Phillip Bretz, M'D' Richard Lynch, D'O'

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PHARMACOGENOMICS DIGITAL
INFRARED LIQUID NITROGEN

• Phillip Bretz, M.D. Richard Lynch, D.O.
• INFRARED INSTITUTE OF THE DESERT

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BREAST CANCER FACTS

• 240,000 new cases annually with 43,000 deaths
• The most common cancer in women except lung
• The biggest killer of women between the ages of
  40 and 55
• One woman dies of breast cancer every fifteen
  minutes (still)

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EVOLUTION OF UNDERSTANDING

• Halstead Theory 1800s Tumor spread by direct
  extension to lymph nodes under the arm. Did you
  get it all generation.
• Natural History Breast cancer should be thought
  of as a systemic disease (From N.S.A.B.P.)
  clinical trials.
• Mircometastasis/Occult metastasis
• Trying to treat with multiple drugs/surgery/radiat
  ion with heterogeneity the big problem
• Coming full circle because of technology,
  Pharmacogenomics, Digital Infrared Imaging,
  Liquid Nitrogen (cryogenic probe).

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OLD PARADIGMmammograms, MRIs,
BSGIs, chemo, surgery, radiationonly 60 of
women with insurance have annual mammo

• MORE RADIATION
• MORE ANXIOUS WAITING PERIODS
• DRAMATIC INCREASE IN COST
• PROLONGED TREATMENT WITH SURGERY,
• CHEMOTHERAPY AND RADIATION
• FINANCIAL AND FAMILY RUIN
• A WOMAN DIES FROM BREAST CANCER EVERY FIFTEEN
  MINUTES (still)

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ROBERT FROST PARADIGM

• NO RADIATION
• 10 BILLION DOLLARS/YEAR SAVED
• NO ANXIOUS WAITING
• TREATMENT IN ONE DAY
• NO SURGERY, CHEMO OR RADIATION
• NO FINANCIAL RUIN
• PUTTING DEATHS FROM BREAST CANCER INTO THE
  HISTORY BOOKS

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ROBERT FROST PARADIGM

• Pharmacogenomics Applying the human genome
  technology to breast cancer diagnosis and
  treatment.
• Digital Infrared Breast Imaging Exploiting the
  zeroth law of thermodynamics, identifying heat
  signatures of developing cancers from
  hypermetabolism to neo-angiogenesis
• Liquid Nitrogen Using the probe to freeze the
  identified ultrasmall tumor down to -200F.

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PHARMACOGENOMICS

• Utilizing the predictive value of OncoVue
  (genetics risk test) to dictate accelerated
  infrared imaging/management
• Saliva DNA analysis
• Identifying SNPs single nucleotide
  polymorphisms (abnormal sequencing of nucleotides
  in the DNA double helix)
• Key is predictive value in pre, peri and post
  menopausal time periods

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LIQUID NITROGEN

• 3MM CRYOGENIC PROBE
• UNDER LOCAL ANESTHESIA
• DONE OUTSIDE HOSPITAL
• TREATMENT IN ONE DAY
• NORMAL ACTIVITY AFTER
• DRAMATIC LOWERING OF COST

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DIGITAL INFRARED BREAST IMAGING WITH
ROBERT FROST

• No harmful radiation
• No breast compression
• For women of all ages especially with dense
  breast tissue, implants and pregnancy
• FDA approved
• Immediate results, no anxious waiting period
• Dramatically lower costs

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IR BREAST IMAGING WITH SENTINEL BREAST
SCAN

• Analysis by computerized algorithms
• Artificial intelligence software (neural network)
• IR has Physiologic and predictive value
• Used in conjunction with OncoVue in an
  accelerated fashion to exploit the predictive
  value of OncoVue
• Currently FDA approved as adjunct procedure with
  mammography, etc.

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BREAST IR TECHNICAL DATA

• FLIRs A40 digital infrared camera
• Field of view/Min focus distance 24X18/0.3m
  (.98ft)
• Spatial Resolution 1.3mrad (can image heat
  generated from a tumor at 1.5mm)
• Thermal sensitivity _at_ 30 C 0.08C
• Image Frequency 50/60Hz, non-interlaced
• Focusing automatic or manual
• Detector focal plane array, un-cooled micro
  bolometer 320,240 pixels
• During each test the breasts are air cooled

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OUR DATA

• Physicians Level 1 IR certified by FLIR
• First 300 IR cases as of 10/07
• Infrared Institute of the Desert began IR breast
  imaging late November 2006
• 502 OncoVue patients
• 40 combined IR and OncoVue
• Physician performs all scans

