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Role of primary site local
 management for ABC patients

    Virgilio Sacchini
     Breast Service
Memorial Sloan-Kettering
Cancer Center - New York
Historical arguments against surgery
in stage IV breast cancer

• Patients were debilitated, bulky disease, survival
  brief
  • Avoid morbidity for unknown benefit

• Measurable disease: can be followed for response

• Fear that removal of the primary tumor would result
  in increased angiogenesis and stimulation of
  dormant disease
National Cancer Database from 1990-93
                         (Khan SA, Surgery 2002)

              6861 (42.8%) no operation
16,023 with
Stage IV
              9162 (57.2%) partial
              mastectomy or total
              mastectomy

                               Survival




                                                   No surgery
National Cancer Database from 1990-93
                          (Khan SA, Surgery 2002)


• Comparing only surgical patients, survival advantage for
  those with clear margins (for both total mastectomy
  and partial mastectomy)
      Survival for Total Mastectomy Patients




                                               Clear margins




                                      Complete excision better then the debulking
National Cancer Database from 1990-93
                      (Khan SA, Surgery 2002)


• Comparing only surgical patients, survival advantage for
  those with clear margins (for both total mastectomy and
  partial mastectomy)                       5 year survival
                           No operation         6.7%
                           Involved Margins
                                   Partial Mast 11.3%
                                     Total Mast 11.5%
                           Clear Margins
                                   Partial Mast 16.6%
                                     Total Mast 18.4%

 Conclusion: complete surgical extirpation of the
    Cancer is associated with improved survival
Current perspective - primary tumor
surgery in Stage IV Breast Cancer ??

• May not respond to systemic therapy in parallel
  with metastatic sites ?
  • grow locally and lead to uncontrolled chest
    wall disease and impaired quality of life
• May serve as a continued source of tumor stem
  cells?
   • lead to new metastatic lesions which are
     resistant to systemic therapy
• More “earlier stage 4”
Current perspective - primary tumor
surgery in Stage IV Breast Cancer ??

• May not respond to systemic therapy in parallel
  with metastatic sites ?
  • grow locally and lead to uncontrolled chest
    wall disease and impaired quality of life


• More “earlier stage 4”
Studies assessing distant metastasis detected by conventional imaging
              with PET/CT in patients with primary breast cancer


                                                                         Patients with
                                                                                           Patients with
                                                                         distant
                                                                                           distant
                                       Patient                           metastases
 First author       Type of study                         No. patients                     metastases
                                       population                        detected by
                                                                                           detected by
                                                                         conventional
                                                                                           PET/CT No. (%)
                                                                         imaging No. (%)

                                       Primary tumor
 Fuster D           Prospective                                60             3 (5)            8 (13)
                                       >3 cm
 Carkaci S          Retrospective      Primary IBC             41            13 (32)          20 (49)
 Alberini J         Prospective        Primary IBC             62            12 (19)          18 (29)
                                       Suspected
 Heusner T          Retrospective                              40             7 (18)          10 (25)
                                       breast cancer
 Groheux D          Retrospective      Stage II and III        39               0              4 (10)



Stage IIA Upstaged IV in 5.5%
                                                           Do we under-treat these early stage IV?)
Naoki Niikura, Naoto T. Ueno J Cancer 2010
Overview
                    (Neuman H, Cancer 2010)


Study        Type          Years              N   % surg   HR




MSKCC 2011
Pooled analysis of hazard ratios for overall mortality for surgery versus no
    surgery for patients with stage-IV breast cancer




•10 studies, mostly database or registry driven, with over 30,000 patients studied, about
50% of them had resection of primary
•With all the biases, most studies show some survival benefit in patients having surgery


                               Jetske Ruiterkamp et Al: Breast Cancer Research and Treatment, 2010
MSKCC Experience
                  (Neuman H, Cancer 2010)




