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Benjamin O. Anderson, M.D.
Recent advances in breast surgery

Implications of resource limitations

Guideline implementation in LMCs
Recent advances in breast surgery

Implications of resource limitations

Guideline implementation in LMCs
1980s: Breast Conservation Surgery

1990s: Percutaneous Needle Biopsy

1990s: Sentinel Node Biopsy

2000s: Oncoplastic Surgery
RADICAL MASTECTOMY   MODIFIED RADICAL MASTECTOMY
BREAST CONSERVING SURGERY
BREAST CONSERVING RADIATION THERAPY
NSABP B-06:
                                     Effect of Lumpectomy v. Mastectomy on Recurrence
                                            Cohort A                     Cohort B                  Cohort C
 DISTANT DISEASE-FREE SURVIVAL (%)




                                                                           YEAR
                                                            No. of patients / No. of recurrences
Total Mastectomy:                               692/265                    569/233                 494/192
Lumpectomy:                                     699/302                    634/282                 520/236
Lumpectomy + XRT:                               714/278                    628/253                 515/204
Fine needle aspirations

Core needle biopsy

Vacuum-assisted biopsy

Excisional biopsy
Slavin, et al. Plast Reconst Surg 90:854, 1992.
Slavin, et al. Plast Reconst Surg 90:854, 1992
Slavin, et al. Plast Reconst Surg 90:854, 1992
Retrospective review (European Institute of Oncology)

                         Specimen   Negative   Margin
                          Volume    Margins    Width
  GROUP 1 (n=30)
                         200 cm3    25 / 30    8.5 mm
 Oncoplastic Resection
   GROUP 2 (n=30)
                         118 cm3    17 / 30    6.5 mm
  Standard Resection

Kaur et al., Ann Surg Oncol: 12:1, 2005
Recent advances in breast surgery

Implications of resource limitations

Guideline implementation in LMCs
Recent advances in breast surgery

Implications of resource limitations

Guideline implementation in LMCs
Colombia
USA                    Colombia


               BREAST CA             BREAST CA
               Incidence: 101        Incidence:
               Mortality: 19         30.3
               Ratio: 19%            Mortality: 12.5
                                     Ratio:     41%




Globocan 2002 (IARC)
2005             2020     2050




Globocan 2002 (IARC) - Colombia
Globocan 2002 (IARC) - Colombia
India
5 year    DISTRIBUTION
 STAGE     EXTENT
                       SURVIVAL   USA     INDIA
   0     Noninvasive    100%      16%     ----          USA:
                                                    90% DCIS or
                                                    early staged
         Early stage
    I     disease       100%      40%     1%      invasive disease
                                                    at diagnosis

         Early stage
   II     disease        86%      34%     23%
          Locally                                      INDIA:
   III   advanced        57%      6%      52%       76% locally
                                                   advanced or
         Metastatic                                metastatic at
   IV     disease        20%      4%      24%        diagnosis


Sources: SEER Survival Monograph (NCI), 2007;
Chopra, Cancer Institute Chennai, India, 2001
Former British colony
20 million population




                          GHANA
› Two-thirds rural

Literacy:
› 76% male, 54% female

Life expectancy:
› 57 years of age
› “Low level” resources

3.6% HIV positive
Komfo Anokye Teaching Hospital (KATH)
Breast Health Center
Komfo Anokye Teaching Hospital (KATH)
Breast Health Center
Komfo Anokye Teaching Hospital (KATH)
Patient with breast cancer (note visible tethering of patient’s right nipple)
Peace and Love Hospital (Kumasi Private Hospital)
T2N1 – Stage II - breast cancer (typical presentation)
Peace and Love Hospital (Kumasi Private Hospital)
T4N1Mx – Stage IIIB -- breast cancer (common locally advanced presentation)
Peace and Love Hospital (Kumasi Private Hospital)
Recurrent breast cancer in axillary lymph node bed
Breast cancer invariably fatal
Cancer caused by social misbehavior
› Oral / nipple contact
› Dirty clothing
› Wearing money in bra

Mastectomy leads to death within few years
Recent advances in breast surgery

Implications of resource limitations

Guideline implementation in LMCs
Recent advances in breast surgery

Implications of resource limitations

Guideline implementation in LMCs
The Breast Health Global Initiative (BHGI) strives to
 develop, implement and study evidence-based,
economically feasible, and culturally appropriate
  guidelines for international breast health and
   cancer control for low and middle income
  countries to improve breast health outcomes.
Comprehensive guidelines by selected expert panels

  Consensus opinions based on evidence review

  Publication of a) consensus and b) individual manuscripts

Global Summit 2002: Health Care Disparities

Global Summit 2005: Resource Stratification

Global Summit 2007: Guideline Implementation
HEALTH
 PRIMARY
PREVENTION
 SYSTEMS
Basic level — Core resources or fundamental services
necessary for any breast health care system to function.

