Catrina Crociani

Comparative effectiveness study of patient-reported outcomes after proton therapy or intensity-modulated radiotherapy for prostate cancer.

Data continue to emerge on the relative merits of different treatment modalities for prostate cancer. The objective of this study was to compare patient‐reported quality‐of‐life (QOL) outcomes after proton therapy (PT) and intensity‐modulated radiation therapy (IMRT) for prostate cancer.

Measuring and Predicting Prostate Cancer Related Quality of Life Changes Using EPIC for Clinical Practice

PURPOSE We expanded the clinical usefulness of EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) by evaluating its responsiveness to health related quality of life changes, defining the minimally important differences for an individual patient change in each domain and applying it to a sexual outcome prediction model. MATERIALS AND METHODS In 1,201 subjects from a previously described multicenter longitudinal cohort we modeled the EPIC-CP domain scores of each treatment group before treatment, and at short-term and long-term followup. We considered a posttreatment domain score change from pretreatment of 0.5 SD or greater clinically significant and p ≤ 0.01 statistically significant. We determined the domain minimally important differences using the pooled 0.5 SD of the 2, 6, 12 and 24-month posttreatment changes from pretreatment values. We then recalibrated an EPIC-CP based nomogram model predicting 2-year post-prostatectomy functional erection from that developed using EPIC-26. RESULTS For each health related quality of life domain EPIC-CP was sensitive to similar posttreatment health related quality of life changes with time, as was observed using EPIC-26. The EPIC-CP minimally important differences in changes in the urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domains were 1.0, 1.3, 1.2, 1.6 and 1.0, respectively. The EPIC-CP based sexual prediction model performed well (AUC 0.76). It showed robust agreement with its EPIC-26 based counterpart with 10% or less predicted probability differences between models in 95% of individuals and a mean ± SD difference of 0.0 ± 0.05 across all individuals. CONCLUSIONS EPIC-CP is responsive to health related quality of life changes during convalescence and it can be used to predict 2-year post-prostatectomy sexual outcomes. It can facilitate shared medical decision making and patient centered care.

Uncertainty and perception of danger among patients undergoing treatment for prostate cancer

Study Type – Therapy (attitude prevalence)

Clinical Use of Expanded Prostate Cancer Index Composite for Clinical Practice to Assess Patient Reported Prostate Cancer Quality of Life Following Robot-Assisted Radical Prostatectomy

Purpose: EPIC‐CP (Expanded Prostate Cancer Index Composite for Clinical Practice) is a short questionnaire that comprehensively measures patient reported health related quality of life at the point of care. We evaluated the feasibility of using EPIC‐CP in the routine clinical care of patients with prostate cancer without research infrastructure. We compared longitudinal patient and practitioner reported prostate cancer outcomes. Materials and Methods: We reviewed health related quality of life outcomes in 482 patients who underwent radical prostatectomy at our institution from 2010 to 2014. EPIC‐CP was administered and interpreted in routine clinical practice without research personnel. We compared practitioner documented rates of incontinence pad use and functional erections to patient reported rates using EPIC‐CP. Results: A total of 708 EPIC‐CP questionnaires were completed. Mean urinary incontinence domain scores were significantly higher (worse) than baseline (mean ± SD 0.6 ± 0.2) 3 and 6 months after treatment (mean 3.1 ± 2.3 and 2.2 ± 2.1, respectively, each p <0.05) but they returned to baseline at 12 months (mean 1.6 ± 1.7, p >0.05). Mean sexual domain scores were significantly worse than baseline (mean 2.4 ± 2.8) at all posttreatment time points (each p <0.05). Practitioners significantly overestimated incontinence pad‐free rates at 3 months (48% vs 39%) and functional erection rates at 3 months (18% vs 12%), 6 months (38% vs 23%) and 12 months (45% vs 23%, each p <0.05). Conclusions: EPIC‐CP is feasible to use in the routine clinical care of patients with prostate cancer without requiring a research infrastructure. Using EPIC‐CP in clinical practice may help practitioners objectively assess and appropriately manage posttreatment side effects in patients with prostate cancer.

