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Thread: (F) Treatment Decisions Comparisons Trends

  1. #141
    Contemporary national trends in prostate cancer risk profile at diagnosis



    Over the past decade prostate cancer (PCa) diagnostic approaches have evolved away from aggressive prostate-specific antigen (PSA) screening. While a goal of these changes is to decrease over diagnosis and treatment, little is known about the downstream effects on PCa risk distribution at the time of diagnosis. To better understand these effects, we used a national cohort of men to investigate temporal trends in PCa risk profile at diagnosis.

    Using the National Cancer Database, we identified men diagnosed with biopsy-confirmed clinically localized prostate adenocarcinoma (T1-4N0M0) from 2004 to 2014. We assessed temporal trends in proportional distribution of National Comprehensive Cancer Network risk groups as well as their sub-components (PSA, Gleason score, clinical T stage). We also evaluated trends in these sub-components among men with intermediate- and high-risk disease as well as those with metastatic disease.

    In our cohort of 755,567 men diagnosed between 2004 and 2014, there was a decrease in the proportion of men diagnosed with low-risk PCa (38.32 to 27.23%, p < 0.001) and a consequent increase in the proportion of localized intermediate-risk (40.49 to 46.72%, p < 0.001) and high-risk diagnoses (21.19 to 26.05%, p < 0.001). This was primarily driven by an increased proportion of Gleason 7 and Gleason 8-10 cancer, respectively. The number of men presenting with metastatic disease consistently increased from 3251 (2.88%) in 2004 to 6886 (7.19%) in 2014 (p < 0.001).

    The proportion of localized intermediate/high risk and metastatic PCa has substantially increased over the past decade, while the proportion of low-risk disease has decreased. This shift has been primarily driven by increased diagnosis of high-grade disease. National guidelines advising against PSA screening may have contributed to these findings.

  2. #142
    Prostate Biopsy Features: A Comparison Between the Pre- and Post-2012 United States Preventive Services Task Force Prostate Cancer Screening Guidelines With Emphasis on African American and Septuagenarian Men
    [2019, Full Text]



    We compare prostate biopsy (Pbx) characteristics from 3 years prior to the 2012 United States Preventive Services Task Force (USPSTF) prostate cancer (PCa) screening guidelines with those of 2018, with a focus on African American (AA) men and healthy men aged 70 to 80 years. We completed a retrospective comparative analysis of 1703 sequential patients that had had a Pbx from 2010 to 2012 (3 years) with 383 patients biopsied in 2018. Data was collected on patient age, race, prostate-specific antigen (PSA), digital rectal examination (DRE), total number of biopsies performed, and Gleason sum score (GSS). The data was analyzed to determine whether the 2012 USPSTF screening recommendations affected PCa characteristics. Two study groups were defined as group A and B, Pbx prior to the 2012 USPSTF screening guidelines and that of 2018, respectively. The study population consisted of 71% high-risk AA patients. In Group A (pre-2012 USPSTF guidelines), 567 patients/year underwent a Pbx versus Group B, 383 patients/year, a 32% reduction post-USPSTF. The annual positive Pbx rate for Group A is 134/year versus Group B with 175/year, a 31% increase post-USPSTF. In Group B, there was a 94% relative increase in total positive biopsies. Group A had high-grade PCa (GSS 7–10) in 51.5% versus 60.5% in Group B, a 9% increase post-USPSTF. The proportion of patients with a PSA 10 ng/mL or higher was 25.4% in group A versus 29.3% in group B. The age group of 70 to 80 years demonstrated an increasing trend for patients with PSA 10 ng/mL and higher, 31% in Group A versus 38% in Group B; high-grade tumors (GSS 7–10) occurred in 61% in Group A versus 65% in Group B. After the 2012 USPSTF guidelines against PCa screening, our study shows decreased prostate cancer screening with decreased Pbx, increased PCa diagnosis, and increased high-grade (GSS 7–10) PCa. These trends were especially notable in the 70- to 80-year age group, which showed a larger proportion of total patients (compared with pre-2012 USPSTF guidelines), increased PCa grades, increased PSA levels, and a higher percentage of patients with greater than 50% positive cores. As our patient population consists of 71% AA patients, our results support aggressive PCa screening for high-risk patients, which includes AA men, men with a family history of PCa, and healthy men aged 70 to 80 years.
    From the Full Text:


    This study shows that the annual Pbx rate decreased by 32% after the 2012 USPSTF PCa screening guidelines but the annual PCa detection rate increased by 31%. High-grade GSS (7–10) PCa increased by 9% after the 2012 USPSTF guidelines.

