Risk factors which predict biopsy upgrading over time in active surveillance for prostate cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 290-290
Author(s):  
Peter Eoin Lonergan ◽  
Samuel L. Washington ◽  
Shoujun Zhao ◽  
Janet E. Cowan ◽  
Hao Nguyen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Active Surveillance ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Grade Group ◽  
Psa Kinetics ◽  
Psa Density ◽  
Clinical Tools

290 Background: Active surveillance (AS) is recognized as the preferred treatment for low risk prostate cancer (PCa). No validated clinical tools currently exist to standardize the frequency of biopsies. We aimed to determine predictors of biopsy upgrading in a contemporary cohort of patients on AS. Methods: Men enrolled on AS at UCSF between 2000-2016 were included. The genomic tests used were Oncotype DX, Decipher and Prolaris. Biopsy upgrade was defined as ISUP grade group ≥ 2 on subsequent biopsy. PSA kinetics was calculated using a linear mixed-effects model for log of PSA, adjusted for clinical characteristics. Multivariable Cox proportional hazards regression models were utilized to identify factors associated with risk of upgrade on follow-up at first surveillance biopsy and at 3, 5 and 10 years. Results: 1,303 men were included. Upgrade-free survival at 3, 5 and 10 years was 73%, 53% and 27% respectively. Median time between diagnostic biopsy and first surveillance biopsy was 13 months (IQR 9-16) with the risk of upgrade at first surveillance biopsy associated with PSA density (hazard ratio [HR] 2.761, 95% confidence interval [CI] 1.895-4.023), and “high” risk genomic score (HR 1.867, 95% CI 1.025-3.401) on multivariable analysis after adjustments. Independent variables significantly associated with risk of upgrade at first surveillance biopsy and at 3, 5 and 10 years on multivariable analysis after adjustments are shown. Conclusions: Our findings suggest that genomic scores and PSA density are risk factors for biopsy upgrading within 3 years of starting AS, however PSA kinetics is associated with risk of upgrade at 5 and 10 years. When used in tandem, genomic scores may identify a subset eligible for AS who could potentially adopt a less intensive surveillance regimen.[Table: see text]

Association of PI-RADS categories and PSA density with active surveillance progression in patients with prostate cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 293-293
Author(s):  
Alex Z. Wang ◽  
Luke P. O'Connor ◽  
Nitin Yerram ◽  
Johnathan Zeng ◽  
Sherif Mehralivand ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Proportional Hazards Model ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Time Interval ◽  
Gleason Grade ◽  
Psa Density ◽  
Definitive Therapy

293 Background: Active surveillance (AS) is now considered a well-accepted alternative for low-favorable intermediate risk prostate cancer over definitive therapy. Few studies have incorporated the use of multi-parametric MRI (mpMRI) into the treatment paradigm. In this study we investigate imaging findings that are predictive of a patient dropping off AS. Methods: Our institutional database was queried for all patients who met criteria for active surveillance from 11/2003 to 5/2017. Criteria for inclusion included ≥ 2 mpMRIs, ≥ 2 prostate biopsies, and a diagnosis of Gleason Grade group (GG) 1 or higher. Patients were excluded if they received any other therapy for the treatment of their prostate cancer such as radiation, chemotherapy, focal therapy, or immunologic therapy. Patient demographics, mpMRI, biopsy and most recent follow-up data were recorded. Factors, including PSA density (PSAD), PSA, lesion size, and PI-RADS category, associated with AS progression were evaluated in Cox Proportional Hazards Model. Results: An analysis of a total of 212 patients were performed during the study time interval. 88 patients were dropped from AS during this time and of those patients the median amount of time before removal was 4.70 years (range, 0.7-10.5). On univariable analysis, PI-RADS category (HR, 1.302 for every increase in 1 unit of the PI-RADS category; 95% CI, 1.046-1.62, p = 0.01) and PSAD (HR, 4.98 for every increase in 0.001 ng/mL/cc; 95% CI, 2.127-11.66; p < 0.001) were found to be associated with being removed from AS. On multivariable analysis, both PI-RADS score (HR, 1.281 for every increase in 1 unit of the PI-RADS category; 95% CI, 1.025-1.6; p = 0.003) and PSAD (HR, 4.188 for every increase in 0.001 ng/mL/cc; 95% CI, 1.640-10.7; p < 0.001) remained associated with being removed from AS. Conclusions: PI-RADS categories and PSAD predict the risk of a patient to drop off active surveillance. AS. Patients with these criteria should be considered high risk in any current AS protocol.[Table: see text]

Can PSA doubling time exactly predict the candidates for active surveillance in patients with low-risk prostate cancer?

