Prostate Cancer Patients Report on Benefits of Proton Therapy

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1 Prostate Cancer Patients Report on Benefits of Proton Therapy Dobson DaVanzo & Associates, LLC Vienna, VA

2 Prostate Cancer Patients Report on Benefits of Proton Therapy Submitted to: National Association for Proton Therapy (NAPT) Submitted by: Joan E. DaVanzo, Ph.D., M.S.W. Kevin Reuter Anne Pick, M.P.H. Tuesday, February 12, 2013 Final Report

3 Table of Contents Introduction... 4 Background... 4 Methods... 5 Key Findings... 5 Detailed Study Findings... 7 Respondent Demographics... 7 EPIC Findings... 9 Satisfaction with Proton Therapy Discussion PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY

4 Introduction The National Association for Proton Therapy (NAPT) commissioned Dobson DaVanzo & Associates, LLC (Dobson DaVanzo) to investigate outcomes and patient satisfaction associated with the use of proton therapy in treating prostate cancer. Background Close to 2,000 patients who were treated for prostate cancer with proton therapy from 1991 to 2010 completed a survey distributed by the Brotherhood of the Balloon (BoB), which examined satisfaction with care, quality of life, emotional and physical health limitations, urinary function, sexual function, bladder function, and bowel function. These 2,000 patients represent approximately 20 percent of all patients who had received proton therapy for prostate cancer prior to The BoB survey incorporated the Expanded Prostate Cancer Index Composite (EPIC), a validated instrument developed by the University of Michigan and UCLA that measures health related quality of life (HRQOL), specifically among men with prostate cancer. EPIC assesses a patient s Health Related Quality of Life (HRQOL) in urinary, sexual, bowel, and hormonal domains. In addition, EPIC derives subscales for each category, which examine function (measure habits associated with the category) and bother (degree of annoyance associated with symptoms related to the category) for each HRQOL category. Urinary scores also contain subcategories related to incontinence (measures loss of bladder control) and irritation/obstruction (measures pain or bleeding associated with urination). The BoB survey also incorporated the American Urological Association (AUA) symptom index, which provides a clinical context for urinary measures (a higher score indicating more severe symptoms), and a Medical Outcomes Study SF-12 score which is a patient s report of physical and mental health status (a higher score indicating better HRQOL) 1. Additionally, items were included to examine patient demographics, 1 THE SF-12 is a validated measure of General Health Function developed by RAND. It examines physical and mental HRQOL, and provides both a physical and mental HRQOL score. PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

5 self-rated health status, clinical characteristics, type of treatment received, and reported problems prior to treatment. Methods Our first step was to tabulate all of the survey responses and calculate descriptive statistics to describe the following characteristics of the sample: age distribution, selfrated health status, types of treatment received, whether the cancer was in remission, pretreatment PSA, pre-treatment Gleason Score, pre-treatment T-Stage, and whether respondent was experiencing any problems with bowel, bladder, or sexual functioning prior to treatment. Our next step was to calculate EPIC scores based on each patients reported post-treatment condition. EPIC Summary Scores were calculated using scoring instructions provided by the University of Michigan and UCLA. Responses for each item in the survey form a Likert scale, transformed linearly to a scale. For each item, a higher score represents a better Health Related Quality of Life (HRQOL). Multi-item summary scores were then created for urinary, bowel, sexual, and hormonal symptoms by averaging items within a response category corresponding to these symptoms. Subscale scores were also calculated for these symptoms, which included function (item measures habits associated with the category) and bother (item measures degree of annoyance associated with symptoms related to the category). Urinary scores also contain subcategories related to incontinence (item that measures loss of bladder control) and irritation/obstruction (items that measure pain or bleeding associated with urination). An AUA symptom index, and Medical Outcomes Study SF-12 score was also calculated for each patient. These measures were then cross-tabulated by treatment modality (whether the patient received proton therapy only or proton plus another type of therapy: hormone or photon therapy), by time elapsed since treatment, and by whether the patient had reported problems associated with sexual, urinary, or bowel function prior to treatment. Individual items relating to satisfaction with proton therapy, quality of life, level of pain, and physical and emotional functioning were also cross tabulated with time since completing proton therapy and treatment modality. Differences were tested using Chi-square and t-tests. Key Findings Approximately 99 percent of respondents stated that they believed they made the best treatment decision for themselves, and 98 percent reported that they had recommended proton therapy to others (Exhibit 15). Approximately 96 percent of patients were satisfied or extremely satisfied with proton therapy (Exhibit 19). PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

