Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry.

PURPOSE: African Americans experience greater prostate cancer risk and mortality than do Caucasians. An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. We explored this in PROCEED (NCT01306890), an FDA-requested registry in over 1900 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T. PATIENTS AND METHODS: OS for patients who received ≥1 sipuleucel-T infusion was compared between African American and Caucasian men using an all patient set and a baseline prostate-specific antigen (PSA)-matched set (two Caucasians to every one African American with baseline PSAs within 10% of each other). Univariable and multivariable analyses were conducted. Survival data were examined using Kaplan-Meier and Cox proportional hazard methodologies. RESULTS: Median follow-up was 46.6 months. Overall survival differed between African American and Caucasian men with hazard ratios (HR) of 0.81 (95% confidence interval [CI]: 0.68-0.97, P = 0.03) in the all patient set and 0.70 (95% CI: 0.57-0.86, P < 0.001) in the PSA-matched set. Median OS was longer in African Americans than in Caucasian men for both analysis sets, e.g., 35.3 and 25.8 months, respectively, in the PSA-matched set. Similar results were observed in the all patient set. Differences were larger when treatment began at lower baseline PSA; curves were more similar among patients with higher baseline PSA. In patients with baseline PSA below the median, the HR was 0.52 (95% CI: 0.37-0.72, P < 0.001), with median OS of 54.3 versus 33.4 months. Known prognostic factors and African American race (multivariable analyses; HR: 0.60, 95% CI: 0.48-0.74, P < 0.001) were independently associated with OS. Use of post-sipuleucel-T anticancer interventions was balanced between races. CONCLUSION: In this exploratory analysis of a registry including nearly 12% African American men with mCRPC, OS was significantly different between African Americans and Caucasians, indicating further research is warranted.

Validating the total illness burden index for prostate cancer (TIBI-CaP) in men with castration-resistant prostate cancer: data from TRUMPET.

AIM: To validate the total illness burden index for prostate cancer (TIBI-CaP) in castration-resistant prostate cancer (CRPC) patients. PATIENTS & METHODS: Baseline comorbidity scores collected using the TIBI-CaP were compared with the baseline patient-reported health-related quality of life using the SF-12v2 and FACT-P questionnaires in 302 patients enrolled in the Treatment Registry for Outcomes in CRPC Patients (TRUMPET). RESULTS: Baseline TIBI-CaP scores were negatively correlated with all baseline SF-12v2 domain/composite (p < 0.001) and FACT-P subscale/total (p < 0.020) scores. There was a significant decreasing linear trend in SF12v2 and FACT-P scores over the categories based on TIBI-CaP quartiles of comorbidity burden (from 'least' to 'severe'). CONCLUSION: The TIBI-CaP is a valid measure of comorbidity burden in patients with CRPC in the real world.

Access to high-volume surgeons and the opportunity cost of performing radical prostatectomy by low-volume providers.

BACKGROUND: Evidence suggests that redirecting surgeries to high-volume providers may be associated with better outcomes and significant societal savings. Whether such referrals are feasible remains unanswered. METHODS: Medicare Provider Utilization and Payment Data, SEER 18, and US Incidence data were used to determine the geographic distribution and radical prostatectomy volume for providers. Access was defined as availability of a high-volume provider within driving distance of 100 miles. The opportunity cost was defined as the value of benefits achievable by performing the surgery by a high-volume provider that was forgone by not making a referral. The savings per referral were derived from a published Markov model for radical prostatectomy. RESULTS: A total of 14% of providers performed>27% of the radical prostatectomies with>30 cases per year and were designated high-volume providers. Providers with below-median volume (≤16 prostatectomies per year) performed>32% of radical prostatectomies. At least 47% of these were within a 100-mile driving distance (median = 22 miles), and therefore had access to a high-volume provider (>30 prostatectomies per year). This translated into a discounted savings of more than $24 million per year, representing the opportunity cost of not making a referral. The average volume for high- and low-volume providers was 55 and 13, respectively, resulting in an annual experience gap of 43 and a cumulative gap of 125 surgeries over 3 years. In 2014, the number of surgeons performing radical prostatectomy decreased by 5% while the number of high- and low-volume providers decreased by 25% and 11% showing a faster decline in the number of high-volume providers compared with low-volume surgeons. CONCLUSIONS: About half of prostatectomies performed by surgeons with below-median annual volume were within a 100-mile driving distance (median of 22 miles) of a high-volume surgeon. Such a referral may result in minimal additional costs and substantially improved outcomes.

Comparative effectiveness of screening strategies for colorectal cancer.

BACKGROUND: Screening for colorectal cancer (CRC) has been successful in decreasing the incidence and mortality from CRC. Although new screening tests have become available, their relative impact on CRC outcomes remains unexplored. This study compares the outcomes of various screening strategies on CRC outcomes. METHODS: A Markov model representing the natural history of CRC was built and validated against empiric data from screening trials as well as the Microstimulation Screening Analysis (MISCAN) model. Thirteen screening strategies based on colonoscopy, sigmoidoscopy, computed tomographic colonography, as well as fecal immunochemical, occult blood, and stool DNA testing were compared with no screening. A simulated sample of the US general population ages 50 to 75 years with an average risk of CRC was followed for up to 35 years or until death. Effectiveness was measured by discounted life years gained and the number of CRCs prevented. Discounted costs and cost-effectiveness ratios were calculated. A discount rate of 3% was used in calculations. The study took a societal perspective. RESULTS: Colonoscopy emerged as the most effective screening strategy with the highest life years gained (0.022 life years) and CRCs prevented (n = 1068) and the lowest total costs ($2861). These values were 0.012 life years gained, 574 CRCs prevented, and a total cost of $3164, respectively, for FOBT; and 0.011 life years gained, 647 CRCs prevented, and a total cost of $4296, respectively, for DNA testing. Improved sensitivity or specificity of a screening test for CRC detection was not sufficient to close the outcomes gap compared with colonoscopy. CONCLUSIONS: Improvement in CRC-detection performance is not sufficient to improve screening outcomes. Special attention must be directed to detecting precancerous adenomas. Cancer 2017;123:1516-1527. © 2017 American Cancer Society.

