Breast

 Cancer  Yield  a/er  Short-­‐

Interval  Follow-­‐Up  Compared  to  
Return  to  Rou=ne  Annual  Screen  in  
Pa=ents  with  Benign  Stereotac=c  or  
Ultrasound  Guided  Biopsy  Results  
JM  Johnson,  MD;  AK  Johnson,  MD;  ES  O'Meara,  
PhD;  D  Migliore8,  PhD;  BM  Geller,  EdD;  P  
Frawley,  SD  Herschorn,  MD;  EN  Hotaling,  MD  
RSNA 96th Scientific Assembly & Annual Meeting,
November 28 – December 3, Chicago, IL.
 Disclosures  
•  No  contributors  have  any  relevant  disclosures.  
 Background  
•  Biopsy  of  breast  lesions  is  increasingly  being  
performed  using  ultrasound  and  stereotacKc  
guidance.  
•  Exact  #  of  percutaneous  breast  biopsies  
performed  annually  in  the  US  is  unknown,  
esKmates  range  500,000  -­‐  1,000,000.  
•  #  of  percutaneous  breast  biopsies  performed  
in  the  US  conKnues  to  increase;  only  20  -­‐  33%  
of  these  biopsy  samples  prove  to  be  cancer.  
 Accuracy  

•  Percutaneous  breast  biopsy  has  been  shown  

to  be  a  highly  accurate  procedure.  
•  With  stereotac=c  biopsies,  reports  of  false-­‐
negaKve  rates  range  from  2.9  –7.8%.  
•  With  ultrasound  guided  core  needle  biopsy,  
reports  of  false-­‐negaKve  rates  range  from  0  -­‐  
1.7%.  
 Concordance  
•  ConfirmaKon  of  lesion  retrieval  aYer  biopsy  is  
essenKal  and  can  be  confirmed  by  specimen  
radiography,  post  biopsy  mammography  and  by  
correlaKon  of  histologic  findings  with  imaging  
characterisKcs.    
•  Imaging–histologic  discordance  aYer  breast  biopsy  
occurs  when  histologic  findings  do  not  provide  a  
sufficient  explanaKon  for  imaging  features.    
•  Imaging–histologic  discordance  at  stereotacKc  or  
ultrasound  guided  biopsy  is  an  indica=on  for  re-­‐
biopsy.    
 Biopsy  Follow-­‐Up  
•  Li^le  evidence  to  guide  how  to  follow-­‐up  paKents  
with  benign  biopsies.    
•  Many  centers  recommend  return  for  a  six-­‐month  
follow-­‐up  unilateral  mammogram  or  ultrasound  to  
ensure  that  there  has  been  no  change  at  the  biopsy  
site.    
•  Other  centers  perform  a  four-­‐month  follow-­‐up  and  
others  return  paKents  to  annual  screening.  
 Mo  Screening  ≠  Mo  Be^er  
•  Using  conservaKve  esKmates,  as  many  as  330,000  
women  annually  receive  a  breast  biopsy  with  benign  
pathology  result.  
•  SIFU  leads  to  increase  healthcare  uKlizaKon  and  
increased  paKent  anxiety.  
•  There  are  adverse  psychological  and  immunological  
impacts  of  biopsy  that  persist  beyond  the  biopsy.  
•  The  effects  may  be  prolonged  with  the  addiKon  of  
short-­‐term  follow-­‐up.  
 Purpose  

•  Our  goal  was  to  compare  the  cancer  

detecKon  rate  and  nodal  status,  stage  
and  tumor  size  following  a  benign  
stereotacKc  or  ultrasound  guided  breast  
biopsy  between  paKents  with  SIFU  and  
RTAS.  
 DefiniKons  

•  SIFU  and  RTAS  defined  based  on  observed  Kme  

since  biopsy,  not  just  radiologist  recommendaKon  
or  indicaKon.    
•  "SIFU"  defined  as  (a)  imaging  3-­‐9  months  aYer  
biopsy  with  (b)  indicaKon  "rouKne  screening"  or  
"short-­‐interval  follow-­‐up".      
•  "RTAS"  defined  as  (a)  imaging  9-­‐18  months  aYer  
biopsy  with  (b)  indicaKon  "rouKne  screening"  or  
"short-­‐interval  follow-­‐up".    
 Rules  
•  Cases  with  findings  of  atypical  hyperplasia  or  lobular  
carcinoma  in  situ  were  excluded.    
•  If  any  cancer  diagnosis  was  found  to  precede  the  
benign  biopsy  or  occurred  within  the  following  90  
days,  the  biopsy  was  excluded.    
•  We  required  3  months  of  follow-­‐up  for  cancer  
detecKon  at  post-­‐biopsy  imaging.  
•  We  examined  biopsies  that  resulted  from  both  
screening  and  diagnosKc  evaluaKons.  
 Rules  2  
•  Only  core  biopsies  with  ultrasound  or  stereotacKc  
guidance  were  evaluated.  
•  Any  cases  in  which  there  was  a  repeat  biopsy  within  3  
months  or  before  follow-­‐up  imaging  were  excluded  
due  to  the  likelihood  of  represenKng  discordant  
radiology-­‐pathology  results.    
•  Diagnosis  of  ipsilateral  invasive  cancer  or  DCIS  within  3  
months  of  the  1st  follow-­‐up  imaging  exam  and  tumor  
characterisKcs  were  determined  through  linkage  with  
pathology  databases  and  tumor  registries.  
Methods  
 Results  

