A comparison of prostate health index, total PSA, %free PSA, and proPSA in a contemporary US population-The MiCheck-01 prospective trial.

BACKGROUND: Increasing numbers of patients are presenting with aggressive prostate cancer (CaP); therefore, there exists a need to optimally identify these patients pre-biopsy. OBJECTIVES: To compare the accuracy of total prostate specific antigen (PSA), %free PSA, and prostate health index (PHI) to differentiate between patients without CaP, with non-aggressive (Gleason 3 + 3, non-AgCaP) and with aggressive (Gleason ≥ 3 + 4, AgCaP) in a contemporary US population. DESIGN, SETTINGS, AND PARTICIPANTS: Serum samples were collected from 332 US patients scheduled for biopsy due to an elevated age-adjusted PSA. Site and Central biopsy pathologic assessment were performed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Testing of PSA, free PSA, proPSA, and PHI was performed along with central pathology review. Test performance using logistic regression analysis for differentiating CaP from non-CaP as well as non-AgCaP from AgCaP was evaluated. RESULTS AND LIMITATIONS: Central pathology review resulted in 32 upgrades including 14 Gleason 3 + 3 scores being upgraded to AgCaP with final distribution of 148 no-CaP, 64 non-AgCaP, and 120 AgCaP patients. Receiver operator curve (ROC) analysis of the different tests showed that PHI performed best at differentiating CaP from no-CaP subjects (area under the receiver operator curve 0.79). In contrast, the different tests were essentially equivalent in differentiating AgCaP vs. non-AgCaP. CONCLUSIONS: In this recent US study of prebiopsy patients we observed a high proportion of AgCaP patients consistent with previous studies in contemporary US populations. Central Gleason review is recommended for multi-institutional studies comparing biomarkers. PHI was superior to PSA, free PSA, %free PSA, and proPSA in detecting CaP in this population but was not superior at differentiating AgCaP from non-AgCaP.

Three-year Active Surveillance Outcomes in a Contemporary Community Urology Cohort in the United States.

OBJECTIVES: To determine the 3-year outcomes of men with prostate cancer managed with active surveillance (AS) in a cohort of geographically diverse community-based urology practices. AS is the management of choice for a majority of men with lower risk prostate cancer.1,2,3 Little is known about the contemporary "real-world" follow-up and adherence rates in the most common setting of urologic care, community (private) practice.4 METHODS: We retrospectively evaluated outcomes for men diagnosed between January 1, 2013 and May 31, 2014 with National Comprehensive Cancer Network (NCCN) very low, low and intermediate risk prostate cancer who selected AS in 9 large community urology practices. We used univariate and multivariate analyses to describe associations between race, age, insurance status, family history, comorbidity, clinical stage, Gleason score, NCCN risk-group, and PSA density with discontinuation of AS. RESULTS: Five hundred and forty-eight men on AS were followed for a median of 3.35 years. 89% (492) continued to follow-up with diagnosing practice. 32% (171) discontinued AS. On multivariate analysis, increasing NCCN risk classification (Hazard ratio [HR] 1.65, P = 0.02 and HR 2.09, P < 0.01 for low and intermediate risk vs very low risk) was significantly associated with discontinuation. Among those who discontinued AS, surgery and radiation were utilized equally (47% and 53%, respectively, P = 0.48). CONCLUSION: In this community-based cohort of men on AS, a minority was lost to follow-up and adherence to AS was similar to other reports. Disease characteristics more than sociodemographic characteristics correlated with adherence to AS, while surgery and radiotherapy were utilized equally among those discontinuing AS, both suggesting guideline concordant practice of medicine.

Development of a reliable assay to measure glypican-1 in plasma and serum reveals circulating glypican-1 as a novel prostate cancer biomarker.

Prostate cancer is responsible for hundreds of thousands of annual deaths worldwide. The current gold standard in early detection of prostate cancer, the prostate specific antigen test, boasts a high sensitivity but low specificity, resulting in many unnecessary prostate biopsies. Thus, emphasis has been placed on identifying new biomarkers to improve prostate cancer detection. Glypican-1 has recently been proposed as one such biomarker, however further exploration into its predictive power has been hindered by a lack of available, dependable glypican-1 immunoassays. Previously, we identified human glypican-1 as the antigenic target of the MIL-38 monoclonal antibody. Additionally, we have now generated another monoclonal antibody, 3G5, that also recognizes human glypican-1. Here we report the development of a reliable, custom Luminex® assay that enables precise quantitation of circulating human glypican-1 in plasma and serum. Using this assay, we show for the first time that circulating glypican-1 levels can differentiate non-cancer (normal and benign prostatic hyperplasia) patients from prostate cancer patients, as well as benign prostatic hyperplasia patients alone from prostate cancer patients. Our findings strongly promote future investigation into the use of glypican-1 for early detection of prostate cancer.

Partners and partnerships: trends in private oncology practice.

There are approximately 6,500 medical oncologists in private practice in the United States. Regional vacancy rates can range from 30% to 50%, putting enormous stress on existing providers. Regulatory, financial and emotional burdens continue to restructure the medical marketplace.

Integrating palliative care into the outpatient, private practice oncology setting.