    Despite a 32% reduction in the total number of biopsies there was a 94% increase in the total number of positive biopsies in 2018. As our patient population included 71% AA men, these findings suggest that the USPSTF should immediately endorse PCa screening in high-risk populations to decrease the rising trend of PCa morbidity, mortality, and the high cost to treat advanced PCa. We strongly recommend that PSA- and DRE-based PCa screening should be made available, especially to AA men, men with a family history of PCa, and healthy men age 70 to 80 years.

    Main Points
    • This study shows that, in the authors' patient population, the annual prostate biopsy (Pbx) rate decreased by 32% after the 2012 US Preventive Services Task Force (USPSTF) prostate-cancer (PCa) screening guidelines but the annual PCa detection rate increased by 31%.
    • High-grade Gleason sum score (GSS; 7–10) PCa increased by 9% after the 2012 USPSTF guidelines.
    • Despite a 32% reduction in the total number of biopsies there was a 94% increase in the total number of positive biopsies in 2018.
    • As the patient population included 71% African American (AA) men, these findings suggest that the USPSTF should immediately endorse PCa screening in high-risk populations to decrease the rising trend of PCa morbidity, mortality, and the high cost to treat advanced PCa.
    • The authors strongly recommend that prostate-specific antigen-and digital rectal examination-based PCa screening should be made available, especially to AA men, men with a family history of PCa, and healthy men age 70 to 80 years.

  3. #143
    Patient-Centered Approach to Develop the Patient’s Preferences for Prostate Cancer Care (PreProCare) Tool
    [2019, Full Text]



    Objectives. To describe the development of our Patient Preferences for Prostate Cancer Care (PreProCare) tool to aid patient-centered treatment decision among localized prostate cancer patients. Methods. We incorporated patient and provider experiences to develop a patient preference elicitation tool using adaptive conjoint analysis. Our patient-centered approach used systematic literature review, semistructured patient interviews, and provider focus groups to determine the treatment attributes most important for decision making. The resulting computer-based PreProCare tool was pilot tested in a clinical setting. Results. A systematic review of 56 articles published between 1995 and 2015 yielded survival, cancer recurrence, side effects, and complications as attributes of treatment options. We conducted one-on-one interviews with 50 prostate cancer survivors and 5 focus groups of providers. Patients reported anxiety, depression, treatment specifics, and caregiver burden as important for decision making. Providers identified clinical characteristics as important attribute. Input from stakeholders’ advisory group, physicians, and researchers helped finalize 15 attributes for our PreProCare preference assessment tool. Conclusion. The PreProCare tool was developed using a patient-centered approach and may be a feasible and acceptable preference clarification intervention for localized prostate cancer patients. The PreProCare tool may translate into higher participant engagement and self-efficacy, consistent with patients’ personal values.

  4. #144
    Epidemiological Determinants of Advanced Prostate Cancer in Elderly Men in the United States
    [2019, Full Text]



    In this study, we examined the effects of individual-level and area-level characteristics on advanced prostate cancer diagnosis among Medicare eligible older men (ages 70+ years). We analyzed patients from the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database (2000-2007) linked to US Census and County Business Patterns data. Cluster-adjusted logistic regression models were used to quantify the effects of individual preventive health behavior, clinical and demographic characteristics, area-level health services supply, and socioeconomic characteristics on stage at diagnosis. The fully adjusted model was used to estimate county-specific effects and predicted probabilities of advanced prostate cancer. In the adjusted analyses, low intensity of annual prostate-specific antigen (PSA) testing and other preventive health behavior, high comorbidity, African American race, and lower county socioeconomic and health services supply characteristics were statistically significantly associated with a higher likelihood of distant prostate cancer diagnosis. The fully adjusted predicted proportions of advanced prostate cancer diagnosis across 158 counties ranged from 3% to 15% (mean: 6%, SD: 7%). County-level socioeconomic and health services supply characteristics, individual-level preventive health behavior, demographic and clinical characteristics are determinants of advanced stage prostate cancer diagnosis among older Medicare beneficiaries; other health care-related factors such as family history, lifestyle choices, and health-seeking behavior should also be considered as explanatory factors.

