scholarly journals Sepsis of Patients Infected by SARS-CoV-2: Real-World Experience From the International HOPE-COVID-19-Registry and Validation of HOPE Sepsis Score

2021 ◽  
Vol 8 ◽  
Author(s):  
Mohammad Abumayyaleh ◽  
Iván J. Nuñez-Gil ◽  
Ibrahim El-Battrawy ◽  
Vicente Estrada ◽  
Víctor Manuel Becerra-Muñoz ◽  
...  
Keyword(s):  
High Risk ◽  
Mortality Rate ◽  
Troponin I ◽  
Risk Group ◽  
Multivariable Analysis ◽  
High Morbidity ◽  
International Consensus ◽  
Peripheral Oxygen Saturation ◽  
Current Smoking ◽  
Sepsis Score

Background: Patients with sepsis with a concomitant coronavirus (COVID-19) infection are related to a high morbidity and mortality rate. We investigated a large cohort of patients with sepsis with a concomitant COVID-19, and we developed a risk score for the estimation of sepsis risk in COVID-19.Methods: We conducted a sub-analysis from the international Health Outcome Predictive Evaluation Registry for COVID-19 (HOPE-COVID-19-Registry, NCT04334291). Out of 5,837 patients with COVID-19, 624 patients were diagnosed with sepsis according to the Sepsis-3 International Consensus.Results: In multivariable analysis, the following risk factors were identified as independent predictors for developing sepsis: current smoking, tachypnoea (>22 breath per minute), hemoptysis, peripheral oxygen saturation (SpO2) <92%, blood pressure (BP) (systolic BP <90 mmHg and diastolic BP <60 mmHg), Glasgow Coma Scale (GCS) <15, elevated procalcitonin (PCT), elevated troponin I (TnI), and elevated creatinine >1.5 mg/dl. By assigning odds ratio (OR) weighted points to these variables, the following three risk categories were defined to develop sepsis during admission: low-risk group (probability of sepsis 3.1–11.8%); intermediate-risk group (24.8–53.8%); and high-risk-group (58.3–100%). A score of 1 was assigned to current smoking, tachypnoea, decreased SpO2, decreased BP, decreased GCS, elevated PCT, TnI, and creatinine, whereas a score of 2 was assigned to hemoptysis.Conclusions: The HOPE Sepsis Score including nine parameters is useful in identifying high-risk COVID-19 patients to develop sepsis. Sepsis in COVID-19 is associated with a high mortality rate.

scholarly journals A Novel Signature Constructed by Immune-Related LncRNA Predicts the Immune Landscape of Colorectal Cancer

2021 ◽  
Vol 12 ◽  
Author(s):  
Mengyu Sun ◽  
Tongyue Zhang ◽  
Yijun Wang ◽  
Wenjie Huang ◽  
Limin Xia
Keyword(s):  
Colorectal Cancer ◽  
High Risk ◽  
Immune Cell ◽  
Cox Regression ◽  
Risk Group ◽  
Univariate Analysis ◽  
The Cancer Genome Atlas ◽  
High Morbidity ◽  
Cox Regression Analysis ◽  
Chemotherapy Drugs

Colorectal cancer (CRC) has the characteristics of high morbidity and mortality. LncRNA not only participates in the progression of CRC through genes and transcription levels, but also regulates the tumor microenvironment and leads to the malignant phenotype of tumors. Therefore, we identified immune-related LncRNAs for the construction of clinical prognostic model. We searched The Cancer Genome Atlas (TCGA) database for original data. Then we identified differentially expressed irlncRNA (DEirlncRNA), which was paired and verified subsequently. Next, univariate analysis, Lasso and Cox regression analysis were performed on the DEirlncRNA pair. The ROC curve of the signature was drawn, and the optimal cut-off value was found. Then the cohort was divided into a high-risk and a low-risk group. Finally, we re-evaluated the signature from different perspectives. A total of 16 pairs of DEirlncRNA were included in the construction of the model. After regrouping according to the cut-off value of 1.275, the high-risk group showed adverse survival outcomes, progressive clinicopathological features, specific immune cell infiltration status, and high sensitivity to some chemotherapy drugs. In conclusion, we constructed a signature composed of immune-related LncRNA pair with no requirement of the specific expression level of genes, which shows promising clinical predictive value in CRC patients.

scholarly journals Establishment of an immune-related gene pair model to predict colon adenocarcinoma prognosis

