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From the

ESO-MBC Guidelines Task Force

to the

First Consensus Conference for
Advanced Breast Cancer

                     Fatima Cardoso, MD
           ESO Breast Cancer Program Coordinator
Director Breast Cancer Unit & Breast Cancer Research Program
                 Champalimaud Cancer Center
                       Lisbon, Portugal
THE MAGNITUDE OF THE PROBLEM


        1 out of 8 women
will have BC during their lifespan
Death is (usually) due to distant
           metastases
           In Europe :
1 diagnosis every 2,5 minutes
  1 death every 6,5 minutes
Are guidelines needed?


     Breast Cancer
Despite ↑ incidence - ↓ mortality


  * Screening & early diagnosis
  * Education & advocacy
         but also
  * Better treatment options
  * Better treatment strategies
BUT
The evolution as been
quite different between
adjuvant and
metastatic settings
   WHY?
Different diseases?
Different biology?
Different aims?
Different attitude of
physicians?
Advances in EARLY BC are measured in YEARS (DECADES)
OS of MBC pts between 1974 - 2000
            1.0




             .8


                                                              1995-2000

             .6                              1990-1994




             .4                                    1985-1989

                                                     1980-1984

             .2                                            1974-1979



            0.0
                  0         12               24             36            48   60
Giordano SH, et al, Cancer 100:44-52, 2004
                                                  Months


      Advances in METASTATIC BC are measured in DAYS – MONTHS
             (max: few years; median survival MBC= 2-3 yrs)
                      Are MBC guidelines needed? definitely YES
RISK OF RECURRENCE REMAINS PRESENT THROUGHOUT ALL
                     PATIENTS’ LIFETIME
             16

             14                            Saphner T et al. J Clin Oncol 1996; 14: 2738–2746.

Recurrence 12
                                                            Node-negative
rate/year (%)
              10                                            Node-positive

              8

              6

              4

              2

              0
               0     1    2   3   4    5       6      7      8      9     10
                                                                         Time (years)

                   Are MBC guidelines needed? definitely YES
COMPLIANCE WITH GUIDELINES LEADS TO
           IMPROVED OUTCOMES

• 1,541 women with node(-) disease treated in Quebec 1988-1994
• Applied 1992 St. Gallen risk criteria and treatment
  recommendations
• Risk category and compliance with guidelines were significant
  independent predictors of survival (p<.0005)




                                          Hebert-Croteau, et al. JCO 2004
Compliments of                                                    Conducted by




         Wide-reaching assessment of the needs/preferences of 1342 women
          living with MBC in 13 countries (USA, UK, France, Spain, Poland, Belgium,
          Mexico, Argentina, Egypt, Australia, Brazil, Canada, Venezuela)




   On January 25, 2008, the Metastatic Breast Cancer (MBC) Advocacy Working Group comprised
    of 16 patient advocates groups from 7 countries, convened in New York, to share insights on
    the current obstacles and discuss potential solutions for better addressing unmet needs of
    women with MBC.
Bridge Survey - Key Findings
       MBC Receives Too Little Attention
•Almost 6 in 10 women in Europe feel that MBC receives too little
attention in general, and 54% say EBC receives more attention
than MBC.

•Most women do not feel that healthcare professionals,
researchers, the media, women with EBC, and the governments
pay enough attention to MBC.

•Many women advocate for an increase in a wide variety of MBC-
related educational or support activities, especially support
groups and written materials, but also conferences.
Bridge Survey - Key Findings
               GUILT! FEAR! LONELINESS!

•Throughout the survey there is a worrying picture of feelings of
guilt, abandonment, isolation, and loneliness during the hard
journey through MBC..

• 44% of respondents reported being afraid to talk open about
their disease and 52% said their friends and family were uneasy
talking about the disease.

• 78% of women living with MBC had never participated in a
clinical trial & 56% of these women were never invited to
consider a clinical trial.

