1. An Integrated Approach to Breast Cancer Control A flexible approach that can be adapted to national or local circumstances

2. Incidence and Mortality

3. Age-Specific Incidence

4. Age-Specific Mortality

5. Linking Early Detection with Treatment Screen Positive Mortality data (Screened or study patients or population) Screened Diagnosis made/not Staged or not Refuse therapy Receive therapy after delay (good/bad) Receive prompt therapy (good/bad) Survival for x years

6. Outline of an Approach  Education/recruitment and screening are undertaken at multiple peripheral sites – community health centers – or a mobile site  Peripheral sites screen either by CBE or mammography, complete relevant data modules and send to the data center, or enter data via an internet site.  Mammograms, if done could be read immediately, at intervals of a few days, or digital transmission could be used  Second reading of mammogram may be performed at a referral center, either national site or international by film or digital transmission –Improves quality –A valuable training opportunity  Screen positive persons are referred to a regional hospital or the cancer center for diagnosis, and treatment and completion of additional data modules  All treatment decisions are taken by a combined team of surgeon, radiation and medical oncologists. Ideally, the treatment approach should be defined and identical for screened and unscreened patients.  Treatment progress and outcome is recorded on data forms

7. Mammography versus CBE  In most low and middle income countries, it will not be possible to undertake large screening mammography programs because of limited availability of equipment, technical and professional expertise, and the potential impact on other health programs  Clinical breast examination may be performed instead. This requires less equipment, but well trained personnel to do the examination – in some countries, only doctors are allowed to  Some screening centers may use one method and some another –Ultrasound may also be considered, although this also requires equipment (more readily available) and skilled professionals –If enough women are screened, the pros and cons of each approach can be examined –Over time, more women may undergo mammography as additional machines are acquired and expertise developed  Whatever methods are adopted, quality assurance is required

8. Comparison with Unscreened Patients  At all hospital sites, until total screening coverage is obtained unscreened patients will continue to present.  Such patients can be compared to screened patients (if required, separately for CBE and mammography) with respect to stage of disease, treatment administered and treatment outcome, (if followed up).  A third group of patients that may need separate analysis are screen negative patients presenting some time after screening

9. Mammography Site Hospital/ Cancer Center Registry/ Data Center Community Health Center/Clinic

10. Logigram Central Diagnostic And Treatment Facility Data Center District or Gynae Hospital; Biopsy, Screening Mammography? Educational Recruitment and Screening Facilities; Screen Positive Persons Referred for Diagnosis and Treatment Standard (Unscreened) Referrals From Primary Care Physicians or Other Sources Some Interval Occurrences in Previously screen Negative Persons Records of all patients screened and all diagnoses made are kept at each institution/clinic and provided to the Data Center

11. Data Collection  It is imperative to collect data at all steps in the process  Each participating clinic/hospital/center should be assigned a number  Each person screened or presenting with possible breast cancer should be assigned a number  Personal identifiers may include name and address for purposes of contacting the person, but data can be readily anonymized for purposes of analysis or submission to the data center if required  Project coordination can be from within the country or outside the country (e.g., via data transmissions by e- mail or direct data entry into a web site.

12. Data Collection Templates Module 1: Identifiers and Demographics Module 2: Education Module 3: Recruitment Module 4: Clinical Breast Examination Module 5: Mammography Module 6: Diagnostic Work-up Screen Positive Module 7: Referral - no screening Module 8: Consultation; not screened Module 9: Pathology Module 10: Epidemiology Module 11: Family History; females Module 12: Family History; males Module 13: Past History Module 14: Disease Sites Module 15: Stage Module 16: Receptor Status Module 17: Treatment Module 18: Treatment Response Use of Modules Detection center: 1 - 4 or 5 Diagnostic center: 6 - 9 Treatment center: 13 – 18 Optional: 10 – 12 Summary Modules Module 19: Summary - Overview Module 20: Summary - Screening Center Module 21: Summary - Diagnostic Center Module 22: Summary - Treatment Center

13. Implementation  Implementation of an integrated program for breast cancer control will require a number of steps to be taken, including: –Identification of all key figures and involvement in decisions about the program –Identify screening sites, diagnostic sites and treatment sites and develop uniform approaches to each element, including data collection –Identify training needs, additional staff and trainers, and develop appropriate curricula

14. Outcome Measures  Extent of disease and survival in screened and unscreened patients –stage distribution –overall survival and survival by stage  Delay in diagnosis and in initiating treatment: –Time from first symptom to the start of treatment in screened and unscreened patients –Time from screening to the start of treatment in screen positive patients –Time to diagnosis and time from diagnosis to definitive treatment in screen positive patients

15. Potential Weaknesses  The study is not randomized, such that if differences between screened and unscreened patients are found, these could be, in part, due to biases: –Patients with slowly growing disease may account for a higher fraction of cases in the screened group –Patients may appear to survive longer if detected earlier (by screening).  In patients screened for the first time, these biases may be overwhelmed by the detection of patients with relatively advanced cancer who have not sought medical advice and have a poor treatment outcome  Unless treatment is identical for all patients, differences in survival may arise from differences in treatment  If a high fraction of patients refuse therapy, survival (or mortality) comparisons will be difficult or impossible to interpret

16. Strengths  Although the study design has weaknesses, it will lead to more uniform and disciplined treatment of women with breast cancer  Since all women will be followed up, better information on response to therapy and survival, regardless of how the cancer is detected, should be obtained  This approach should provide an indication of the benefits (or lack of benefits) of screening, although such benefits may change over time due to: –Increased awareness of breast cancer (whether from directed programs or not), may result in overall earlier stage and an improved treatment outcome even in unscreened women. –If screening is performed at 2-5 year intervals, the first screening round is likely to include more patients with advanced cancer who have previously failed to take medical advice.  If data is collected, the effect on outcome of various subgroups within the populations can be examined and biases quantified

17. Medline Bibliography Breast cancer control in developing countries