6 Ninety-one percent of patients reported that their quality of life was better or the same today than it was before their treatment, and only 9 percent reported that their quality of life was worse (Exhibit 21). Ninety-three percent of respondents reported that physical health or emotional problems did not interfere, or interfered very little, with their social activities (Exhibit 23). Those who completed proton therapy for the treatment of prostate cancer had similar urinary, bowel, and hormonal HRQOL scores as healthy individuals. Proton therapy patients did have lower sexual HRQOL scores than healthy individuals; however this finding was mostly associated with those patients who received hormone therapy in addition to proton therapy. When looking at patients who received only proton therapy for the treatment of prostate cancer (did not receive hormone or photon therapy), proton therapy patients reported equivalent HRQOL to healthy individuals, except for one HRQOL category ( Sexual Bother 2 ) (Exhibit 3). Respondents who were treated with photon therapy in addition to proton therapy had lower bowel, sexual, and hormonal HRQOL scores than proton only respondents (Exhibit 4a). Those who received hormone therapy in addition to proton therapy had lower sexual and hormonal HRQOL scores than proton only respondents. Those receiving photon or hormone therapy in addition to proton therapy also reported lower SF-12 Physical Component Score (PCS) scores compared to those only receiving proton therapy, indicating a lower physical HRQOL (Exhibit 4b). 2 Patients rating of the level of annoyance associated with their sexual symptoms PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

7 Respondent Demographics More than half of respondents (52.5%) completed the BoB survey at least 3 years following the completion of their treatment (Exhibit 1). All survey respondents received proton therapy (n=1862), 16 percent of respondents also received hormone therapy, and 10 percent received photon therapy (Exhibit 2). Additionally, most respondents (96.9 percent) had not received any other treatment prior to their proton therapy. The majority of respondents received proton therapy between ages 61 and 70 with over one-quarter (28.1 percent) receiving proton therapy between ages 66 and 70. Prior to treatment, over one-quarter of patients (27.3 percent) reported problems with urinary function, and 23.8 percent reported problems with sexual function. Overall, less than four percent of respondents reported Fair or Poor health following proton therapy, while 78 percent reported Very Good or Excellent health. PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

8 Number of Respondents Detailed Study Findings Exhibit 1. Respondent s Time Elapsed since the Completion of Proton Therapy to Completing the Survey years 1 years 2 years 3 years 4 years 5 years 6 or more years Years Since Treatment Exhibit 2: Characteristics of Sample Variable Results Age Distribution (n=1862) % 22.4% 28.1% 15.2% 6.1% Self Rated Health Status (n=1860) Excellent Very Good Good Fair Poor Problems Experienced Prior to Treatment (n=798) 34.0% 44.3% 18.3% 3.1% 0.3% Sexual Urinary Bowel Other 23.8% 27.3% 1.8% 0.8% Treatment Received Prior to Proton (n=109) Surgery Cyro HIFU Other Type of Treatment Received (n=1862) Proton Photon Hormones 100.0% 10.0% 16.2% Pre-treatment T-Stage (n=1026) T1 T2 T Cancer in Remission (n=1760) Yes No 95.1% 4.9% Pre-treatment PSA (n=1750) Mean Median Standard Dev Pre-treatment Gleason Score (n=1586) Mean Median Standard Dev PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

