scholarly journals External validation of H2ARDD score for the prediction of heart failure events in patients with atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
N Taniguchi ◽  
Y Miyasaka ◽  
Y Suwa ◽  
S Harada ◽  
E Nakai ◽  
...  
Keyword(s):  
Heart Failure ◽  
Confidence Interval ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Predictive Accuracy ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Kaplan Meier ◽  
History Of

Abstract Background Heart failure is an important consequence in patients with atrial fibrillation (AF) which is associated with worse prognosis. The H2ARDD score, calculated from 5 clinical risk factors, was reported as a predictor of heart failure events in patients with AF. However, this score has not been externally validated. Purpose The purpose of this study was to evaluate and validate the usefulness of the H2ARDD score for the prediction of heart failure events in AF patients. Methods We used prospective data of patients with AF followed up from 2007 to 2017 in our institute. Patients with active cancer were excluded according to the previous report. H2ARDD score was calculated as follows; history of heart disease=2 points, anemia=1 point, renal dysfunction=1 point, diabetes =1 point, diuretic use=1 point (range from 0 to 6 points). Outcome of interest was defined as heart failure events including new-onset heart failure and death with heart failure. Heart failure was ascertained based on the Framingham criteria. Univariable and multivariable Cox-proportional hazards model were used to assess the risk of heart failure events. Heart failure events-free survival was estimated with Kaplan-Meier methods, and the predictive accuracy of the H2ARDD score for the prediction of heart failure events was measured by the area under the receiver operating characteristic (ROC) curve. Results Of 562 AF patients, 522 (age 69±10 year–old, 64.9%men) met study criteria. Patients who had a history of heart disease was 185 (35%), diabetes mellitus was 135 (26%), anemia was 54 (10%), renal dysfunction was 221 (43%), and diuretic use was 193 (37%). The mean H2ARDD score was 1.88±1.57. Of all study patients, 84 (16.2%) developed heart failure events during a mean follow–up of 54±42 months. Patients who developed heart failure events in 1 year was 24 (4.6%). In multivariable Cox–proportional hazards model, H2ARDD score was shown as an significant predictor for heart failure events (hazard ratio: 1.56, 95% confidence interval: 1.36 - 1.79, P<0.0001), independently of age (per 10 years, hazard ratio: 1.35, 95% confidence interval: 1.03 – 1.78, P<0.05). In the Kaplan–Meier analyses stratified by H2ARDD score (0–1, 2–3, 4–6), patients who had a higher H2ARDD sore had significantly worse heart failure event-free survival (log-rank P<0.0001) (Figure 1). The area under the ROC curve for the prediction of heart failure events in 1-year was 0.812 (95% confidence interval: 0.737 – 0.887, P<0.0001), and the best cut-off value was ≥4 points (sensitivity: 67%, specificity: 83%) (Figure 2). Conclusion H2ARDD score was demonstrated as a significant independent predictor for the prediction of heart failure events, with high predictive accuracy. H2ARDD score may be useful for heart failure risk stratification of AF patients. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

scholarly journals Evaluation of Changes on World Stock Exchanges in Connection with the SARS-CoV-2 Pandemic. Survival Analysis Methods

Risks ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 121
Author(s):  
Beata Bieszk-Stolorz ◽  
Krzysztof Dmytrów
Keyword(s):  
Survival Analysis ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Stock Exchange ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Stock Exchanges ◽  
Analysis Methods ◽  
Hazards Model ◽  
Kaplan Meier

The aim of our research was to compare the intensity of decline and then increase in the value of basic stock indices during the SARS-CoV-2 coronavirus pandemic in 2020. The survival analysis methods used to assess the risk of decline and chance of rise of the indices were: Kaplan–Meier estimator, logit model, and the Cox proportional hazards model. We observed the highest intensity of decline in the European stock exchanges, followed by the American and Asian plus Australian ones (after the fourth and eighth week since the peak). The highest risk of decline was in America, then in Europe, followed by Asia and Australia. The lowest risk was in Africa. The intensity of increase was the highest in the fourth and eleventh week since the minimal value had been reached. The highest odds of increase were in the American stock exchanges, followed by the European and Asian (including Australia and Oceania), and the lowest in the African ones. The odds and intensity of increase in the stock exchange indices varied from continent to continent. The increase was faster than the initial decline.

scholarly journals Association between milk and yogurt intake and mortality: a community-based cohort study (Yamagata study)

BMC Nutrition ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Akiko Nakanishi ◽  
Erika Homma ◽  
Tsukasa Osaki ◽  
Ri Sho ◽  
Masayoshi Souri ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Hazard Analysis ◽  
Total Mortality ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Milk Intake ◽  
Community Based ◽  
Hazards Model ◽  
Kaplan Meier