•  Total  of  19,598  benign  biopsies  among  

18,367  women  were  idenKfied.  
–  Post-­‐biopsy  imaging  
•  SIFU  7397  
•  RTAS  3604  
•  Other  8597  
 Demographics  
SIFU  (N  =  7397)   RTAS  (N  =  3604)  

CharacterisKc   %   %  
Age  
<40   6   5.5  
40-­‐49   34   35.3  
50-­‐59   31.8   31.7  
60-­‐69   16.6   16  
70-­‐79   9.3   9  
≥80   2.3   2.5  
Race/ethnicity  
White,  non-­‐hispanic   90.5   89  
Black,  non-­‐hispanic   3.6   4.1  
Asian/Pacific  Islander   2   2.7  
 Demographics  
SIFU  (N  =  7397)   RTAS  (N  =  3604)  

CharacterisKc   %   %  
BMI  (kg/m2)  
<25   43   43.5  
25  to  <30   28.8   29  
30  to  <35   16.8   16.6  
≥35   11.4   11  
Current  HRT   17.4   17.5  
Family  history  of  breast  cancer   17.2   19.4  
No  breast  symptoms,  by  self-­‐report   78   91.6  
 Demographics  
SIFU  (N  =  7397)   RTAS  (N  =  3604)  

CharacterisKc   %   %  

Mammographic  (BI-­‐RADS)  breast  density   -­‐   -­‐  

Almost  enKrely  fat   4.8   4.7  

Sca^ered  fibroglandular  densiKes   38.8   35.9  

Heterogeneously  dense   49.2   50.2  

Extremely  dense   7.2   9.3  

Pre-­‐biopsy  imaging  was  for  rou=ne  screening   76   77.6  

 Breast  Cancer  w/in  3  months  aYer  
post-­‐biopsy  imaging  
SIFU   RTAS  

N  benign  biopsies   7397   3604  

Incident  ipsilateral  breast  cancer  cases  diagnoses  

40   18  
w/in  3  months  a/er  post-­‐biopsy  imaging,  N  

Rate  per  1000  imaging  exams  (95%  CI)   5.4  (3.9,  7.4)   5.0  (3.0,  7.9)  

Invasive  cancer  (nonmissing),  N   26  (40)   12  (18)  

Percent  (95%  CI)   65%  (48%,  79%)   67%  (41%,  87%)  

Breast  Cancer  w/in  3  months  aYer  
post-­‐biopsy  imaging  
SIFU   RTAS  

Among  invasive  cancers  

Node  posi=ve  (non  missing),  N   7  (23)   3  (10)  

Percent  (95%  CI)   30%  (13%,  53%)   30%  (7%,  76%)  

Late  stage  (III  or  IV)  (non  missing),  N   4  (22)   3  (10)  

Percent  (95%  CI)   18%  (5%,  40%)   30%  (7%,  65%)  

Large  size  (≥20  mm)  (non  missing),  N   4  (22)   3  (11)  

Percent  (95%  CI)   18%  (5%,  40%)   27%  (6%,  61%)  

 Conclusion  

•  Our  results  do  not  show  a  staKsKcally  

significant  difference  in  the  rate  of  ipsilateral  
cancer  detecKon  between  SIFU  and  RTAS  
following  a  benign  breast  biopsy.    
•  Rates  of  invasive  cancer  and  posiKve  nodal  
status  also  did  not  achieve  staKsKcal  
significance  between  the  groups.    
 Conclusion  2  
•  Having  a  benign  breast  biopsy  is  a  posiKve  risk  factor  
for  breast  cancer  (Breast  Cancer  Risk  Assessment  
Tool  and  Gail  Model).  
•  Despite  the  posiKve  relaKve  risk  factor  associated  
with  a  biopsy,  the  ideal  method  of  follow-­‐up  for  
women  with  benign  concordant  breast  biopsies  has  
not  been  studied.    
•  Our  results  suggest  that  the  pracKce  of  SIFU  
following  a  benign  biopsy  may  not  offer  significant  
advantage  over  RTAS  considering  the  cost  and  Kme  
involved.  
 Strengths  
•  Large  sample  of  both  paKents  and  radiologists  
which  is  representaKve  of  diverse  US  pracKces.    
•  To  our  knowledge,  this  is  the  first  study  to  assess  
the  outcome  differences  between  SIFU  and  RTAS  
following  a  benign  concordant  breast  biopsy.    
•  PaKent,  radiologic,  and  cancer  data  within  the  
BCSC  provides  an  opportunity  to  examine  follow-­‐
up  outcomes  in  a  large  data  set  collected  in  a  
common  format.  
 Weaknesses  
•  Small  #  of  cancers  detected  precludes  sub-­‐groups  
analysis  for  difference  in  outcome  between  groups  
(i.e.,  older  versus  younger,  white  versus  non-­‐white,  
HRT  vs.  no  HRT,  etc.).    
•  RetrospecKve  nature  has  inherent  weaknesses  
including  possibility  of  incorrectly  filed  data  and  
missing  data  points.    
•  Predominance  of  White,  non-­‐Hispanic  paKents  
(~85%)  in  our  data  set  limits  generalizability  of  our  
data  to  non-­‐Whites.  
 Clinical  Relevance  
•  These  results  suggest  that  the  
pracKce  of  SIFU  following  a  benign  
biopsy  may  not  offer  significant  
advantage  over  RTAS  considering  the  
cost  and  Kme  involved.  
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