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Breast Cancer in the Developing World: Meeting the Unforeseen Challenge to Women, Health, Equity Towards an Inclusive Cl PowerPoint Presentation
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Breast Cancer in the Developing World: Meeting the Unforeseen Challenge to Women, Health, Equity Towards an Inclusive Clinical Trials Research Agenda. Julie R. Gralow, M.D. Professor and Director, Breast Medical Oncology University of Washington School of Medicine

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slide2

Breast Cancer in the Developing World: Meeting the Unforeseen Challenge to Women, Health, Equity

Towards an Inclusive Clinical Trials Research Agenda

Julie R. Gralow, M.D.

Professor and Director, Breast Medical Oncology

University of Washington School of Medicine

Fred Hutchinson Cancer Research Center

Seattle Cancer Care Alliance

towards an inclusive clinical trials research agenda in breast cancer areas for study
Towards an Inclusive Clinical Trials Research Agenda in Breast Cancer Areas for Study
  • Epidemiology
  • Risk Factors (including genetics)
  • Risk Reduction (Prevention)
  • Screening and Early Detection
  • Diagnosis
  • Treatment
  • Quality of Life and Survivorship
slide4
Breast Cancer TreatmentWhy Treatments Effective in One Population Are Not Always Appropriate for Other Populations
  • Resource differences
  • Cultural and social differences
  • Cancer differences
  • Patient differences
  • Etc….
slide5
Cancer DifferencesGenomic Profiling of Cancer: Breast Cancer is NOT One Disease!Multiple breast cancer subtypes

Luminal Subtype A

Luminal Subtype B

Basal Subtype

Normal Breast–like

HER-2+

  • Subtypes vary with respect to:
  • Likelihood of recurrence
  • Sites of metastases
  • Response to treatment
  • Frequency of subtypes varies across populations –additional subtypes likely exist

Sorlie et al, Proc NatlAcadSci 100:8418, 2003

slide6

Patient DifferencesPharmacogenomics: Inherited Differences in Enzymes that Metabolize Cancer Drugs Can Lead to Differences in Efficacy and Toxicity

We inherit different forms of the enzyme that metabolizes

tamoxifen: CYP2D6

% of US Caucasian population

78%

15%

7%

What are the genetics in the rest of the world?

Tamoxifen is an inactive drug – it needs to be converted to its active forms

Rapid metabolizer

Intermediate metabolizer

Poor metabolizer

Plasma endoxifen levels

Jin Y et al, J Natl Cancer Inst 2005

ukraine breast cancer assistance project 1997 2000
Ukraine Breast Cancer Assistance Project1997-2000
  • US Agency for International Development (USAID)
  • Program for Appropriate Technology in Health (PATH)
  • Ukrainian Ministry of Health
  • University of Washington
ukraine breast cancer assistance project goals
Ukraine Breast Cancer Assistance Project Goals
  • To strengthen breast cancer services throughout Ukraine
    • Screening
    • Diagnosis
    • Treatment
    • Rehabilitation

Treatment project goal:

To define effective, practical therapies that can be delivered safely

assessment of systemic treatment practice in ukraine 3 oblasts
Assessment of Systemic Treatment Practice in Ukraine (3 Oblasts)
  • Limited discussion of disease + treatment – “Don’t say the word”
  • Treatment decisions based on drug cost/availability, not science
  • Number of cases treated and exact regimens difficult to determine
  • Most newly diagnosed patients got preoperative chemotherapy for 10-12 months
  • Very low doses of chemotherapy used – “Ukrainian women cannot tolerate “Western” doses”
slide10

Survival Related to Delivered Doseof Adjuvant Chemotherapy

20 Year Follow-up of a Milan Study

If chemotherapy is given, it should be given at the full dose as proven to work in clinical trials

Overall survival

Control

1.0

0.9

<65% of dose

0.8

65-84% of dose

0.7

85% of dose

0.6

Probability of Overall Survival

0.5

0.4

0.3

0.2

0.1

0.0

5

10

15

20

Years after Mastectomy

Bonadonna G et al, N Engl J Med 332,1995

slide11

Ukraine Preoperative Chemotherapy Clinical Trial: Designed in Partnership

Pre-Treatment Evaluation

Biopsy for diagnosis of invasive breast cancer (+ tissue bank)

Evaluation of local/regional and possible metastatic disease

Preoperative Chemotherapy

ADRIAMYCIN 60 mg/m2 + CYTOXAN 600 mg/m2

Intravenously every 3 weeks x 4 doses

(Trial supplied chemotherapy only, no supplies or supportive care drugs)

Surgery

Mastectomy or lumpectomy with lymph node dissection

Post-Surgical Treatment

Not specified per study: Could include further chemotherapy, hormone therapy, or radiation

ukraine breast cancer assistance project outcomes
Ukraine Breast Cancer Assistance Project Outcomes
  • “Western” doses of chemotherapy safe and effective
  • Education + experience with clinical trials
  • Presentation of results at national + international conferences
  • Unexpected development: Refusal of surgery by some women with significant responses
  • Consent process created dialogue between physician and patient
from don t say the word in 1997 to the 1 st march for life and hope in 2001 kiev ukraine
From “Don’t Say the Word” in 1997 to the 1st “March for Life and Hope” in 2001 Kiev, Ukraine