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Evaluating breast cancer control programs

Evaluating breast cancer control programs. R. Sankaranarayanan MD Head, Screening Group World Health Organization (WHO) International Agency for Research on Cancer (IARC) Lyon, France http://screening.iarc.fr. Monitoring & Evaluation. Process measures Participation in screening

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Evaluating breast cancer control programs

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  1. Evaluating breast cancer control programs R. Sankaranarayanan MD Head, Screening Group World Health Organization (WHO) International Agency for Research on Cancer (IARC) Lyon, France http://screening.iarc.fr

  2. Monitoring & Evaluation • Process measures • Participation in screening • Screening quality • Screen positivity • Compliance with referral • Breast cancer/benign tumour detection rates

  3. Process measures for screening test quality • % with radiographically acceptable mammograms (97%) • % undergoing a technical repeat screening test (<3%) • % undergoing additional imaging at the time of screening examination (<5%) • % of women recalled for further assessment • < 7% for initial screening round • < 5% for repeat rounds Perry et al., Annals of Oncology 2008;19:614-622

  4. Monitoring & EvaluationIntermediate outcome measure • % of screen detected cancers that are invasive (~90%) • Stage distribution • Proportion of women with breast cancer  2 cms • Proportion of node negative barest cancer • Proposition of ER +ve tumours • Proportion of patients completing the prescribed course of treatment • Proportion of cancers treated with breast conservation • Case fatality rate • 2 and 5 year survival rates

  5. Monitoring & EvaluationFinal outcome measure • Incidence rate of early and advanced cancers • Mortality from breast cancer in both arms • Adverse events • Quality of life

  6. Sources of data • Program database • Population based cancer registry • National population identity registers • Mortality registration offices • Deaths records from other source (e.g. insurance) • House visits

  7. Randomized trial of breast self-examination in shanghai (1989-1991) 1/2 • Women born between 1925 – 1958 • Randomized women on basis of 519 textile factories • Intervention group • 132 979 women • intensive training in breast self-examination • two subsequent reinforcement sessions and multiple reminders to practice the technique • Control group • 133,085 women • training sessions on the prevention of low back pain • All women followed for the development of breast diseases and for death from breast cancer Thomas et al., J Nalt Cancer Inst 2002;94:1445-57

  8. Randomized trial of breast self-examination in shanghai (1989-1991) 2/2 • 2,387 women with benign breast disease in intervention and 1296 in control group • 3627 biopsies in the intervention and 2398 in the control group • Benign breast disease 2387 in the intervention group and 1296 in the control group • 864 breast cancers in the intervention and 896 in the control group •  T1 disease. 49% in the intervention and 45% in the control group • Breast cancer deaths similar in both groups • 135 (0.10%) in study vs 131 (0.10%) in the control group (CR:1.04, P=0.72) Thomas et al., J Nalt Cancer Inst 2002;94:1445-57

  9. Screening by clinical examination of the breast in a trial in the Philippines • 202 health centres randomized in Manila • 340 000 women aged 35-64 years • Intervention group (151 000 women) • Screening between 1996-1997; 138 400 participated • CBE provided by trained nurses and midwives • Test positivity 2.5% (n = 3479) • Compliance with diagnosis 34% (n = 1220) • Control group • General health education campaigns by municipal authorities and voluntary bodies • Follow-up for cancer incidence and mortality Pisani et al., Int J Cancer. 2006;118(1):149-54

  10. Breast cancer cases diagnosed in the intervention cohort of the Philippines trial Pisani et al., Int J Cancer. 2006;118(1):149-54

  11. Randomized controlled trial of CBE in Mumbai, India(1997-Continuing, Tata Memorial Centre) Dinshaw et al., Oncology. 2007;73:145-153

  12. Randomized controlled trial of CBE in Mumbai, India(1997-Continuing, Tata Memorial Centre) Breast cancer detection rates * Detection rates per screened women Dinshaw et al., Oncology. 2007;73:154-61

  13. Trivandrum Breast Cancer Screening Study (TBCS) Objective: Evaluate the extent of stage shift, survival improvement and mortality reduction observed as a result of a package of interventions consisting of breast awareness, CBE and improving public and professional awareness on breast cancer, its early clinical diagnosis and prompt treatment

  14. Trivandrum Breast Cancer Screening Study (TBCS) Aims: • Decrease the frequency of advanced (stages IIB, III, IV) breast cancers from the current 80% of all breast cancer cases to 55% over a period of 7 years • Decrease the incidence rates of advanced breast cancers by 30% over a 7-year period • Increase 3-year survival of breast cancer patients from the current 55% to 75% • Ultimately reduce breast cancer mortality by 20% in the intervention as compared to the control clusters

  15. 227 clusters randomizedIn Trivandrum District, Kerala, India Control119 clusters Intervention108 clusters Household enumeration, door-to-door identification of eligible women (Age 30-60 years, no debilitating disease) Consent formIndividual questionnaire Consent formIndividual questionnaire Education on BSE, early detection/Rx of breast cancer, CBE, breast clinics, FNAC, biopsy, staging, treatment Education on early detection of cervical neoplasia, cervical early detection clinics, treatment Follow-up for breast and cervix cancer incidence and mortality Trivandrum Breast Cancer Screening Study (TBCS) Study design:

  16. Participation and compliance

  17. Trivandrum Breast Cancer Screening Study (TBCS) Input and early outcome measures: • Diagnostic mammograms: 573 (140/10 000 women) • Diagnostic ultrasonograms: 526 (131/10 000 women) • Diagnostic FNAC: 293 (73/10 000 women) • Excision biopsies: 51 (12/10 000 women)

  18. Trivandrum Breast Cancer Screening Study (TBCS) Characteristic of breast cancers in the study groups (2005-2008)

  19. Percentage of patients presenting in at late stages, Sarawak province, Malaysia Sarawak State Devi et al., Ann Oncol. 2007;18(7):1172-1176

  20. Frequency of early breast cancer and survival in South Korea, 1989-2004University of Ulsan Medical Centres, Seoul (5001 patients) Son BH et al., Arch Surg. 2006 Feb;141(2):155-60

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