Limited level — Second-tier resources or services that
produce major improvements in outcome such as survival.

Enhanced level — Third-tier resources or services that are
optional but important, because they increase the number
and quality of therapeutic options and patient choice.

Maximal level — Highest-level resources or services used in
some high resource countries that have lower priority on
the basis of extreme cost and/or impracticality.
CONSENSUS STATEMENTS
                              Early Detection
                              Diagnosis
                              Treatment
                              Health Care Systems
                              8 Stratified Tables
                              10 Individual Manuscripts


Cancer: 113 (8 suppl), 2008
HEALTH CARE SYSTEMS         EARLY DETECTION    DIAGNOSIS




STAGE I              STAGE II   LOCALLY ADVANCED   METASTATIC
“Health care guidelines do not improve
outcome unless they are implemented.”

QUESTION: How can information be
disseminated such that they are
implemented and sustained within a
target country?
Dissemination & implementation (D&I) research

Education and training programs

Technology application and development

IMPLEMENTATION STRATEGY: Create BHGI
Learning Laboratories in different parts of the
world to develop and test educational modules
based on BHGI guidelines and to model program
expansion to other LMCs.
HopeXchange Medical Center
Oct 16, 2008, Kumasi
Breast Cancer Awareness March
Oct 16, 2008, Kumasi
Breast Cancer Awareness March
Oct 16, 2008, Kumasi
Breast Cancer Awareness March
Oct 16, 2008, Kumasi
HopeXchange: Institute for Professional Training
Training in early detection, diagnosis and treatment
adjusted for low-income country resources
– Curriculum based on BHGI Guidelines
– International faculty to teach and learn

D&I methodology applied in-country
Educational outcomes assessed and reported
BHGI / HopeXchange Planning Team
January 31, 2009, Kumasi
Ghana College of Physicians and Surgeons
 – Paul Nyame, MD
Korle-Bu Teaching Hospital
 – Joe-Nat Clegg-Lamptey, MD
Komfo Anokye Teaching Hospital (KATH)
 – Anthony Nsiah-Asare, MD / Baffour Awuah, MD
Peace and Love Hospital
 – Beatrice Wiafe, MD (Kumasi)
Reach for Recovery
 – Gladys Boateng
HopeXchange Medical Center
 – Riccardo Massetti, MD / Mario Cappello
Ghana Breast Cancer Alliance (GBCA) meeting
January 30, 2009, Kumasi
Colombia
National Early Detection Program
Target: Middle-Income Countries
BHGI Breast Early Detection Module (BSM):
– Patient education
– Screening (CBE + mammography)
– Diagnosis (imaging / tissue sampling / pathology)
– Triage to linked diagnosis and treatment programs

Model early detection program for other middle-
income regions of Latin America, Eastern Europe
and Asia Pacific.
Colombian National Early Detection Program
National Cancer Institute, Bogota (1934)
Readiness Assessment Tool Development Project
NCI Director Meeting
Readiness Assessment Tool Development Project
BHGI / NCI Research Team Meeting
Study Design

                   Health Care Centers Randomization
                                                                                         20 HMOs
                      Stratified by Insurance Plan


          Control Group                                  Intervention Group             Informed consent
        Enroll 7,000 women                               Enroll 7,000 women

                                                    Training for primary care MDs,
                                                  nurses, radiologists, technologists   Technical skills training
No intervention in health care center
                                                         and breast specialists         Clinical Breast Exam


       Screening based on                           Implement screening program         Screening invitation,
     current clinical practices                         In health care center           documentation,
                                                                                        patient follow-up,
                                                                                        quality control, etc
       Screening based on                        Screening mammogram with diagnostic
     current clinical practices                       Follow-up in women > age 50


       Follow-up in one year                             Follow-up in one year          Outcome Variables

                                                                                        Clinical stage
                                                                                        Cancer incidence
                                  Statistical Analysis                                  Evaluation of participation
                                                                                        Cost assessment
                                                                                        Adverse effects
Breast Cancer Screening Trial
Public (Regimen Contributivo) Health Care Center Visit
Mamografías en el estudio