9 EPIC Findings EPIC Scores were compared for the following three subgroups of patients: 1) respondents who received proton therapy for the treatment of prostate cancer; 2) respondents who received only proton therapy for the treatment of prostate cancer (excludes patients also receiving hormone or photon therapy); 3) respondents who did not have prostate cancer. We found no differences in urinary or bowel summary or subscale scores across the three groups (Exhibit 3). Sexual summary scores, and sexual bother and function sub-scores however, were lower for those who had received proton therapy (indicating a lower HRQOL) than for the healthy control group (p<0.05). When comparing those who received only proton therapy for the treatment of their prostate cancer (excluding those who also received photon or hormone therapy), proton only therapy patients had a significantly lower HRQOL in only the Sexual Bother category than the healthy group (p<0.05), but higher than those who received either hormone or photon therapy. Exhibits 4a and 4b show a comparison across groups who had prostate cancer: 1) patients who received only proton therapy; 2) patients who received proton therapy plus photon therapy, and; 3) patients who received hormone therapy in addition to proton therapy. Exhibit 4a shows summary EPIC scores, Exhibit 4b shows the sub-scores. We found greater variation in EPIC scores across these groups (some of this variation is related to unequal group sizes). However, those patients who had received only proton therapy had the highest EPIC scores on 13 of the 18 sub-score measures. The proton only patients had the highest EPIC scores for Sexual Summary, Sexual Function, and Sexual Bother (p<0.05), as well as Hormonal Summary, Hormonal Function, and Hormonal Bother (p<0.05). Those also being treated with hormone therapy had a sexual summary score of 39.9 and those also being treated with photon therapy had a sexual summary score of These scores are lower than the Sexual Summary score of those receiving only proton therapy for their treatment (57.8) (p<0.05). Respondents who received photon therapy had lower bowel and hormonal scores (p<0.05), while those receiving hormone therapy had lower hormonal scores compared to proton only patients (p<0.05). Exhibit 5 shows that the length of time a patient has been receiving hormone therapy is also associated with lower sexual HRQOL. In particular, those on hormone therapy for greater than 24 months had an average EPIC sexual function score of just 26.2 (vs for those on hormone therapy for less than 24 months) (p<0.05). Overall, however, length of hormone therapy was not associated with major differences between the groups (due to small sample sizes). PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

10 Exhibit 3. EPIC Scores of Patients Who Have Underwent Proton Therapy for Treatment of Prostate Cancer Compared to EPIC Scores of Patients Who Have Not Been Diagnosed with Prostate Cancer. Patients w/ Prostate Cancer who Had Proton Therapy (n=1961) Patients w/ Prostate Cancer who only Had Proton Therapy (n=1487) Patients w/o Prostate Cancer (n=112) Urinary Summary Urinary Function Urinary Bother Urinary Irritative Urinary Incontinence Bowel Summary Bowel Function Bowel Bother Sexual Summary 53.7* Sexual Function 49.5* Sexual Bother 63.1* 66.7* 74.3 Hormonal Summary Hormonal Function Hormonal Bother * 92.8 Satisfaction AUA Symptom Score SF-12 PCS SF-12 MCS *p<0.05. Note: SF-12 PCS= Physical Component Score, a selfrated physical health status. SF-12 MCS= Mental Component Score, a self-rated mental health status. Exhibit 4a. EPIC Scores of Patients Who Have Underwent Proton Therapy for Treatment of Prostate Cancer by Treatment Modality (Summary Scores) Just Proton (n=1487) Proton and Photon (n=186) Proton and Hormone (n=302) Urinary Summary Bowel Summary * 91.3 Sexual Summary 57.8* 35.9* 39.9* Hormonal Summary 93.3* 88.4* 87.7*. *p<0.05 PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

11 Exhibit 4b. EPIC Scores of Patients Who Have Underwent Proton Therapy for Treatment of Prostate Cancer by Treatment Modality Just Proton (n=1487) Proton and Photon (n=186) Proton and Hormone (n=302) Urinary Summary Urinary Function Urinary Bother Urinary Irritative Urinary Incontinence Bowel Summary * 91.3 Bowel Function * 91.7 Bowel Bother * 90.8 Sexual Summary 57.8* 35.9* 39.9* Sexual Function 53.7* 30.8* 35.5* Sexual Bother 66.7* 47.3* 50.2* Hormonal Summary 93.3* 88.4* 87.7* Hormonal Function 91.4* 86.1* 84.9* Hormonal Bother 94.9* 90.3* 90.0* Satisfaction * 93.2 AUA Symptom Score SF-12 PCS * 50.3* SF-12 MCS *p<0.05 PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

