Prospective Oncotype DXR Genomic Prostate ScoreTM Test Data Presented at AUA and Published in Urology Establish Tests Ability to Increase Use and Persistence on Active Surveillance in Prostate Cancer Patients
News Article | May 13, 2017
Separate Analysis Published in Urology Demonstrates GPS Test Greatly Increases Both Use and Persistence on Active Surveillance An interim analysis of the 1,200-patient study evaluated the impact the GPS test had on treatment decisions and persistence on active surveillance at one year following diagnosis. Results from 258 patients demonstrated that use of the GPS test changed initial treatment recommendations for 23 percent of patients, which is consistent with previously reported studies and highlights the value of the test in guiding initial treatment decisions. Sixty-two percent of the GPS-tested patient population selected active surveillance compared to 40 percent of the men who did not receive the test. Of men who selected active surveillance initially, the vast majority (89 percent) remained on active surveillance at one year based on personalized genomic information from the GPS test. "With emerging clinical outcomes data, I believe we will observe a significant increase in urologists adopting state-of-the-art technologies to bring precision medicine to men newly diagnosed with prostate cancer," said Eric A. Klein, M.D., chairman, Glickman Urological and Kidney Institute, Cleveland Clinic, and principal investigator of the original Oncotype DX development studies conducted at the Cleveland Clinic. "When we see a patient who has localized cancer, genomic analysis provides information beyond traditional factors, such as Gleason score or PSA, to enable us to more accurately distinguish aggressive or life-threatening disease from indolent disease that can be effectively monitored with active surveillance. That's precision medicine in practice." First-ever Prospective Validation Study of a Tissue-based Molecular Marker in Prostate Cancer Reconfirms GPS Test as an Accurate Predictor of Adverse Pathology The initial findings from 122 patients across 19 centers demonstrated that the GPS result was a strong and independent predictor of adverse pathology across very low-, low- and intermediate-risk patients. Importantly, these prospective validation study results are consistent with previously published studies based on retrospective patient cohorts. "Treatment decision-making can be emotionally difficult for prostate cancer patients and their families. By identifying patients who can choose active surveillance with confidence, we can help ensure that the majority of men diagnosed with prostate cancer will be able to avoid potentially life-altering side effects and improve their quality of life," said Lawrence Karsh, M.D., F.A.C.S., a urologist and director of the clinical research department at The Urology Center of Colorado and a principal investigator of the study. "Our study shows that the GPS test can clearly identify patients who are more appropriate for active surveillance, using state-of-the-art technology to guide treatment decisions while potentially identifying patients whose biological risk requires more immediate intervention." Designed by Genomic Health based on results from multiple studies led by Cleveland Clinic, the University of California, San Francisco, and the Center for Prostate Disease Research, the Oncotype DX Genomic Prostate Score test analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide an individual score that, in combination with other clinical factors, further clarifies the current and future risk of the cancer prior to treatment intervention. The test enables confident treatment decisions to provide the opportunity for low- and intermediate-risk patients to avoid prostatectomy or radiation - and their side effects - while identifying men who need immediate definitive treatment. To learn more about the Oncotype DX Genomic Prostate Score test, visit www.OncotypeDX.com or www.MyProstateCancerTreatment.org. Dr. Eric Klein is a paid consultant of Genomic Health, Inc. in providing speaker and education services for the Oncotype DX Genomic Prostate Score (GPS) test. About Genomic Health Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care by addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 750,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype SEQ® Liquid Select™ test. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our business model; the applicability of clinical study results to actual outcomes; the impact of results from clinical studies on market adoption of Oncotype DX tests; unanticipated costs or delays in research and development efforts; and other risks and uncertainties set forth in our filings with the Securities and Exchange Commission, including our most recent report on Form 10-Q for the quarter ended March 31, 2017. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements. NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, DCIS Score, Oncotype SEQ, Liquid Select, Genomic Prostate Score, Oncotype DX AR-V7 Nucleus Detect and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners. 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Klein E.A.,Glickman Urological and Kidney Institute |
Thompson I.M.,University of Texas Health Science Center at San Antonio
World Journal of Urology | Year: 2012
Objectives: To place chemoprevention of prostate cancer in current clinical context. Methods: Review of recently published updates of large, randomized, controlled trials of primary chemoprevention of prostate cancer. Results: With extended post-intervention follow-up, SELECT demonstrated a 17% increased risk of prostate cancer relative to placebo in the vitamin E alone arm. Two other trials in men with high-grade PIN demonstrated no effect of selenium alone or in combination with soy and lycopene. Trials of 5α-reductase inhibitors show an approximate 25% relative risk reduction in men at average risk and in those with an "elevated" PSA and prior negative biopsy, but adoption of these agents in clinical practice has been limited by concerns over an apparently increased risk of high-grade disease. Conclusions: Primary prevention of prostate cancer remains an attractive goal because of its prevalence and treatment-related morbidity. Neither selenium nor vitamin E prevents prostate cancer. The benefit/risk ratio for 5α-reductase inhibitors can be improved by limiting their use to men at high risk. © 2012 Springer-Verlag.