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jihang Luo ◽  
Puyu Liu ◽  
Leibo Wang ◽  
Yi Huang ◽  
Yuanyan Wang ◽  
...  
Keyword(s):  
Colon Cancer ◽  
High Risk ◽  
Gene Pair ◽  
Risk Group ◽  
Colon Adenocarcinoma ◽  
High Risk Group ◽  
High Morbidity ◽  
Related Gene ◽  
Immune Genes ◽  
Immune Related Gene

Abstract Background Colon cancer is the most common type of gastrointestinal cancer and has high morbidity and mortality. Colon adenocarcinoma (COAD) is the main pathological type of colon cancer, and much evidence has supported the correlation between the prognosis of COAD and the immune system. The current study aimed to develop a robust prognostic immune-related gene pair (IRGP) model to estimate the overall survival of patients with COAD. Methods The gene expression profiles and clinical information of patients with colon adenocarcinoma were obtained from the TCGA and GEO databases and were divided into training and validation cohorts. Immune genes were selected that showed a significant association with prognosis. Results Among 1647 immune genes, a model with 17 IRGPs was built that was significantly associated with OS in the training cohort. In the training and validation datasets, the IRGP model divided patients into the high-risk group and low-risk group, and the prognosis of the high-risk group was significantly worse (P<0.001). Univariate and multivariate Cox proportional hazard analyses confirmed the feasibility of this model. Functional analysis confirmed that multiple tumor progression and stem cell growth-related pathways were upregulated in the high-risk groups. Regulatory T cells and macrophages M0 were significantly highly expressed in the high-risk group. Conclusion We successfully constructed an IRGP model that can predict the prognosis of COAD, providing new insights into the treatment strategy of COAD.

scholarly journals Persistent Sterile Peritoneal Inflammation after Catheter Removal for Refractory Bacterial Peritonitis Predicts Full-Blown Encapsulating Peritoneal Sclerosis

2013 ◽  
Vol 33 (5) ◽  
pp. 507-514 ◽  
Author(s):  
Yuk-Yi Wong ◽  
Ping-Nam Wong ◽  
Siu-Ka Mak ◽  
Shuk-Fan Chan ◽  
Yuen-Yi Cheuk ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Group ◽  
High Risk Group ◽  
Catheter Removal ◽  
Control Group ◽  
High Morbidity ◽  
Dialysis Catheter ◽  
Peritoneal Inflammation ◽  
Bacterial Peritonitis ◽  
Inflammatory Phase

BackgroundEncapsulating peritoneal sclerosis (EPS) is the most serious complication of peritoneal dialysis, having high morbidity and mortality. To improve outcomes, early diagnosis is needed to direct treatment during the early inflammatory phase. However, in the early inflammatory phase, clinical features are nonspecific, and no reliable diagnostic criteria have been established. Because bacterial peritonitis and termination of dialysis are two important risk factors triggering the progression of EPS, patients with refractory bacterial peritonitis necessitating dialysis catheter removal are at particularly high risk of developing EPS. Many of these patients might indeed experience non-resolving sterile peritonitis (probably the inflammatory phase of EPS) before progression to full-blown disease (that is, the presence of intestinal obstruction). We undertook a retrospective study to compare, in this particular situation, the clinical characteristics of patients with or without sterile peritoneal inflammation, assessing their clinical outcomes in terms of short-term mortality and the chance of developing full-blown EPS.MethodsOur retrospective review included 62 patients whose dialysis catheter was removed because of refractory peritonitis between January 2005 and December 2010.ResultsOf the 62 patients identified, 39 (63%) had persistent sterile peritoneal inflammation (“high-risk” group, n = 39), and 23 (37%) had resolution of inflammation without significant intra-abdominal collection after catheter withdrawal (“control” group, n = 23). Compared with the control group, the high-risk group had a significantly longer PD duration (71.6 ± 43.3 months vs 42.3 ± 29.9 months, p = 0.003), a higher dialysate-to-plasma ratio (D/P) of creatinine (0.768 ± 0.141 vs 0.616 ± 0.091, p = 0.004), and a higher computed tomography score for EPS (7.69 ± 2.98 vs 1.00 ± 1.00, p < 0.001). During the 6-month study period, the high-risk group had a higher chance of developing full-blown EPS (31% vs 0%, p = 0.002) and a higher 6-month all-cause mortality (36% vs 4.3%, p = 0.004)ConclusionsPersistent sterile peritoneal inflammation was common after dialysis catheter removal for refractory bacterial peritonitis, and the patients with such inflammation were at high risk of progression to full-blown EPS.

