SelfExamination or no SelfExamination

1
Self-Examination or no Self-Examination?

• That is the question on this 8th day of
• January, 2003.
• Krista Moreno Roybal, MD

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To Shanghai we must go

• Randomized Trial of Breast Self-Examination in
  Shanghai Final Results David B. Thomas, Dao Li
  Gao, Roberta M. Ray, Wen Wan Wang, Charlene J.
  Allison, Fan Liang Chen, Peggy Porter, Yong Wei
  Hu, Guan Lin Zhao, Lei Da Pan, Wenjin Li,
  Chunyuan Wu, Zakia Coriaty, Ilonka Evans, Ming
  Gang Lin, Helge Stalsberg, Steven G. Self
  
  Journal of the National Cancer
  Institute, Vol. 94, No.19, October 2, 2002
• The goal to determine whether Breast Self-Exam
  (BSE) reduces the of women dying of breast
  cancer

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What do the Guidelines and the Women say

• The U.S. Preventive Health Services Task Force
  states there is insufficient evidence to
  recommend for or against
• Womens actions speak louder than words

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Study Design

• 266, 064 current and retired textile workers,
  from 519 factories
• Ages 30-64
• Randomized by factory to a group receiving
  instruction on BSE or control
• Intervention- intensive instruction both in
  groups and individually

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Did you get it right? Or are you still around?

• Approximately 2400 women from each arm of the
  study, were evaluated for proficiency at six
  different intervals. The women were given 4 min
  to palpate three silicone models
• BSE workers visited each factory every 1-2 months
  to report on deaths, transfers and retirements

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Data processing and Analysis

• No clustering effect
• Stratification based on the hospital affiliation
  of factory
• Categorical variables were compared using
  chi-square

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RESULTS

• RANDOMIZATION
• The two groups were similar with respect to risk
  factors for breast cancer and other variables
• The factories in instruction and control groups
  were also similar with respect to hospital
  affiliation, of employees, time of initiation
  of trial activities

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RESULTS

• COMPLIANCE
• Baseline instruction-high attendance- 98.5
• Reinforcement sessions decreasing attendance
• Session 1 95
• Session 2 83

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RESULTS

• PROFICIENCY
• Instruction Group higher proportion
  consistently found lumps
• Lump-detecting ability was greatest immediately
  after the video, and declined to pre-video
  proficiency by 1 year later

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RESULTS

• INTERMEDIATE VARIABLES
• Slightly fewer women in the instruction group
  were diagnosed with breast cancer, but the
  difference was not statistically significant (p
  .47)
• Instruction group 864
• Control group - 896
• The number of women with benign biopsies was more
  than double

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RESULTS

• DETECTION AND TREATMENT OF
• How was the Breast Cancer Found?
• Only 2.7 and 3.6 initially found by CBE
• 81.9 reportedly found by BSE
• Comparable information was not ascertained in the
  control group, 96.4 found them accidentally or
  by themselves

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RESULTS

• MORTALITY
• Instruction group 4.0 died
  and 7.4 left the STIB
• Control group 4.5 died
  and 7.5 left the STIB
• 0.12 of the women in the instruction and
  control groups developed Breast CA and Died

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RESULTS

• SURVIVAL
• Eliminated any affect of lead-time bias
• No difference in survival from breast cancer for
  women from the two arms of the study

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Discussion

• Duration adequate
• N-number large
• Intervention appropriate
• Randomization well done as
  well as Exclusions
• Women worked in factories of equal size, hospital
  affl, and diagnostic facilities

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Blinding Issue

• Patients and Investigators were not blinded.
• Effect of behavioral changes on overall decreased
  mortality in the instruction group
• Also, more women in the instruction group had
  breast-conserving surgeries (4.4 vs 2.7)

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Conclusions Reasonable

• YES. All things considered, this study showed
  that the efficacy of BSE for decreasing breast
  cancer mortality is UNPROVEN
• Intensive instruction did not reduce mortality
  from Breast CA
• Programs to encourage BSE in absence of
  mammography would be unlikely to reduce mortality
• Women who choose to do BSE may have increased
  chance of having benign biopsy

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External Validity

• Is this data generalizable? Does this apply to
  women outside rural China, where there was no
  access to mammography?
• Implications unclear in women with routine mammos
  and who are very motivated and proficient in BSE

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What about CBE?

• The clinical breast exam is widely recommended
  and practiced
• Its effectiveness is dependent on its precision
  and accuracy
• On a recent collection of evidence by JAMA,
  reported in The Rational-Clinical examination
  here is some info on the best technique to use

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Data Synthesis

• Indirect evidence supports the effectiveness of
  CBE, especially when women are screened with both
  CBE and mammography
• The proper technique includes
• Positioning
• Thoroughness of the search
• Vertical-strip search pattern
• Proper position and movement of the fingers
• CBE duration of at least 3 minutes per breast

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Positioning

• Clinical breast exam requires flattening the
  breast tissue against the patients chest
• The lateral tissue
• The medial tissue
• Breast Boundaries-tissue extends laterally toward
  the axilla and superiorly toward the clavicle

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Examination PatternThoroughness of the Search

• Palpation begins in the axilla and extends in a
  straight line down the midaxillary line to the
  bra line.
• The entire breast tissue is covered in this
  manner, between the clavicle and the bra line in
  a vertical fashion

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Proper position and movement of fingers

• The 3 middle fingers are held together, with the
  MCP joints slightly flexed.
• The pads, not tips, of the fingers are the
  examining surfaces
• Each area is palpated by making small circles, as
  if following the edge of dime
• 3 different pressures-light, med, deep, are used
  at each spot to ensure palpation at all levels of
  tissue

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Duration of exam

• A careful exam of an average-sized breast takes 3
  minutes
• This is much longer than the 1.8 min most
  physicians take to exam both breasts and teach SBE

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Other Issues

• Palpation of supraclavicular and axillary regions
  to detect adenopathy is standard though UNTESTED
• Palpation of nipple should be same. Some texts
  call for squeezing nipple to express
  discharge-NOT USEFFUL PROGNOSTIC FACTOR
• Inspection-Importance UNPROVEN, no adequate data
  support recommendations

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Bottom Line

• Screening CBEs should be conducted for women at
  risk for Breast Cancer, women older than 40 years
  of age
• A well-conducted CBE can detect 50 of
  asymptomatic cancers and may contribute to
  reduction of mortality rate