  5. #145
    GAY & BISEXUAL MEN LIVING WITH PROSTATE CANCER [2018, Book with some online chapter summaries and several free chapters]


  6. #146
    Comparative effectiveness of treatments for high-risk prostate cancer patients



    ● RP demonstrated 10-year prostate-cancer specific mortality, compared to EBRT + ADT.
    ● We observed 10-year survival benefits for EBRT + BT ADT, compared to RP.
    ● RP can provide superior cancer control with cost advantage for high-risk disease.

    To determine the comparative effectiveness of primary radical prostatectomy (RP) compared to external bean radiation therapy (EBRT) with androgen deprivation therapy (ADT), or EBRT plus brachytherapy (BT) with or without ADT among Medicare fee-for-service beneficiaries with high-risk prostate cancer, for 10-year, mortality (overall and prostate cancer-specific), complications, health service use, and cost.

    This population-based cohort study used Surveillance, Epidemiology, and End Results Medicare data. Eligible patients were men aged 66 or older and diagnosed with high-risk prostate cancer between 1996 and 2003. Outcomes evaluated were 10-year overall mortality and prostate cancer-specific mortality, complications, health service use, and cost. We used Cox regression, Poisson regression, and Generalized Linear Model (GLM) log-link models to assess the outcomes.

    Main findings
    The 10-year overall mortality of EBRT + ADT was comparable to that of the RP group (hazard ratio [HR] = 1.09, confidence interval [CI] = 0.721.66). The EBRT + BT ADT group had overall survival advantage compared to RP (HR = 0.47, CI = 0.310.73). Compared to the RP group, EBRT + ADT group had higher 10-year prostate cancer-specific mortality (HR = 2.19, CI = 1.925.21). Both EBRT + ADT and EBRT + BT ADT were associated with higher 10-year cost (odds ratio = 1.72, CI = 1.352.20; and odds ratio = 1.63, CI = 1.292.04), compared to RP group. Complications and health service use varied across 3 treatment groups and across phases of care.

    Principal conclusions
    Our results also demonstrate long-term overall survival benefits for EBRT + BT ADT, and greater bowel and bladder side effects over a decade, compared to RP. The RP group had advantage for long-term prostate-cancer specific mortality, compared to EBRT + ADT group. Thus, RP can provide superior cancer control with clear cost advantage for older men with high-risk disease. In terms of value proposition, our results support RP as preferred treatment option, compared to EBRT + ADT and EBRT + BT ADT for high-risk prostate cancer patients.

  7. #147
    Precision Medicine for Localized Prostate Cancer: Time to Move Beyond NCCN Risk Stratification?
    [2019, Editorial, Full Text]


    Prostate cancer is the leading cause of cancer treatment–related years lived with disability for men worldwide.1 This has driven a disruptive change in management of favorable-risk prostate cancer such that nearly all National Comprehensive Cancer Network (NCCN) very low-risk patients are recommended conservative management rather than radical therapy.2 Simultaneously, at the other end of the risk spectrum, treatment intensification with more potent systemic therapies has been the subject of recent trials for men with higher-risk disease (eg, NCT02772588 ). Given this tremendous heterogeneity, how does one decide how best to personalize treatment for men who harbor disease outside of the extreme ends of this spectrum?