scholarly journals PEAK TROPONIN I GREATER THAN 5 TIMES THE 99TH PERCENTILE AFTER PCI DOES NOT DEFINE A HIGH–RISK GROUP

2013 ◽  
Vol 61 (10) ◽  
pp. E1879
Author(s):  
Michael Butler ◽  
Matthew Sacrinty ◽  
William Little ◽  
Robert Applegate ◽  
Michael Kutcher ◽  
...  
Keyword(s):  
High Risk ◽  
Troponin I ◽  
Risk Group ◽  
High Risk Group

scholarly journals Clinical and Radiographic Predictors of Intracerebral Hemorrhage Outcome

2018 ◽  
Vol 7 (1-2) ◽  
pp. 118-136 ◽  
Author(s):  
Fawaz Al-Mufti ◽  
Ahmad M. Thabet ◽  
Tarundeep Singh ◽  
Mohammad El-Ghanem ◽  
Krishna Amuluru ◽  
...  
Keyword(s):  
Patient Outcome ◽  
High Risk ◽  
Mortality Rate ◽  
Intracerebral Hemorrhage ◽  
Functional Independence ◽  
High Morbidity ◽  
High Risk Patients ◽  
The Us ◽  
Risk Patients

Background: Intracerebral hemorrhage (ICH) represents 10-15% of all stroke cases in the US annually. Fewer than 40% of these patients ever reach long-term functional independence, and mortality rate is roughly 40% at 1 month. Due to the high morbidity and mortality rates after ICH, early detection of high-risk patients would be beneficial in directing the management course and goals of care. This review aims to discuss relevant clinical and radiographic characteristics that can serve as predictors of poor prognosis and examine their efficacy in predicting patient outcomes after ICH. Summary: A literature review was conducted on various clinical and radiographic factors. They were examined for their predictive value in relation to ICH outcome. Studies that focused on each of these factors were included, and their results analyzed for trends with regard to incidence, patient outcome, and mortality rate. Key Message: In this review, we examined clinical and radiographic characteristics that have been found to be significantly associated to a varying degree with poor outcome. Clinical and radiographic predictors of poor patient outcome are invaluable when it comes to identifying high-risk patients and triaging accordingly as well as guiding decision-making.

scholarly journals MIPSS70+ V2.0 and Revised Cytogenetics Changes Predict Outcomes of Allogeneic Transplantation with Fludarabine and Melphalan Conditioning in Patients with Myelofibrosis

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1752-1752
Author(s):  
Haris Ali ◽  
Ibrahim Aldoss ◽  
Dongyun Yang ◽  
Saloomeh Mokhtari ◽  
Samer K. Khaled ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Group ◽  
Multivariable Analysis ◽  
Prognostic Models ◽  
Intermediate Risk ◽  
Transplant Outcomes ◽  
Cytogenetic Changes ◽  
The Impact ◽  
Very High

