Combidex

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Combidex

• A Patients Experience

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Who Is This Guy?

• PCa patient
• Diagnosed 1996
• Palmieri
• Initial treatment failure
• Radiation seed implant
• Established local failure
• Could not confirm has it spread ??
• Control w/Intermittent Hormone Therapy

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Who Are You?

• Heard of Combidex?
• Been there?
• Interested?

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Why This Discussion?

• Availability?
• Obstacles
• Cost
• Distance
• How to overcome
• What is the value?

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Why Combidex?

• Searching for a definitive indicator
• of tumor migration outside the capsule.
• All commonly available scan methods
• have questionable specificity.
• CT
• Bone scan
• Prostacint
• PET/CT
• Testing shows Combidex provides
• sensitivity and specificity of 90

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What Combidex?

• Non-invasive evaluation
• MRI scan with special contrast agent
• Contrast is nano particles of iron
• Drip infusion
• Blood macrophages carry
• iron to lymph nodes

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How Combidex

• Normal node
• Spacing allows iron interlace with cells
• MRI scan shows nodes as black
• Cancer invaded node
• Cell spacing dense
• Iron does not interlace
• Scan shows nodes as white

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Where Combidex

• US FDA has not approved the contrast agent
• Only available in The Netherlands
• City of Nijmegen, near Amsterdam

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Cost of Combidex

• Air travel to Netherlands
• 2500 to 3500
• Complete charge from Nijmegen hospital 1900 or
  2470

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Cost of Combidex

• Air travel to Netherlands
• 2500 to 3500
• Complete charge from Nijmegen hospital 1900 or
  2470
• Self pay

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The Financials

• They dont ask for payment upon entry

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The Financials

• They dont ask for payment upon entry
• They dont ask for payment before departure

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The Financials

• They dont ask for payment upon entry
• They dont ask for payment before departure
• They send you an invoice later

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The Financials

• They dont ask for payment upon entry
• They dont ask for payment before departure
• They send you an invoice later
• They accept a US personal check

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The Financials

• They dont ask for payment upon entry
• They dont ask for payment before departure
• They send you an invoice later
• They accept a US personal check
• They trust you!

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The Financials

• They dont ask for payment upon entry
• They dont ask for payment before departure
• They send you an invoice later
• They accept a US personal check
• They trust you!
• Imagine that!

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Concerned About Traveling Overseas?

• Dont be they make it easy
• English spoken there
• The language of international commerce
• All travel providers
• Hotels
• Restaurants
• Medical providers
• People on the street
• Passport

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Arrangements

• Contact UMC St. Radboud hospital
• Nijmegen, Netherlands
• Radiology department
• Solange Estourgie
• S.Estourgie_at_rad.umcn.nl
• Use e-mail!

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My Friend Solange

• French heritage
• Good command of English language
• Responsive
• Helpful

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Travel Tips

• Air travel to Amsterdam (Ahmsterdahm)
• Train connection to Nijmegen
• Ask Solange for
• Hotel contacts
• List
• bookings.com
• Hospital location

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Air Travel

• United Air Lines
• Direct OHare to Amsterdam
• May not be lowest cost
• Investigate

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Money Matters

• Walking around money
• All cash transactions are in Euros -
• Currency exchanges in airport locations, train
  stations, on the street
• US Dollar buys about 1/2 Euro
• ?

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Train Connection

• Great system
• Terminal in Amsterdam Airport
• Trip time 1 ¾ hours
• One train change mid way
• Ask for itinerary
• Train departure times (prompt)
• Platform/track (spoor)

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Train Guide
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The Train

• Modern equipment
• Good condition
• Clean
• Quiet
• Smooth
• Two classes of service
• Second class
• Lowest price
• First class
• Same car
• Same accommodations
• Less crowded

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My Hotel

• Hotel Courage
• Small, family, quaint
• Next to River Waal
• Near town center
• Selection of restaurants
• Walk from train station 20 minutes
• Taxi to hospital
• Ask for English speaking driver
• About 20

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Hotel Courage
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Navigation Aids
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The Hospital

• Newer facility
• Large, sprawling
• Difficult to find the
• correct entrance
• Depend on the taxi driver

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Guidance System

• All facility areas are numbered
• Follow the overhead signs
• Select path that brackets your destination number

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The ProcessDay one

• Consult with the doctor
• Barentz
• Takahashi
• Allergies
• Diabetes
• Glaucoma
• Drip infusion of the
• contrast agent
• 30 minutes
• Doctor attended