Aboumarzouk O.M.,Royal Bournemouth Hospital |
Aboumarzouk O.M.,Islamic University of Gaza |
Monga M.,Glickman Urological and Kidney Institute |
Kata S.G.,Ninewells Hospital and Medical School |
And 2 more authors.
Journal of Endourology | Year: 2012
Background and Purpose: Urinary stones >2cm are traditionally managed with percutaneous nephrolithotomy (PCNL). Recently, flexible ureteroscopy and laser lithotripsy) (FURSL) has been used to manage them with comparable results. In a comparative study of renal stones between 2 and 3cm, FURSL was reported to need less second-stage procedures and be just as effective as PCNL. Our purpose was to review the literature for renal stones >2cm managed by ureteroscopy and holmium lasertripsy. Materials and Methods: A systematic review and quantitative meta-analysis was performed using studies identified by a literature search from 1990s (the first reported large renal stones treated ureteroscopically) to August 2011. All English language articles reporting on a minimum of 10 patients treated with FURSL for renal stones >2cm were included. Two reviewers independently extracted the data from each study. The data of studies with comparable results were included into a meta-analysis. Results: In nine studies, 445 patients (460 renal units) were reportedly treated with FURSL. The mean operative time was 82.5 minutes (28-215min). The mean stone-free rate was 93.7% (77%-96.7%), with an average of 1.6 procedures per patient. The mean stone size was 2.5cm. An overall complication rate was 10.1%. Major complications developed in 21 (5.3%) patients and minor complications developed in 19 (4.8%) patients. A subgroup analysis shows that FURSL has a 95.7% stone-free rate with stones 2-3cm and 84.6% in those >3cm (P=0.01), with a minor complication rate of 14.3% and 15.4%, respectively, and a major complication rate of 0% and 11.5%, respectively. Conclusion: In experienced hands, FURSL can successfully treat patients with stones >2cm with a high stone-free rate and a low complication rate. Although the studies are from high-volume experienced centers and may not be sufficient to alter everyday routine practice, this review has shown that the efficacy of FURSL allows an alternative to PCNL. © 2012 Mary Ann Liebert, Inc.
Abd El-Latif A.,Glickman Urological and Kidney Institute |
Watts K.E.,Pathology and Laboratory Medicine Institute |
Elson P.,Taussig Cancer Institute |
Fergany A.,Glickman Urological and Kidney Institute |
Hansel D.E.,Cleveland Clinic
Journal of Urology | Year: 2013
Purpose: We determined the ability of bladder biopsy and transurethral resection of the bladder to accurately predict bladder cancer variants on radical cystectomy since certain variants may affect prognosis and treatment. Materials and Methods: We retrospectively evaluated the records of 302 patients who underwent biopsy and/or transurethral resection of the bladder followed by radical cystectomy from 2008 to 2010. The frequency of variant morphology and the sensitivity of the precystectomy material was determined using pathological findings at radical cystectomy as the final result. Results: Bladder cancer variants were identified in 159 patients (53%) on initial biopsy/transurethral resection and/or final pathological evaluation at radical cystectomy. The most common variant was urothelial carcinoma with squamous differentiation in 72 of 159 patients (45%), followed by micropapillary urothelial carcinoma in 41 (26%). In 9 patients (6%) variant morphology was identified only on biopsy/transurethral resection bladder and not on final radical cystectomy pathological assessment. The remaining 150 patients (94%) showed variant morphology on radical cystectomy with (79 or 53%) or without (71 or 47%) variant morphology on the preceding biopsy/transurethral resection. The sensitivity of variant detection showed a broad range by variant subtype. Overall, initial biopsy/transurethral resection sensitivity was 39% for predicting variant morphology on radical cystectomy. Conclusions: Overall sensitivity for predicting bladder cancer variants from biopsy/transurethral resection of the bladder sampling is relatively low. This is likely due to sampling and tumor heterogeneity rather than to an inaccurate pathological diagnosis. Additional predictive markers of variant morphology may be useful to determine which tumors contain aggressive variants that may alter outcomes or therapy. © 2013 American Urological Association Education and Research, Inc.
Purysko A.S.,Glickman Urological and Kidney Institute |
Leao Filho H.M.,HCor Hospital Do Coracao |
Herts B.R.,Glickman Urological and Kidney Institute
Seminars in Oncology | Year: 2012
Imaging has an ancillary but important role in the detection, staging, and follow-up of bladder cancer. Computed tomography urography (CTU) has widely replaced intravenous urography (IVU) and is currently the imaging modality most commonly used for the initial evaluation of patients with or suspected of having bladder tumors, as CTU allows a fast and comprehensive evaluation of the urinary tract in a single exam. Magnetic resonance imaging (MRI) affords better soft tissue contrast, which allows for more accurate staging than can be achieved with other imaging modalities; the role of MRI in bladder cancer is expected to grow. Despite myriad technical advances, imaging of the bladder has several limitations and technical challenges. The performance of the common and some promising newer imaging modalities in the evaluation of bladder cancer are discussed. © 2012 Elsevier Inc.