Abstract Several prognostic models have been developed to predict survival outcomes and response in patients with myelofibrosis (MF). MIPSS70 prognostic system, developed by incorporation of all the key clinical characteristics, cytogenetics, and mutational factors into one system, has recently been revised to MIPSS70+ v2.0 with refinements in degrees of anemia, cytogenetics, and HMR. While allogeneic hematopoietic cell transplantation (alloHCT) is the only curative treatment for patients with MF, limited data exists on the impact of molecular markers on transplant outcomes. Here, we evaluated the transplant outcome in MF patients who uniformly received fludarabine/melphalan (FluMel) conditioning at City of Hope and assessed the impact of cytogenetics, somatic mutations on transplant outcomes based on a 72 gene next-generation sequencing (NGS) panel and MIPSS 70+ v2.0. A total of 110 consecutive MF patients (primary: n=58, secondary: n=52) without prior acute leukemic transformation, underwent alloHCT between 2004 and 2017. Median age at the time of transplant was 58.5 years (range: 38-72 years) with median interval from diagnosis of primary or secondary MF to HCT of 15.2 months (range: 1.6-332.5 months). AlloHCT donors were matched related (n=51), matched unrelated (n=44), and mismatched unrelated (n=15). Intermediate-2 and High risk by DIPSS accounted for 83 (76%) of patients at the time of transplant. Tacrolimus/Sirolimus-based GVHD prophylaxis was used in 100 (91%) patients, and 16 had splenectomy prior to alloHCT. Pre-transplant DNA sample were available for 93 patients and cytogenetics information was available for 106 patients; among which 60 had abnormal cytogenetics. Based on recently developed revised cytogenetic risk stratification on transplant outcomes, we identified 67 patients (61%) in favorable, 24 (22%) in unfavorable, and 15 (14%) in very high risk groups. Median number of 2 mutations were detected with at least one mutation in 95% (n=88) of patients. JAK2 V617F was the most common alteration noted in 54 (58.1%) patients. Other common mutations were ASXL1 (n=41, 44%), CALR type 1 (n=15, 16.1%), TET2 (n=12, 13%) SRSF2 and DNMT3A (each n=10, 11%). No detectable mutations were found in 5 (5.4%) patients. HMR genes (ASLX1, EZH2, IDH1/2, SRSF2, and U2AF1) were identified in 48 patients (52%), with 30 patients (32%) carrying one and 18 patients (19%) carrying more than 1 HMRs. With a median follow-up of 63.7 months (range: 11.9-158.5), 5 year overall survival (OS) and non-relapse mortality (NRM) were 65% (95% CI: 54-73) and 17% (95%CI: 10%-24%), respectively. Detailed transplant outcomes were previously reported (Ali et al. American Society of Hematology. Vol. 130. Atlanta, GA: Blood; 2017:199) (Figure 1a). On multivariable analysis, unfavorable and VHR cytogenetic changes had significantly shorter OS and PFS (p=0.001 and 0.008), and relapse risk (p=0.035) (Figure1b). Triple negative status (p=0.063), HMR (p=0.73), and more than 1 HMR (p=0.59) did not significantly impact survival post-HCT. (Figure1c) Similarly, CALR type 1 (p=0.42), and ASXL1 (p=0.29) mutations also did not impact survival after HCT. Only CBL mutation was significantly associated with lower OS (HR=2.64, 95% CI: 1.09-6.38, p=0.032) and lower DFS (HR=4.35, 95% CI: 1.83-10.36, p<0.001), largely attributable to increased NRM (HR=3.68, 95% CI: 1.45-9.35, p=0.004). In addition U2AF1 mutations were significantly associated with NRM (HR=3.42, 95%CI: 1.50-7.80, p=0.009). Per MIPSS70+ 2.0, patients were classified into intermediate (n=11), high (n=47), or very high-risk (VHR) (n=35). MIPSS70+ 2.0 predicted OS, DFS, and NRM. Compared to high risk group, intermediate risk patients had better OS (HR=0.291, 95% CI: 0.04-2.26) and DFS (HR=0.24, 95% CI: .03-1.91), whereas VHR group had much lower OS (HR=5.05, 95% CI: 2.39-10.74, p=<0.001) and DFS (HR=3.87, 95% CI: 1.9.0-7.88 p<0.001). (Figure 1d) Compared to high risk, intermediate risk group had lower and VHR had higher NRM (HR=0.51, 95% CI: 0.06-4.23), and (HR=3.24, 95% CI: 1.47 - 7.13, p=0.004), respectively. In summary, we are presenting one of the largest single center experiences of FluMel-based alloHCT for MF patients, demonstrating revised cytogenetic changes and MIPSS70+ v2.0 accurately predicts transplant outcomes, thus would better inform physicians and patients in discussing and decision making about alloHCT. Figure. Figure. Disclosures Ali: Incyte Corporation: Membership on an entity's Board of Directors or advisory committees. Khaled:Juno: Other: Travel Funding; Alexion: Consultancy, Speakers Bureau; Daiichi: Consultancy. Salhotra:Kadmon Corporation, LLC: Consultancy. Stein:Amgen Inc.: Speakers Bureau; Celgene: Speakers Bureau. Forman:Mustang Therapeutics: Other: Licensing Agreement, Patents & Royalties, Research Funding.

scholarly journals Risky Fertility Behavior, Breastfeeding Practices and Neonatal Mortality Risk: Evidence from Repeated Cross-Sectional Nationally Representative Data

2020 ◽  
Vol 2 (6) ◽  
Author(s):  
Matthew A. Alabi ◽  
Grace E. Ihimekpen ◽  
Taofeek A. Hassan
Keyword(s):  
High Risk ◽  
Mortality Rate ◽  
Neonatal Mortality ◽  
Risk Group ◽  
Fertility Behavior ◽  
High Risk Group ◽  
Health Seeking ◽  
Live Births ◽  
Breastfeeding Practices ◽  
Seeking Behavior

