Evaluating breast cancer control programs

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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
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Monitoring Evaluation

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

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Process measures for screening test quality

• with radiographically acceptable mammograms
  (?97)
• undergoing a technical repeat screening test
  (
• undergoing additional imaging at the time of
  screening examination (
• of women recalled for further assessment

Perry et al., Annals of Oncology 200819614-622
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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

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Monitoring EvaluationFinal outcome measure

• Incidence rate of early and advanced cancers
• Mortality from breast cancer in both arms
• Adverse events
• Quality of life

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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

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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 2002941445-57
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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 (CR1.04, P0.72)

Thomas et al., J Nalt Cancer Inst 2002941445-57
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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. 2006118(1)149-54
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Breast cancer cases diagnosed in the intervention
cohort of the Philippines trial
Pisani et al., Int J Cancer. 2006118(1)149-54
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Randomized controlled trial of CBE in Mumbai,
India(1997-Continuing, Tata Memorial Centre)
Dinshaw et al., Oncology. 200773145-153
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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. 200773154-61
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Objective
Trivandrum Breast Cancer Screening Study (TBCS)

• 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

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Aims
Trivandrum Breast Cancer Screening Study (TBCS)

• 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

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Study design
Trivandrum Breast Cancer Screening Study (TBCS)
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Participation and compliance
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Input and early outcome measures
Trivandrum Breast Cancer Screening Study (TBCS)

• 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)

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Characteristic of breast cancers in the study
groups (2005-2008)
Trivandrum Breast Cancer Screening Study (TBCS)
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Percentage of patients presenting in at late
stages, Sarawak province, Malaysia
Sarawak State
Devi et al., Ann Oncol. 200718(7)1172-1176
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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 Feb141(2)155-60