    What clinicians have always used, and what we still use today to guide nearly all treatment decisions in all cancer types, are prognostic biomarkers. In prostate cancer, the classic examples are prostate-specific antigen (PSA), TNM stage, and Gleason grade (eg, International Society of Urological Pathology grade groups). Usually these variables are combined into multivariable models, such as NCCN risk groups, that have improved performance over single-variable models to identify which patients will ultimately experience recurrence or die from prostate cancer. Patients in general with a high PSA, Gleason score, and T-stage have a worse prognosis than a typical patient with a low PSA, Gleason score, and T-stage, regardless of whether they are treated with surgery, radiation therapy, or observation. However, although these biomarkers help determine who is more likely to have recurrence, they do not indicate which patients will intrinsically derive greater relative benefit from a given therapy, and thus they are prognostic and not predictive biomarkers.

    Although predictive biomarkers are ideal biomarkers for clinical decision making, “ultra-prognostic” biomarkers can effectively serve as biomarkers to drive therapeutic decisions. An ultra-prognostic biomarker is one that can accurately predict which patients have such a favorable outcome of interest that treatment intensification would be futile and improbable to show any benefit. For example, if low-risk patients have a 1% risk of distance metastasis and very high-risk patients have a 30% risk, even if androgen deprivation therapy (ADT) has the same relative effect in both groups, the absolute benefit would be clinically meaningful only in the higher risk group because the risk of metastasis is so small in low-risk patients that the harms of the treatment would outweigh any possible benefit.

    How well do NCCN risk groupings, on which we base nearly all treatment decisions, perform in accurately discriminating which patients will experience recurrence, develop metastatic disease, or die from prostate cancer? To many people's surprise, the classic 3-tiered NCCN risk groups commonly have an area under the curve (AUC) (a test of discriminatory ability) of only 0.50 to 0.65 (by comparison, a random coin flip would have an AUC of 0.5).3

    The expanded Zumsteg (or MSKCC) 4-tier system improved the original NCCN system by stratifying the heterogeneous intermediate-risk subgroup into favorable and unfavorable groups based on primary Gleason pattern, percentage of positive biopsy cores, and number of intermediate risk factors.4 This stratification of intermediate-risk prostate cancer has been validated in over 7500 intermediate-risk patients across multiple independent datasets and various treatment modalities and is now codified in NCCN guidelines.2, 4, 5, 6, 7 One of the most important elements of the favorable/unfavorable intermediate risk classification, in terms of clinical decision making, was the realization that favorable intermediate-risk patients have a very small risk of metastasis and prostate cancer–specific mortality, similar to low-risk prostate cancer in fact, and therefore seem to derive relatively little absolute benefit from the addition of ADT to radiation.4, 7 Nevertheless, substantial heterogeneity remains, particularly for those with unfavorable intermediate-risk disease, and better ways to discriminate pretreatment indolent and aggressive disease in these patients are still needed.
    See Full Text

    Genomic Classifier for Guiding Treatment of Intermediate-Risk Prostate Cancers to Dose-Escalated Image Guided Radiation Therapy Without Hormone Therapy [2019, Full Text]



    The National Comprehensive Cancer Network (NCCN) has recently endorsed the stratification of intermediate-risk prostate cancer (IR-PCa) into favorable and unfavorable subgroups and recommend the addition of androgen deprivation therapy (ADT) to radiation therapy (RT) for unfavorable IR-PCa. Recently, more accurate prognostication was demonstrated by integrating a 22-feature genomic classifier (GC) to the NCCN stratification system. Here, we test the utility of the GC to better identify patients with IR-PCa who are sufficiently treated by RT alone.

    Methods and Materials
    We identified a novel cohort comprising 121 patients with IR-PCa treated with dose-escalated image guided RT (78 Gy in 39 fractions) without ADT. GC scores were derived from tumors sampled in diagnostic biopsies. Multivariable analyses, including both NCCN subclassification and GC scores, were performed for biochemical failure (prostate-specific antigen nadir + 2 ng/mL) and metastasis occurrence.

    By NCCN subclassification, 33 (27.3%) and 87 (71.9%) of men were classified as having favorable and unfavorable IR-PCa, respectively (1 case unclassifiable). GC scores were high in 3 favorable IR-PCa and low in 60 unfavorable IR-PCa. Higher GC scores, but not NCCN risk subgroups, were associated with biochemical relapse (hazard ratio, 1.36; 95% confidence interval [CI], 1.09-1.71] per 10% increase; P = .007) and metastasis (hazard ratio, 2.05; 95% CI, 1.24-4.24; P = .004). GC predicted biochemical failure at 5 years (area under the curve, 0.78; 95% CI, 0.59-0.91), and the combinatorial NCCN + GC model significantly outperformed the NCCN alone model for predicting early-onset metastasis (area under the curve for 5-year metastasis of 0.89 vs 0.86 [GC alone] vs 0.54 [NCCN alone]).

