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Wendy S.

Harpham, MD, FACP


www.wendyharpham.com

Wendy S. Harpham has no conflicts of interest


regarding this presentation.

H
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RESEARCH
3% adults w/ ca in trials (vs 8O% peds)
6O% trials accrue enough patients

PATIENT CARE
Cure sometimes, relieve as often as possible,
and comfort always.
Hippocrates

Complexity of Science
Modern Patients
Empowered
Access to med info
Distressed

Trial Rx
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BEST

MED

Complexity of Science
Modern Patients
Stopping Rx
Uncertainty

Watch/Wait

On/Off Label Rx

Trial Rx

Hospice Rx
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Nov 1990: Dx Stage III indolent NHL

11/90-05/91:
06/92-07/92:
08/92:
01/93-05/93:

Promace MOPP chemotherapy (CR)


XRT mini-mantle XRT (CR)
Bone marrow harvest
Interferon

05/93: Recurrent disease

Nov 1990: Dx Stage III indolent NHL

11/90-05/91:
06/92-07/92:
08/92:
01/93-05/93:

Promace MOPP chemotherapy (CR)


XRT mini-mantle XRT (CR)
Bone marrow harvest
Interferon

05/93: Recurrent disease

Watch and wait


Standard chemo
Auto BMT (no sib match for allo)
Clinical trials

Nov 1990: Dx Stage III indolent NHL

11/90-05/91:
06/92-07/92:
08/92:
01/93-05/93:

Promace MOPP chemotherapy (CR)


XRT mini-mantle XRT
(CR)
Bone marrow harvest
Interferon

06/93-09/93: Phase I IDEC C2B8, Stanford


06/93-09/93: Phase I IDEC C2B8, Stanford
02/94-05/94: Phase I/II trial IDEC C2B8
02/95-10/95: FND chemotherapy
05/97-08/97: Phase I/II trial C2B8, Dallas
05/9806/98: Rituximab
12/0511/07: GM-CSF + Rituximab
03/14: routine follow-up NED

(PR)
(PR)
(CR)
(CR)
(CR)
(CR)
(CR)
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Best
Empower
Support
Tool

Manage uncertainty
Encourage
Decide

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Verbalize the Mission

Calms fear of being sweet-talked


Calms fear of being a guinea pig
Humanizes legal protections

My goal is to help you


determine the best treatment.
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Fact: Trials are designed


to answer scientific questions.

Can researchers
really want
whats best for me?

COMPASSION

Your welfare is always


my top priority.
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No track record
Few patients benefit

TRUST

Standard Rx

chance recovery

Phase I Trial

? chance recovery

Knowing all the facts


leads you to the best decision.
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Emotions

Perceptions

Beliefs

Social pressures
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Stopping treatment
is giving up, failing,
losing the battle.

Battle imagery no longer useful

Best is an informed decision


in keeping with your values.
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Stress
Stress
Urgency
Urgency

More than you want to get going,


you want to make the best decision.
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Evaluation
Your accurate reporting enables me to give you
expect.
an accurate assessment of what you can expect
and hope for.
Weigh Options

Decide
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Focus only on options that


offer reality-based hope.

?
Watch/Wait

On/Off Label Rx

Trial Rx

Hospice Rx

Quackery
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Declining trial means letting


go of one hope.

Trial Rx

Hospice Rx

Quackery
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Hope for rare recovery


Hope for slow progression
For better trial
For new Rx

Declining trial means letting go


of hope treatment can help.
Realistic hope is about
what is possible.
Hospice Rx
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Can expect one thinghope for another

Hope doesnt have to be strong

Benefit from unique balance


Where there is hope, there is life.
Harpham
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Instincts
Both options offer hope.

All hopes
Real Chance

Trial Rx

Hospice Rx
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Meaning matters
I want you to explore meaning,
but with others.
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REGRET

Trial
Wish Id used
my time better.

Hospice
Wish Id had
that chance.

NO REGRET

Trial
Glad I did
everything.

Hospice
Glad I used my
time well.

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BMT

Seattle Stanford

Chemo

W&W

+++

++

+/-

----

+/?

--

----

+++

+++

++

----

----

----

---

-?

+?

+++

---

-?

+?

+++

---

+++?

--

+++

---

+++

+++

--

+++

---

++?

++?

--

+++

---

--

--

+++

+++

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Unexpected problems are


familiartreatable.
Cancer exposes the
uncertainty.

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Clarify Options
I have confidence

in you.

Weigh Options
You have the info and tools.

I will support
your decision.

Decide

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They have
confidence

in me.

Clarify Options I have the

info and tools.

Weigh Options

They will
support
my decision.

Decide
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Evaluation
Best decision

Empower
Support
Tool

Weigh Options

Manage uncertainty

Encourage

Decide

Decide
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Nov 1990: Dx Stage III indolent NHL

11/90-05/91:
06/92-07/92:
08/92:
01/93-05/93:

Promace MOPP chemotherapy (CR)


XRT mini-mantle XRT
(CR)
Bone marrow harvest
Interferon

06/93-09/93: Phase I IDEC C2B8, Stanford


06/93-09/93: Phase I IDEC C2B8, Stanford
02/94-05/94: Phase I/II trial IDEC C2B8
02/95-10/95: FND chemotherapy
05/97-08/97: Phase I/II trial C2B8, Dallas
05/9806/98: Rituximab
12/0511/07: GM-CSF + Rituximab
03/14: routine follow-up

(PR)
(PR)
(CR)
(CR)
(CR)
(CR)
(CR)
(CR)

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The best decision for each patient


is the best decision for everyone.

Phase I trials offer choice, hope, meaning.


For some patients, Phase I treatment is best.

Wendy S. Harpham, MD
www.wendyharpham.com

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