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Use of Conservative Management for Low-Risk Prostate Cancer in the Veterans Affairs Integrated Health Care System From 2005-2015
Loeb, Stacy; Byrne, Nataliya; Makarov, Danil V; Lepor, Herbert; Walter, Dawn
PMCID:6134433
PMID: 29800017
ISSN: 1538-3598
CID: 3165622
Active Surveillance Offers Functional Advantages Without Impacting Survival for Low-risk Prostate Cancer [Comment]
Loeb, Stacy
PMID: 29169932
ISSN: 1873-7560
CID: 3541022
A Multi-Institutional Prospective Trial Confirms Noninvasive Blood Test Maintains Predictive Value in African American Men
Punnen, Sanoj; Freedland, Stephen J; Polascik, Thomas J; Loeb, Stacy; Risk, Michael C; Savage, Stephen; Mathur, Sharad C; Uchio, Edward; Dong, Yan; Silberstein, Jonathan L
PURPOSE/OBJECTIVE:The 4Kscore® test accurately detects aggressive prostate cancer and reduces unnecessary biopsies. However, its performance in African American men has been unknown. We assessed test performance in a cohort of men with a large African American representation. MATERIALS AND METHODS/METHODS:Men referred for prostate biopsy at 8 Veterans Affairs medical centers were prospectively enrolled in the study. All men underwent phlebotomy for 4Kscore test assessment prior to prostate biopsy. The primary outcome was the detection of Grade Group 2 or higher cancer on biopsy. We assessed the discrimination, calibration and clinical usefulness of 4Kscore to predict Grade Group 2 or higher prostate cancer and compared it to a base model consisting of age, digital rectal examination and prostate specific antigen. Additionally, we compared test performance in African American and nonAfrican American men. RESULTS:Of the 366 enrolled men 205 (56%) were African American and 131 (36%) had Grade Group 2 or higher prostate cancer. The 4Kscore test showed better discrimination (AUC 0.81 vs 0.74, p <0.01) and higher clinical usefulness on decision curve analysis than the base model. Test prediction closely approximated the observed risk of Grade Group 2 or higher prostate cancer. There was no difference in test performance in African American and nonAfrican American men (0.80 vs 0.84, p = 0.32), The test outperformed the base model in each group. CONCLUSIONS:The 4Kscore test accurately predicts aggressive prostate cancer for biopsy decision making in African American and nonAfrican American men.
PMID: 29223389
ISSN: 1527-3792
CID: 3130752
Health state utilities among contemporary prostate cancer patients on active surveillance
Loeb, Stacy; Curnyn, Caitlin; Walter, Dawn; Fagerlin, Angela; Siebert, Uwe; Mühlberger, Nick; Braithwaite, R Scott; Schwartz, Mark D; Lepor, Herbert; Sedlander, Erica
Background/UNASSIGNED:Active surveillance (AS) is the most rapidly expanding management option for favorable-risk prostate cancer (PCa). Early studies suggested substantial decrements in utility (quality of life weights) from disease-related anxiety. Our objective was to determine utilities for contemporary AS patients using different instruments. Methods/UNASSIGNED:We performed a systematic review of PubMed, PMC and OVID for utility measurements in modern AS patients. We then examined utilities among 37 men on AS participating in focus groups between 2015-2016 using the generic EurQol five dimensions questionnaire (EQ-5D-3L) and Patient Oriented Prostate Utility Scale (PORPUS), a PCa-specific instrument. Results/UNASSIGNED:The systematic review found previous studies with utilities for PCa treatment and historical watchful waiting populations, but none specifically in contemporary AS. In our AS population, the mean EQ-5D-3L score was 0.90±0.16 (median, 1.00; range, 0.21-1.00) and PORPUS was 0.98±0.03 (median, 0.99; range, 0.84-1.00). The Spearman correlation between the EQ-5D-3L and PORPUS was 0.87 (P<0.0001), and 38% of patients had a difference >0.1 between instruments. Conclusions/UNASSIGNED:Most contemporary AS patients had high utility scores suggesting that they perceive themselves in good health without a major decrement in quality of life from the disease. However, some patients had substantial differences in utility measured with generic versus disease-specific instruments. Further study is warranted into the optimal instrument for utility assessment in contemporary AS patients.