                      Editorial: Cardoso, The Breast 18 (2009) 271–272
TIME TO CHANGE!
ESO–MBC Task Force Recommendations

Preparatory work:
Task Force created; meetings; some decisions:

   1. MBC guidelines cannot be rigid
   2. Should be built on principles and not on specific
      treatment regimens
   3. Need to be in line with latest research findings (biology…)

             1st Session: EBCC-4 (Nice, March 2006):
               Are MBC guidelines possible? YES


               1st step: 12 Statements (Principles)
12 Statements ESO-MBC Task Force




        The Breast 16, 9–10, 2007
ESO–MBC Task Force Recommendations
  2nd Step: Discuss each statement in detail and
 provide recommendations for each specific topic

              2nd Session:
              EBCC-5 (Berlin, April 2008)

              1. Can metastatic breast cancer be cured?
              2. Management of CNS metastases:
                 A new era for a growing problem
              3. Treating metastatic breast cancer:
                 Is more always better?
ESO–MBC Task Force Recommendations




         Cardoso et al, J Natl Cancer Inst 2009; 101: 1174–1181




      Pagani O, Senkus E, et al. J Natl Cancer Inst 2010; 102: 1–8




                         Manuscripts available in www.abc-lisbon.org
ESO–MBC Task Force Recommendations
          2nd Step: Discuss each statement in detail and
         provide recommendations for each specific topic

                      3rd Session: EBCC-7
                      (Barcelona, March 2010)

1. Follow-up issues in MBC:
   a. How should MBC be followed?
   b. Should MBC be diagnosed as early as possible?
2. Open questions on chemo and endocrine therapies in MBC:
   a. What patients need their doctors to focus on?
      (patient and doctor perspective)
   b. How many lines of therapy should be given?
   c. Role of maintenance therapy
                                              Manuscripts in preparation
TIME TO CHANGE!

Do ABC1 attendees agree?

      With the enthusiastic support of Eisai.
          A very special THANK YOU to
               Susan McCutcheon!
      … and to all who answered the survey.
So far, 224 Responses from over 50 countries
               (72% are Healthcare Professionals)

Over 80% agree that generally the treatment of ABC is not as
                 high profile, as early BC
             In your opinion, why is treatment of ABC not as high profile, as early BC?


                     Lack of clinical trials in this area
  Lack of clear and applicable management guidelines
                            Lack of patient motivation
                 Lack of charity work targeted at ABC
                       Lack of funding for treatments
                            Lack of clinical resources
                      Less of a governmental priority
                  Lack/less of advocacy involvement
     Lack of high level evidence for treatment options
                                   It is too challenging
                        Lack of clear treatment goals
                                                            0.00   0.50   1.00   1.50   2.00   2.50   3.00
NCCN and ESMO guidelines are used by many
       but not all & there are gaps

        Why would international consensus guidelines for ABC be useful?


80.0%

70.0%

60.0%

50.0%

40.0%

30.0%

20.0%

10.0%

0.0%
        Would not be   Help improve Help ensure      Help ensure     Help ensure    Help improve Other (please
          of help         patient   consistency of      funding       consistent       resource    specify)
                        outcomes        care         available for   training and   allocation for
                                                      the optimal    education of        ABC
                                                     management       health care
                                                        of ABC         providers
How can we ensure success of ABC1 guidelines?

What measures do you suggest to increase the implementation
of the international consensus guidelines being developed at
the ABC1 conference worldwide?

            Publication
            Patient Advocacy Involvement
            Good Quality Guidelines
            On-going Education Regionally and Locally
            Lobbying Government and Health Care Providers
            Use Digital Media / Internet to Spread
            Adoption by Other Groups (NCCN, ESMO, WHO etc)
            Widespread Circulation to all Oncologists
TIME TO CHANGE!

Apply the main principles of modern oncology:
    Multidisciplinary treatment
     Specialized breast cancer units
     Evidence-based medicine
           (please STOP “eminence-based” medicine!!)
     Individualized (tailored) therapy

 Remember the specificities of ABC setting

 Patient’s preferences & active participation
TIME TO CHANGE!

