North of Scotland Clinical Management Guideline (CMG): Breast … · 2019-07-23 · abdomen &...
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North of Scotland Clinical Management Guideline (CMG): Breast Cancer General Principles All patients must be discussed at MDT meeting throughout their patient journey as required. All patients referred for investigation of symptoms potentially indicative of breast cancer should receive an appointment to a specialist breast out-patient clinic. The Scottish Breast Screening Programme (SBSP) invites women aged between 50 and 70 years old for screening every three years. Women are recalled for assessment in accordance with SBSP radiology guidelines. Patients should be vetted in accordance with the Scottish Referral Guidelines for Suspected Cancer. Throughout the patient pathway, PREDICT will be used to support clinical decision-making. Where available, clinical trials should always be considered as the preferred option for all eligible patients and consideration given to national referral. Patients must be involved in all decision-making relating to their care with informed consent required for patients undergoing treatment. A list of SACT regimens is provided (page 7). Full regional SACT Protocols will be developed and linked to from this document. Lead Group: NCA Breast Cancer Clinical Management Guideline Review Group File Reference: NCA-CMG-BRE19 Approved: June 28 th , 2019 Published: July 23 rd , 2019 For symptoms of suspected Breast Cancer, please refer to the Scottish Referral Guidelines for Suspected Cancer Page 1 Contents Page 2 – Treatment Overview Page 3 – Adjuvant Treatment and Endocrine Therapy Page 4 – Adjuvant Treatment – HER2 Positive and Triple Negative Page 5 – Adjuvant Bisphosphonates and Neo-adjuvant Therapy Page 6 – Treatment of Metastatic Disease Page 7 – List of agreed SACT Regimens Page 8 – T Staging Page 9 – N M Staging Page 10 - Definitions *High Risk Any of G3 T3 or T4 Node positive HER2 positive Young Age *Low / Intermediate Risk Any of G1 or G2 T1 or T2 Node negative HER2 negative Risk definitions used throughout this CMG
Transcript of North of Scotland Clinical Management Guideline (CMG): Breast … · 2019-07-23 · abdomen &...
North of Scotland Clinical Management Guideline (CMG): Breast Cancer
General Principles All patients must be discussed at MDT meeting throughout their patient journey as required. All patients referred for investigation of symptoms potentially indicative of breast cancer should receive an appointment to a specialist
breast out-patient clinic. The Scottish Breast Screening Programme (SBSP) invites women aged between 50 and 70 years old for screening every three years.
Women are recalled for assessment in accordance with SBSP radiology guidelines. Patients should be vetted in accordance with the Scottish Referral Guidelines for Suspected Cancer. Throughout the patient pathway, PREDICT will be used to support clinical decision-making. Where available, clinical trials should always be considered as the preferred option for all eligible patients and consideration given to
national referral. Patients must be involved in all decision-making relating to their care with informed consent required for patients undergoing treatment. A list of SACT regimens is provided (page 7). Full regional SACT Protocols will be developed and linked to from this document.
Lead Group: NCA Breast Cancer Clinical Management Guideline Review Group File Reference: NCA-CMG-BRE19Approved: June 28th, 2019 Published: July 23rd, 2019
For symptoms of suspected Breast Cancer, please refer to the Scottish Referral Guidelines for Suspected Cancer
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ContentsPage 2 – Treatment OverviewPage 3 – Adjuvant Treatment and Endocrine TherapyPage 4 – Adjuvant Treatment – HER2 Positive and Triple NegativePage 5 – Adjuvant Bisphosphonates and Neo-adjuvant TherapyPage 6 – Treatment of Metastatic DiseasePage 7 – List of agreed SACT RegimensPage 8 – T StagingPage 9 – N M StagingPage 10 - Definitions
*High RiskAny of G3 T3 or T4 Node positive HER2 positive Young Age
*Low / Intermediate RiskAny of G1 or G2 T1 or T2 Node negative HER2 negative
Risk definitions used throughout this CMG
North of Scotland Clinical Management Guideline (CMG): Breast Cancer Approved 28/06/19
Diagnosis, Staging, Evaluation Treatment and Pathological Parameters
Primary Diagnosis(One-stop clinic)
History and physical
examinationMammography
USS+/- MRI
Core Biopsy
TNM Staging
All patients
MDTmeeting
Operable by Conservation
Surgery or Mastectomy
If appropriate: CT chest,
abdomen & pelvis
+/- Bone scan
No
Neo-adjuvant therapy (see page 5)
Metastatic disease (see page 6)Staging positive
Staging negative
Yes Candidate for Neo-adjuvant therapy
Neo-adjuvant therapy (see page 5)
Yes
Surgery
No
<4 lymph nodes
positive
4 lymph nodes positive, positive
SNB or clinical suspicion of
metastatic disease
CT chest, abdomen & pelvis
+/- Bone scan
Stag
ing
po
siti
ve
ER NegativePR NegativeHER2 Negative(see page 4)
HER2 Positive(see page 4)
ER PositiveHER2 Negative(see page 3)
Consider Radiotherapy
Stag
ing
cle
ar
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Consider referral for genetic testing
North of Scotland Clinical Management Guideline (CMG): Breast Cancer Approved 28/06/19
Pathological Parameters Adjuvant Treatment ER +ve HER2 -ve
ER PositiveHER2 Negative
If appropriate:Genomic testing
Node negative
Consider SACT+/- Adjuvant bisphosphonates if
postmenopausal(see page 5)