Relief of Urinary Symptom Burden after Primary Prostate Cancer Treatment

Purpose: Harms of prostate cancer treatment on urinary health related quality of life have been thoroughly studied. In this study we evaluated not only the harms but also the potential benefits of prostate cancer treatment in relieving the pretreatment urinary symptom burden. Materials and Methods: In American (1,021) and Spanish (539) multicenter prospective cohorts of men with localized prostate cancer we evaluated the effects of radical prostatectomy, external radiotherapy or brachytherapy in relieving pretreatment urinary symptoms and in inducing urinary symptoms de novo, measured by changes in urinary medication use and patient reported urinary bother. Results: Urinary symptom burden improved in 23% and worsened in 28% of subjects after prostate cancer treatment in the American cohort. Urinary medication use rates before treatment and 2 years after treatment were 15% and 6% with radical prostatectomy, 22% and 26% with external radiotherapy, and 19% and 46% with brachytherapy, respectively. Pretreatment urinary medication use (OR 1.4, 95% CI 1.0–2.0, p = 0.04) and pretreatment moderate lower urinary tract symptoms (OR 2.8, 95% CI 2.2–3.6) predicted prostate cancer treatment associated relief of baseline urinary symptom burden. Subjects with pretreatment lower urinary tract symptoms who underwent radical prostatectomy experienced the greatest relief of pretreatment symptoms (OR 4.3, 95% CI 3.0–6.1), despite the development of deleterious de novo urinary incontinence in some men. The magnitude of pretreatment urinary symptom burden and beneficial effect of cancer treatment on those symptoms were verified in the Spanish cohort. Conclusions: Men with pretreatment lower urinary tract symptoms may experience benefit rather than harm in overall urinary outcome from primary prostate cancer treatment. Practitioners should consider the full spectrum of urinary symptom burden evident before prostate cancer treatment in treatment decisions.

Clinical Use of EPIC for Clinical Practice (EPIC-CP) to Assess Patient-Reported Prostate Cancer Quality-of-Life Following Robot-Assisted Radical Prostatectomy.

Purpose: EPIC‐CP (Expanded Prostate Cancer Index Composite for Clinical Practice) is a short questionnaire that comprehensively measures patient reported health related quality of life at the point of care. We evaluated the feasibility of using EPIC‐CP in the routine clinical care of patients with prostate cancer without research infrastructure. We compared longitudinal patient and practitioner reported prostate cancer outcomes. Materials and Methods: We reviewed health related quality of life outcomes in 482 patients who underwent radical prostatectomy at our institution from 2010 to 2014. EPIC‐CP was administered and interpreted in routine clinical practice without research personnel. We compared practitioner documented rates of incontinence pad use and functional erections to patient reported rates using EPIC‐CP. Results: A total of 708 EPIC‐CP questionnaires were completed. Mean urinary incontinence domain scores were significantly higher (worse) than baseline (mean ± SD 0.6 ± 0.2) 3 and 6 months after treatment (mean 3.1 ± 2.3 and 2.2 ± 2.1, respectively, each p <0.05) but they returned to baseline at 12 months (mean 1.6 ± 1.7, p >0.05). Mean sexual domain scores were significantly worse than baseline (mean 2.4 ± 2.8) at all posttreatment time points (each p <0.05). Practitioners significantly overestimated incontinence pad‐free rates at 3 months (48% vs 39%) and functional erection rates at 3 months (18% vs 12%), 6 months (38% vs 23%) and 12 months (45% vs 23%, each p <0.05). Conclusions: EPIC‐CP is feasible to use in the routine clinical care of patients with prostate cancer without requiring a research infrastructure. Using EPIC‐CP in clinical practice may help practitioners objectively assess and appropriately manage posttreatment side effects in patients with prostate cancer.

PD18-08 PROSPECTIVE MULTICENTER COMPARISON OF OPEN AND ROBOTIC RADICAL PROSTATECTOMY: THE PROST-QA/RP2 CONSORTIUM

distance (intermediate [12.5-49.9miles] and long [49.9-249.9miles] vs. short [<12.5miles]) and the effect of distance on OM were calculated using multivariate regression analyses. Additional analyses evaluated the distance effect on OM in all patients and in selected subgroups. RESULTS: Overall, 54.5%, 33.4%, and 12.1% traveled short, intermediate, and long distances, respectively. Residency in rural area, and receiving treatment at academic/high-volume centers independently predicted long travel distance. Non-Hispanic blacks and Medicaid-insured were less likely to travel long distances (all P<0.001). At multivariate analysis, traveling intermediate distance (hazard ratio [HR]1⁄40.97; 95% confidence interval (CI)1⁄40.95-0.99; P<0.001) and long distance (HR1⁄40.87; 95% CI1⁄40.83-0.92; P<0.001) were associated with lower OM risk, as compared to short distance (Figure 1). In subgroup analyses, long travel distance was associated with decreased OM in non-Hispanic whites, privately-insured, Medicare-insured, and patients treated at academic or high-volume centers (P<0.001), but not in non-Hispanic blacks (P1⁄40.3). Long travel distance was associated with an increased OM in Medicaidinsured patients (P<0.001; Figure 2). CONCLUSIONS: Our results suggest that interestingly not only patients traveling longer distances live longer, but that even if they are going the extra mile, their OM outcomes are likely to be influenced by baseline socioeconomic and facility specific factors. Specifically, we observed concerning socioeconomic disparities in the access to care regarding a higher travel burden, which translated into less favorable OM outcomes for non-Hispanic blacks and non-privately insured patients.