      Pruebas                Intervenciòn            Control
Mamografias Solicitadas   3627        100.0%   690             23.1%
Mamografias Realizadas    2681         73.9%   386             55.9%
Instituto Nacional de Salud Publica (Public)
Fundacion Mexicana para la Salud (NGO)
Major advances in breast surgery include breast
conservation surgery, needle sampling for
diagnosis, sentinel node biopsy and oncoplastic
surgery
Improvements in LMCs require adaptation to
existing resources and require coordination of
surgery with other disciplines
Dissemination and implementation through
BHGI Learning Laboratories can steer guideline
application in LMCs
BHGI Executive Committee:
–     Gabriel N. Hortobágyi, Chair (MD Anderson)
–     Annetta Hewko (Komen for the Cure)
–     Joe Harford (NCI Office of International Affairs)
    BHGI Research Team:
–     Wenjin Li, Research Manager
–     David Thomas, Senior Research Advisor
–     Gabrielle Kane, Curriculum Specialist
    BHGI Program Staff:
–     Leslie Sullivan, Senior Program Manager
–     Marisa Hartman, Program Coordinator
–     Sandra Distelhorst, Publication Editor
Early Detection Panel 2007       Treatment Panel 2007
 – Cheng-Har Yip, MD (Malaysia)   – Alexandru Eniu, MD (Romania)

 – Robert Smith, PhD (USA)        – Robert Carlson, MD (USA)



 Diagnosis Panel 2007             Health Care Systems 2007
 – Roman Shyyan, MD (Ukraine)     – Ed Azavedo, MD, PhD (Sweden)

 – Stephen Sener, MD (USA)        – Joe Harford, PhD (USA)




Cancer: 113 (8 suppl), 2008
Italy                    Turkey             Argentina
  – Riccardo Masetti      – Vahit Osmen      – Eduardo Cazap
  – Alberto Costa         – Nuran Bese       Lebanon
 Egypt                    Colombia           – Nagi El Saghir
  – Sharif Omar           – Carlos Rada      Pakistan
  – Ahmed Elzawawy        – Raul Murillo     – Zeba Aziz
  – Mohamed Shalan        – Sandra Diaz
                                             India
 South Africa             Austria            – Raj Badwe
  – Justus Apffelstaedt   – Raimund Jakesz   – Ketayun Dinshaw




Cancer: 113 (8 suppl), 2008
www.bhgi.info

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Bhgi Learning Lab 2009 Pan Arab