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 65-65
Author(s):  
Satoru Maruyama ◽  
Nobuo Shinohara ◽  
Takashige Abe ◽  
Ataru Sazawa ◽  
Katsuya Nonomura
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Active Surveillance ◽  
Doubling Time ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Biochemical Relapse ◽  
Free Survival ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer

65 Background: Currently, there are few well-validated data of PSA kinetics (PSA doubling time [PSADT] and PSA velocity) in active surveillance protocols. The objective of the study was to elucidate whether PSADT could predict patients with low-risk prostate cancer suitable for active surveillance (AS). Methods: The study included 149 consecutive patients treated with radical prostatectomy (RP). We selected patients who could be candidates for AS (PSA≤10ng/ml and Gleason score (GS)≤3+3 and cT1-2N0M0). PSA had been measured two times at least in a year before surgery. After all, from April 2000 to March 2008, we retrospectively reviewed a total of 47 patients (median age were 64 years, range: 53-75). Patients were divided into the following two groups: patients whose PSADT<36 months (Rapid group) and the others (Non-rapid group). We determined the respective rates of upgrading, upstaging and biochemical relapse-free survival (bRFS) in each group. Risk factors were evaluated using a Cox proportional hazards model. Results: In the whole specimen of 47 pts, upgraded to Gleason score 7-8, extracapsular extension (ECE: pT3a disease), seminal vesicle involvement and upstaged were 23 (49%), 7 (15%), none (0%) and 7 (15%), respectively. No statistical significance was observed in occurrence rates of upgrading and upstaging between Rapid group (56%, 19%) and Non-rapid group (45%, 13%). There was no significant difference in biochemical-free survival rates in two groups (5-year bRFS were 71% and 77%, respectively). The Cox proportional hazards analysis demonstrated that any pre-operative factors including PSADT were not significant risk factors for biochemical relapse. Conclusions: Our findings revealed that pre-opeative PSADT did not reliably predict pathology and prognosis after RP in those who were candidates for AS. PSADT is not suitable for selection criteria and for monitoring on active surveillance.

scholarly journals The development and validation of a prognostic nomogram and nomogram application software among men treated with abiraterone acetate and/or enzalutamide for metastatic castration-resistant prostate cancer

2020 ◽  
Author(s):  
Takashi Kawahara ◽  
Yusuke Saigusa ◽  
Shuko Yoneyama ◽  
Masashi Kato ◽  
Ippei Kojima ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Abiraterone Acetate ◽  
Cox Proportional Hazards ◽  
Mobile App ◽  
Application Software ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

Abstract BACKGROUND:With widespread medication choices for metastatic castration-resistant prostate cancer (mCRPC) is now available, on the other hand biomarker to predict the efficacy of each mCRPC treatment has not been established.Objective:This study developed prognostic nomogram to predict prognosis in CRPC patients who received abiraterone acetate (ABI) and/or enzalutamide (ENZ).Design, Setting, and Participants:A total of 568 mCRPC patients received ABI and/or ENZ from 2012 to 2017 were enrolled in this study. We developed prognostic nomogram based on the risk factors by Cox proportional hazards regression model.Outcome Measurements and Statistical Analysis:The nomogram was also assessed for discriminatory ability with the concordance index (C-index). We repeated 5-fold cross-validation 2000 times to estimate the C-index and reported the means of the estimated C-index for the training and validation sets. And we also developed nomogram application software (app) based on this nomogram.Results and Limitations:The median overall survival (OS) was 24.7 months. A multivariable analysis showed that the time to CRPC, pre-chemotherapy, baseline PSA, baseline ALP, and baseline LDH were independent risk factors for the OS (HR: 0.521, 1.681, 1.439, 1.827, 12,123, p:0.001, 0.001, <0.001, 0.019, <0.001)). C-index was 0.72 in training cohort and 0.71 in validation cohort.CONCLUSIONS:We developed nomograms to predict the OS for Japanese mCRPC patients who received ABI and/or ENZ. The advent of mCRPC prognosis prediction app will facilitate greater accessibility for clinical use.Patient SummaryThis study developed and validated a nomogram for predicting the prognosis of mCRPC patients who receive ABI/ENZ treatment using clinical information. This study also developed mobile app to facilitate clinical usage.

scholarly journals The Development and Validation of a Prognostic Nomogram and Nomogram Application Software Among Men Treated with Abiraterone Acetate and/or Enzalutamide for Metastatic Castration-resistant Prostate Cancer

