Diagnosis and Treatment of Early Breast Cancer Frances Wright MD MEd FRCSC.
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Transcript of Diagnosis and Treatment of Early Breast Cancer Frances Wright MD MEd FRCSC.
![Page 1: Diagnosis and Treatment of Early Breast Cancer Frances Wright MD MEd FRCSC.](https://reader036.fdocuments.us/reader036/viewer/2022081519/56649c745503460f949269d0/html5/thumbnails/1.jpg)
Diagnosis and Treatment of Early Breast Cancer
Frances Wright MD MEd FRCSC
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Objectives
• imaging & diagnosis• historical overview of surgical treatment• current practice
– breast surgery– axillary staging
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Radiologic Work-up
• Common– Mammogram– Ultrasound
• Good for young women• Usually targeted
• Uncommon– Galactogram– MRI
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Mammogram
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Some cancers are not found until they reach this size
A mammogram can find cancer when it is only this size
www.obsp.on.ca
Benefits of Mammogram
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Survival and Stage of Breast Cancer
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Mammogram X-ray of the Breast
• No screening tool 100% effective
• 85-90% of all breast cancers in women > 50 can be identified on mammogram
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Mammograms and Cancer
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Ultrasound of Breast Cancer
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Magnetic Resonance Imaging
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MRI
• Advantage– Not affected by breast density– Can identify occult disease
• Disadvantage– Dependent on who does the imaging– Sensitive, not very specific– Need MRI biopsy capability
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Breast MRI – Screening…
• Who should get ?– Screening - evidence
• BRCA mutation carriers• Untested 1st degree relatives of carriers• Family history of hereditary cancer syndrome;
risk > 25%– Screening – no good evidence
• Prior chest radiation before age 30 (Hodgkins)• Some women with LCIS/atypia
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MRI for Surgeons
• Treatment Planning – 3% of contralateral breast cancers are occult to
physical exam/ mammo (Lehman 2007)– Occult primary with axillary mets– Paget’s disease of the nipple– Invasive lobular carcinoma – Extent of disease work up– Evaluation of residual disease
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Breast Imaging Reporting & Data Systems = BIRADSInterpretation Risk Ca
0 Incomplete assessment
1 Negative 0.05%
2 Benign 0.05%
3 Probably benign 2%
4 Suspicious 15 - 50%
5 Highly suspicious 95 - 99%
6 Known cancer 100%
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Imaging
• BIRADs classification
1
2
3 5
4
Needs biopsyNo action
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The work-up: Pathology
• Core needle biopsy– Gives more information – – type of cells – invasive vs. non-invasive
• Fine needle biopsy – not done as much now– Malignant vs. not malignant– Rule out cyst
• Excisional biopsy - uncommon now
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Ductal carcinoma in situ
Invasive ductal carcinoma
Pathology: Ductal Carcinoma in situ and Invasive ductal Carcinoma
No lymph node involvement
Potential lymph node involvement
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• There must be clinical, radiologic and pathologic agreement (concordance) in diagnosis
• If one doesn’t fit – consider surgical excisional biopsy
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The evolution of breast surgery
• Halsted 1852 - 1922 • tumour begins small• systematic progression
to surrounding tissues
• involvement of lymphatics leads to distant spread
• local control = cure
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The evolution of breast surgery
• Halstedian principles• radical mastectomy
– Breast, pectoralis major and minor and axillary tissue
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The evolution of breast surgery
• Bernard Fisher • breast cancer systemic
at onset• surgery impact is local• lumpectomy + RT =
mastectomy
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The evolution of breast surgery
• “Fisherian” theory• breast conservation
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The evolution of breast surgery
Halstedian principles
radical mastectomy
versus
“Fisherian” theory
breast conservation
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Breast conservation
• Removal of tumour with a margin of normal tissue
• Suitable for clinical stage I-II tumours (< 5cm, mobile)
• Post-operative radiation to reduce local recurrence rates
• Acceptable cosmetic outcome• Equivalent survival to mastectomy
• higher local recurrence rate 7-8% vs. 5%
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Importance of local control
• Local control is important• 42,000 women in 78 RCT meta-analysis• For every 4 local recurrences at 5 years, 1 life
lost at 15 years (Early breast cancer trialists collaborative
group meta-analysis 2005)
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Mastectomy
• Large or multicentric tumours• Unacceptable cosmesis, small breast : tumour ratio• Persistent positive margins with conserving surgery• Contraindication to radiation• Patient preference
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Surgical Treatment of Early Breast Cancer
Breast
Breast conservation
or
Mastectomy
Axilla
Sentinel Node Biopsy possible axillary dissection
or
Level I/II axillary dissection
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Axillary Surgery
• Axillary status most significant prognostic indicator• Role in determining need for adjuvant therapy• Provides local control if nodes involved with tumour• Controversial survival benefit
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Why Axillary Surgery?
