Breast Cancer Hormone receptor status report


 

Breast Invasive Carcinoma - Hormone Receptor  
  2007-02-23 Cancer Case Summary
Diagnosis  
  Example  Diagnosis  
  RIGHT BREAST PNL BIOPSY - INVASIVE DUCTAL CARCINOMA, ER+, PR+, HER2-   
  For LHC cases, the Diagnosis and Microscopic are in the "Addendum" field.  
   
  Example Referred in Diagnosis  
  Referred-in PRHC 06:S1234-K:  
  RIGHT BREAST PNL BIOPSY - INVASIVE DUCTAL CARCINOMA, ER+, PR+, HER2-   
  For referred-in cases, Diagnosis is in the "Diagnosis" field and detailed findings are in the Microscopic.
Microscopic (Referred In Cases) or Addendum  
# Report Header Dictation Options Note
       
DIAGNOSIS    
  SITE (PROCEDURE) - INVASIVE DUCTAL CARCINOMA  Dx in Addendum  or Dx (Ref-in)
  ESTROGEN RECEPTOR NEGATIVE | POSITIVE  
     PROGESTERONE RECEPTOR NEGATIVE | POSITIVE  
     HER2   NEGATIVE | POSITIVE  
    INDETERMINATE ((ADDENDUM TO FOLLOW))  
       
  HORMONE RECEPTORS BY IMMUNOHISTOCHEMICAL STAINING  
1 Block Tested: PRHC 06:Snnnn-A1  
  Fixative 10% neutral buffered formalin  
  Fixation Duration 6 - 48 h | Other than 6-48 h (see note) | Unknown  
       
2 Estrogen Receptor    
  Antibody Used 6F11  
  % cells positive ER ___ %   
       
  *** ER INTERPRETATION NEGATIVE ER 0-<1%   nuclear positivity
    LOW POSITIVE ER 1-9% nuclear positivity
    POSITIVE ER => 10% nuclear positivity
       
3 Progesterone Receptor    
  Antibody Used PgR 312  Novacastra PgR 312 since 2003-03
  % cells positive PR ___ %  
       
  *** PR INTERPRETATION NEGATIVE PR 0-<1%   nuclear positivity
    LOW POSITIVE PR 1-9% nuclear positivity
    POSITIVE PR => 10% nuclear positivity
       
4 HER2/neu   QMPLS 2006 HER2 Protocol
  Adequacy of Sample Satisfactory | Unsatisfactory (state reason and refer for FISH) Eg. Artifacts involve most of sample; Normal ducts stain; Tissues fixed in other than 10% NBF; Crush, edge or retraction artifact in core bx
  Antibody #1 AO485  
  % cells positive* ___ % "% Positive" = Strong, Complete Membr staining in xx% of inv tumour cells
  Staining:    
  Intensity NA | Absent | Weak | Moderate | Strong  
  Uniformity NA | Absent | Present  
  Homogeneous, dark
circumferential
NA | Absent | Present  
       
  Antibody #2 Tab 250  
  % cells positive* ___ % see AO485 above
  Staining:    
  Intensity NA | Absent | Weak | Moderate | Strong  
  Uniformity NA | Absent | Present  
  Homogeneous, dark
circumferential
NA | Absent | Present  
       
  *** HER2 INTERPRETATION POSITIVE Intense, Uniform, Circumferential cell membr staining in >30% of invasive tumour
    INDETERMINATE. FISH TO FOLLOW. Weak staining OR <30% (but more than 10%) of invasive tumour cells stained
      Indications for FISH Testing (O'Malley)
    NEGATIVE No staining, or pale incomplete membrane staining in any % of cells, or weak, complete staining in <10% of cells
5 Internal Consult Name of reviewing pathologist Every report is reviewed internally before reporting
6 Comments None or specify  
       
  Notes    
  CRITERIA FOR ER PR STATUS (% Nuclear Positivity)  
  Negative: 0-<1% | Low Positive: 1-9% | Positive: =>10%   
       
  THRESHOLD FOR POSITIVE* HER2 > 30% of invasive tumour cells positive*  
  * % cells positive for HER2 is % invasive tumour cells exhibiting uniform homogenous dark circumferential membrane staining
       
  ASSAYS IN USE AND CONTROLS FOR ER, PR AND HER2  
  ER, PR and HER2 assays were developed at LHC and validated by split sample testing in a reference laboratory. 
  HER2 split sample validation is repeated twice annually with a reference laboratory following provincial testing guidelines
  ER, PR and HER2 (HER2 confirmed by FISH or PCR) positive and negative quality control slide  
  LHC is accredited by the Ontario Quality Management Program Laboratory Services (QMP-LS) and participates in External Quality
  Assurance from QMP-LS and the College of American Pathologists  
       
  FIXATION FOR HER2    
  Six to 48 h fixation for HER2 tests is recommended by the CAP/ASCO Guideline. In general, when fixation duration is other than 6-48 h,
  or is unknown, and the HER2 result is Negative, the CAP/ASCO Guideline states that the result "may not" be valid.
   However, our data confirm that the assay in our laboratory is valid under these conditions  
End of the usual LHC Report    
       
  Addendum if FISH Reported   Indications for FISH Testing (O'Malley)
  HER2/neu FISH    
  Method Vysis Report when result of FISH available
  Ratio HER2/ Chromosome 17 signal State ratio  
  *** HER2 Interpretation by FISH Positive or Negative for Gene over expression Positive Ratio =>2 (Vysis)
       
  HER2/neu PCR Not Done or specify as below  
  Referral Laboratory    
  Ratio State ratio  
  *** HER2 Interpretation by PCR Not amplified Negative Ratio <1.8
    Borderline for low amplification Borderline Ratio 1.8-1.9
    Amplified Positive Ratio =>2
       
  INDICATIONS FOR FISH TEST Email from Dr O'Malley 2006-02-24; Modified to CAP Guideline 2007-01
1 NON-UNIFORM distribution or WEAK but complete, obvious circumferential staining in => 10% of cells. i.e. <10% is NEG; do not FISH 
2 Intense, complete membrane staining of <= 30% cells (Rare)  
3 Discordant results betw 2 ab, i.e. one ab shows mod or strong membrane staining, but the other ab is negative
4 Cytoplasmic staining obscures result; Repeat assay and if persistent, refer for FISH  
5 Artifacts involve most of sample; Fixative other than 10% NBF; Crush, edge or retraction artifact in core bx
       
  RESULTS NOT REQUIRING FISH TEST    
1 Normal tissue stains; Tumor is HER2 negative - Does not require FISH (O'Malley). (CAP says Reject sample)
2 If 2 blocks of tumor are tested & only 1 block is unequivocally HER2 pos w 2 ab, this does not need FISH; report 'positive'
   
  REFERENCE  
  Wolff AC et al. Guideline for HER2 Testing in Breast Cancer. Archives Pathol Lab Med 2007;131:18-43
  Estrogen Receptor: Harvey JCO 17:1474-1481, 1999; O'Malley_2005