PMCID:5911532
PMID: 29732277
ISSN: 2223-4691
CID: 3163852
Development and Validation of a Novel Integrated Clinical-Genomic Risk Group Classification for Localized Prostate Cancer
Spratt, Daniel E; Zhang, Jingbin; Santiago-Jiménez, María; Dess, Robert T; Davis, John W; Den, Robert B; Dicker, Adam P; Kane, Christopher J; Pollack, Alan; Stoyanova, Radka; Abdollah, Firas; Ross, Ashley E; Cole, Adam; Uchio, Edward; Randall, Josh M; Nguyen, Hao; Zhao, Shuang G; Mehra, Rohit; Glass, Andrew G; Lam, Lucia L C; Chelliserry, Jijumon; du Plessis, Marguerite; Choeurng, Voleak; Aranes, Maria; Kolisnik, Tyler; Margrave, Jennifer; Alter, Jason; Jordan, Jennifer; Buerki, Christine; Yousefi, Kasra; Haddad, Zaid; Davicioni, Elai; Trabulsi, Edouard J; Loeb, Stacy; Tewari, Ashutosh; Carroll, Peter R; Weinmann, Sheila; Schaeffer, Edward M; Klein, Eric A; Karnes, R Jeffrey; Feng, Felix Y; Nguyen, Paul L
Purpose It is clinically challenging to integrate genomic-classifier results that report a numeric risk of recurrence into treatment recommendations for localized prostate cancer, which are founded in the framework of risk groups. We aimed to develop a novel clinical-genomic risk grouping system that can readily be incorporated into treatment guidelines for localized prostate cancer. Materials and Methods Two multicenter cohorts (n = 991) were used for training and validation of the clinical-genomic risk groups, and two additional cohorts (n = 5,937) were used for reclassification analyses. Competing risks analysis was used to estimate the risk of distant metastasis. Time-dependent c-indices were constructed to compare clinicopathologic risk models with the clinical-genomic risk groups. Results With a median follow-up of 8 years for patients in the training cohort, 10-year distant metastasis rates for National Comprehensive Cancer Network (NCCN) low, favorable-intermediate, unfavorable-intermediate, and high-risk were 7.3%, 9.2%, 38.0%, and 39.5%, respectively. In contrast, the three-tier clinical-genomic risk groups had 10-year distant metastasis rates of 3.5%, 29.4%, and 54.6%, for low-, intermediate-, and high-risk, respectively, which were consistent in the validation cohort (0%, 25.9%, and 55.2%, respectively). C-indices for the clinical-genomic risk grouping system (0.84; 95% CI, 0.61 to 0.93) were improved over NCCN (0.73; 95% CI, 0.60 to 0.86) and Cancer of the Prostate Risk Assessment (0.74; 95% CI, 0.65 to 0.84), and 30% of patients using NCCN low/intermediate/high would be reclassified by the new three-tier system and 67% of patients would be reclassified from NCCN six-tier (very-low- to very-high-risk) by the new six-tier system. Conclusion A commercially available genomic classifier in combination with standard clinicopathologic variables can generate a simple-to-use clinical-genomic risk grouping that more accurately identifies patients at low, intermediate, and high risk for metastasis and can be easily incorporated into current guidelines to better risk-stratify patients.
PMID: 29185869
ISSN: 1527-7755
CID: 3541032
The use of Twitter to facilitate sharing of clinical expertise in urology [Case Report]
Sternberg, Kevan M; Loeb, Stacy L; Canes, David; Donnelly, Laura; Tsai, Mitchell H
The use of social media in the urologic community is common and increasing. Although the potential benefits of platforms like Twitter have been described in the literature, the use of social media in the clinical context of Urology has not been explored.In this case report, we describe how we used Twitter to share ideas about the clinical management of a complex urologic patient. By posting a clinical scenario, a timely discussion was generated with global participation and expert suggestions. This knowledge was applied to the surgical management of a patient with positive clinical outcomes.The ability of Twitter to facilitate rapid communication with a wide network of contributors makes it a potentially useful tool for clinical decision making. Care must be taken to ensure patient confidentiality and caution used appropriately when evaluating the sources and content of the clinical information shared.
