Thermal Ablation Techniques for Breast Cancer

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Thermal Ablation Techniques for Breast Cancer

• Jo Anne Zujewski Ted Trimble
• Cancer Therapy Evaluation Program
• Division of Cancer Diagnosis and Treatment
• National Cancer Institute

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Minimally invasive local therapies

• Multiple modalities in development
• cryoablation, radiofrequency ablation, focused
  ultrasound, interstitial laser, microwave devices
  
• Multiple NCI sponsored investigators expressed
  interest in developing these devices
• Workshop help in conjunction with SABCS December
  2006 with multidisciplinary intergroup
  attendance to discuss research development
  strategies

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Potential benefits/risks

• Benefits
• Increased access in remote areas, improved
  cosmesis, decreased health care costs (avoids
  operating room costs)
• Disadvantages
• Margin status cannot be obtained with current
  imaging modalities
• Need for nodal staging does not avoid surgical
  procedure (at present)
• Long term outcomes are currently excellent
  randomized trials of outcome not feasible given
  the need for large sample sizes and changing
  technologies

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Take home points from 2006

• There is interest in developing these
  technologies in breast cancer
• Of the many potential applications, the most
  enthusiasm is for small invasive T1 tumors
• DCIS is of interest for the future. At present
  imaging modalities are not optimal for DCIS.
• The excellent long-term outcome for these
  patients must be maintained (3 at 10 years)

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Take home points 2

• Early phase development could consist of a series
  of well-designed pilot studies of the ablate and
  resect design
• Imaging outcomes will be co-developed studies
  may be powered for imaging endpoints
• Genomic profiling for prognosis potentially in
  lieu of surgical nodal biopsy- may be answered in
  next 3-5 years

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Take home points 3

• Outcomes for short term studies
• Ability to ablate tumor in vast majority of
  patients in multi-center setting (is 100
  reasonable?)
• No-go for given technology if the ablation
  technology results in residual positive MARGINS
  in a that is greater that in first surgical
  excision (suggest 30)
• Goal is to improve upon the results for first
  surgical excision, as the correction for
  positive margins with ablative technologies is
  not possible

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Take home 4

• Short term trials should include reliable measure
  of cosmesis
• Cosmesis is important-but not at the risk of
  increased local failures
• Is it feasible to do a non-inferiority RCT in
  this very good risk population?
• Consider alternatives-follow treated groups
  long-term to ensure that local recurrence is
  acceptable (less than 3 at 10 years)
• Potential problem-technologies safe in very low
  risk will likely spread to higher risk
  population that have not been tested

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Action items post 2006 meeting

• Two pilot feasibility and safety trials under
  development
• ACOSOG study
• Cryoablation
• ACRIN study
• HIFU (MRI guided focused ultrasound)