Background: Notwithstanding government efforts in improving maternal and child health, childhood mortality still remains a serious burden in the country, with neonatal mortality rate of 39 deaths and under-five mortality rate of 132 per 1,000 live births. This has implication on Sustainable Development Goals (SDGs) targeted towards reducing under-fiver mortality rate to 25 deaths per 1,000 live births by the year 2030. This study examined risky fertility behavior, breastfeeding practices, and neonatal mortality risk in Nigeria. Materials and methods: This study involved the analysis of secondary data, Nigeria Demographic and Health Survey (pooled dataset of the three most recent surveys, NDHS, 2008, 2013 and 2018). The sample size was a weighted sample of 94,062 women aged 15-49 years with 172, 252 live births for the ten years period. Descriptive statistics and cox-proportional hazard model were performed using Stata 14.1 software. Results: Nearly two thirds (64.0%) of births were high risk. The practice of breastfeeding among the women was quite poor, just (39.5%) initiated breastfeeding within one hour of childbirth, though (74.0%) reported breastfeeding their child for a minimum of 12 months. The independent effect of risky fertility behavior (RFB) was associated with elevated hazards of neonatal mortality, with the highest risk observed among births belonging to the multiple high-risk group (HR=2.1, p<0.01). Adjusting for breastfeeding practices, maternal/child characteristics and maternal health seeking behavior was associated with elevated hazard of neonatal mortality with the highest hazard observed among births belonging to the multiple high-risk group (HR=1.76, p<0.05). Other factors associated with elevated hazard for neonatal mortality are sex of the child, maternal level of education and breastfeeding duration. Conclusion: RFB was associated with elevated hazard for neonatal mortality, even after adjusting for breastfeeding practices, maternal and child characteristics and maternal health-seeking behavior thereby lending credence to Mosley and Chen theory.

scholarly journals Statistical Design of Phase II/III Clinical Trials for Testing Therapeutic Interventions in COVID-19 Patients

2020 ◽  
Author(s):  
Shesh Rai ◽  
Chen Qian ◽  
Jianmin Pan ◽  
Anand Seth ◽  
Deo Kumar Srivast ◽  
...  
Keyword(s):  
High Risk ◽  
Mortality Rate ◽  
Sample Size ◽  
Risk Group ◽  
Primary Response ◽  
High Risk Group ◽  
Intermediate Risk ◽  
Group Sequential Design ◽  
Interim Analyses ◽  
Toxicity Monitoring

Abstract Background Due to unknown features of the COVID-19 disease and complexity of the patient population, traditional clinical trial designs on treatments may not be optimal in such patients. We propose two independent clinical trials designs based on careful grouping of patient and outcome measures.Methods Using the World Health Organization ordinal scale on patient status, we classify treatable patients (Stages 3-7) into two risk groups. Patients in Stages 3, 4 and 5 are categorized as the intermediate-risk group while patients in Stages 6 and 7 are categorized as the high-risk group. To ensure that an intervention, if deemed efficacious, is promptly made available to vulnerable patients, we propose a group sequential design incorporating four factors stratification, two interim analyses, and a toxicity monitoring rule for the intermediate-risk group. The primary response variable (binary variable) is based on the proportion of patients discharged from hospital by the 15th day. The goal is to detect a meaningful improvement in this response rate. For the high-risk group, we propose a group sequential design incorporating three factors stratification, two interim analyses, and without toxicity monitoring. The primary response variable for this design is the 30 days mortality, and the goal is to detect a meaning reduction in mortality rate.Results Required sample size and toxicity boundaries are calculated for each scenario. Sample size requirements for the designs with interim analyses are marginally greater than the ones without. In addition, for both the intermediate-risk group and the high-risk group, conducting two interim analyses have almost identical required sample size compared with just one interim analysis. Conclusions We recommend using composite endpoints, with binary outcome for those in Stages 3, 4 and 5 with a power of 90% to detect an improvement of 20% in response rate, and 30 days mortality rate outcome for those in Stages 6 and 7 with a power of 90% to detect 15% (effect size) reduced mortality rate, in the trial design. For the intermediate-risk group, two interim analyses for efficacy evaluation along with toxicity monitoring are encouraged. For the high-risk group, two interim analyses without toxicity monitoring is advised.

