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Can we predict it ?
Late metastasis
Joseph	
  Gligorov	
  MD,	
  PhD	
  
ESO	
  Advanced	
  Breast	
  Cancer	
  Task	
  Force	
  
APHP-­‐HUEP-­‐Tenon,	
  Paris	
  
InsDtut	
  Universitaire	
  de	
  Cancérologie	
  
Université	
  Pierre	
  &	
  Marie	
  Curie,	
  Sorbonne	
  Universités	
  
Conflict	
  of	
  interest	
  
•  Amgen®	
  
•  Genomic	
  Health®	
  
•  Eisai®	
  
•  Roche-­‐Genentech®	
  
•  Nanostring	
  ®	
  
•  Novar;s	
  ®	
  
Clinical	
  trials	
  support,	
  advisory	
  boards,	
  speaker	
  
DEFINITIONS	
  AND	
  IMPORTANCE	
  
Defini;ons	
  &	
  importance	
  
•  Late: 	
   	
   	
   	
  	
  
•  Metastasis:	
   	
  .	
  micro	
  mets	
  ?	
  
	
   	
   	
   	
   	
  .	
  macro	
  mets	
  ?	
  
	
   	
   	
   	
   	
  .	
  the	
  way	
  we	
  detect	
  the	
  mets	
  ?	
  
	
  
•  Importance: 	
  .	
  Is	
  it	
  frequent	
  ?	
  
	
   	
   	
   	
   	
  .	
  Is	
  it	
  life	
  threatening	
  ?	
  
	
   	
   	
   	
   	
  .	
  Is	
  breast	
  cancer	
  mortality	
  s;ll	
  important	
  as	
  a	
  
	
   	
   	
   	
   	
  main	
  risk	
  of	
  early	
  death	
  aNer	
  a	
  long	
  period	
  
	
   	
   	
   	
   	
  of	
  follow-­‐up	
  ?	
  
0	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  2	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  5	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  10	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  15	
  	
  	
  	
  	
  	
  	
  years	
  ?	
  
Defini;ons	
  &	
  importance	
  
•  Late: 	
   	
   	
   	
  	
  
•  Metastasis:	
   	
  .	
  micro	
  mets	
  ?	
  
	
   	
   	
   	
   	
  .	
  macro	
  mets	
  ? 	
   	
   	
   	
  .	
  Clinical	
  events	
  
	
   	
   	
   	
   	
  .	
  Local	
  or	
  distant	
  mets	
  ?	
  
	
  
•  Importance: 	
  .	
  Let’s	
  see	
  the	
  datass	
  it	
  frequent	
  ?	
  
	
   	
   	
   	
   	
  .	
  Is	
  it	
  life	
  threatening	
  ?	
  
	
   	
   	
   	
   	
  .	
  Is	
  breast	
  cancer	
  mortality	
  s;ll	
  important	
  as	
  a	
  
	
   	
   	
   	
   	
  main	
  risk	
  of	
  early	
  death	
  aNer	
  a	
  long	
  period	
  
	
   	
   	
   	
   	
  of	
  follow-­‐up	
  ?	
  
0	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  2	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  5	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  10	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  15	
  	
  	
  	
  	
  	
  	
  years	
  
FREQUENCY	
  OF	
  LATE	
  METASTATIS	
  	
  
Joseph Gligorov  : Breast Cancer late metastasis
Influence	
  of	
  chemo	
  and	
  pN	
  status	
  
Influence	
  on	
  mortality	
  
Conclusion	
  1	
  
•  According	
  to	
  EBCTCG	
  publica;on	
  
	
  
–  Overall	
  breast	
  cancer	
  popula;on	
  treated	
  in	
  adjuvant	
  seXng	
  with	
  
tamoxifen	
  present	
  an	
  absolute	
  risk	
  of	
  late	
  recurrence	
  aNer	
  5	
  years	
  
between	
  10-­‐15%	
  
–  This	
  risk	
  is	
  higher	
  in	
  pN+	
  popula;on	
  who	
  do	
  not	
  receive	
  chemotherapy	
  
(#	
  20%)	
  compared	
  to	
  pN0	
  with	
  or	
  without	
  chemotherapy	
  (7	
  to	
  8%)	
  