  • 2. Recent advances in breast surgery Implications of resource limitations Guideline implementation in LMCs
  • 3. Recent advances in breast surgery Implications of resource limitations Guideline implementation in LMCs
  • 4.
  • 5. 1980s: Breast Conservation Surgery 1990s: Percutaneous Needle Biopsy 1990s: Sentinel Node Biopsy 2000s: Oncoplastic Surgery
  • 6. RADICAL MASTECTOMY MODIFIED RADICAL MASTECTOMY
  • 9. NSABP B-06: Effect of Lumpectomy v. Mastectomy on Recurrence Cohort A Cohort B Cohort C DISTANT DISEASE-FREE SURVIVAL (%) YEAR No. of patients / No. of recurrences Total Mastectomy: 692/265 569/233 494/192 Lumpectomy: 699/302 634/282 520/236 Lumpectomy + XRT: 714/278 628/253 515/204
  • 10.
  • 11. Fine needle aspirations Core needle biopsy Vacuum-assisted biopsy Excisional biopsy
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  • 19. Slavin, et al. Plast Reconst Surg 90:854, 1992.
  • 20. Slavin, et al. Plast Reconst Surg 90:854, 1992
  • 21. Slavin, et al. Plast Reconst Surg 90:854, 1992
  • 22.
  • 23.
  • 24. Retrospective review (European Institute of Oncology) Specimen Negative Margin Volume Margins Width GROUP 1 (n=30) 200 cm3 25 / 30 8.5 mm Oncoplastic Resection GROUP 2 (n=30) 118 cm3 17 / 30 6.5 mm Standard Resection Kaur et al., Ann Surg Oncol: 12:1, 2005
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  • 33.
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  • 35.
  • 36. Recent advances in breast surgery Implications of resource limitations Guideline implementation in LMCs
  • 37. Recent advances in breast surgery Implications of resource limitations Guideline implementation in LMCs
  • 39. USA Colombia BREAST CA BREAST CA Incidence: 101 Incidence: Mortality: 19 30.3 Ratio: 19% Mortality: 12.5 Ratio: 41% Globocan 2002 (IARC)
  • 40. 2005 2020 2050 Globocan 2002 (IARC) - Colombia
  • 41. Globocan 2002 (IARC) - Colombia
  • 42. India
  • 43. 5 year DISTRIBUTION STAGE EXTENT SURVIVAL USA INDIA 0 Noninvasive 100% 16% ---- USA: 90% DCIS or early staged Early stage I disease 100% 40% 1% invasive disease at diagnosis Early stage II disease 86% 34% 23% Locally INDIA: III advanced 57% 6% 52% 76% locally advanced or Metastatic metastatic at IV disease 20% 4% 24% diagnosis Sources: SEER Survival Monograph (NCI), 2007; Chopra, Cancer Institute Chennai, India, 2001
  • 44. Former British colony 20 million population GHANA › Two-thirds rural Literacy: › 76% male, 54% female Life expectancy: › 57 years of age › “Low level” resources 3.6% HIV positive
  • 45. Komfo Anokye Teaching Hospital (KATH) Breast Health Center
  • 46. Komfo Anokye Teaching Hospital (KATH) Breast Health Center
  • 47. Komfo Anokye Teaching Hospital (KATH) Patient with breast cancer (note visible tethering of patient’s right nipple)
  • 48. Peace and Love Hospital (Kumasi Private Hospital) T2N1 – Stage II - breast cancer (typical presentation)
  • 49. Peace and Love Hospital (Kumasi Private Hospital) T4N1Mx – Stage IIIB -- breast cancer (common locally advanced presentation)
  • 50. Peace and Love Hospital (Kumasi Private Hospital) Recurrent breast cancer in axillary lymph node bed
  • 51. Breast cancer invariably fatal Cancer caused by social misbehavior › Oral / nipple contact › Dirty clothing › Wearing money in bra Mastectomy leads to death within few years
  • 52. Recent advances in breast surgery Implications of resource limitations Guideline implementation in LMCs
  • 53. Recent advances in breast surgery Implications of resource limitations Guideline implementation in LMCs
  • 54. The Breast Health Global Initiative (BHGI) strives to develop, implement and study evidence-based, economically feasible, and culturally appropriate guidelines for international breast health and cancer control for low and middle income countries to improve breast health outcomes.
  • 55. Comprehensive guidelines by selected expert panels Consensus opinions based on evidence review Publication of a) consensus and b) individual manuscripts Global Summit 2002: Health Care Disparities Global Summit 2005: Resource Stratification Global Summit 2007: Guideline Implementation
  • 57. Basic level — Core resources or fundamental services necessary for any breast health care system to function. Limited level — Second-tier resources or services that produce major improvements in outcome such as survival. Enhanced level — Third-tier resources or services that are optional but important, because they increase the number and quality of therapeutic options and patient choice. Maximal level — Highest-level resources or services used in some high resource countries that have lower priority on the basis of extreme cost and/or impracticality.
  • 58. CONSENSUS STATEMENTS Early Detection Diagnosis Treatment Health Care Systems 8 Stratified Tables 10 Individual Manuscripts Cancer: 113 (8 suppl), 2008
  • 59. HEALTH CARE SYSTEMS EARLY DETECTION DIAGNOSIS STAGE I STAGE II LOCALLY ADVANCED METASTATIC