12 Exhibit 5. EPIC Scores of Patients Who Were Treated with Hormone Therapy in Addition to Proton Therapy by Months Treated with Hormone Therapy <24 months Hormone Therapy (n=247) 24 months Hormone Therapy (n=55) Urinary Summary Urinary Function Urinary Bother Urinary Irritative Urinary Incontinence Bowel Summary Bowel Function Bowel Bother Sexual Summary Sexual Function * Sexual Bother Hormonal Summary Hormonal Function Hormonal Bother Satisfaction AUA Symptom Score SF-12 PCS SF-12 MCS *p<0.05 As shown in Exhibit 6, those who received only proton therapy had the lowest percentage of total reported functional problems prior to treatment, relative to the groups who received combined treatment. When comparing respondents who reported problems with sexual, urinary, or bowel function prior to treatment, those who received hormone therapy in addition to proton therapy had a lower hormonal and sexual HRQOL, while those who also received photon therapy reported a lower sexual HRQOL (p<0.05) and a lower Hormone Bother score (p<0.05) compared to respondents receiving only proton therapy (Exhibit 7). PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

13 Exhibit 6. Proportion of Patients Reporting Problems with Sexual Function, Urinary Function, Bowel Function or Other Problems Prior to Treatment by Treatment Modality Sexual Function Urinary Function Bowel Function Other Problems Total Treatment Modality n % n % n % n % n % Only Receiving Proton Therapy (n=1487) % % % % % Receiving Proton and Photon Therapy (n=186) % % 4 2.2% 1 0.5% % Receiving Proton and Hormone Therapy (n=302) % % 3 1.0% 1 0.3% %. Exhibit 7. EPIC Scores Post-Treatment of Patients Reporting Problems with Sexual, Urinary, Bowel, or Other Function Prior to Treatment by Treatment Modality Proton Therapy Only (n=601) Proton and Photon Therapy (n=78) Proton and Hormone Therapy (n=160) All Treatment Modalities (n=779) Urinary Summary Urinary Function Urinary Bother Urinary Irritative Urinary Incontinence Bowel Summary Bowel Function Bowel Bother Sexual Summary 47.6* 27.4* 34.5* 44.3 Sexual Function 43.9* 22.8* 31.1* 40.7 Sexual Bother 55.9* 38.4* 43.3* 52.8 Hormonal Summary 91.9* * 90.9 Hormonal Function 89.8* * 88.7 Hormonal Bother 93.8* 89.3* 88.8* 92.7 Satisfaction AUA Symptom Score SF-12 PCS SF-12 MCS *p <0.05 Although respondents who received only proton therapy reported lower sexual problems prior to treatment, Exhibit 8 shows that of those who did report sexual problems prior to treatment, patients who received only proton therapy had the highest sexual EPIC scores post-treatment compared to those who received other treatment modalities in addition to proton therapy (p<0.05). Exhibit 9 and 10, show that of those who reported problems PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

14 with urinary and bowel function prior to treatment, respectively, treatment modality did not have a substantial effect on post-treatment EPIC scores. Exhibit 8. EPIC Summary Scores Post-Treatment of Patients Reporting Problems with Sexual Function Prior to Treatment by Treatment Modality Proton Therapy Only (n=326) Photon and Proton Therapy (n=53) Hormone and Proton Therapy (n=96) All Treatment Modalities (n=441) Sexual Summary 36.7* 25.8* 26.3* 34.2 Sexual Function 33.6* 20.8* 22.2* 30.8 Sexual Bother 43.5* 36.9* 35.9* *p<0.05 Exhibit 9. EPIC Summary Scores Post-Treatment of Patients Reporting Problems with Urinary Function Prior to Treatment by Treatment Modality Proton Therapy Only (n=390) Proton and Photon Therapy (n=45) Hormone and Proton Therapy (n=105) All Treatment Modalities (n=503) Urinary Summary Urinary Function Urinary Bother Urinary Irritative Urinary Incontinence Exhibit 10. EPIC Summary Scores Post-Treatment of Patients Reporting Problems with Bowel Function Prior to Treatment by Treatment Modality Proton Therapy Only (n=29) Photon and Proton Therapy (n=4) Hormone and Proton Therapy (n=3) All Treatment Modalities (n=26) Bowel Summary Bowel Function Bowel Bother In comparison, Exhibit 11 shows EPIC scores by treatment modality of respondents that did not report problems prior to treatment. Patients receiving only proton therapy who did not report problems prior to treatment had higher HRQOL scores in several areas, compared to those also receiving other treatments (p<0.05). Proton only patients scored higher in all sexual and hormone categories compared to respondents receiving photon therapy and those receiving hormone therapy (p<0.05) among these patients. PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