            IT IS OUR RESPONSIBILITY
        REACH THE CONSENSUS GUIDELINES

    APPLY THE GUIDELINES IN OUR CLINICAL PRACTICE

                  SPREAD THE WORD!

            DEMAND (specially advocates!)
           IMPLEMENTATION OF GUIDELINES

TOGETHER WE CAN and WE WILL
     MAKE THE CHANGE!
      MEDIAN SURVIVAL:
    from years to decades!

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ABC1 - F. Cardoso - Opening and introduction

  • 1. From the ESO-MBC Guidelines Task Force to the First Consensus Conference for Advanced Breast Cancer Fatima Cardoso, MD ESO Breast Cancer Program Coordinator Director Breast Cancer Unit & Breast Cancer Research Program Champalimaud Cancer Center Lisbon, Portugal
  • 2. THE MAGNITUDE OF THE PROBLEM 1 out of 8 women will have BC during their lifespan Death is (usually) due to distant metastases In Europe : 1 diagnosis every 2,5 minutes 1 death every 6,5 minutes
  • 3. Are guidelines needed? Breast Cancer Despite ↑ incidence - ↓ mortality * Screening & early diagnosis * Education & advocacy but also * Better treatment options * Better treatment strategies
  • 4. BUT The evolution as been quite different between adjuvant and metastatic settings WHY? Different diseases? Different biology? Different aims? Different attitude of physicians?
  • 5. Advances in EARLY BC are measured in YEARS (DECADES)
  • 6. OS of MBC pts between 1974 - 2000 1.0 .8 1995-2000 .6 1990-1994 .4 1985-1989 1980-1984 .2 1974-1979 0.0 0 12 24 36 48 60 Giordano SH, et al, Cancer 100:44-52, 2004 Months Advances in METASTATIC BC are measured in DAYS – MONTHS (max: few years; median survival MBC= 2-3 yrs) Are MBC guidelines needed? definitely YES
  • 7. RISK OF RECURRENCE REMAINS PRESENT THROUGHOUT ALL PATIENTS’ LIFETIME 16 14 Saphner T et al. J Clin Oncol 1996; 14: 2738–2746. Recurrence 12 Node-negative rate/year (%) 10 Node-positive 8 6 4 2 0 0 1 2 3 4 5 6 7 8 9 10 Time (years) Are MBC guidelines needed? definitely YES
  • 8. COMPLIANCE WITH GUIDELINES LEADS TO IMPROVED OUTCOMES • 1,541 women with node(-) disease treated in Quebec 1988-1994 • Applied 1992 St. Gallen risk criteria and treatment recommendations • Risk category and compliance with guidelines were significant independent predictors of survival (p<.0005) Hebert-Croteau, et al. JCO 2004
  • 9. Compliments of Conducted by  Wide-reaching assessment of the needs/preferences of 1342 women living with MBC in 13 countries (USA, UK, France, Spain, Poland, Belgium, Mexico, Argentina, Egypt, Australia, Brazil, Canada, Venezuela)  On January 25, 2008, the Metastatic Breast Cancer (MBC) Advocacy Working Group comprised of 16 patient advocates groups from 7 countries, convened in New York, to share insights on the current obstacles and discuss potential solutions for better addressing unmet needs of women with MBC.
  • 10. Bridge Survey - Key Findings MBC Receives Too Little Attention •Almost 6 in 10 women in Europe feel that MBC receives too little attention in general, and 54% say EBC receives more attention than MBC. •Most women do not feel that healthcare professionals, researchers, the media, women with EBC, and the governments pay enough attention to MBC. •Many women advocate for an increase in a wide variety of MBC- related educational or support activities, especially support groups and written materials, but also conferences.
  • 11. Bridge Survey - Key Findings GUILT! FEAR! LONELINESS! •Throughout the survey there is a worrying picture of feelings of guilt, abandonment, isolation, and loneliness during the hard journey through MBC.. • 44% of respondents reported being afraid to talk open about their disease and 52% said their friends and family were uneasy talking about the disease. • 78% of women living with MBC had never participated in a clinical trial & 56% of these women were never invited to consider a clinical trial. Editorial: Cardoso, The Breast 18 (2009) 271–272