•   2000-2004, database review
•   186 patients stage IV
•   Surgery 69 (37%) – No surgery 117 (63%)
•   Median f/u 53 months
•   Improvement in median survival from
    33months to 40months
Predictors of Survival of Patients Presenting With Stage IV Breast Cancer
                         and an Intact Primary Tumor
                        No.       Hazard Ratio    95% CI          P
Surgery
Resection             69 (37%)       0.71        0.47-1.1        .10
No resection                       Reference
ER status
Positive              127 (68%)      0.47        0.29-0.76       .002
Negative                           Reference
PR status
Positive              74 (40%)       0.57        0.37-0.90       .02
Negative                           Reference
HER-2/neu
Amplified             59 (32%)       0.51        0.34-0.77       .001
Not amplified                      Reference
Age at stage IV
                                      1.0        0.98-1.01       .73
diagnosis
Solitary metastasis
Yes                   24 (13%)        1.2        0.62-2.4        .57
No                                 Reference
Bone metastases
Yes                   122 (66%)       1.7         1.1-2.8        .02
No                                 Reference
Visceral metastases
Yes                   111 (60%)       2.3         1.4-3.6       <.001
No                                 Reference
Local surgery in Stage IV disease
    molecular subtype analysis

                           Kaplan-Meier survival estimates, by surgery triple_neg
               1.00




                                                                            p = 0.004
               0.75




                                                                                                               Not
               0.50




                                                                                                         Triple negative
               0.25




                           p=0.44
                                                                                                          Triple negative
               0.00




                       0                       20                      40                           60
                                                       analysis time
                                 surgery = 0/triple_neg = 0            surgery = 0/triple_neg = 1
                                 surgery = 1/triple_neg = 0            surgery = 1/triple_neg = 1


Surgery had a benefit in non-triple negative
Surgery had no benefit in triple negative
Conclusion: resection of the primary in stage IV breast cancer is associated
with improved survival in some molecular subtypes                                                   Neuman H et al. Cancer 2010
for Change in Management
• Resection of the primary may improve survival
• Better local control at diagnosis may
  • prevent wound problems in future
  • decrease symptoms due to chest wall disease
  • better quality of life
Surgical resection of the primary tumor, chest wall control, and
            survival in women with metastatic breast cancer
Methods: Lynn Sage, Northwestern Memorial Databases from 1995-2005, with
stage IV with intact primary, 27month median f/u, 103 Pts with chest wall information




                                                       44 surgery



                                                   59 no surgery




                                              H Hazard et Al, Cancer 2008
(Hazard HW, Cancer, 2008)




                                      103 patients with               10 (16%)
                                      chest wall info                 palliative surgery
                         44 surgery                   59 no surgery
                                                                      13 (21%)
                                                                      palliative radiation
Chest wall/breast free     36 (82%)                       20 (24%)           p=0.002

Symptomatic chest dz       8 (18%)                        29 (49%)          p=0.002

 Conclusion: Nearly half of patients who do not have primary
resected, will become symptomatic. Early resection can significantly
decrease chest wall/ breast symptoms.
Conclusion (Facts)
• Retrospective evidence that resection the primary
  tumor is associated with improved survival in selected
  Pts
• Chest wall symptoms can be improved with resection
  of the primary
• Basic science evidence suggesting that resection of the
  primary may decrease re-seeding

 For definitive change in standard of care, prospective
 randomized trials are needed.
Randomized trials open or starting
 Location      NCT        Timing             Sample SIZE

 India         00193778   After 6 cycle CH         350
 Turkey        00557986   Before CH                271
 Austria       01015625   Before CH                254
 Netherlands   01392586   Before CH                516
 USA           01242800   After 6 cycle CH         616
 ECOG 2108
ECOG 2108 (Seema Khan P.I.)
      Register 880 women


     Optimal systemic therapy
   70% response/stable disease


    Randomize 616 women

Palliative local   Elective local therapy
 therapy, 308               308
What do we know about
          surgical timing ?
                   Surgery before vs. after      Significant
                     chemotherapy (n)         surgery benefit ?
Boston (Bafford)         36 vs. 24                 Before