    We demonstrated the accuracy of the GC for predicting disease recurrence in IR-PCa treated with dose-escalated image guided RT alone. Our findings highlight the need to evaluate this GC in a prospective clinical trial investigating the role of ADT-RT in clinicogenomic-defined IR-PCa subgroups.
    See Full Text.
    Last edited by DjinTonic; 07-18-2019 at 04:03 PM.

  8. #148
    Treatment Facility Volume and Survival in Patients with Advanced Prostate Cancer
    [2019, Full Text]



    Despite improvements in medical management of advanced prostate cancer (aPC), it continues to be a leading cause of cancer death in men. Contemporary management of men with aPC is complex and requires resources to be more readily available at high-volume facilities.

    To determine the relationship between facility volume and survival in men with aPC.

    Design, setting, and participants
    The National Cancer Database (NCDB) was queried from 2004 to 2013 for aPC, defined as T4, N+, or M+ disease, identifying 64 815 patients. Six predefined patient cohorts were evaluated. Cohort “A” included all patients with aPC. “B” cohorts included only M0 patients. “C” cohorts included only M1 patients. Facilities were divided into quartiles based on median treatment volume (patients/yr).

    Diagnosis and management of aPC at an NCDB-reporting facility.

    Outcome measurements and statistical analysis
    Overall survival (OS) was assessed as a function of facility volume. Multivariable Cox regression models were fitted. Cox regressions using natural cubic splines were used to test for nonlinear relationships between volume and OS.

    Results and limitations
    OS improved as facility volume increased (top quartile vs bottom quartile, hazard ratio 0.82, 95% confidence interval 0.77–0.88, p < 0.001) and was consistent across patient cohorts. Spline models demonstrate a continuous decrease in hazard of death as volume increases. Limitations include the retrospective analysis and a lack of precise treatment information.

    In this retrospective analysis of nearly 65 000 men who presented with aPC, we demonstrate an association between higher facility volume and improvements in OS. This OS advantage persisted with similar magnitudes of effect after narrowing the cohorts by disease and treatment characteristics.

    Patient summary
    In this retrospective review of the National Cancer Database, we analyzed the association between treatment facility volume and survival in men who are diagnosed with advanced prostate cancer. We found that survival improved as volume increased, indicating a possible imbalance of resources and expertise that favors higher-volume facilities.
    From the Full Text:

    Patient characteristics
    This patient population was predominantly Caucasian (78%), with African-American men comprising 18% of the cohort. Of the men, 73% were >60 yr old and only 5% were <50 yr old. Many men received care using Medicare (48%) as their primary insurance, while 31% used private insurance or managed care plans. Notably, this cohort appeared to have good access to insurance coverage; only 5% of men used Medicaid and only 4% were uninsured. Table 1 details the patient characteristics pertinent to this study.
    In this retrospective analysis of nearly 65 000 men who presented with advanced PC, we demonstrate that management at a high-volume facility (top quartile, >5.6 patients/yr) confers a significant survival advantage when compared with management at a facility in the lowest quartile (<1.8 patients/yr)...In total, these findings imply that there may be differences in the management of advanced PC between lower- and higher-volume TFs, which affect survival. These findings are consistent with data demonstrating survival advantages following management at high-volume TFs in other systemic/advanced disease states, such as multiple myeloma [10] and metastatic renal cell carcinoma
    In this NCDB review of nearly 65 000 men who presented with advanced PC, management at a high-volume TF was significantly associated with better OS, with the effect on OS increasing continuously as a function of TF volume. This association remained true even after narrowing the cohort to select for more homogeneous groups with regard to disease and treatment characteristics. Although the precise underlying mechanism for this association is not known, these findings may be used by both clinicians and researchers to optimize treatment strategies for men with advanced PC
    [TF = Treatment Facility]
    Last edited by DjinTonic; 07-22-2019 at 03:27 PM.