15 Exhibit 11. EPIC Summary Scores Post-Treatment of Patients Not Reporting Problems with Sexual, Urinary, Bowel, or Other Function Prior to Treatment by Treatment Modality Proton Therapy Only (n=898) Proton and Photon Therapy (n=103) Proton and Hormone Therapy (n=142) All Treatment Modalities (n=1092) Urinary Summary Urinary Function Urinary Bother Urinary Irritative Urinary Incontinence Bowel Summary Bowel Function * Bowel Bother Sexual Summary 64.4* 42.7* 46.2* 61.3 Sexual Function 60.0* 36.9* 40.5* 56.7 Sexual Bother 74.0* 54.1* 58.2* 71.3 Hormonal Summary 94.2* 88.5* 88.7* 93.3 Hormonal Function 92.5* 85.6* 85.5* 91.4 Hormonal Bother 95.6* 91.0* 91.4* 94.9 Satisfaction AUA Symptom Score SF-12 PCS SF-12 MCS *p <0.05 Exhibit 12a and 12b show EPIC scores by length of time since treatment. Overall, length of time since the completion of treatment did not play a significant role in respondents HRQOL, except those who had just completed proton therapy (0 years since treatment) had lower urinary (summary, bother and irritative) HRQOL scores (p<0.05). AUA symptom scores (indicating worse urinary symptoms) were higher (symptoms were worse) for this group (p<0.05), showing that a lower urinary HRQOL was associated with worse urinary symptoms. Respondents completing the survey one year following treatment had higher sexual function and sexual bother HRQOL scores (p<0.05), while those six or more years following the completion of proton therapy had lower sexual HRQOL scores (p<0.05), urinary incontinence scores (p<0.05), and SF-12 PCS scores (indicating a lower physical HRQOL) (p<0.05). These differences, however, are largely thought to be associated with increased age as opposed to effects of the cancer therapy. PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

16 Exhibit 12a. EPIC Summary Scores by Length of Time since Treatment. 0 years (n=265) 1 year (n=352) Years Since Proton Therapy 2 years (n=305) 3 years (n=236) 4 years (n=144) 5 years (n=138) 6 years+ (n=497) Urinary Summary 87.3* * Bowel Summary Sexual Summary * Hormonal Summary *p <0.05 Exhibit 12b. EPIC Summary and Subscale Scores by Length of Time since Treatment. 0 years (n=265) 1 year (n=143) Years Since Proton Therapy 2 years (n=261) 3 years (n=385) 4 years (n=307) 5 years (n=76) 6 years + (n=308) Urinary Summary 87.3* * Urinary Function Urinary Bother 83.0* Urinary Irritative 85.2* Urinary Incontinence * Bowel Summary Bowel Function Bowel Bother Sexual Summary * Sexual Function * * Sexual Bother * * Hormonal Summary Hormonal Function Hormonal Bother Satisfaction AUA Symptom Score 7.9* SF-12 PCS * SF-12 MCS *p<0.05 PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

17 Satisfaction with Proton Therapy As seen in Exhibits 13 and 14, patients were satisfied with their proton therapy experience, both by time since treatment completion and by modality. A vast majority (98.5 percent) of respondents rated their proton therapy experience as Excellent or Good, while less than one percent of respondents rated their experience as Poor. Satisfaction did not differ significantly by time elapsed since receiving treatment, or by treatment modality, although those receiving only proton therapy were slightly more likely to rate their proton therapy experience as Excellent rather than Good (Exhibit 14). Exhibit 13. Overall, how would you rate your proton experience? (By Time Since Completion of Therapy) Poor Fair Good Excellent Total Years since proton therapy n % n % n % n % n 0 years 0 0.0% 3 1.2% % % years 4 1.1% 3 0.9% % % years 1 0.3% 4 1.3% % % years 0 0.0% 0 0.0% % % years 1 0.7% 3 2.0% % % years 1 0.7% 1 0.7% % % years % 2 0.4% % % 495 Total % % % % 1911 Exhibit 14. Overall, how would you rate your proton experience? (By Treatment Modality) Poor Fair Good Excellent Total Treatment Modality n % n % n % n % n Only Receiving Proton Therapy % % % % 1485 Receiving Proton and Photon Therapy 1 0.5% 1 0.5% % % 143 Receiving Proton and Hormone Therapy 1 0.3% 2 0.7% % % 300 Approximately 99 percent of respondents stated that they believed they made the best treatment decision for themselves, both by time since completion of therapy (Exhibit 15), or by treatment modality (Exhibit 16). Additionally, 98 percent reported that they had recommended proton therapy to others (Exhibits 17 and 18). PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