• Clinical Examination – not accurate– 35-40% of non-palpable nodes have histological
evidence of metastases (Luini 2005)
• Prognosis – The most important prognosticator– Presence, size and number of metastases in LNs
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Why Axillary Surgery?
• Aids in determining best adjuvant therapy– 50% of adjuvant systemic therapy decisions need
axillary staging (Olivotto 1998)
– 30% of breast cancer patients might be considered for post mastectomy radiation (Manitoba data)
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Why Axillary Surgery?
• Local control issues– 5% survival benefit (Orr 1999)
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Likelihood of having lymph node involvement
Diameter of primary tumour
Percent with positive axillary nodes
0.5 - 0.9 cm 21 %
1.0 - 1.9 cm 33 %
2.0 – 2.9 cm 45 %
3.0 – 3.9 cm 55 %
4.0 – 4.9 cm 60 %
> 5.0cm 70 %
Carter 1989
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The sentinel node for breast cancer
• Cabanas 1977 - penile cancer and inguinal nodes• Morton 1992 - melanoma• Krag 1994 - isotope in breast cancer• Guiliano - blue dye in breast cancer• Albertini - blue dye and isotope
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Sentinel node concept
• First node or nodes in the draining nodal basin most likely to harbour metastases
• Status of the sentinel node reflects the status of the entire nodal basin
• If found to be negative, no further axillary nodes removed
• Enables staging with less morbidity
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tumour
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Radioisotope +/-Blue Dye
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radioactivity
blue dye
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Identifying the Sentinel Lymph Node
• Gamma Probe used intra-operatively to identify “hot” node
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Identifying the Sentinel Lymph Node
• Blue dye is injected under the areola by the surgeon intra-operatively to aid SN identification
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Pathological evaluation
• Axillary dissection - bi-valve of 10 - 20 nodes • retrieval of fewer nodes (1-3) allows more extensive
evaluation– H & E multiple sections every 2-3mm– immunohistochemical staining (IHC)
– No accepted standard
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Weaver 2005
Effect of additional sections on identification of LN metastases
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Do LN micromets indicate a worse survival?
• LN micromets (< 0.2 mm or 0.2-2mm) indicate that the patient has a worse overall survival
Noguchi 2002, ASCO 2005
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Who should get a Sentinel Lymph Node Biopsy?
• T1, T2 breast cancer with clinically negative nodes– ASCO guidelines (2005) also support SLN in T2
cancers (non-randomized data) • Multicentric breast cancer• DCIS with mastectomy
Cancer Care Ontario 2009
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DCIS – a few caveats
• *If doing a mastectomy• *Mastectomy and immediate reconstruction• * Large area > 5cm
– 27% will have an invasive foci
• *Core biopsy with suspected or proven micro-invasion – 10% risk of axillary mets with micro-invasion
• +/- Palpable
Adamovich 2003, ASCO 2005*, Cancer Care Ontario 2009
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Who should NOT get a SLNB?
• Inflammatory breast cancer (T4)
Cancer Care Ontario 2009
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Inconclusive or inadequate evidence
• Pregnancy – case reports only (blue dye concerns)• Before pre-operative therapy• T3 or T4 tumors• DCIS (without mastectomy)• Suspicious palpable axillary nodes• Prior breast surgery• After pre-operative systemic therapy (ongoing
study)
Cancer Care Ontario 2009
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Why Sentinel Lymph Node biopsy?
• Assessment of randomized patients (SLN vs ALND) @ 6, 24 months
• Less pain• Less numbness• Less arm swelling• Better arm mobility
Veronesi 2003
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Sentinel node biopsy by whom?