Treatment registry for outcomes in patients with castration-resistant prostate cancer (TRUMPET): a methodology for real-world evidence and research.

AIM: This study seeks to improve the understanding of treatment patterns and associated health-related quality of life (HRQoL), clinical outcomes and healthcare utilization in US patients with castration-resistant prostate cancer (CRPC). PATIENTS & METHODS: Treatment Registry for Outcomes in CRPC Patients (TRUMPET) is a US-based, prospective, observational multicenter registry (NCT02380274) involving patients with CRPC and their caregivers. Patients initiating their first active treatment course will be enrolled from urology and medical oncology practices, with data captured up to 4 years. RESULTS: Information on prescribing patterns, HRQoL, clinical outcomes and healthcare utilization will be collected. CONCLUSION: TRUMPET will enable scientific understanding of disease management in terms of HRQoL, clinical outcomes and healthcare utilization in clinical practice for patients with CRPC.

Radical Prostatectomy or External Beam Radiation Therapy vs No Local Therapy for Survival Benefit in Metastatic Prostate Cancer: A SEER-Medicare Analysis.

PURPOSE: We assessed survival after radical prostatectomy, intensity modulated radiation therapy or conformal radiation therapy vs no local therapy for metastatic prostate cancer adjusting for patient comorbidity, androgen deprivation therapy and other factors. MATERIALS AND METHODS: We identified men 66 years old or older with metastatic prostate cancer treated with radical prostatectomy, intensity modulated radiation therapy, conformal radiation therapy or no local therapy in the SEER-Medicare linked database from 2004 to 2009. Multivariable Cox proportional hazards models before and after inverse propensity score weighting were used to assess all cause and prostate cancer specific mortality. Competing risk regression analysis was done to assess prostate cancer specific mortality. RESULTS: Of 4,069 men with metastatic prostate cancer radical prostatectomy in 47, intensity modulated radiation therapy in 88 and conformal radiation therapy in 107 were selected as local therapy vs no local therapy in 3,827. Radical prostatectomy was associated with a 52% decrease (HR 0.48, 95% CI 0.27-0.85) in the risk of prostate cancer specific mortality after adjusting for sociodemographics, primary tumor characteristics, comorbidity, androgen deprivation therapy and bone radiation within 6 months of diagnosis. Intensity modulated radiation therapy was associated with a 62% decrease (HR 0.38, 95% CI 0.24-0.61) in the risk of prostate specific cancer specific mortality. Conformal radiation therapy was not associated with improved survival compared to no local therapy. Propensity score weighting yielded comparable results. Competing risk analysis revealed a 42% and 57% decrease (SHR 0.58, 95% CI 0.35-0.95 and SHR 0.43, 95% CI 0.27-0.68, respectively) in the risk of prostate cancer specific mortality for radical prostatectomy and intensity modulated radiation therapy. CONCLUSIONS: Local therapy with radical prostatectomy and intensity modulated radiation therapy but not with conformal radiation therapy was associated with a survival benefit in men with metastatic prostate cancer. This finding warrants prospective evaluation in clinical trials.

One-year follow-up of collaborative depression care for low-income, predominantly Hispanic patients with cancer.

OBJECTIVE: This study assessed longer-term outcomes of low-income patients with cancer (predominantly female and Hispanic) after treatment in a collaborative model of depression care or in enhanced usual care. METHODS: The randomized controlled trial, conducted in safety-net oncology clinics, recruited 472 patients with major depression symptoms. Patients randomly assigned to a 12-month intervention (a depression care manager and psychiatrist provided problem-solving therapy, antidepressants, and symptom monitoring and relapse prevention) or enhanced usual care (control group) were interviewed at 18 and 24 months after enrollment. RESULTS: At 24 months, 46% of patients in the intervention group and 32% in the control group had a ≥50% decrease in depression score over baseline (odds ratio=2.09, 95% confidence interval=1.13-3.86; p=.02); intervention patients had significantly better social (p=.03) and functional (p=.01) well-being. Treatment receipt among intervention patients declined (72%, 21%, and 18% at 12, 18, and 24 months, respectively); few control group patients reported treatment receipt (10%, 6%, and 13%, respectively). Significant differences in receipt of counseling or antidepressants disappeared at 24 months. Depression recurrence was similar between groups (intervention, 36%; control, 39%). Among patients with depression recurrence, intervention patients were more likely to receive treatment after 12 months (34% versus 10%; p=.03). At 24 months, attrition (262 patients, 56%) did not vary by group; 22% were deceased, 20% declined further participation, and 14% could not be located. CONCLUSIONS: Collaborative care reduced depression symptoms and enhanced quality of life; however, results call for ongoing depression symptom monitoring and treatment for low-income cancer survivors.