Nguyen C.T.,Glickman Urological and Kidney Institute |
Kattan M.W.,Cleveland Clinic
Asian Journal of Andrology | Year: 2012
Greater understanding of the biology and epidemiology of prostate cancer in the last several decades have led to significant advances in its management. Prostate cancer is now detected in greater numbers at lower stages of disease and is amenable to multiple forms of efficacious treatment. However, there is a lack of conclusive data demonstrating a definitive mortality benefit from this earlier diagnosis and treatment of prostate cancer. It is likely due to the treatment of a large proportion of indolent cancers that would have had little adverse impact on health or lifespan if left alone. Due to this overtreatment phenomenon, active surveillance with delayed intervention is gaining traction as a viable management approach in contemporary practice. The ability to distinguish clinically insignificant cancers from those with a high risk of progression and/or lethality is critical to the appropriate selection of patients for surveillance protocols versus immediate intervention. This chapter will review the ability of various prediction models, including risk groupings and nomograms, to predict indolent disease and determine their role in the contemporary management of clinically localized prostate cancer. © 2012 AJA, SIMM & SJTU. All rights reserved.
Tripp D.A.,Queen's University |
Nickel J.C.,Queen's University |
Shoskes D.,Glickman Urological and Kidney Institute |
Koljuskov A.,Queen's University
World Journal of Urology | Year: 2013
Objectives: There are two objectives: (1) Examine quality of life (QoL) and mood between chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) patients and spouses over a 2-year period; (2) Longitudinally assess CP/CPPS patient pain, disability, and pain catastrophizing over a 2-year period. Methods: Forty-four CP/CPPS diagnosed men and their spouses participated. Patients completed demographics, QoL, depression, anxiety, pain, disability, and catastrophizing across the study. Spouses completed QoL, depression, and anxiety. Patients/spouses were not different in education, but patients were older (49 years; SD = 9.56). The average symptom duration was 8.68 (SD = 7.61). Couples were married or common law, and majority of patients were employed. Due to attrition, approximately 21 couples provided analyzable data. Results: Patients and spouses physical QoL did not statistically differ over time from one another, and both increased over the study period. Mental QoL increased over time, but patients reported lower QoL. Patients reported more depression and anxiety, but both measures remained stable over time for spouses and patients. Finally, patient only analyses showed that disability did decrease over time from a high at 6 months, but pain and catastrophizing showed stability over the 2 years. Conclusions: Patients reported worse mental QoL, depression, and anxiety compared to spouses, and spouses reported significant stable levels of depression and anxiety similar to patients. Further, patient catastrophizing, pain, and disability did not reduce over the 2-year assessment period. These results provide further impetus for the development and implementation of mental health strategies alongside continued medical efforts in couples suffering from CP/CPPS. © 2013 Springer-Verlag Berlin Heidelberg.
Nickel J.C.,Queen's University |
Shoskes D.A.,Glickman Urological and Kidney Institute
BJU International | Year: 2010
• Our traditional approach to managing the chronic prostatitis (CP) syndromes has not been very successful for many of our patients. • Our developing understanding of CP/chronic pelvic pain syndrome (CP/CPPS) as a heterogeneous syndrome rather than a homogenous disease has allowed us to develop treatment strategies based on individual patient characteristics. • By considering each patient as a unique individual and tailoring treatments to a specific patient's clinical 'phenotype' we improve our therapeutic outcomes. © 2010 BJU International.
King A.B.,Glickman Urological and Kidney Institute |
Goldman H.B.,Glickman Urological and Kidney Institute
Current Urology Reports | Year: 2014
Bladder outlet obstruction (BOO) in women has received less focus in the past, as compared with BOO in men; however, more recently, studies have further examined BOO and voiding dysfunction in women to define the various etiologies, diagnostic criteria, and treatment strategies. The differential diagnosis in women is broad and includes anatomic, neurologic, and functional etiologies. This review focuses on the functional etiologies, including dysfunctional voiding, Fowler 's syndrome, and primary bladder neck obstruction in adult women. © Springer Science+Business Media 2014.
Montague D.K.,Glickman Urological and Kidney Institute
Advances in Urology | Year: 2012
The published evidence concerning the safety, efficacy, and patient satisfaction for implantation of the current model of the artificial urinary sphincter (AS 800) in men with post prostatectomy urinary incontinence was the objective of this review. A Pub Med English language literature search from 1995 to 2011 was performed. A majority of men who undergo AUS implantation for post prostatectomy urinary incontinence achieve satisfactory results (0 to 1 pad per day). Infection rates range from 0.46 to 7%, cuff erosion rates range from 3.8 to 10%, and urethral atrophy ranges from 9.6 to 11.4%. Kaplan-Meier 5 year projections for freedom from any reoperation were 50% for a small series and 79.4% for a larger series. Kaplan-Meier projections for freedom from mechanical failure were 79% at 5 years and 72% at 10 years. In another series 10 year projections for freedom from mechanical failure were 64%. Although the artificial urinary sphincter (AUS) is the gold standard for the treatment of this disorder, most men will continue to need at least one pad per day for protection, and they are subject to a significant chance of future AUS revision or replacement. Copyright © 2012 Drogo K. Montague.