• Specialized multidisciplinary technique involving surgeon, nuclear medicine and
pathology• Surgeons should be familiar with risks/benefits and
perform breast surgery routinely• Recommended surgeons have performed at least 20
cases with “back up” axillary dissection first• Should have a localization rate > 90%• Should have false negative rate < 5%
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What’s the early evidence for sentinel lymph node biopsy?
• ALMANAC trial 2006, Veronesi 2003 – no difference in staging, survival
• Veronesi 2003 - prospective randomized trial – 516 patients (T1) ages 40-75, randomized to either– SLNB + automatic ALND– SLNB and ALND only if SNB positive
• Outcomes variables– Breast cancer events (axillary mets, Supraclav mets,
recurrence in ipsilateral breast, or contra lateral breast, distant mets), morbidity
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What’s the evidence for Sentinel Node Biopsy?
• Results– 32.3% LN positive in ALND– 35.5% LN positive in SLNB
• Accuracy of SLNB (from automatic ALND group) 97%
• No cases of axillary metastases in group that underwent SLN alone
• No difference in breast cancer events between 2 groups
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NSABP 32 Sentinel lymph node biopsy compared with conventional ALND in clinically node negative
patients with breast cancer
Women with invasive breast cancer (n=5611)
Randomized
SLNB + ALND
Group I
SLNB and ALND Only if SLNB positiveGroup II
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Technical Issues with the SLNB
• NSABP 32 – Stratification
• Age (≤ 49, > 50) • Surgical treatment plan (lumpectomy vs. mastectomy)• Clinical tumor size (≤ 2cm, 2.1-4cm, ≥4.1cm)
– All surgeons did 1-5 pre-qualifying cases of SLNB• SLNB identified with both blue dye,
radioactive tracerKrag 2007
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Technical Issues with the SLNB
• Demographics and Results– 97% were T1/ T2– Technical success 97%, median number of
SLNs removed was 2– SLN positivity rate 26% and 25.7%– Location
• 98.6% located in axillary level I, II• 0.5% located in level III• 1% elsewhere (internal mammary, supraclavicular)
Krag 2007
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Technical aspects of the Sentinel node biopsy
• Overall positive rate 29.2%• 1.4% SLN outside of axillary levels I, II• 24.3% labeled with radioactivity only (no blue
dye)• 9.8% False negative
– Need to palpate axilla for very firm suspicious nodes
– Lateral breast cancers, previous excisional biopsy, fewer nodes (i.e. 1 node 17.7%, 2 nodes 10%, 3 nodes 6.9%) higher FN
Krag et al. Lancet 2007. 8: 881-888
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Update from B-32 2010No difference in overall survival
Group I SLNB + ALND
Group IISLNB and ALND
only if SLNB positive
Deaths 140/1975 169/2011
Overall survival (8 year KM estimate)
91.8% 90.3%
Number of regional node recurrences
8 14
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Update for Z0010
• Data from ASCO update only (no paper)• Study design – prospective, multicentre
– 5210 women who had lumpectomy, SNLB and bilateral iliac crest bone marrow aspiration
– Negative sentinel nodes and the bone marrow aspirates were examined by IHC
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Update for Z0010
• Results– Median patient age 56– 85% of tumors < 2cm– 80% invasive ductal and 80% ER positive– 76% (n=3995) sentinel nodes were
negative• 349 patients (10%) had IHC positive nodes
– Bone marrow micromets found in 104/ 3413 (3%) of patients examined
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Update for Z0010
• Results– IHC positive bone marrow not related to tumor size – 5 year survival
• 93% histologically identified positive SNB• 96% with IHC positive SNB or nodes with no metastases• Bone marrow mets not associated with overall worse survival
– Predictors of survival: histologically positive SNB, younger age, tumor size (not IHC positive node, not bone marrow mets)
• Conclusion: routine examination of sentinel node with IHC not warranted
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Update for Z0011• Inclusion criteria
– T1, T2– Lumpectomy (negative margins) and positive SLNB– All patients received radiation– All patients received adjuvant therapy
• Exclusion– Implants, multicentric disease, bilateral breast cancer, neo-adjuvant
chemotherapy or hormonal therapy, history of ipsilateral axillary surgery, pregnant/ lactating, mastectomy
– IHC only positive SLN– Distant mets– ***Matted nodes, gross extranodal disease at time of SLNB and