A multiple biomarker risk score for guiding clinical decisions using a decision curve approach

2011 ◽  
Vol 19 (4) ◽  
pp. 874-884 ◽  
Author(s):  
Maria F Hughes ◽  
Olli Saarela ◽  
Stefan Blankenberg ◽  
Tanja Zeller ◽  
Aki S Havulinna ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Troponin I ◽  
Risk Model ◽  
Risk Group ◽  
Disease Prediction ◽  
Intermediate Risk ◽  
Net Benefit ◽  
Cvd Risk ◽  
Risk Thresholds

Aims: We assessed whether a cardiovascular risk model based on classic risk factors (e.g. cholesterol, blood pressure) could refine disease prediction if it included novel biomarkers (C-reactive protein, N-terminal pro-B-type natriuretic peptide, troponin I) using a decision curve approach which can incorporate clinical consequences. Methods and results: We evaluated whether a model including biomarkers and classic risk factors could improve prediction of 10 year risk of cardiovascular disease (CVD; chronic heart disease and ischaemic stroke) against a classic risk factor model using a decision curve approach in two prospective MORGAM cohorts. This included 7739 men and women with 457 CVD cases from the FINRISK97 cohort; and 2524 men with 259 CVD cases from PRIME Belfast. The biomarker model improved disease prediction in FINRISK across the high-risk group (20⊟40%) but not in the intermediate risk group, at the 23% risk threshold net benefit was 0.0033 (95% CI 0.0013−0.0052). However, in PRIME Belfast the net benefit of decisions guided by the decision curve was improved across intermediate risk thresholds (10⊟20%). At pt = 10% in PRIME, the net benefit was 0.0059 (95% CI 0.0007⊟0.0112) with a net increase in 6 true positive cases per 1000 people screened and net decrease of 53 false positive cases per 1000 potentially leading to 5% fewer treatments in patients not destined for an event. Conclusion: The biomarker model improves 10-year CVD prediction at intermediate and high-risk thresholds and in particular, could be clinically useful at advising middle-aged European males of their CVD risk.

Postrandomization analysis assessing survival following radiation therapy (RT) with or without 6 months of androgen suppression therapy (AST) for localized prostate cancer (PCa)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5129-5129
Author(s):  
P. L. Nguyen ◽  
M. H. Chen ◽  
C. J. Beard ◽  
M. Loffredo ◽  
A. A. Renshaw ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prognostic Factors ◽  
High Risk ◽  
Risk Group ◽  
Multivariable Analysis ◽  
Intermediate Risk ◽  
Risk Of Death ◽  
Increased Risk ◽  
High Risk Disease ◽  
Severe Comorbidity

5129 Background: 6 months of AST+RT was shown to improve survival vs. RT alone in men with unfavorable-risk localized PCa, but it is unknown if this benefit applied to all risk subgroups. Methods: Among 206 men with clinical T1b-T2b PCa and at least 1 unfavorable feature (PSA>10 or Gleason >=7 or MRI evidence of T3 disease) randomized to 70Gy of RT with or without 6 months of AST, we performed post-randomization subgroup analyses within four subgroups defined by both risk group (high risk [Gleason 8–10 or PSA >20] or intermediate risk [all others]), and by ACE-27 comorbidity level (no/limited comorbidity or moderate/severe comorbidity). Within the 4 subgroups a log-rank test was used to compare Kaplan Meier estimates of survival (requiring p < 0.05/4 or p < 0.0125 to adjust for multiple comparisons) and within the 2 risk groups we used Cox multivariable analysis (MVA) to assess the association of treatment with the risk of death after adjusting for known prognostic factors. Results: After a median follow-up 8.2 yrs, 74 men died. In men with no or minimal comorbidity, estimates of survival were significantly higher among those who received AST+RT vs. RT alone, regardless of whether they had intermediate risk disease (90.9 vs. 85.8% at 7yrs, p = 0.009) or high-risk disease (88.9% vs. 51.2% at 7yrs, p = 0.007). In men with moderate or severe comorbidity, no difference in survival was observed after AST+RT vs. RT in intermediate risk (p = 0.2) or high risk (p = 0.5). After adjusting for known prognostic factors, treatment with RT as compared to AST+RT was associated with an increased risk of death in men with intermediate (AHR: 3.0 [95% CI: 1.3 to 7.2]; p = 0.01) and high risk disease (AHR: 3.3 [95% CI: 0.94 to 11.3]; p = 0.06) in a model that adjusted for the interaction between treatment and comorbidity. Conclusions: Among men with T1b-T2b prostate cancer who have no or minimal comorbidity, the addition of 6 months of AST to RT was associated with improved survival in men with both intermediate risk and high-risk disease. Among men with moderate to severe comorbidity, neither risk group appeared to benefit from the addition of AST. No significant financial relationships to disclose.

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