  • 13. ESO–MBC Task Force Recommendations Preparatory work: Task Force created; meetings; some decisions: 1. MBC guidelines cannot be rigid 2. Should be built on principles and not on specific treatment regimens 3. Need to be in line with latest research findings (biology…) 1st Session: EBCC-4 (Nice, March 2006): Are MBC guidelines possible? YES 1st step: 12 Statements (Principles)
  • 14. 12 Statements ESO-MBC Task Force The Breast 16, 9–10, 2007
  • 15. ESO–MBC Task Force Recommendations 2nd Step: Discuss each statement in detail and provide recommendations for each specific topic 2nd Session: EBCC-5 (Berlin, April 2008) 1. Can metastatic breast cancer be cured? 2. Management of CNS metastases: A new era for a growing problem 3. Treating metastatic breast cancer: Is more always better?
  • 16. ESO–MBC Task Force Recommendations Cardoso et al, J Natl Cancer Inst 2009; 101: 1174–1181 Pagani O, Senkus E, et al. J Natl Cancer Inst 2010; 102: 1–8 Manuscripts available in www.abc-lisbon.org
  • 17. ESO–MBC Task Force Recommendations 2nd Step: Discuss each statement in detail and provide recommendations for each specific topic 3rd Session: EBCC-7 (Barcelona, March 2010) 1. Follow-up issues in MBC: a. How should MBC be followed? b. Should MBC be diagnosed as early as possible? 2. Open questions on chemo and endocrine therapies in MBC: a. What patients need their doctors to focus on? (patient and doctor perspective) b. How many lines of therapy should be given? c. Role of maintenance therapy Manuscripts in preparation
  • 18. TIME TO CHANGE! Do ABC1 attendees agree? With the enthusiastic support of Eisai. A very special THANK YOU to Susan McCutcheon! … and to all who answered the survey.
  • 19. So far, 224 Responses from over 50 countries (72% are Healthcare Professionals) Over 80% agree that generally the treatment of ABC is not as high profile, as early BC In your opinion, why is treatment of ABC not as high profile, as early BC? Lack of clinical trials in this area Lack of clear and applicable management guidelines Lack of patient motivation Lack of charity work targeted at ABC Lack of funding for treatments Lack of clinical resources Less of a governmental priority Lack/less of advocacy involvement Lack of high level evidence for treatment options It is too challenging Lack of clear treatment goals 0.00 0.50 1.00 1.50 2.00 2.50 3.00
  • 20. NCCN and ESMO guidelines are used by many but not all & there are gaps Why would international consensus guidelines for ABC be useful? 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Would not be Help improve Help ensure Help ensure Help ensure Help improve Other (please of help patient consistency of funding consistent resource specify) outcomes care available for training and allocation for the optimal education of ABC management health care of ABC providers
  • 21. How can we ensure success of ABC1 guidelines? What measures do you suggest to increase the implementation of the international consensus guidelines being developed at the ABC1 conference worldwide? Publication Patient Advocacy Involvement Good Quality Guidelines On-going Education Regionally and Locally Lobbying Government and Health Care Providers Use Digital Media / Internet to Spread Adoption by Other Groups (NCCN, ESMO, WHO etc) Widespread Circulation to all Oncologists
  • 22. TIME TO CHANGE! Apply the main principles of modern oncology: Multidisciplinary treatment  Specialized breast cancer units  Evidence-based medicine (please STOP “eminence-based” medicine!!)  Individualized (tailored) therapy Remember the specificities of ABC setting Patient’s preferences & active participation
  • 23. TIME TO CHANGE! IT IS OUR RESPONSIBILITY REACH THE CONSENSUS GUIDELINES APPLY THE GUIDELINES IN OUR CLINICAL PRACTICE SPREAD THE WORD!  DEMAND (specially advocates!) IMPLEMENTATION OF GUIDELINES TOGETHER WE CAN and WE WILL MAKE THE CHANGE! MEDIAN SURVIVAL: from years to decades!