three or more involved SLNs
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Update for Z0011
• Study schema • Sentinel node positive• Randomized to ALND
or no further axillary treatment– ALND – had to have at
least 10 nodes and be performed within 42 days of positive SLNB
• Both groups got whole breast radiation and adjuvant systemic therapy
Annals of Surgery 2010
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Update for Z0011
• Planned accrual of 1900 patients– 891 patients randomized (35 then excluded
as withdrew consent) ****• Intention to treat analysis
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Z0011 study sample Remember accrual meant To be 1900 (46%)
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Z0011 Results
• Median patient age 56 (67% > 50)– 83% invasive ductal, 83% ER positive, 40% LVI, 30%
Grade III, – 96% had adjuvant systemic therapy (either chemo
{46%} or hormones {58%} p=NS)
• Median total number of positive nodes with ALND = 1
• Median number of positive nodes with SLNB = 1
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Treatment received Results ALND n=388 SNLB n=425
Median number of nodes removed
17 2
Positive nodes, % (n)
0 0.88% (3) 6.9% (28)
1 58.1% (198) 71.8% (290)
2 19.9% (68) 18.3% (74)
>3 21.1% (72) 3% (12) )
Unknown 47 21
Regional recurrence in ipsilateral axilla
0.5% (2) 0.9% (4)
Local recurrence (median 6.3 year)
3.6%(15) 1.8% (8)
Receipt of adjuvant therapy
403 (96%) 423 (97%)
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Z0011 data
• 27% (n=97) in ALND arm had additional nodal mets removed by ALND
• At a median of 6.3 years – authors suggest that not all non SN metastases develop into clinically detectable disease
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Z0011 Caveats
• Study is significantly underpowered (meant to accrue 1900, accrued < 900)
• Most patients were post menopausal • All the patients had a lumpectomy and
whole breast radiation– Likely irradiating lower axilla
• 96% of patients had systemic therapy– Which lowers rate of loco-regional
recurrence
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Caveats with Z0011
• Patients with extranodal disease, three or more involved SLNs and matted nodes were excluded
• Median f/u is 6.3 years– Is this too short for breast cancer?
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Z0011 Conclusions
• In a certain subset of patients with minimal disease in axilla, having a lumpectomy, radiation and systemic therapy– Is it ok to omit the ALND?– Maybe – discuss with the patient risks and
benefits– Talk with your tumor board
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What to do in the meantime?
Pathology Definition What to do
pN0 (i-) No regional node mets, IHC negative
Nothing
pN0 (i+) < 0.2mm Nothing
pN1 mi Micro metastases > 0.2 mm - 2mm
ALND*
pN1> 2mm
ALND*
* Discuss at Tumor board/ with patient/ Nomogram
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Options….
• Memorial Sloan Kettering Nomogram – predict the likelihood of non sentinel lymph
node metastases after a positive SLN biopsy
• Looks at tumour factors – Nuclear grade, LVI, multifocal, ER status,
number of negative LN, Number of positive LN, pathological size of tumour, method of detecting sentinel LN.
http://www.mskcc.org/nomograms Van Zee 2003
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Breast Cancer Treatment in the 20th Century:Quest for the Ideal Local-regional Therapy
1900 2000
Radical Mastectomy
Extended Radical Mastectomy
Modified Radical Mastectomy
Lumpectomy
BC + RT
Ax LND
BCT + RT
Sentinel Node BiopsyI D E A L T H E R A P Y
1950 Radiation
Overtreatment
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Summary
• Evolution of breast cancer surgery from more to less
• More and more specialized • Less morbidity for patient
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Update from B-32 2010
• Patient Reported Morbidity Data – Arm symptoms (tenderness, swelling, pain, tightness,
numbness, weakness)– Arm avoidance– Social and occupational activity limitations
• More arm symptoms for ALND vs SLNB at 6 mos and 12 mos
• From 12-36 mos < 15% of either ALND, SLNB patients reported moderate or greater severity of any given symptom or activity limitation
JCO 2010
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Update from B-32 2010
• Shoulder range of motion, arm volumes and numbness/ tingling
• Shoulder abduction– Peaked at 1 week for ALND (75%), SLNB (41%)
• Numbness and tingling – peaked at 6 months– ALND (49%, 23%), SLNB (15%, 10%)
• Arm volume ≥ 10% at 36 months – ALND 14%, SLNB 8%