Boston (Cady)            30 vs. 45                  Both

MDACC (Rao)              47 vs. 28                  After
   Chicago
                         26 vs. 21                  Both
   (Hazard)
Conclusion (what to do now?)
            When Surgery Reasonable
•   Good response to metastatic sites/non
    response-progression to the primary
•   “one almost positive” (ER+/HER2+) with
    response to the treatment
•   Minimal Stage 4
•   Chest wall recurrence without distant
    metastasis or good response to the distant
    mets

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ABC1 - V. Sacchini - Role of primary site local management for advanced breast cancer patients

  • 1. Role of primary site local management for ABC patients Virgilio Sacchini Breast Service Memorial Sloan-Kettering Cancer Center - New York
  • 2. Historical arguments against surgery in stage IV breast cancer • Patients were debilitated, bulky disease, survival brief • Avoid morbidity for unknown benefit • Measurable disease: can be followed for response • Fear that removal of the primary tumor would result in increased angiogenesis and stimulation of dormant disease
  • 3. National Cancer Database from 1990-93 (Khan SA, Surgery 2002) 6861 (42.8%) no operation 16,023 with Stage IV 9162 (57.2%) partial mastectomy or total mastectomy Survival No surgery
  • 4. National Cancer Database from 1990-93 (Khan SA, Surgery 2002) • Comparing only surgical patients, survival advantage for those with clear margins (for both total mastectomy and partial mastectomy) Survival for Total Mastectomy Patients Clear margins Complete excision better then the debulking
  • 5. National Cancer Database from 1990-93 (Khan SA, Surgery 2002) • Comparing only surgical patients, survival advantage for those with clear margins (for both total mastectomy and partial mastectomy) 5 year survival No operation 6.7% Involved Margins Partial Mast 11.3% Total Mast 11.5% Clear Margins Partial Mast 16.6% Total Mast 18.4%  Conclusion: complete surgical extirpation of the Cancer is associated with improved survival
  • 6. Current perspective - primary tumor surgery in Stage IV Breast Cancer ?? • May not respond to systemic therapy in parallel with metastatic sites ? • grow locally and lead to uncontrolled chest wall disease and impaired quality of life • May serve as a continued source of tumor stem cells? • lead to new metastatic lesions which are resistant to systemic therapy • More “earlier stage 4”
  • 7. Current perspective - primary tumor surgery in Stage IV Breast Cancer ?? • May not respond to systemic therapy in parallel with metastatic sites ? • grow locally and lead to uncontrolled chest wall disease and impaired quality of life • More “earlier stage 4”
  • 8. Studies assessing distant metastasis detected by conventional imaging with PET/CT in patients with primary breast cancer Patients with Patients with distant distant Patient metastases First author Type of study No. patients metastases population detected by detected by conventional PET/CT No. (%) imaging No. (%) Primary tumor Fuster D Prospective 60 3 (5) 8 (13) >3 cm Carkaci S Retrospective Primary IBC 41 13 (32) 20 (49) Alberini J Prospective Primary IBC 62 12 (19) 18 (29) Suspected Heusner T Retrospective 40 7 (18) 10 (25) breast cancer Groheux D Retrospective Stage II and III 39 0 4 (10) Stage IIA Upstaged IV in 5.5% Do we under-treat these early stage IV?) Naoki Niikura, Naoto T. Ueno J Cancer 2010
  • 9. Overview (Neuman H, Cancer 2010) Study Type Years N % surg HR MSKCC 2011
  • 10. Pooled analysis of hazard ratios for overall mortality for surgery versus no surgery for patients with stage-IV breast cancer •10 studies, mostly database or registry driven, with over 30,000 patients studied, about 50% of them had resection of primary •With all the biases, most studies show some survival benefit in patients having surgery Jetske Ruiterkamp et Al: Breast Cancer Research and Treatment, 2010