•  The	
  influence	
  of	
  adjuvant	
  tamoxifen	
  	
  
–  is	
  s;ll	
  clear	
  between	
  5	
  to	
  10	
  years	
  in	
  ER	
  &	
  PR	
  posi;ve	
  disease	
  
–  Is	
  less	
  clear	
  aNer	
  5	
  years	
  in	
  PR	
  &/or	
  ER	
  poor	
  disease	
  
•  Risk	
  of	
  late	
  recurrence	
  clearly	
  impact	
  mortalit	
  
MORE	
  RECENT	
  DATA	
  
Influence	
  of	
  histological	
  type	
  
Pestalozzi et al., J Clin Oncol 26:3006-3014.2008
Prat A, Perou CM. Molecular Oncology 2011
Clinical-­‐pathological	
  characterisDcs	
  	
  
of	
  the	
  current	
  intrinsic	
  subtypes	
  of	
  breast	
  cancer	
  
Informa;ons	
  from	
  neoadjuvant	
  data	
  
Luminal	
  A	
   Luminal	
  B/HER2-­‐	
   Luminal	
  B/HER2+++	
  
HER2+++	
  non	
  luminal	
   Triple	
  nega;ve	
  
?	
  
Rates	
  of	
  distant	
  recurrences	
  and	
  breast-­‐specific	
  
survival	
  in	
  TNBC	
  and	
  other	
  breast	
  cancers.	
  
RFS OS
Dent R et al. Clin Canc Res 2007
Joseph Gligorov  : Breast Cancer late metastasis
HR+	
  
HR-­‐	
  
Time	
  to	
  distant	
  recurrence	
  
Smoothed	
  hazard	
  rate	
  curves	
  for	
  risk	
  of	
  recurrence	
  
Clearly	
  in:	
  
	
  
	
  -­‐pN+	
  populaDon,	
  
	
  
	
  -­‐	
  premenopausal	
  women	
  at	
  Dme	
  
	
  of	
  tamoxifen	
  
	
  
ITT 	
  	
  :	
  intent-­‐to-­‐treat	
  	
  
COX 	
  :	
  cox	
  regression	
  model	
  
IPCW 	
  :	
  inverse	
  probability	
  of	
  censoring	
  weighted	
  
SCC 	
  :	
  Shao,	
  Chang,	
  Chow	
  model	
  
Joseph Gligorov  : Breast Cancer late metastasis
Conclusion	
  2	
  
•  Histological	
  type	
  might	
  influence	
  the	
  risk	
  of	
  late	
  
relapse	
  
•  Intrinsic	
  subtypes	
  might	
  also	
  influence	
  the	
  risk	
  of	
  late	
  
relapse	
  and	
  par;cularly	
  according	
  to	
  the	
  efficacy	
  of	
  
systemic	
  treatments	
  
–  Chemotherapy	
  for	
  TNBC	
  
–  an;HER2	
  treatments	
  for	
  HER2	
  posi;ve	
  BC	
  
•  the	
  main	
  popula;on	
  for	
  which	
  the	
  iden;fica;on	
  of	
  a	
  
late	
  risk	
  of	
  relapse	
  remains	
  the	
  most	
  important	
  is	
  the	
  
HR	
  posi;ve	
  popula;on	
  
•  We	
  have	
  possible	
  treatment	
  op;ons	
  to	
  propose	
  to	
  the	
  
pa;ents	
  
CAN	
  WE	
  PREDICT	
  LATE	
  METASTASIS	
  ?	
  
New	
  considera;ons	
  
•  Target	
  popula;on	
  is	
  HR	
  posi;ve	
  popula;on	
  
•  Predic;ng	
  late	
  metastasis:	
  2	
  informa;ons	
  
– Prognos;c:	
  improving	
  OS	
  
– Predic;on:	
  	
  
•  defining	
  popula;on	
  s;ll	
  sensi;ve	
  to	
  endocrine	
  
treatment	
  
•  Trying	
  to	
  find	
  new	
  targets	
  to	
  prevent	
  late	
  relapse	
  
ROR	
  score	
  was	
  calculated	
  using	
  the	
  test	
  variables	
  that	
  include:	
  