  9. #149
    Changing clinical trends in 10,000 robot-assisted laparoscopic prostatectomy patients and impact of the 2012 USPSTF statement against PSA screening


    To evaluate the clinical trend changes in our robot-assisted laparoscopic prostatectomy (RALP) practice and to investigate the effect of 2012 US Preventive Services Task Force (USPSTF) statement against PSA screening on these trends.

    Data of 10,000 RALPs performed by a single surgeon between 2002 and 2017 were retrospectively analyzed. Time trends in successive 1,000 cases for clinical, surgical and pathological characteristics were analyzed with linear and logistic regression. Time-trend changes before and after USPSTF statement were compared using a logistic regression model and likelihood-ratio test.

    Unfavorable cancer characteristics rate, including D'Amico high risk, pathological non-organ confined disease and Gleason score ≥4+4 increased from 11.5% to 23.3%, 14% to 42.5% and 7.7% to 20.9% over time, respectively (p<0.001 for all). Significant time-trend changes were detected after USPSTF statement with an increase in the positive trend of Gleason ≥4+4 and increase in the negative trends of Gleason ≤3+4 tumors. There was a significant negative trend in the rate of Full NS (nerve-sparing) with a decrease from 59.3% to 35.7%, and a significant positive trend in Partial NS with an increase from 15.8% to 62.5% over time (p<0.001 for all). Time-trend slope in "high-grade" Partial NS significantly decreased and "low-grade" Partial NS significantly increased after USPSTF statement. Overall positive surgical margin (PSM) rate increased from 14.6% to 20.3% in the first vs. last 1,000 cases (p<0.001), with a significantly positive slope after USPSTF statement.

    The proportion of high-risk patients increased in our series over time with a significant impact of USPSTF statement on pathological time-trends. This stage migration resulted in decreased utilization of high-quality NS and increased performance of poor-quality NS. This article is protected by copyright. All rights reserved.
    Article about this study:

    Changing clinical trends in 10,000 robot-assisted laparoscopic prostatectomy patients and impact of the 2012 USPSTF statement against PSA screening [2019]


    Flagged by Forum Brother Michael F.

  10. #150
    Practice Patterns and Outcomes Among Patients With N0M0 Prostate Cancer and a Very High Prostate-Specific Antigen Level
    [2019, Full Text]



    Background: Management of patients with a very high prostate-specific antigen (PSA) level (≥98.0 ng/mL) but clinically localized (N0M0) prostate cancer is challenging. This study sought to determine practice patterns and outcomes among these patients. Patients and Methods: A total of 748,825 patients with prostate cancer from 2004 through 2012 were identified using the National Cancer Database. These patients were subdivided by PSA level (0–9.9, 10.0–19.9, 20.0–39.9, 40.0–59.9, 60.0–79.9, 80.0–97.9, and ≥98.0 ng/mL), nodal status (N0 vs N1), and distant metastases (M0 vs M1). Rates of locoregional treatment and 5-year overall survival (OS) in each group were determined. Survival was compared using Cox regression after adjusting for multiple patient-specific factors. Results: The rate of locoregional treatment for patients with N0M0 disease and PSA level ≥98.0 ng/mL was significantly lower than for those with N1M0 disease (52.6% vs 60.4%; P<.001) or N0M0 disease and PSA level <98.0 ng/mL (52.6% vs 86.6%; P<.001). The 5-year OS rate was similar for patients with N1M0 disease and those with N0M0 disease and a very high PSA level (63.2% vs 59.1%; adjusted hazard ratio [aHR], 0.91; P=.063). The survival benefit associated with locoregional treatment was higher among those with N0M0 disease and a very high PSA level than among those with N1M0 disease (aHR, 0.28 vs 0.44; P<.001). Conclusions: Patients with clinical N0M0 disease and a very high PSA level (≥98.0 ng/mL) have outcomes similar to those with N1 disease but receive locoregional treatment at a lower rate. Future work is needed to investigate the utility of locoregional treatment in this population.


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