2020 ◽  
Author(s):  
Takashi Kawahara ◽  
Yusuke Saigusa ◽  
Shuko Yoneyama ◽  
Masashi Kato ◽  
Ippei Kojima ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Abiraterone Acetate ◽  
Cox Proportional Hazards ◽  
Mobile App ◽  
Application Software ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

Abstract Background:With widespread medication choices for metastatic castration-resistant prostate cancer (mCRPC) is now available, on the other hand biomarker to predict the efficacy of each mCRPC treatment has not been established.Objective:This study developed prognostic nomogram to predict prognosis in CRPC patients who received abiraterone acetate (ABI) and/or enzalutamide (ENZ).Design, Setting, and Participants:A total of 568 mCRPC patients received ABI and/or ENZ from 2012 to 2017 were enrolled in this study. We developed prognostic nomogram based on the risk factors by Cox proportional hazards regression model.Outcome Measurements and Statistical Analysis:The nomogram was also assessed for discriminatory ability with the concordance index (C-index). We repeated 5-fold cross-validation 2000 times to estimate the C-index and reported the means of the estimated C-index for the training and validation sets. And we also developed nomogram application software (app) based on this nomogram.Results and Limitations:The median overall survival (OS) was 24.7 months. A multivariable analysis showed that the time to CRPC, pre-chemotherapy, baseline PSA, baseline ALP, and baseline LDH were independent risk factors for the OS (HR: 0.521, 1.681, 1.439, 1.827, 12,123, p:0.001, 0.001, <0.001, 0.019, <0.001)). C-index was 0.72 in training cohort and 0.71 in validation cohort.Conclusion:We developed nomograms to predict the OS for Japanese mCRPC patients who received ABI and/or ENZ. The advent of mCRPC prognosis prediction app will facilitate greater accessibility for clinical use.Patient SummaryThis study developed and validated a nomogram for predicting the prognosis of mCRPC patients who receive ABI/ENZ treatment using clinical information. This study also developed mobile app to facilitate clinical usage.

scholarly journals 17-Gene Genomic Prostate Score Test Results in the Canary Prostate Active Surveillance Study (PASS) Cohort

2020 ◽  
Vol 38 (14) ◽  
pp. 1549-1557 ◽  
Author(s):  
Daniel W. Lin ◽  
Yingye Zheng ◽  
Jesse K. McKenney ◽  
Marshall D. Brown ◽  
Ruixiao Lu ◽  
...  
Keyword(s):  
Active Surveillance ◽  
Proportional Hazards ◽  
Specific Antigen ◽  
Score Test ◽  
Cox Proportional Hazards ◽  
Surveillance Study ◽  
Gleason Grade ◽  
Grade Group ◽  
Cox Proportional Hazards Models ◽  
Immediate Surgery

PURPOSE The 17-gene Onco type DX Genomic Prostate Score (GPS) test predicts adverse pathology (AP) in patients with low-risk prostate cancer treated with immediate surgery. We evaluated the GPS test as a predictor of outcomes in a multicenter active surveillance cohort. MATERIALS AND METHODS Diagnostic biopsy tissue was obtained from men enrolled at 8 sites in the Canary Prostate Active Surveillance Study. The primary endpoint was AP (Gleason Grade Group [GG] ≥ 3, ≥ pT3a) in men who underwent radical prostatectomy (RP) after initial surveillance. Multivariable regression models for interval-censored data were used to evaluate the association between AP and GPS. Inverse probability of censoring weighting was applied to adjust for informative censoring. Predictiveness curves were used to evaluate how models stratified risk of AP. Association between GPS and time to upgrade on surveillance biopsy was evaluated using Cox proportional hazards models. RESULTS GPS results were obtained for 432 men (median follow-up, 4.6 years); 101 underwent RP after a median 2.1 years of surveillance, and 52 had AP. A total of 167 men (39%) upgraded at a subsequent biopsy. GPS was significantly associated with AP when adjusted for diagnostic GG (hazards ratio [HR]/5 GPS units, 1.18; 95% CI, 1.04 to 1.44; P = .030), but not when also adjusted for prostate-specific antigen density (PSAD; HR, 1.85; 95% CI, 0.99 to 4.19; P = .066). Models containing PSAD and GG, or PSAD, GG, and GPS may stratify risk better than a model with GPS and GG. No association was observed between GPS and subsequent biopsy upgrade ( P = .48). CONCLUSION In our study, the independent association of GPS with AP after initial active surveillance was not statistically significant, and there was no association with upgrading in surveillance biopsy. Adding GPS to a model containing PSAD and diagnostic GG did not significantly improve stratification of risk for AP over the clinical variables alone.

scholarly journals Natural history of prostate cancer on active surveillance: stratification by MRI using the PRECISE recommendations in a UK cohort