•  Pearson	
  correlaDons	
  with	
  prototypical	
  gene	
  expression	
  profiles	
  for	
  the	
  four	
  intrinsic	
  Subtypes	
  	
  
•  ProliferaDon	
  score	
  
•  Pathologic	
  tumor	
  size	
  
OP	
   pN0	
   pN+	
  
transATAC	
  study:	
  
PAM50	
  vs	
  Oncotype	
  Dx	
  vs	
  IHC4	
  (RE,	
  RP,	
  HER2,Ki67)	
  	
  	
  
Clinical	
  variables	
  
Sestak	
  I	
  et	
  al,	
  JNCI	
  2013	
  
Trans ATAC & ABCSG-8
Distant recurrence – post 5 years
San Antonio Breast Cancer – Cancer Therapy and Research Center at UT Health Science Center – December 10-14, 2013
Courtesy of Sestak I et al.
ChangeinLRχ2Statistic
94.1
67.9
0
10
20
30
40
50
60
70
80
90
100
CTS ROR
Univariate Multivariate
HR (95% CI) for IQR
Univariate
CTS
Nodal status, grade, tumour size, age, treatment
1.96 (1.73-2.21)
ROR score (PAM 50) 2.69 (2.12-3.43)
61.4
35.3
Multivariate*
1.80 (1.57-2.06)
2.07 (1.63-2.64)
*When added to other score
10
20
30
40
50
60
70
80
90
100
0
Luminal A vs Luminal B
according to PAM50
San Antonio Breast Cancer – Cancer Therapy and Research Center at UT Health Science Center – December 10-14, 2013
HR (95% CI) P-value
Luminal A (N=1530 (71.6%)) - -
Luminal B (N=542 (25.4%)) 2.89 (2.07- 4.02) <0.0001
051015
5 6 7 8 9 10
Follow-up time [years]
Luminal B
Luminal A
Distantrecurrence(%)
4.1%
12.9%
051015
Courtesy of Sestak I et al.
E-module in Oncotype Dx is
predictive of late reccurence
Among women with tumours
most sensitive to oestrogen,
with a high E-module score,
the recurrence rate more
than doubled from 5.7% in
the first five years to 13.6%
in the subsequent five years.
However, if they had a low
E-module score, there was
little difference in recurrence
rates between the first five
years and the next five
years: 10.3% versus 12.3%.”
Dowsett M et al. EBCC 2014
Breast	
  Cancer	
  Index:	
  
•  Molecular	
  Grade	
  Index	
  
•  HOXB13/IL17BR	
  
The	
  predic;ve	
  value	
  of	
  the	
  marker	
  seems	
  
depedent	
  of	
  the	
  previous	
  treatment	
  exposure	
  …	
  
Sgroi	
  et	
  al.	
  Lancet	
  Oncol	
  2013	
  
Endopredict	
  clinicalscore	
  was	
  calculated	
  using:	
  
•  ProliferaDon	
  associated	
  genes	
  
•  HR	
  associated	
  genes	
  
•  Clinical	
  parameters	
  (tumour	
  size	
  &	
  nodal	
  status)	
  
Dubsky	
  P	
  et	
  al.	
  BJC	
  2013	
  
ER	
  pathway	
  seems	
  to	
  be	
  the	
  “driver”…	
  
Joseph Gligorov  : Breast Cancer late metastasis
Mikempergher	
  L	
  et	
  al.	
  Mol	
  Oncology	
  2013	
  
Conclusion	
  3	
  
•  Clinical	
  parameters	
  s;ll	
  remains	
  crucial	
  for	
  
evalua;ng	
  the	
  risk	
  of	
  late	
  relapse	
  (pN,	
  pT)	
  
•  ER	
  pathway	
  ac;va;on	
  seems	
  to	
  be	
  crucial	
  also	
  
and	
  maight	
  help	
  to	
  “predict”	
  the	
  benefit	
  of	
  
prolonged	
  endocrine	
  treatment	
  in	
  popula;ons	
  at	
  
risk	
  of	
  late	
  relapse	
  
•  New	
  approaches	
  and	
  signatures	
  might	
  help	
  us	
  to	
  
find	
  new	
  tools	
  in	
  pa;ent	
  at	
  risk	
  of	
  late	
  relapse	
  
and	
  not	
  candidate	
  for	
  prolonged	
  endocrine	
  
treatment	
  
THANKS	
  

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Joseph Gligorov : Breast Cancer late metastasis

