cancer Grid Breast Cancer management guidelines – Sept 2019 Management Schema for locally Advanced breast cancer (T3-4, any N, N2-3 any T) Clinical diagnosis of advanced breast cancer Histopathological confirmation with core biopsy and breast imaging as appropriate (Clip placement , skin marking to localize the primary tumor prior to NACT) Metastatic work up (XrayChest, USG abdomen and pelvis, , LFT , Bone Scan, CECT CHEST /ABDO, PETCT ) No Metastatic disease Metastatic disease Modified radical mastectomy with primary Follow algorithm for metastatic breast closure cancer Feasible Not Feasible or patient keen on BCS Modified radical mastectomy Neoadjuvant therapy Neoadjuvant chemotherapy 1,2 (Re(Re-asses afterwith clinical2- 4 cycles evaluation for feasibility after everyfor BCS) cycle confirming maximal response) * No response MRM or second line chemotherapy based on operability Modified Radical Mastectomy or BCS as feasible9 Completion of Adjuvant systemic therapy, radiotherapy, hormone therapy or targeted therapy P Page 6 of 18 National Cancer Grid Breast Cancer management guidelines – Sept 2019 Systemic therapy* T1/T2 N0 ER/PR +/HER neg TNBC Her2 positive Only endocrine therapy if 6 # AC/EC or 4# AC/EC- 4 # Taxanes + Trastuzumab q 3 wk – maint • pT< 2cm and 4# AC/EC- 4 # Taxanes q 3 Trastuzumab (total 1 yr) • ER/PR strong positive wk or and 4# AC/EC- 12 # Taxanes + • Grade 1/ 2 and DD 4# AC-4# Taxanes q 2 Trastuzumab q wk – maint • Postmenopausal wk or Trastuzumab (total 1 yr) woman 4# AC/EC- 12 # Taxanes q 12 # Taxanes + Trastuzumab q wk – wk or maint Trastuzumab (total 1 yr) 4-6 # AC/EC 6# TC or 6# TCH f/b maint Trastuzumab or 6# CMF /CAF/CEF 4-6# TC • Choice of chemotherapy to be given depends upon patient’s and tumour characteristics . • Rare pathological subtypes : treatment to be individualised. Page 7 of 18 National Cancer Grid Breast Cancer management guidelines – Sept 2019 Systemic therapy (Adjuvant/ Neoadjuvant) T3N0/T4 N0/ any node positive ER/PR +/HER neg TNBC1 Her2 positive 4# AC/EC- 4 # Taxanes + 6 # AC/EC or Trastuzumab q 3 wk – maint 4# AC/EC- 4 # Taxanes q 3 wk or Trastuzumab (total 1 yr). or DD 4# AC-4# Taxanes q 2 wk or 4# AC/EC- 12 # Taxanes + Trastuzumab q wk – maint 4# AC/EC- 12 # Taxanes q wk or Trastuzumab (total 1 yr). or 6# TC. or 6# TCH f/b maint Trastuzumab 6# CMF /CAF/CEF. or 1.Mainatance Capecitabine in TNBC that don’t achieve pCR after complete NACT AC – adriamycin/cyclophosphamide, EC- epirubicin/ cyclophosphamide, TC – docetaxel/ cyclophosphamide, CMF – cyclophosphamide, methotrexate,5-fluorouracil, P- Paclitaxel, TCH – docetaxel,Carboplatin,trastuzumab Choice of chemotherapy depends on patient and tumor characteristics Page 8 of 18 National Cancer Grid Breast Cancer management guidelines – Sept 2019 Hormone Therapy for all ER &/or PR positive Ø Adjuvant hormonal therapy for all ER/PR(+) patients (start 2 weeks after last cycle of chemotherapy) for minimum 5 years Ø Tamoxifen for 5years in premenopausal patients is standard adjuvant hormonal therapy For premenopausal women with high risk disease Tamoxifen with ovarian suppression may be considered Switch therapy: 2-5 years Tamoxifen AI for 5 years may be considered after confirming post menopausal status before starting AI. Tamoxifen for 10 years to be considered in high risk patients/node positive patients.