Adult UrologyOncology: Prostate/Testis/Penis/UrethraClinical Use of Expanded Prostate Cancer Index Composite for Clinical Practice to Assess Patient Reported Prostate Cancer Quality of Life Following Robot-Assisted Radical Prostatectomy

Purpose: EPIC‐CP (Expanded Prostate Cancer Index Composite for Clinical Practice) is a short questionnaire that comprehensively measures patient reported health related quality of life at the point of care. We evaluated the feasibility of using EPIC‐CP in the routine clinical care of patients with prostate cancer without research infrastructure. We compared longitudinal patient and practitioner reported prostate cancer outcomes. Materials and Methods: We reviewed health related quality of life outcomes in 482 patients who underwent radical prostatectomy at our institution from 2010 to 2014. EPIC‐CP was administered and interpreted in routine clinical practice without research personnel. We compared practitioner documented rates of incontinence pad use and functional erections to patient reported rates using EPIC‐CP. Results: A total of 708 EPIC‐CP questionnaires were completed. Mean urinary incontinence domain scores were significantly higher (worse) than baseline (mean ± SD 0.6 ± 0.2) 3 and 6 months after treatment (mean 3.1 ± 2.3 and 2.2 ± 2.1, respectively, each p <0.05) but they returned to baseline at 12 months (mean 1.6 ± 1.7, p >0.05). Mean sexual domain scores were significantly worse than baseline (mean 2.4 ± 2.8) at all posttreatment time points (each p <0.05). Practitioners significantly overestimated incontinence pad‐free rates at 3 months (48% vs 39%) and functional erection rates at 3 months (18% vs 12%), 6 months (38% vs 23%) and 12 months (45% vs 23%, each p <0.05). Conclusions: EPIC‐CP is feasible to use in the routine clinical care of patients with prostate cancer without requiring a research infrastructure. Using EPIC‐CP in clinical practice may help practitioners objectively assess and appropriately manage posttreatment side effects in patients with prostate cancer.

MP83-19 REAL-WORLD USE OF EPIC FOR CLINICAL PRACTICE (EPIC-CP) TO ASSESS PATIENT-REPORTED PROSTATE CANCER QUALITY-OF-LIFE IN THE CLINICAL SETTING

INTRODUCTION AND OBJECTIVES: Prostate cancer practitioners tend to underestimate the severity of patients’ treatment-related side effects. We developed the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) to facilitate patient-reported health-related quality of life (HRQOL) assessment at the point-of-care (Chang P et al, J Urol Sep 2011). In this study, we sought to demonstrate the feasibility of EPIC-CP use in the routine clinical care of prostate cancer patients, and to compare longitudinal patient-reported and practitioner-reported prostate cancer outcomes. METHODS: We reviewed practitionerand patient-reported HRQOL outcomes in 482 patients who underwent radical prostatectomy at our institution from 2010 to 2014. All EPIC-CP questionnaires were administered and interpreted in routine clinical practice flow without research personnel. To assess practitioner-reported outcomes, we reviewed practitioners’ documentation of patients’ incontinence pad use (yes/no) and erections sufficient for intercourse (yes/no). We used the paired t-test and Wilcoxon signed-rank test to compare preand posttreatment EPIC-CP domain scores, and Fisher’s exact test to compare patient-reported and practitioner-reported outcomes. We considered pvalues 0.05). Patient-reported incontinence pad-free rates using EPIC-CP at 3, 6, and 12 months were 39%, 70%, and 76%, respectively, which were consistent with our practitioner-reported rates. Mean sexual domain scores were significantly worse than baseline (2.4 2.8) at 3 months (7.0 3.5), 6 months (5.7 3.1), and 12 months (5.9 3.3; p < 0.05 for all). Practitioners significantly overestimated the rate of functional erections compared to patients’ EPIC-CP-reported rates at 3 months (18% vs 12%, p < 0.05) and 12 months (45% vs 23%, p < 0.05). Bowel and vitality/hormonal scores were unchanged, and urinary irritation/obstruction scores significantly improved after surgery. CONCLUSIONS: EPIC-CP is feasible to use in the routine clinical care of prostate cancer patients without requiring research infrastructure. Using EPIC-CP in clinical practice may help practitioners objectively assess the severity of patients’ post-treatment side effects. Source of Funding: This study was supported by a grant from the UrologyCare Foundation Research Scholars Program and Dornier Medtech entitled “Measuring Prostate Cancer Patient Reported Outcomes at the Point of Care.”

Comparative Effectiveness Study of Patient-Reported Outcomes following Proton Therapy or IMRT for Prostate Cancer

Data continue to emerge on the relative merits of different treatment modalities for prostate cancer. The objective of this study was to compare patient‐reported quality‐of‐life (QOL) outcomes after proton therapy (PT) and intensity‐modulated radiation therapy (IMRT) for prostate cancer.