Dobson DaVanzo & Associates, LLC Vienna, VA 703.260.1760 www.dobsondavanzo.com

Prostate Cancer Patients Report on Benefits of Proton Therapy: Follow-on Study

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PRESENTED TO: The National Proton Conference

PREPARED FOR: The National Association for Proton Therapy (NAPT)

PREPARED BY:Joan DaVanzo, Ph.D., M.S.W., and Kevin Reuter

April 1, 2014

• The National Association for Proton Therapy (NAPT) commissioned Dobson DaVanzo & Associates, LLC (Dobson | DaVanzo) to investigate clinical outcomes and patient satisfaction through a follow-on study to a 2013 report of patients treated with proton therapy for prostate cancer

• Our 2014 results are highly consistent with the results from the 2013 study

• We also present new analyses based on information captured in a revised and enhanced survey instrument

Purpose and Overview

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• Last year’s survey was completed by approximately 2,000 prostate cancer therapy patients who received proton therapy between 1991 and 2010

• The survey instrument collected information related to:• Patient demographics• Patient clinical characteristics• Pre-treatment complaints• Post-treatment Health Related Quality of Life (HRQOL)• Patient satisfaction

• The survey incorporated a validated instrument, known as the Expanded Prostate Index Composite (EPIC), developed by the University of Michigan and UCLA to measure prostate cancer patients’ self-reported HRQOL• Scores were calculated on a 1-100 scale with 100 indicating the best

HRQOL

2013 Survey Overview

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• The 2014 NAPT survey was completed by 3,798 prostate cancer therapy patients who received proton therapy between 1991 and 2013

• This was approximately twice the number of patients completing the 2013 survey and represents approximately 17% of all patients who received proton therapy for treatment of prostate cancer during this time period

• Surveys were completed by former patients across 12 different proton therapy centers, an additional 5 centers from 2013

• The survey instrument collected similar information to the 2013 survey, as well as additional information on

• Patient demographics, including health insurance and education• Patient clinical characteristics, including pre-treatment chronic conditions• Patients’ decision to choose proton therapy

• This year’s survey continued to collect important HRQOL information, but used the validated short-form EPIC instrument to reduce burden on respondents

2014 Survey Overview

• High levels of patient satisfaction• Approximately 99% of respondents believed they had made the best

treatment decision for themselves• Post-treatment HRQOL comparable to healthy individuals

• Those who received proton therapy for the treatment of prostate cancer had similar urinary, bowel, and hormonal HRQOL measures as a cancer-free control group

• There were some differences across treatment modalities• Respondents treated with photon therapy in addition to proton therapy

had lower bowel, sexual, and hormonal HRQOL scores compared to those receiving only proton therapy (p<0.05)

• Respondents treated with hormone therapy in addition to proton therapy had lower sexual and hormonal HRQOL scores compared to those receiving only proton therapy (p<0.05)

2013 Survey Results

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• Baseline statistics calculated on the patient population (e.g., age, time since treatment, clinical characteristics)

• EPIC scores and patient satisfaction statistics also calculated for survey respondents

• HRQOL measures cross tabulated with time since completion of proton therapy, age, pre-treatment health status, and treatment modality (proton therapy only, hormone therapy in addition to proton, and photon therapy in addition to proton)

• Multivariate regression analyses used to identify significant predictors of high HRQOL scores

2014 Survey Methodology

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Patient Demographics

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2013 Survey 2014 Survey

Average Age 69.1 Years 70.2 YearsAverage Time Since Treatment 1.8 Years 4.1 Years% Receiving Only Proton Therapy 79.9% 80.9%Median Pre-Treatment PSA 4 to 9.99 4 to 9.99Median Pre-Treatment Gleason 6 7

Average Time Since Treatment

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Less Than 6 Months

1 Year 2 Years 3 Years 4 Years 5 Years 6-10 Years

10+ Years

0%

10%

20%

30%

40%

50%

60%53%

24%

5%3% 2% 2%

6% 5%8%

16% 15% 15%11% 9%

19%

7%

2013 Survey

2014 Survey

Time Since Treatment

% o

f Res

po

nd

ents

Distribution of Respondents by Time since Treatment

• Health insurance• 61% Commercially-insured• 51% Medicare• 8% Military health insurance• 6% MediGap

• Education• 99% high school graduates or additional education• 68% completed 4-year college degree or additional education

• Chronic conditions prior to treatment• 1.1 chronic conditions on average• Most commonly reported chronic conditions:

• 42% high blood pressure or hypertension• 18% arthritis or rheumatism• 11% diabetes

Patient Demographics: New Information Collected in 2014 Survey

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• Of those responding to the 2014 survey:

• 98% believed they had made the best treatment decision for themselves

• 98% rated their proton therapy experience as “excellent” (88%) or “good” (10%)

• 96% were “satisfied” (15%) or “extremely satisfied” (81%) with their proton therapy treatment

• 96% have recommended proton therapy to others

Patient Satisfaction in 2014 Comparable to 2013 Survey Group

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• 97% of respondents reported no recurrence of cancer• This is consistent with recent findings from a study by the

University of Florida1 and favorable compared to other treatment modalities• According to a recent estimate, 10 to 30% of prostatectomy patients

have a recurrence of prostate cancer during their lifetime• According to a 2006 study, 11% of IMRT patients have a recurrence of

prostate cancer within 8 years following their treatment3

Recurrence of Prostate Cancer: 2014 Survey

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Sources: 1. University of Florida Proton Therapy Institute. (2014). Proton therapy for prostate cancer results in long-term patient survival and excellent quality of life.