Endocrine therapySee below
High risk
Low risk
Consider SACT+/- Adjuvant bisphosphonates if
postmenopausal(see page 5)
Node positive
Post-menopausal + Pre-menopausal
Endocrine Therapy (ER + and or PR+)
Pre-menopausal at diagnosis
Post-menopausal at diagnosis
Low / Intermediate risk*
High risk*or
Contraindication to tamoxifenor
Intolerant of tamoxifen
Aromatase inhibitor for 5 yearsor
Consider Tamoxifen for 5/10 years
Contraindication to aromatase inhibitor
orIntolerant of aromatase inhibitor
Conside Tamoxifen for 5/10 years then aromatase inhibitor for 5 years (if post-menopausal after 5 years)
orTamoxifen for 10 years
Consider ovarian suppression for 5-10 years + aromatase inhibitor (AI) or tamoxifen
Consider AI for an additional 2-5 yearsor
No further endocrine treatment
Consider Tamoxifen for 5/10 years
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North of Scotland Clinical Management Guideline (CMG): Breast Cancer Approved 28/06/19
Pathological Parameters Adjuvant Treatment Triple Negative
ER NegativePR Negative
HER2 Negative
Node Negative
Node positive
Has had NACT and poor
pathological response
Consider SACT (based on PREDICT and other risk factors)
SACT+/- adjuvant bisphosphonate if post-
menopausal (see page 5)
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Consider SACT+/- adjuvant bisphosphonate if post-
menopausal (see page 5)
Pathological Parameters Adjuvant Treatment HER2 +ve
HER2 PositiveNode positive
orTumour > 1cm
Tumour 0.5 - 1cm
No
Chemotherapy plus HER2 targeted therapy
+/- adjuvant bisphosphonate if post-
menopausal
Yes
Consider SACT if adverse features +/-adjuvant bisphosphonates if post-menopausal
Yes
No
Endocrine therapy(see page 3)
ER positive
ER negative No endocrine therapy
ER positive
ER negative No endocrine therapy
ER negative
ER positive
No endocrine therapy
Consider endocrine therapy
(see page 3)
North of Scotland Clinical Management Guideline (CMG): Breast Cancer Approved 28/06/19
Adjuvant Bisphosphonates
Post-menopausal women* (by stated
parameters or PREDICT score) of disease
recurrence
No adjuvant bisphosphonateNo
Bisphosphonate offered as per protocol
Yes
Neo-adjuvant Therapy
*Irrespective of whether they have had chemotherapy, women who are postmenopausal, men at higher risk and pre-menopausal women who warrant ovarian suppression: i.e. ER
Low/ negative, or ER4-8 with one or more of the following features – HER2 positive or Grade 3 or T3 or 4 or node positive.
Patients with low risk disease should not routinely be offered adjuvant bisphosphonates unless specific additional factors merit discussion on an individual patient basis .
Bisphosphonate treatment can be started concurrently with chemotherapy or on completion of chemotherapy.
High Risk* For the
purposes of downstaging
HER2 NegativeER Positive
Triple Negative
HER2 PositiveAny ER
Considerchemotherapy or
endocrine therapy +/-adjuvant
bisphosphonates ifpost-menopausal
Considerchemotherapy +/-
adjuvantbisphosphonates ifpost-menopausal
Considerchemotherapy +/-
HER2 targetedtherapy +/- adjuvantbisphosphonates ifpost-menopausal
Surgery +/- Radiotherapy
Post-menopausal + Pre-menopausal
ER/PR positive ER/PR negative
Endocrine therapy (see page 3)
Consider adjuvant
capecitabine
If HER2 positive , complete targeted therapy
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North of Scotland Clinical Management Guideline (CMG): Breast Cancer Approved 28/06/19
Treatment of Metastatic disease
Metastatic Diagnosis
Bone Metastases
Bisphosphonate or denosumab with
other treatment(see page 5)
ER Positive
ER Negative
Hormone treatment candidate?
First LineAromatase inhibitor +/- goserelin+/- CDK 4/6 inhibitor (if HER2-ve)
Yes
Second LineAlternative AI +/- everolimus or
tamoxifen or fulvestrant +/- CDK 4/6 inhibitor
Third LineAlternative AI +/- everolimus or
tamoxifen or fulvestrant
Suitable for SACT
No
Progression
Progression
Progression
Supportive carePalliative RT if
indicated
No
HER2 positive
HER2 negativeYes
Previous taxane +
trastuzumab?
No or >6 month since adjuvant trastuzumab
Yes and <6 months since adjuvant trastuzumab
Taxane + trastuzumab + HER2 targeted
therapy
Trastuzumab emtansine
Progression
Consider other options
Previous anthracycline?
Previous taxane?
Consideranthracycline
Yes
No
Yes and <12 months ago
No or >12 months ago
TaxaneProgression
Consider other optionsProgression
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Progression
North of Scotland Clinical Management Guideline (CMG): Breast Cancer – SACT Approved 28/06/19
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RSP = Regional SACT Protocols.These SACT regimens may change during the subsequent development of RSPs.
Embedded links will be provided once these protocols have been developed and published.
North of Scotland Clinical Management Guideline (CMG): Breast Cancer - T Staging Approved 28/06/19
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North of Scotland Clinical Management Guideline (CMG): Breast Cancer – N M Staging Approved 28/06/19
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North of Scotland Clinical Management Guideline (CMG): Breast Cancer – Definitions Approved 28/06/19
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DefinitionsUSS Ultrasound ScanMRI Magnetic Resonance ImagingMDT Multi-disciplinary Team TNM Tumour, Node, Metastasis (Staging)SNB Sentinel Node BiopsyER Oestrogen Receptor PR Progesterone ReceptorHER2 Human Epidermal Growth Factor Receptor 2CT Computerised TomographySACT Systemic Anti-Cancer TherapyRT Radiotherapy