18 Exhibit 15. Do you feel you made the best treatment decision for yourself? (By Time Since Completion of Therapy) Yes No Total Years since proton therapy n % n % n 0 years % 0 0.0% years % 3 0.9% years % 2 0.7% years % 1 0.4% years % 5 3.5% years % 4 2.9% years % % 492 Total % % 1901 Exhibit 16. Do you feel you made the best treatment decision for yourself? (By Treatment Modality) Yes No Total Treatment Modality n % n % n Only Receiving Proton Therapy % % 1475 Receiving Proton and Photon Therapy % 7 3.9% 179 Receiving Proton and Hormone Therapy % 5 1.7% 297 Exhibit 17. Have you recommended proton therapy to others? (By Time Since Completion of Therapy) Yes No Total Years since proton therapy n % n % n 0 years % % years % % years % 7 2.3% years % 2 0.9% years % 2 1.4% years % 1 0.7% years % 6 1.2% 493 Total % % 1908 PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

19 Exhibit 18. Have you recommended proton therapy to others? (By Treatment Modality) Yes No Total Treatment Modality n % n % n Only Receiving Proton Therapy % % 1480 Receiving Proton and Photon Therapy % 2 1.1% 179 Receiving Proton and Hormone Therapy % 5 1.7% 299 Exhibit 19 shows that 81.5% of patients reported being Extremely Satisfied with their treatment. Patients 5 years since therapy were less likely to report being Extremely Satisfied, but were more likely to report being Satisfied. Exhibit 20 shows that proton only patients were more likely to respond that they were Extremely Satisfied with their treatment. Exhibit 19. Overall, how satisfied are you with the treatment you received for your prostate cancer? (By Time Since Completion of Treatment) Extremely Dissatisfied Dissatisfied Uncertain Satisfied Extremely Satisfied Years since proton therapy n % n % n % n % n % n 0 years 2 0.8% 0 0.0% % % % years 2 0.6% 1 0.3% % % % years 2 0.7% 2 0.7% 7 2.4% % % years 0 0.0% 0 0.0% 9 3.8% % % years 1 0.7% 1 0.7% 4 2.8% % % years 2 1.5% 0 0.0% 5 3.7% % % years % 6 1.2% % % % 488 Total % % % % % 1898 Total Exhibit 20. Overall, how satisfied are you with the treatment you received for your prostate cancer? (By Treatment Modality) Extremely Dissatisfied Dissatisfied Uncertain Satisfied Extremely Satisfied Treatment Modality n % n % n % n % n % n Only Receiving Proton Therapy 8 0.5% 8 0.5% % % % 1460 Receiving Proton and Photon Therapy 1 0.6% 1 0.6% 8 4.5% % % 179 Receiving Proton and Hormone Therapy 1 0.3% 1 0.3% % % % 296 Total PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

20 Quality of Life Ninety-one percent of patients reported that their quality of life was better (29.0 percent) or the same (62.1 percent) today as it was before their treatment, while only nine percent reported that their quality of life had declined (Exhibit 21). This differed across treatment modalities with proton only therapy patients reporting the best quality of life following treatment (92.6 percent reporting better or same). Eighteen percent of respondents who received photon therapy in addition to proton therapy and fourteen percent receiving hormone therapy in addition to proton therapy rated their QOL as worse today than before treatment. In contrast, only seven percent of respondents receiving only proton therapy reported their QOL as worse today than before treatment (Exhibit 22). Additionally, those rating their quality of life as Better Than appeared to decline substantially after five years post-treatment (Exhibit 21). Exhibit 21. How would you describe your QOL today- better than, same as, or worse than before the treatment? (By Time Since Completion of Treatment) Better Than Same As Worse Than Total Years since proton therapy n % n % n % n 0 years % % % years % % % years % % % years % % % years % % % years % % % years % % % 492 Total % % % 1899 Exhibit 22. How would you describe your QOL today- better than, same as, or worse than before the treatment? (By Treatment Modality) Better Than Same As Worse Than Total Treatment Modality n % n % n % n Only Receiving Proton Therapy % % % 1473 Receiving Proton and Photon Therapy % % % 182 Receiving Proton and Hormone Therapy % % % 300 PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

