Randomized Trial of Breast Self-Examination in Shanghai: Final Results

							Self-Examination or no Self-
Examination?


That is the question on this 8th day of
January, 2003.

Krista Moreno Roybal, MD
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
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

   Women’s actions speak louder than
    words
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
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
Data processing and Analysis
   No clustering effect

   Stratification based on the hospital
    affiliation of factory

   Categorical variables were compared
    using chi-square
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
RESULTS
   COMPLIANCE
       Baseline instruction-high attendance-
        98.5%
       Reinforcement sessions – decreasing
        attendance –
            Session 1 – 95%
            Session 2 – 83%
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
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
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”
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
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
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
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%)
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
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
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
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
Positioning
   Clinical breast exam requires flattening
    the breast tissue against the patient’s
    chest
       The lateral tissue
       The medial tissue

       Breast Boundaries-tissue extends laterally
        toward the axilla and superiorly toward the
        clavicle
Examination Pattern
Thoroughness 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
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
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
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
Bottom Line
   Screening CBE’s 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