  • 1. Can we predict it ? Late metastasis Joseph  Gligorov  MD,  PhD   ESO  Advanced  Breast  Cancer  Task  Force   APHP-­‐HUEP-­‐Tenon,  Paris   InsDtut  Universitaire  de  Cancérologie   Université  Pierre  &  Marie  Curie,  Sorbonne  Universités  
  • 2. Conflict  of  interest   •  Amgen®   •  Genomic  Health®   •  Eisai®   •  Roche-­‐Genentech®   •  Nanostring  ®   •  Novar;s  ®   Clinical  trials  support,  advisory  boards,  speaker  
  • 4. Defini;ons  &  importance   •  Late:           •  Metastasis:    .  micro  mets  ?            .  macro  mets  ?            .  the  way  we  detect  the  mets  ?     •  Importance:  .  Is  it  frequent  ?            .  Is  it  life  threatening  ?            .  Is  breast  cancer  mortality  s;ll  important  as  a            main  risk  of  early  death  aNer  a  long  period            of  follow-­‐up  ?   0                    2                              5                                                  10                                                  15              years  ?  
  • 5. Defini;ons  &  importance   •  Late:           •  Metastasis:    .  micro  mets  ?            .  macro  mets  ?        .  Clinical  events            .  Local  or  distant  mets  ?     •  Importance:  .  Let’s  see  the  datass  it  frequent  ?            .  Is  it  life  threatening  ?            .  Is  breast  cancer  mortality  s;ll  important  as  a            main  risk  of  early  death  aNer  a  long  period            of  follow-­‐up  ?   0                    2                              5                                                  10                                                  15              years  
  • 6. FREQUENCY  OF  LATE  METASTATIS    
  • 8. Influence  of  chemo  and  pN  status  
  • 10. Conclusion  1   •  According  to  EBCTCG  publica;on     –  Overall  breast  cancer  popula;on  treated  in  adjuvant  seXng  with   tamoxifen  present  an  absolute  risk  of  late  recurrence  aNer  5  years   between  10-­‐15%   –  This  risk  is  higher  in  pN+  popula;on  who  do  not  receive  chemotherapy   (#  20%)  compared  to  pN0  with  or  without  chemotherapy  (7  to  8%)   •  The  influence  of  adjuvant  tamoxifen     –  is  s;ll  clear  between  5  to  10  years  in  ER  &  PR  posi;ve  disease   –  Is  less  clear  aNer  5  years  in  PR  &/or  ER  poor  disease   •  Risk  of  late  recurrence  clearly  impact  mortalit  
  • 12. Influence  of  histological  type   Pestalozzi et al., J Clin Oncol 26:3006-3014.2008
  • 13. Prat A, Perou CM. Molecular Oncology 2011 Clinical-­‐pathological  characterisDcs     of  the  current  intrinsic  subtypes  of  breast  cancer  
  • 14. Informa;ons  from  neoadjuvant  data   Luminal  A   Luminal  B/HER2-­‐   Luminal  B/HER2+++   HER2+++  non  luminal   Triple  nega;ve   ?  
  • 15. Rates  of  distant  recurrences  and  breast-­‐specific   survival  in  TNBC  and  other  breast  cancers.   RFS OS Dent R et al. Clin Canc Res 2007
  • 18. Time  to  distant  recurrence   Smoothed  hazard  rate  curves  for  risk  of  recurrence  
  • 19. Clearly  in:      -­‐pN+  populaDon,      -­‐  premenopausal  women  at  Dme    of  tamoxifen     ITT    :  intent-­‐to-­‐treat     COX  :  cox  regression  model   IPCW  :  inverse  probability  of  censoring  weighted   SCC  :  Shao,  Chang,  Chow  model  