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ONCOVUE PLUS IR

• 40 patients out of 300 or 13
• Below average risk - 5
• Low risk 5
• Average risk 5
• Above average risk 12
• High risk 8
• Very High risk 4
• Flipper (low risk now AAR later) - 1

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BREAST CANCERS DIAGNOSED
WITH IR

• 27 breast cancers confirmed on biopsy or 9
• 13 had pure IDC or 48 of cancer patients
• 2 inflammatory cancers or 7.4 of patients
• 6 pure DCIS or 22 of cancer patients
• 1 infiltrating colloid carcinoma or 3.7
• 1 infiltrating lobular carcinoma or 3.7
• 1 had two cancers in one breast DCIS and IDC or
  3.7, another had bilateral cancer (1)
• 1 neuroendocrine tumor (rare) or 3.7
• 1 mixed IDC and DCIS

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BREAST CANCER DIAGNOSED WITH
IR CONTINUED

• 21/27 or 77 mammo and IR agreed
• 1 or 3.7 refused mammogram
• 3 or 11 had false negative mammo
• 13 or 48 had positive physical exam
• 13 or 48 had positive ultrasound

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IR POSITIVE BIOPSY NEGATIVE

• 9 patients suspicious for cancer on IR had
  negative biopsy for cancer, false rate 22
• All 9 had pathology, e.g. not normal
• overall sensitivity rate of 100
• Of the 40 patients we thought had cancer on IR 31
  did for a specificity rate of 78
• 4/9 or 44 had fat necrosis, most frequent
• 8/9 or 88 mammo IR agreed on biopsy

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NEGATIVE IR

• 135/300 or 45 patients had IR, 109(80)
  agreement with mammo
• 22/135 or 16 with IR underwent biopsy to
  exclude cancer and all except one was benign or
  false negative rate of .74

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RE-CAP FACTS

• False positive rate 22
• False negative rate .74
• Sensitivity rate 100
• Specificity rate 78
• 31 cancers identified or 10.3 of 300 pts.
• 4 other site cancers identified or 1.3 pts.
• 1 arterial occlusion

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MOST INFLUENTIAL SOURCE

• Threshold - 27/27 or 100
• Neural Network - 19/27 or 70
• Comments - 19/27 or 70
• Evaluation - 17/27 or 62
• Patient Score 11/27 or 40
• Neural Network - 19/27 70, - 10/27, 37
• Patient Score - 11/27, 40, -17/27, 62

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PRIOR LUMPECTOMY COMBINED WITH
RADIATION AND IR

• 17 patients had prior lumpectomy RT
• 10 had external beam radiation 59
• 7 patients had mammosite 41
• All were at least one year out from RT
• 8 had negative IR findings 47
• 9 had mixed findings 52 (pending)
• 0 had positive IR for recurrent cancer

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MRIs ORDERED DUE TO IR

• 75/300 had MRI with abnormal IR or 25
• 18/75 24 had totally negative MRI
• 34/75 45 had indeterminate findings
• 6/75 8 had bilateral findings
• 9/75 12 were indeterminate for DCIS
• 60.7 MRI had some findings
• 5/75 6.6 had agreement with IR for CA
• 49/75 65 total indeterminate findings
• 14/75 18 IR positive (pending)

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PENDING

• 48 patients are pending or 16
• Biggest reason is multiple small targets on MRI
  or no specific identifiable target
• These patients may alter current data

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OTHER CANCERS DIAGNOSED
WITH IR

• 2 Lung cancers
• 2 Patients with CLL (chronic lymphocytic
  leukemia) picked up axillary nodes
• 1.3 of patients
• 1 patient with occlusion of distal superficial
  femoral /popliteal artery was detected

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HIGH RISK MASTECTOMY NO!
EPIGENOMICS

• With supressor genes identified we believe we can
  affect the outcome!
• Life style changes (diet and exercise)
• Active prevention (Tamoxifen/Evista)
• Accelerated surveillance with IR
• Vaccine trials
• Supplements (large doses of Vit D)

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OTHER DATA

• 1 male out of 300
• 2mm smallest benign lesion
• 5mm smallest malignant lesion
• 1 patient stopped the study because the wind was
  too cold
• 1 patient had hot implants in 115 degree heat
  and could not cool

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CONCLUSION

• While melding Pharmcogenomics, Digital
• Infrared and Cryoablation is a work in
  progress we believe there are now definitely
• two roads to go down either
• Old paradigm
• or
• Robert Frost Paradigm
• Its up to Americas women

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• www.DesertBreastInstitute.com