  • 60. “Health care guidelines do not improve outcome unless they are implemented.” QUESTION: How can information be disseminated such that they are implemented and sustained within a target country?
  • 61. Dissemination & implementation (D&I) research Education and training programs Technology application and development IMPLEMENTATION STRATEGY: Create BHGI Learning Laboratories in different parts of the world to develop and test educational modules based on BHGI guidelines and to model program expansion to other LMCs.
  • 62. HopeXchange Medical Center Oct 16, 2008, Kumasi
  • 63. Breast Cancer Awareness March Oct 16, 2008, Kumasi
  • 64. Breast Cancer Awareness March Oct 16, 2008, Kumasi
  • 65. Breast Cancer Awareness March Oct 16, 2008, Kumasi
  • 66. HopeXchange: Institute for Professional Training Training in early detection, diagnosis and treatment adjusted for low-income country resources – Curriculum based on BHGI Guidelines – International faculty to teach and learn D&I methodology applied in-country Educational outcomes assessed and reported
  • 67. BHGI / HopeXchange Planning Team January 31, 2009, Kumasi
  • 68. Ghana College of Physicians and Surgeons – Paul Nyame, MD Korle-Bu Teaching Hospital – Joe-Nat Clegg-Lamptey, MD Komfo Anokye Teaching Hospital (KATH) – Anthony Nsiah-Asare, MD / Baffour Awuah, MD Peace and Love Hospital – Beatrice Wiafe, MD (Kumasi) Reach for Recovery – Gladys Boateng HopeXchange Medical Center – Riccardo Massetti, MD / Mario Cappello
  • 69. Ghana Breast Cancer Alliance (GBCA) meeting January 30, 2009, Kumasi
  • 71. Target: Middle-Income Countries BHGI Breast Early Detection Module (BSM): – Patient education – Screening (CBE + mammography) – Diagnosis (imaging / tissue sampling / pathology) – Triage to linked diagnosis and treatment programs Model early detection program for other middle- income regions of Latin America, Eastern Europe and Asia Pacific.
  • 72. Colombian National Early Detection Program National Cancer Institute, Bogota (1934)
  • 73. Readiness Assessment Tool Development Project NCI Director Meeting
  • 74. Readiness Assessment Tool Development Project BHGI / NCI Research Team Meeting
  • 75.
  • 76. Study Design Health Care Centers Randomization 20 HMOs Stratified by Insurance Plan Control Group Intervention Group Informed consent Enroll 7,000 women Enroll 7,000 women Training for primary care MDs, nurses, radiologists, technologists Technical skills training No intervention in health care center and breast specialists Clinical Breast Exam Screening based on Implement screening program Screening invitation, current clinical practices In health care center documentation, patient follow-up, quality control, etc Screening based on Screening mammogram with diagnostic current clinical practices Follow-up in women > age 50 Follow-up in one year Follow-up in one year Outcome Variables Clinical stage Cancer incidence Statistical Analysis Evaluation of participation Cost assessment Adverse effects
  • 77. Breast Cancer Screening Trial Public (Regimen Contributivo) Health Care Center Visit
  • 78. Mamografías en el estudio Pruebas Intervenciòn Control Mamografias Solicitadas 3627 100.0% 690 23.1% Mamografias Realizadas 2681 73.9% 386 55.9%
  • 79. Instituto Nacional de Salud Publica (Public) Fundacion Mexicana para la Salud (NGO)
  • 80. Major advances in breast surgery include breast conservation surgery, needle sampling for diagnosis, sentinel node biopsy and oncoplastic surgery Improvements in LMCs require adaptation to existing resources and require coordination of surgery with other disciplines Dissemination and implementation through BHGI Learning Laboratories can steer guideline application in LMCs
  • 81. BHGI Executive Committee: – Gabriel N. Hortobágyi, Chair (MD Anderson) – Annetta Hewko (Komen for the Cure) – Joe Harford (NCI Office of International Affairs) BHGI Research Team: – Wenjin Li, Research Manager – David Thomas, Senior Research Advisor – Gabrielle Kane, Curriculum Specialist BHGI Program Staff: – Leslie Sullivan, Senior Program Manager – Marisa Hartman, Program Coordinator – Sandra Distelhorst, Publication Editor
  • 82. Early Detection Panel 2007 Treatment Panel 2007 – Cheng-Har Yip, MD (Malaysia) – Alexandru Eniu, MD (Romania) – Robert Smith, PhD (USA) – Robert Carlson, MD (USA) Diagnosis Panel 2007 Health Care Systems 2007 – Roman Shyyan, MD (Ukraine) – Ed Azavedo, MD, PhD (Sweden) – Stephen Sener, MD (USA) – Joe Harford, PhD (USA) Cancer: 113 (8 suppl), 2008
  • 83. Italy Turkey Argentina – Riccardo Masetti – Vahit Osmen – Eduardo Cazap – Alberto Costa – Nuran Bese Lebanon Egypt Colombia – Nagi El Saghir – Sharif Omar – Carlos Rada Pakistan – Ahmed Elzawawy – Raul Murillo – Zeba Aziz – Mohamed Shalan – Sandra Diaz India South Africa Austria – Raj Badwe – Justus Apffelstaedt – Raimund Jakesz – Ketayun Dinshaw Cancer: 113 (8 suppl), 2008