2. Patient Advocates for Advanced Cancer Treatments. (2012). Prostate Cancer Recurrence After Prostatectomy3. Zelefsky et. al (2006). Long-Term Outcome of High Dose Intensity Modulated Radiation Therapy for Patients With Clinically Localized

Prostate Cancer. The Journal of Urology, 176 (4):1415-1419

HRQOL: Comparison of 2013 and 2014 Survey Results to Control Group

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0

20

40

60

80

100 93.189.3 92.6

59.7

90.6 87.391.3

62.1

92.988.2

92.4

61.42013 Survey

2014 Survey

Control Group (Patient's w/o Prostate Cancer)

HRQOL Category

HR

QO

L Sc

ore

• Proton therapy patients completing the 2013 and 2014 survey had similar urinary, bowel, and sexual HRQOL measures as a control group of healthy individuals

EPIC HRQOL Scores of Patients Who Have Received Only Proton Therapy for Treatment of Prostate Cancer

HRQOL by Treatment Modality: 2014 Survey

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Note: *p<0.05, **p<0.01

Urinary

IncontinenceUrinary

Irritative Bowel Sexual

Proton Only (n=2,998) 90.6 87.3 91.3 62.1

Proton and Photon (n=79) 87.8 88.7 85.6** 47.6**

Proton and Hormones (n=460) 88.9* 85.6* 91.0 48.3**

Proton and Both (n=154) 91.2 87.0 87.3** 42.5**

Patients w/o Prostate Cancer (Control Group) (n=112) 92.9 88.2 92.4 61.4

Circled in red= Significantly lower HRQOL than control group

EPIC HRQOL Scores by Treatment Modality

• Those receiving hormone therapy in addition to proton therapy had significantly lower urinary incontinence, urinary irritative, and sexual HRQOL compared to the control group (p<0.05)

• Those receiving photon therapy and those receiving photon and hormone therapy had lower bowel and sexual HRQOL on average than the control group (p<0.05)

HRQOL by Treatment Modality: 2014 Survey (Cont’d.)

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HRQOL by Time Since Completion of Therapy: 2014 Survey

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EPIC HRQOL Scores by Length of Time since Treatment

Time Since Treatment

Urinary Incontinence Urinary Irritative Bowel Sexual

0 Years (n=221) 93.1** 83.7** 94.4** 68.6**

1 Year (n=423) 91.4 85.1** 90.8 65.8**

2 Year (n=442) 91.7 87.3 90.0 66.5**

3 Years (n=430) 92.4** 88.1 91.2 61.6

4-5 Years (n=597) 90.1 87.8 91.3 62.8

6-10 Years (n=537) 89.2 89.7** 92.6* 60.1

10+ Years (n=165) 85.9** 88.4 89.3 44.9**

Lowest scores for each HRQOL categoryNote: *p<0.05, **p<0.01

• Modeled the determinants of the self-reported, post-treatment urinary, bowel and sexual HRQOL to identify the factors most predictive of a high HRQOL score

• Only the model predicting sexual HRQOL was significant, predicting 27% of the variance in sexual HRQOL.

• Significant predictors of higher HRQOL included:• Higher education (p<0.001)• Presence of commercial (p<0.05) or MediGap insurance (p<0.001)

• Significant predictors of lower HRQOL included: • Presence of sexual function problems prior to treatment (p<0.001)• Presence of chronic conditions prior to treatment (p<0.001)• Increased age (p<0.001) • Longer time since treatment (p<0.001)• Receiving hormone therapy (p<0.05) or photon therapy (p<0.001)

Regression Analysis: 2014 Survey

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Surgery

Conventional Radiation (such as IMRT)

Brachytherapy (seed implant)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

91.6%

91.8%

89.3%

87.7%

84.6%

82.1%

65.4%

75.0%

69.2%

Fewer Bowel Side Effects

Fewer Sexual Side Effects

Fewer Urinary Side Effects

% of Respondents

Why Did Patients Choose Proton Therapy Over Other Treatment Modalities? 2014 Survey• The most common reason for choosing proton therapy over other

treatment modalities was the desire for fewer side effects than other treatment options

Decision to Choose Proton Therapy, Side Effects, 2014 Survey Results

Questions?

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Dobson DaVanzo & Associates, LLC (Dobson|DaVanzo) is a health care economics consulting firm based in the Washington, D.C.

metropolitan area.

Contact information:(703) 260-1760

joan.davanzo@dobsondavanzo.comwww.dobsondavanzo.com

450 Maple Avenue East, Suite 303Vienna, VA 22180

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