  • 11. MSKCC Experience (Neuman H, Cancer 2010) • 2000-2004, database review • 186 patients stage IV • Surgery 69 (37%) – No surgery 117 (63%) • Median f/u 53 months • Improvement in median survival from 33months to 40months
  • 12. Predictors of Survival of Patients Presenting With Stage IV Breast Cancer and an Intact Primary Tumor No. Hazard Ratio 95% CI P Surgery Resection 69 (37%) 0.71 0.47-1.1 .10 No resection Reference ER status Positive 127 (68%) 0.47 0.29-0.76 .002 Negative Reference PR status Positive 74 (40%) 0.57 0.37-0.90 .02 Negative Reference HER-2/neu Amplified 59 (32%) 0.51 0.34-0.77 .001 Not amplified Reference Age at stage IV 1.0 0.98-1.01 .73 diagnosis Solitary metastasis Yes 24 (13%) 1.2 0.62-2.4 .57 No Reference Bone metastases Yes 122 (66%) 1.7 1.1-2.8 .02 No Reference Visceral metastases Yes 111 (60%) 2.3 1.4-3.6 <.001 No Reference
  • 13. Local surgery in Stage IV disease molecular subtype analysis Kaplan-Meier survival estimates, by surgery triple_neg 1.00 p = 0.004 0.75 Not 0.50 Triple negative 0.25 p=0.44 Triple negative 0.00 0 20 40 60 analysis time surgery = 0/triple_neg = 0 surgery = 0/triple_neg = 1 surgery = 1/triple_neg = 0 surgery = 1/triple_neg = 1 Surgery had a benefit in non-triple negative Surgery had no benefit in triple negative Conclusion: resection of the primary in stage IV breast cancer is associated with improved survival in some molecular subtypes Neuman H et al. Cancer 2010
  • 14. for Change in Management • Resection of the primary may improve survival • Better local control at diagnosis may • prevent wound problems in future • decrease symptoms due to chest wall disease • better quality of life
  • 15. Surgical resection of the primary tumor, chest wall control, and survival in women with metastatic breast cancer Methods: Lynn Sage, Northwestern Memorial Databases from 1995-2005, with stage IV with intact primary, 27month median f/u, 103 Pts with chest wall information 44 surgery 59 no surgery H Hazard et Al, Cancer 2008
  • 16. (Hazard HW, Cancer, 2008) 103 patients with 10 (16%) chest wall info palliative surgery 44 surgery 59 no surgery 13 (21%) palliative radiation Chest wall/breast free 36 (82%) 20 (24%) p=0.002 Symptomatic chest dz 8 (18%) 29 (49%) p=0.002  Conclusion: Nearly half of patients who do not have primary resected, will become symptomatic. Early resection can significantly decrease chest wall/ breast symptoms.
  • 17. Conclusion (Facts) • Retrospective evidence that resection the primary tumor is associated with improved survival in selected Pts • Chest wall symptoms can be improved with resection of the primary • Basic science evidence suggesting that resection of the primary may decrease re-seeding  For definitive change in standard of care, prospective randomized trials are needed.
  • 18. Randomized trials open or starting Location NCT Timing Sample SIZE India 00193778 After 6 cycle CH 350 Turkey 00557986 Before CH 271 Austria 01015625 Before CH 254 Netherlands 01392586 Before CH 516 USA 01242800 After 6 cycle CH 616 ECOG 2108
  • 19. ECOG 2108 (Seema Khan P.I.) Register 880 women Optimal systemic therapy 70% response/stable disease Randomize 616 women Palliative local Elective local therapy therapy, 308 308
  • 20. What do we know about surgical timing ? Surgery before vs. after Significant chemotherapy (n) surgery benefit ? Boston (Bafford) 36 vs. 24 Before Boston (Cady) 30 vs. 45 Both MDACC (Rao) 47 vs. 28 After Chicago 26 vs. 21 Both (Hazard)
  • 21. Conclusion (what to do now?) When Surgery Reasonable • Good response to metastatic sites/non response-progression to the primary • “one almost positive” (ER+/HER2+) with response to the treatment • Minimal Stage 4 • Chest wall recurrence without distant metastasis or good response to the distant mets

Notas del editor

  1. Pooled analysis of hazard ratios for overall mortality for surgery versus no surgery for patients with stage-IV breast cancer