2020 ◽  
Author(s):  
Francesco Giganti ◽  
Armando Stabile ◽  
Vasilis Stavrinides ◽  
Elizabeth Osinibi ◽  
Adam Retter ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Rank Test ◽  
Gleason Grade ◽  
Clinical Progression ◽  
Radiological Progression ◽  
Grade Group ◽  
Psa Density

Abstract Objectives The PRECISE recommendations for magnetic resonance imaging (MRI) in patients on active surveillance (AS) for prostate cancer (PCa) include repeated measurement of each lesion, and attribution of a PRECISE radiological progression score for the likelihood of clinically significant change over time. We aimed to compare the PRECISE score with clinical progression in patients who are managed using an MRI-led AS protocol. Methods A total of 553 patients on AS for low- and intermediate-risk PCa (up to Gleason score 3 + 4) who had two or more MRI scans performed between December 2005 and January 2020 were included. Overall, 2161 scans were retrospectively re-reported by a dedicated radiologist to give a PI-RADS v2 score for each scan and assess the PRECISE score for each follow-up scan. Clinical progression was defined by histological progression to ≥ Gleason score 4 + 3 (Gleason Grade Group 3) and/or initiation of active treatment. Progression-free survival was assessed using Kaplan-Meier curves and log-rank test was used to assess differences between curves. Results Overall, 165/553 (30%) patients experienced the primary outcome of clinical progression (median follow-up, 74.5 months; interquartile ranges, 53–98). Of all patients, 313/553 (57%) did not show radiological progression on MRI (PRECISE 1–3), of which 296/313 (95%) had also no clinical progression. Of the remaining 240/553 patients (43%) with radiological progression on MRI (PRECISE 4–5), 146/240 (61%) experienced clinical progression (p < 0.0001). Patients with radiological progression on MRI (PRECISE 4-5) showed a trend to an increase in PSA density. Conclusions Patients without radiological progression on MRI (PRECISE 1-3) during AS had a very low likelihood of clinical progression and many could avoid routine re-biopsy. Key Points • Patients without radiological progression on MRI (PRECISE 1–3) during AS had a very low likelihood of clinical progression and many could avoid routine re-biopsy. • Clinical progression was almost always detectable in patients with radiological progression on MRI (PRECISE 4–5) during AS. • Patients with radiological progression on MRI (PRECISE 4–5) during AS showed a trend to an increase in PSA density.

scholarly journals Risk Factors for Adverse Events in Household Contacts Prescribed Preventive Treatment for Drug-resistant Tuberculosis Exposure

2020 ◽  
Author(s):  
Amyn A Malik ◽  
Mercedes C Becerra ◽  
Timothy L Lash ◽  
Lisa M Cranmer ◽  
Saad B Omer ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Preventive Treatment ◽  
Cox Proportional Hazards ◽  
Drug Resistant ◽  
Event Analysis ◽  
Crude Odds Ratio ◽  
Household Contacts

Abstract Background Completion of tuberculosis (TB) preventive treatment is important to optimize efficacy; treatment-related adverse events (AEs) sometimes result in discontinuation. This study describes the occurrence of AEs and their risk factors during a 6-month, 2-drug, fluoroquinolone-based preventive treatment for household contacts of patients with drug-resistant TB in Karachi, Pakistan. Methods The primary outcome was development of any clinical AE during preventive treatment. Adverse events were categorized using the AE grading tables of the National Institutes of Health. Time-to-event analysis with Kaplan-Meier curves and Cox proportional hazards models accounting for recurrence were used to analyze associated risk factors. Results Of the 172 household contacts on preventive treatment, 36 (21%) developed 64 AEs during 813 months of treatment. The incidence of AEs over 6 months of treatment was 7.9 per 100 person-months; 16 per 100 person-months with a fluoroquinolone and ethionamide, and 4.4 per 100 person-months with a fluoroquinolone and ethambutol. There were 53 (83%) grade 1 and 11 grade 2 AEs, with no grade 3 or 4 AEs. In multivariable analysis, the risk of AEs was higher in contacts prescribed ethionamide as compared to ethambutol adjusting for age, sex, and body mass index (adjusted hazard ratio, 2.1 [95% confidence interval {CI}, 1.2–3.6]). Overall, there was no notable difference in treatment completion among the contacts who experienced an AE and those who did not (crude odds ratio, 1.1 [95% CI, .52–2.5]). Conclusions A fluoroquinolone-based preventive treatment regimen for drug-resistant TB exposure is well tolerated. Regimens with ethionamide are more likely to result in AEs.