  • 21. Conclusion  2   •  Histological  type  might  influence  the  risk  of  late   relapse   •  Intrinsic  subtypes  might  also  influence  the  risk  of  late   relapse  and  par;cularly  according  to  the  efficacy  of   systemic  treatments   –  Chemotherapy  for  TNBC   –  an;HER2  treatments  for  HER2  posi;ve  BC   •  the  main  popula;on  for  which  the  iden;fica;on  of  a   late  risk  of  relapse  remains  the  most  important  is  the   HR  posi;ve  popula;on   •  We  have  possible  treatment  op;ons  to  propose  to  the   pa;ents  
  • 22. CAN  WE  PREDICT  LATE  METASTASIS  ?  
  • 23. New  considera;ons   •  Target  popula;on  is  HR  posi;ve  popula;on   •  Predic;ng  late  metastasis:  2  informa;ons   – Prognos;c:  improving  OS   – Predic;on:     •  defining  popula;on  s;ll  sensi;ve  to  endocrine   treatment   •  Trying  to  find  new  targets  to  prevent  late  relapse  
  • 24. ROR  score  was  calculated  using  the  test  variables  that  include:   •  Pearson  correlaDons  with  prototypical  gene  expression  profiles  for  the  four  intrinsic  Subtypes     •  ProliferaDon  score   •  Pathologic  tumor  size   OP   pN0   pN+  
  • 25. transATAC  study:   PAM50  vs  Oncotype  Dx  vs  IHC4  (RE,  RP,  HER2,Ki67)      
  • 26. Clinical  variables   Sestak  I  et  al,  JNCI  2013  
  • 27. Trans ATAC & ABCSG-8 Distant recurrence – post 5 years San Antonio Breast Cancer – Cancer Therapy and Research Center at UT Health Science Center – December 10-14, 2013 Courtesy of Sestak I et al. ChangeinLRχ2Statistic 94.1 67.9 0 10 20 30 40 50 60 70 80 90 100 CTS ROR Univariate Multivariate HR (95% CI) for IQR Univariate CTS Nodal status, grade, tumour size, age, treatment 1.96 (1.73-2.21) ROR score (PAM 50) 2.69 (2.12-3.43) 61.4 35.3 Multivariate* 1.80 (1.57-2.06) 2.07 (1.63-2.64) *When added to other score 10 20 30 40 50 60 70 80 90 100 0
  • 28. Luminal A vs Luminal B according to PAM50 San Antonio Breast Cancer – Cancer Therapy and Research Center at UT Health Science Center – December 10-14, 2013 HR (95% CI) P-value Luminal A (N=1530 (71.6%)) - - Luminal B (N=542 (25.4%)) 2.89 (2.07- 4.02) <0.0001 051015 5 6 7 8 9 10 Follow-up time [years] Luminal B Luminal A Distantrecurrence(%) 4.1% 12.9% 051015 Courtesy of Sestak I et al.
  • 29. E-module in Oncotype Dx is predictive of late reccurence Among women with tumours most sensitive to oestrogen, with a high E-module score, the recurrence rate more than doubled from 5.7% in the first five years to 13.6% in the subsequent five years. However, if they had a low E-module score, there was little difference in recurrence rates between the first five years and the next five years: 10.3% versus 12.3%.” Dowsett M et al. EBCC 2014
  • 30. Breast  Cancer  Index:   •  Molecular  Grade  Index   •  HOXB13/IL17BR  
  • 31. The  predic;ve  value  of  the  marker  seems   depedent  of  the  previous  treatment  exposure  …   Sgroi  et  al.  Lancet  Oncol  2013  
  • 32. Endopredict  clinicalscore  was  calculated  using:   •  ProliferaDon  associated  genes   •  HR  associated  genes   •  Clinical  parameters  (tumour  size  &  nodal  status)  
  • 33. Dubsky  P  et  al.  BJC  2013   ER  pathway  seems  to  be  the  “driver”…  
  • 35. Mikempergher  L  et  al.  Mol  Oncology  2013  
  • 36. Conclusion  3   •  Clinical  parameters  s;ll  remains  crucial  for   evalua;ng  the  risk  of  late  relapse  (pN,  pT)   •  ER  pathway  ac;va;on  seems  to  be  crucial  also   and  maight  help  to  “predict”  the  benefit  of   prolonged  endocrine  treatment  in  popula;ons  at   risk  of  late  relapse   •  New  approaches  and  signatures  might  help  us  to   find  new  tools  in  pa;ent  at  risk  of  late  relapse   and  not  candidate  for  prolonged  endocrine   treatment