PMID: 28591771
ISSN: 1527-974x
CID: 4115652
Informational needs during active surveillance for prostate cancer: A qualitative study
Loeb, Stacy; Curnyn, Caitlin; Fagerlin, Angela; Braithwaite, R Scott; Schwartz, Mark D; Lepor, Herbert; Carter, H Ballentine; Ciprut, Shannon; Sedlander, Erica
OBJECTIVE:To understand the informational needs during active surveillance (AS) for prostate cancer from the perspectives of patients and providers. METHODS:We conducted seven focus groups with 37 AS patients in two urban clinical settings, and 24 semi-structured interviews with a national sample of providers. Transcripts were analyzed using applied thematic analysis, and themes were organized using descriptive matrix analyses. RESULTS:We identified six themes related to informational needs during AS: 1) more information on prostate cancer (biopsy features, prognosis), 2) more information on active surveillance (difference from watchful waiting, testing protocol), 3) more information on alternative management options (complementary medicine, lifestyle modification), 4) greater variety of resources (multiple formats, targeting different audiences), 5) more social support and interaction, and 6) verified integrity of information (trusted, multidisciplinary and secure). CONCLUSIONS:Patients and providers described numerous drawbacks to existing prostate cancer resources and a variety of unmet needs including information on prognosis, AS testing protocols, and lifestyle modification. They also expressed a need for different types of resources, including interaction and unbiased information. PRACTICAL IMPLICATIONS/CONCLUSIONS:These results are useful to inform the design of future resources for men undergoing AS.
PMCID:5808852
PMID: 28886974
ISSN: 1873-5134
CID: 2888782
Biomarkers in active surveillance
Loeb, Stacy; Tosoian, Jeffrey J
The use of active surveillance (AS) is increasing for favorable-risk prostate cancer. However, there remain challenges in patient selection for AS, due to the limitations of current clinical staging. In addition, monitoring protocols relying on serial biopsies is invasive and presents risks such as infection. For these reasons, there is substantial interest in identifying markers that can be used to improve AS selection and monitoring. In this article, we review the evidence on serum, urine and tissue markers in AS.
PMCID:5861276
PMID: 29594029
ISSN: 2223-4691
CID: 3010952
Active Surveillance for Prostate Cancer
Loeb, Stacy
PMID: 30288148
ISSN: 1523-6161
CID: 3329072
Active Surveillance Versus Watchful Waiting for Localized Prostate Cancer: A Model to Inform Decisions
Loeb, Stacy; Zhou, Qinlian; Siebert, Uwe; Rochau, Ursula; Jahn, Beate; Mühlberger, Nikolai; Carter, H Ballentine; Lepor, Herbert; Braithwaite, R Scott
BACKGROUND:An increasing proportion of prostate cancer is being managed conservatively. However, there are no randomized trials or consensus regarding the optimal follow-up strategy. OBJECTIVE:To compare life expectancy and quality of life between watchful waiting (WW) versus different strategies of active surveillance (AS). DESIGN, SETTING, AND PARTICIPANTS/METHODS:A Markov model was created for US men starting at age 50, diagnosed with localized prostate cancer who chose conservative management by WW or AS using different testing protocols (prostate-specific antigen every 3-6 mo, biopsy every 1-5 yr, or magnetic resonance imaging based). Transition probabilities and utilities were obtained from the literature. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS/UNASSIGNED:Primary outcomes were life years and quality-adjusted life years (QALYs). Secondary outcomes include radical treatment, metastasis, and prostate cancer death. RESULTS AND LIMITATIONS/CONCLUSIONS:All AS strategies yielded more life years compared with WW. Lifetime risks of prostate cancer death and metastasis were, respectively, 5.42% and 6.40% with AS versus 8.72% and 10.30% with WW. AS yielded more QALYs than WW except in cohorts age >65 yr at diagnosis, or when treatment-related complications were long term. The preferred follow-up strategy was also sensitive to whether people value short-term over long-term benefits (time preference). Depending on the AS protocol, 30-41% underwent radical treatment within 10 yr. Extending the surveillance biopsy interval from 1 to 5 yr reduced life years slightly, with a 0.26 difference in QALYs. CONCLUSIONS:AS extends life more than WW, particularly for men with higher-risk features, but this is partly offset by the decrement in quality of life since many men eventually receive treatment. PATIENT SUMMARY/UNASSIGNED:More intensive active surveillance protocols extend life more than watchful waiting, but this is partly offset by decrements in quality of life from subsequent treatment.
PMCID:5694372
PMID: 28844371
ISSN: 1873-7560
CID: 3070402