Race as an independent factor for survival in breast cancer patients according to analysis of the National Cancer Database (NCDB).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18155-e18155 ◽  
Author(s):  
Drew Carl Drennan Murray ◽  
Shruti Bhandari ◽  
Phuong Ngo ◽  
Sarah Mudra ◽  
Rachana Shirish Lele ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Proportional Hazards ◽  
Early Stage ◽  
Tumor Biology ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Independent Factor ◽  
Breast Cancer Patients ◽  
Delayed Treatment

e18155 Background: Black (B) women after early stage of diagnosis have been shown to have double the risk of white (W) women for failing to receive adjuvant chemotherapy. Despite lower incidence of breast cancer in B patients, they are more likely to die of the disease. Worse outcomes in B populations have been related to clinical and socioeconomic factors. However, the determination of improved access and its effects on survival in black patients remains uncertain. Methods: 1042844 patients diagnosed between 2004 and 2014 with stage I-III breast cancer were identified in the NCDB. Only W and B races were analyzed with established risk factors of age, stage, comorbidity score, and insurance status. Data was analyzed using univariable and multivariable logistic and Cox proportional hazards regression models. Odds Ratio (OR) for binary outcome, Hazard Ratio (HR) for time-to-event (survival) outcome along with 95% confidence interval (95% CI) are reported. Results: Among the total population 85.5% were W, 10.6% B, and 3.9% other. B were more likely to be uninsured (OR: 1.66; 95% CI: 1.59 - 1.72; p < 0.0001), or have Medicaid (OR: 2.01; 95% CI: 1.96 - 2.07; p < 0.0001). B were also diagnosed at later stage (stage 3 OR: 1.59; 95% CI: 1.57 - 1.63; p < 0.0001) with higher co-morbidities (OR: 2.49; 95% CI: 2.34 - 2.67; p < 0.0001) consistent with prior studies. B were more likely to experience delayed treatment (OR: 2.15; 95% CI: 2.10 - 2.20; p < 0.0001). B race remained an independent factor associated with higher likelihood of death compared to W patients (HR: 1.32; 95% CI: 1.3 - 1.34; p < 0.0001) in multivariable analysis. Conclusions: This large database study demonstrates that even when controlling for established risk factors such lack of insurance or Medicaid, higher comorbidities, and later stage at diagnosis, B patients were more likely to experience delays in treatment initiation and worse overall survival. This suggests race remains an independent risk factor for poor outcome even when clinical factors are matched. Further analysis including tumor biology should be examined to better understand this persistent disparity.

Abstract TMP112: Subsequent Hemorrhage in Children With Untreated Brain Arteriovenous Malformation: Higher Risk With Unbalanced Inflow and Outflow Angioarchitecture

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Li Ma ◽  
Yu Chen ◽  
Yuanli Zhao
Keyword(s):  
Risk Factors ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Venous Drainage ◽  
Cox Proportional Hazards ◽  
Arteriovenous Shunt ◽  
Increased Risk ◽  
Potential Risk Factors ◽  
Venous Ectasia

Instruction: Children with brain arteriovenous malformations (bAVM) are at risk of life-threatening hemorrhage in their early lives. Our aim was to analyze various angiographic features of bAVM in conjunction with other morphological risk factors to predict the risk of subsequent hemorrhage during follow-up in children. Methods: We identified all consecutive children admitted to our institution for bAVMs between July 2009 and September 2015. Children with at least 1 month of treatment-free follow-up after diagnosis were included in further analysis. The effects of bAVM features on hemorrhagic presentation were studied. Annual rates of AVM rupture as well as several potential risk factors for subsequent hemorrhage were analyzed using Kaplan-Meier analyses and Cox proportional hazards regression models. Results: We identified 110 patients with a mean follow-up period of 2.1 years (range, 1 month-15.4 years). The average annual risk of hemorrhage from untreated AVMs was 4.3%. Risk factors predicting hemorrhagic presentation in multivariable analysis were no generalized venous ectasia, deep venous drainage, fast arteriovenous shunt, and deep location. No generalized venous ectasia in conjunction with fast arteriovenous shunt was predictive of subsequent hemorrhage (RR, 7.55; 95%CI, 1.96-29.06). The annual rupture risk was 11.1% in bAVMs without generalized venous ectasia but with fast arteriovenous shunt. Conclusions: bAVM angiographic features suggesting unbalanced inflow and outflow might be helpful to identify children at higher risk for hemorrhage. No generalized venous ectasia and fast artriovenous shunt might be associated with an increased risk for hemorrhagic presentation and subsequent hemorrhage in pediatric patients with untreated bAVM.

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