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Prostate Cancer Patient- Reported Outcomes:

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(1)

Prostate Cancer Patient- Reported Outcomes:

What Do We Know and What is Still Unknown

Ronald Chen, MD MPH

Associate Professor, Dept Radiation Oncology University of North Carolina at Chapel Hill

(2)

Why Do We Study PROs?

• To help patients make an informed decision on treatment

Prostate cancer: many treatment options – similar cure rates, but different side effects (confusing)

Clinicians need high-quality research data to communicate to their patients

• Helps clinicians treat side effects -- thereby improving the lives of cancer survivors

(3)

Litwin MS, et al. JAMA 273:129-35, 1995.

(4)

PROs in Prostate Cancer

• Relatively well-studied

• Multiple validated instruments

Some in multiple languages

• Numerous prospective cohort studies examined PROs after prostate cancer treatments

(5)

WHAT DO WE KNOW?

(WHAT DO PATIENTS NEED TO KNOW?)

(6)

Surgery vs. Radiotherapy

• PROS-QA Study

1,201 patients

Recruited from: Harvard (Beth-Israel), Cleveland Clinic, Wash U, Michigan, UCLA, MD Anderson Validated instrument: Expanded Prostate Cancer

Index Composite (EPIC-26)

Sexual function, urinary incontinence, urinary obstruction, bowel function, hormone

Sanda MG, et al. NEJM 358:1250-61, 2008.

(7)

PROS-QA: Sexual Function

Nerve sparing better recovery

Erections (ability, quality, frequency), orgasm

(8)

PROS-QA: Urinary Function

Burning, bleeding, weak stream, frequency

(9)

PROS-QA: Bowel Function

Urgency, frequency, blood, pain, incontinence

(10)

PROS-QA: Hormonal/Vitality

Hot flashes, breast, energy, weight

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What Do We Not Know (1)

• How to communicate these research results to patients?

(12)

PROS-QA: Sexual Function

Nerve sparing better recovery

Erections (ability, quality, frequency), orgasm

(13)

What Do We Not Know (1)

• How to communicate these research results to patients?

What is a clinically-meaningful difference?

1/2 standard deviation (yes/no)

What does this “feel” like to the patient?

(14)
(15)

What Do We Not Know (2)

• Does treatment affect everyone the same way?

Of course not

• Patient with normal sexual function at

baseline: “what are my chances of preserving function after treatment?”

Patient with poor sexual function at baseline

(16)

PROS-QA: Sexual Function

Nerve sparing better recovery

Erections (ability, quality, frequency), orgasm

(17)

Functional Levels

• Prostate Cancer Symptom Indices

Chen RC, et al. J Clin Oncol 27:3916-22, 2009.

(18)

Functional Levels

• Prostate Cancer Symptom Indices

Chen RC, et al. J Clin Oncol 27:3916-22, 2009.

(19)

Functional Levels

• Prostate Cancer Symptom Indices

Chen RC, et al. J Clin Oncol 27:3916-22, 2009.

(20)

What Do We Not Know (3)

• Outcomes of “real world” patients

• Most PRO studies are published by a few institutions

Are these results generalizable to your patient?

My results are likely different than Dr. Sanda’s Are results the same across countries?

• Need studies including patients from smaller hospitals

• Need every physician everywhere to collect PRO as part of clinical care

(21)

Collecting PRO in Clinic

• Weekly assessment of PROs during RT

Start easy: paper

While patient waiting to see physician

Real-time feedback to physician for symptom management

Allows me to describe outcomes to my (potential) patients

• Easy buy-in from patients, nurses

(22)
(23)

Collecting PRO in Clinic

• Collect PRO during treatment for management of acute symptoms

Diao K, et al (Chen). Practi Radiat Oncol, in press.

(24)

What Do We Not Know (4)

PROs of new treatments

Comparative outcomes of modern treatment options

New exciting treatment technologies: robotic surgery, Cyberknife, proton radiation treatment

Do these really improve quality of life?

New treatments (e.g. abiraterone, enzalutamide)

Do current instruments fully capture relevant PROs?

PRO researchers need to keep up with the rapidly evolving treatments – timely results

(25)

Rapid Technology Advances

Sheets (Chen). JAMA 307(15):1611-20, 2012.

100 20 3040 50 6070 8090 100

2000 2001 2002 2003 2004 2005 2006 2007 2008

Radiation, %

Year of radiation

IMRT non-IMRT

Almost complete diffusion of IMRT in 8 years

(26)

Rapid Technology Advances

By 2009: 64% robotic

Hu JC. JAMA 302(14):1557-64, 2009.

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What Do We Not Know (4)

PROs of new treatments

Comparative outcomes of modern treatment options

New exciting treatment technologies: robotic surgery, Cyberknife, proton radiation treatment

Do these really improve quality of life?

New treatments (e.g. abiraterone, enzalutamide)

Do current instruments fully capture relevant PROs?

PRO researchers need to keep up with the rapidly evolving treatments – timely results

(28)

What Do We Not Know (5)

• Other potentially important aspects:

Regret

Anxiety about disease

• For each patient, what is his most important domain?

• Can we use PROs to help individualize the care of prostate cancer patients and survivors?

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Summary

• Patient reported outcomes play a central role in helping patients make informed decisions in prostate cancer

• Large body of literature, much is still unknown

• Continued research (clinical, methodology) will directly impact the lives of cancer

survivors

Referencer

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