21 Physical and Emotional Functioning Few studies have empirically examined the prevalence of depression in men with prostate cancer. However, anxiety about cancer as a diagnosis, lack of awareness of treatment options, medical complications, fear of death, and financial burdens are some of the factors that have been shown to lead to depression among prostate cancer patients. 3 Men with prostate cancer at risk for depression include those with advanced prostate cancer, prominent pain symptoms, side effects of treatment and a previous history of clinical depression. 4 Depression has also been strongly correlated to fatigue and pain as symptoms of prostate cancer. 5 Based on survey data, over 93 percent of patients who were treated with proton therapy reported that physical health or emotional problems did not interfere, or interfered little with their social activities (Exhibit 23). Interference was less between two years and five years post treatment, before declining in the six years or more post treatment category. Exhibit 24 shows that 93.5 percent of patients receiving proton only treatment had little or none of their time being affected by physical health or emotional problems, vs percent for proton plus photon therapy or 91.0 percent for proton plus hormonal therapy. 3 Pasquini M, Biondi M. (2007). Depression in cancer patients: a critical review. Clin Pract Epidemiol Ment Health 3: Cliff AM, McDonagh P. (2000). Psychosocial morbidity in prostate cancer II: a comparison of patients and partners. BJU Int 86: Heim HE, Oei TPS. (1993). Comparison of prostate cancer with and without pain. Pain 53: PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

22 Exhibit 23. During the PAST 4 WEEKS, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, etc.)? (By Time Since Completion of Treatment) All of the Time Most of the Time Some of the Time A Little of the Time None of the Time Years since proton therapy n % n % n % n % n % n 0 years 5 2.0% 1 0.4% % % % years 4 1.1% 2 0.6% % % % years 4 1.3% 4 1.3% 6 2.0% % % years 1 0.4% 1 0.4% % % % years 0 0.0% 0 0.0% 6 4.2% % % years 0 0.0% 0 0.0% 6 4.4% % % years % 7 1.4% % % % 496 Total % % % % % 1920 Total Exhibit 24. During the PAST 4 WEEKS, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, etc.)? (By Treatment Modality) All of the Time Most of the Time Some of the Time A Little of the Time None of the Time Treatment Modality n % n % n % n % n % n Only Receiving Proton Therapy % % % % % 1483 Receiving Proton and Photon Therapy 2 1.1% 2 1.1% % % % 182 Receiving Proton and Hormone Therapy 4 1.3% 2 0.7% % % % 301 Total PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT Dobson Davanzo

23 Discussion Between the years 1991 to 2010, approximately 10,000 patients were treated for prostate cancer with proton therapy across the 10 currently operating proton centers in the United States. This study captures close to 20 percent of this population across all centers, with patients having varying ages, clinical conditions, time elapsed since treatment, etc. Proton therapy is unique in that it targets specific tissues, and minimizes damage to healthy tissues, thus minimizing side effects. This differs from other treatments such as photon beam radiation, which often causes negative side effects that affect a patient s quality of life post- treatment. Our results substantiate this anecdotal information, as we found that patients receiving proton therapy for the treatment of prostate cancer were extremely satisfied with their treatment, and reported similar quality of life post-treatment to healthy individuals who have not been diagnosed with prostate cancer. In comparison to patients receiving other treatments in addition to proton therapy (hormone or photon therapy), proton only therapy patients reported that urinary, sexual, and bowel problems interfered less with their life through reporting higher HRQOL EPIC scores in these areas compared to individuals receiving other forms of treatment. PROSTATE CANCER PATIENTS REPORT ON BENEFITS OF PROTON THERAPY FINAL REPORT

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