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The Doctors

• Barentz Takahashi

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The TestDay Two

• MRI scan
• One hour
• Closely spaced scans
• Consultation
• Immediate review of images
• Preliminary assessment of status
• Copy of all scans provided on CD

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The Report

• Several hours of inspection of scans
• Manual coloring of node status
• Green clear
• Red involved
• Yellow - indeterminate
• Written report of findings
• Selected scan images
• Selected colored images
• Video of 360 rotation of body cavity

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My Results

• Bad news
• Many nodes clear
• Limited number of nodes involved
• Conclusion that disease is metatstatic to the
  lymphatic system
• Credibility
• Some nodes clear indicates contrast agent is
  working
• Some nodes involved indicates sensitivity is good
• First time for a conclusive answer !

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My Opinion

• This is the best assessment for disease spread
  available anywhere
• Better than Partin Tables
• Better than CT, Prostascint, PET/CT
• Better than iodine bone scan
• Better than surgical sampling of lymph nodes

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Its a Must For

• Newly diagnosed
• Know your status before selecting treatment
• Recurrent
• Know the extent of spread

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Factoids

• Most customers are from the US
• About three investigations per week
• Analysis time is the pace setter
• Long lead time for appointments
• About 60 days out
• Provider issues
• Barentz part time
• Takahashi gone home

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A Great Experience

• Easy to accomplish
• Excellent service provider
• Bad news, but now I KNOW
• Worth the cost in time and money
• Id do it again

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Now What?

• Made the long trip
• Invested the time
• Spent the money
• Got an answer
• What are you going to do with the information?

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Alternatives

• Nodes clear
• Seek salvage local therapy
• Seeds
• Cryotherapy
• High Intensity Ultrasound
• Nodes Involved
• Seek systemic therapy

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Nodes Involved

• Seek systemic therapy
• Already using Intermittent Hormone Therapy
• Lupron
• Flutamide
• Finasteride
• Seven years
• Hints of declining effectiveness/failure

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Dans IHT History
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Beyond Hormone Therapy

• If Hormone Therapy fails
• Low Testosterone
• PSA ?
• Prominence of hormone independent cells
• Actually low dependence on Testosterone
• Next level of attack
• Chemotherapy
• Second Line Hormonal Therapy (SLHT)
• Several strategies

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Dr. Myers
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SLHT w/Myers

• Three Major Components
• Ketokonazole
• Estrogen
• Leukine

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Ketoconazole Mechanism

• Originally developed as anti-fungal agent
• Reduces adrenal testosterone
• Directly attacks hormone refractory PCa
• Risk of liver damage
• Hydrocortisone
• Ursodiol
• Oral Administration

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Ketoconazole Dosage

• Every 8 Hours
• On the clock
• Original approach high dose
• Complications
• Digestive upset
• Liver stress
• Recent approach Low dose
• Effective
• Reduced complications

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Estrogen Mechanism

• Suppresses testosterone level
• Direct kill of PCa cells
• Binding to receptor

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Estrogen Administration

• Early attempts with oral administration
• Liver complications
• Blood clots, thrombosis, heart attacks
• Current approach - transdermal patches
• Avoids liver and circulatory
• complications
• High dose rate
• Nine patches at a time

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Leukine

• Stimulates the immune system
• White blood cells from bone marrow
• Directly attacks cancer cells
• Daily injections
• Self administered
• 90 day program

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My Experience

• Limited side effects
• After three months
• PSA 5.2 ? 0.5
• Optimism

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Definitions

• Sensitivity
• The probability that a diagnostic test can
  correctly identify the presence of a particular
  disease assuming the proper conduct of the test
  specifically, the number of true positive results
  divided by the sum of the true positive results
  and the false negative results.
• Specificity
• The probability that a diagnostic test can
  correctly identify the absence of a particular
  disease assuming the proper conduct of the test
  specifically, the number of true negative results
  divided by the sum of the true negative results
  and the false positive results a method that
  detects 95 of true PC cases is highly sensitive,
  but if it also falsely indicates that 40 of
  those who do not have PC do have PC then its
  specificity is only 60.

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DefinitionsPlain Language

• Sensitivity
• True positives
• Percentage of tests that correctly detect
  presence of disease.
• Specificity
• True negatives
• Percentage of tests that correctly declare the
  absence of disease.

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Rumors

• Youll go blind!!
• Iron interlaces the retina
• Only concern is with rare iron overload
  diseases
• It negates future CT scans!!
• The iron stays in your system
• Macrophages transform to hemoglobin 2 weeks
• Hemoglobin lifespan 3 4 months
• Excreted through liver bile