CONTEXT: Quality care for patients with cancer is a national priority-for those with noncurable cancer, the stakes are even higher. Strategies to promote integration of palliative care into oncology practice may enhance quality. We have developed a model in which palliative care services are integrated into the private, office-based oncology practice setting. We have evaluated the feasibility and assessed outcomes for both the oncologists and the patients they serve. To our knowledge, an embedded clinic in an outpatient, private practice oncology clinic has not been described previously. OBJECTIVE: The primary outcomes assessed were 1) quality care outcomes through assessment of symptom burden and relief achieved through palliative care consultation, 2) provider satisfaction, 3) volume determined by number of palliative care consultations over time, and 4) time saved for the oncologist as a surrogate for the bottom line of the cancer practice. METHODS: Measurement of: symptom burden and relief with the Edmonton Symptom Assessment System (ESAS), physician acceptance of palliative care services through a provider satisfaction survey and volume of referrals, and billing data to determine potential oncologists' time saved. RESULTS: Palliative care consultation was associated with a reduction in symptom burden by 21%, evidenced by decrease in average total ESAS score from 49.3 to 39. Median provider satisfaction scores rating components of palliative care ranged from 8.5 to 9/10, with an overall provider satisfaction of 9/10. Over the study period, the "embedded" oncology group consultation requests increased 87% (67-120), with each individual oncology provider nearly doubled. The total time saved for the oncology practice in Year 2 was just over four weeks (9720 minutes; 162 hours). CONCLUSION: An embedded palliative care clinic integrated into an office-based oncology practice is feasible and may improve the quality of care. Formal study of this service delivery model is warranted.

Surviving the perfect storm: an RVU-based model to evaluate the continuing impact of MMA on the practice of oncology.

The Resource-Based Relative Value Scale (RBRVS) system instituted by Centers for Medicare and Medicaid Services has lead to the implementation of a new financial analysis paradigm based on relative value units (RVUs). RVU-based financial tools have great potential to allow in-depth analysis of all components of the cancer care delivery system. Because all medical oncology practices must become conversant in RVU terminology and methodology, RVU-based financial tools will allow standardization and benchmarking for intra- and interpractice comparisons. Understanding this approach is essential for sound business management. The emotional and financial pressures facing the medical oncologist in private practice are enormous, with no real relief in sight. The complexity of managing the business of private practice oncology rivals that of managing the complexity of cancer care. With anticipated reductions in total net revenue per clinical treatment protocol per course of care, funds available for providers and their practices will be severely reduced. Only those practices with superlative RVU-based cost and revenue accounting systems will be able to prospectively and efficiently manage their businesses. Clearly, management of the Oncology Practice Econometric Model (OPEM) expense RVU or similar RVU-based data will be required for survival. The purpose of this article is to explore an RVU-based model to analyze the professional, infusion, and therapeutic components of contemporary cancer care.

Impact of long-acting growth factors on practice dynamics and patient satisfaction.

OBJECTIVE: To quantify time expended, patient satisfaction, and econometrics associated with short-acting (sargramostim, epoetin alfa) and long-acting (darbepoetin alfa, pegfilgrastim) growth factors. DESIGN: Retrospective resource utilization and prospective two-phase observational study. METHODS: During week 1, time-motion measurements related to patient treatment and drug preparation were collected for scheduling; check-in; phlebotomy; laboratory; and drug preparation, administration, and recording. Drug utilization for one chemotherapy cycle during weeks 2 and 3 was assessed for sargramostim, pegfilgrastim, epoetin alfa, darbepoetin alfa, sargramostim plus epoetin alfa, and pegfilgrastim plus darbepoetin alfa. Patients completed a satisfaction survey. RESULTS: Among 140 patients (mean age 58 yrs), mean chemotherapy cycle duration was 19 days. A total of 268 events were observed. Mean total staff time/patient visit for drug administration was 22.1 minutes, with most time spent on scheduling (5.5 min) and drug preparation, administration, recording (5.2 min). For sargramostim only versus pegfilgrastim only, pegfilgrastim resulted in a 37% reduction (p < 0.01) in all visits and an 85% reduction (p < 0.01) in mean number of doses. For epoetin alfa only versus darbepoetin alfa only, darbepoetin alfa resulted in a 48% reduction (p < 0.01) in mean number of doses. The most common dosage of epoetin alfa was 40,000 U/week (63.6%) and that of darbepoetin alfa was 200 microg every other week (92%), but complete blood counts were obtained weekly. For pegfilgrastim plus darbepoetin alfa versus sargramostim plus epoetin alfa, a 45% reduction (p < 0.01) in total visits and a 77% reduction (p < 0.01) in mean number of doses were noted in the former group. In 69 patients converted to long-acting drugs, 65 actual hours for a single treatment cycle were saved. For patients receiving pegfilgrastim plus darbepoetin alfa, there was a 45% reduction in total clinic visits, 77% reduction in doses, and staff time savings of 1.9 hours/patient/cycle of chemotherapy. Fifty-four patients completed the survey and trended toward neutral in their responses, with moderate disagreement that receiving injections is painful. CONCLUSION: Long-acting growth factors resulted in significant time savings for staff and providers by reducing the number of necessary office visits for drug administration. These time savings can significantly improve the quality of life for patients, as well as nurses, physicians, and caregivers.