Abstract Background Dairy products are known as health-promoting foods. This study prospectively examined the association between milk and yogurt intake and mortality in a community-based population. Methods The study population comprised of 14,264 subjects aged 40–74 years who participated in an annual health checkup. The frequency of yogurt and milk intake was categorized as none (< 1/month), low (< 1/week), moderate (1–6/week), and high (> 1/day) intake. The association between yogurt and milk intake and total, cardiovascular, and cancer-related mortalities was determined using the Cox proportional hazards model. Results During the follow-up period, there were 265 total deaths, 40 cardiovascular deaths and 90 cancer-related deaths. Kaplan–Meier analysis showed that the total mortality in high/moderate/low yogurt intake and moderate/low milk intake groups was lower than that in none group (log-rank, P < 0.01). In the multivariate Cox proportional hazard analysis adjusted for possible confounders, the hazard ratio (HR) for total mortality significantly decreased in high/moderate yogurt intake group (HR: 0.62, 95% confidence interval [CI]: 0.42–0.91 for high intake, HR: 0.70, 95%CI: 0.49–0.99 for moderate intake) and moderate milk intake group (HR: 0.67, 95% CI: 0.46–0.97) compared with the none yogurt and milk intake groups. A similar association was observed for cancer-related mortality, but not for cardiovascular mortality. Conclusions Our study showed that yogurt and milk intake was independently associated with a decrease in total and cancer-related mortalities in the Japanese population.

Inter-pregnancy interval and later pediatric cardiovascular health of the offspring – a population-based cohort study

2020 ◽  
pp. 1-5
Author(s):  
Majdi Imterat ◽  
Tamar Wainstock ◽  
Eyal Sheiner ◽  
Gali Pariente
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Population Based ◽  
Cox Proportional Hazards ◽  
Cardiovascular Morbidity ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Kaplan Meier ◽  
Inter Pregnancy Interval

Abstract Recent evidence suggests that a long inter-pregnancy interval (IPI: time interval between live birth and estimated time of conception of subsequent pregnancy) poses a risk for adverse short-term perinatal outcome. We aimed to study the effect of short (<6 months) and long (>60 months) IPI on long-term cardiovascular morbidity of the offspring. A population-based cohort study was performed in which all singleton live births in parturients with at least one previous birth were included. Hospitalizations of the offspring up to the age of 18 years involving cardiovascular diseases and according to IPI length were evaluated. Intermediate interval, between 6 and 60 months, was considered the reference. Kaplan–Meier survival curves were used to compare the cumulative morbidity incidence between the groups. Cox proportional hazards model was used to control for confounders. During the study period, 161,793 deliveries met the inclusion criteria. Of them, 14.1% (n = 22,851) occurred in parturient following a short IPI, 78.6% (n = 127,146) following an intermediate IPI, and 7.3% (n = 11,796) following a long IPI. Total hospitalizations of the offspring, involving cardiovascular morbidity, were comparable between the groups. The Kaplan–Meier survival curves demonstrated similar cumulative incidences of cardiovascular morbidity in all groups. In a Cox proportional hazards model, short and long IPI did not appear as independent risk factors for later pediatric cardiovascular morbidity of the offspring (adjusted HR 0.97, 95% CI 0.80–1.18; adjusted HR 1.01, 95% CI 0.83–1.37, for short and long IPI, respectively). In our population, extreme IPIs do not appear to impact long-term cardiovascular hospitalizations of offspring.

scholarly journals Risk Factors for Mortality in Chinese Patients on Continuous Ambulatory Peritoneal Dialysis

2015 ◽  
Vol 35 (2) ◽  
pp. 199-205 ◽  
Author(s):  
Fan Zhang ◽  
Hong Liu ◽  
Xiaoli Gong ◽  
Fuyou Liu ◽  
Youming Peng ◽  
...  
Keyword(s):  
Risk Factors ◽  
Peritoneal Dialysis ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Patient Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Kaplan Meier

ObjectiveThe intent of this study was to evaluate the clinical outcome and risk factors affecting mortality of the continuous ambulatory peritoneal dialysis (CAPD) patients in a single peritoneal dialysis (PD) center over a period of 10 years.Patients and methodsWe retrospectively analyzed patients on PD from June 2001 to June 2011. The clinical and biochemical data were collected from the medical records. Clinical variables included gender, age at the start of PD, smoking status, body mass index (BMI), cause of end-stage renal disease (ESRD), presence of diabetes mellitus and blood pressure. Biochemical variables included hemoglobin, urine volume, residual renal function (RRF), serum albumin, blood urea nitrogen (BUN), creatinine, total cholesterol, triglyceride, comorbidities, and outcomes. Survival curves were made by the Kaplan-Meier method. Univariate and multivariate analyses to identify mortality risk factors were performed using the Cox proportional hazard regression model.ResultsA total of 421 patients were enrolled, 269 of whom were male (63.9%). The mean age at the start of PD was 57.9 ± 14.8 years. Chronic glomerulonephritis was the most common cause of ESRD (39.4%). Estimation of patient survival by Kaplan-Meier was 92.5%, 80.2%, 74.4%, and 55.7% at 1, 3, 5, and 10 years, respectively. Patient survival was associated with age (hazard ratio [HR]: 1.641 [1.027 – 2.622], p = 0.038), cardiovascular disease (HR: 1.731 [1.08 – 2.774], p = 0.023), hypertriglyceridemia (HR: 1.782 [1.11 – 2.858], p = 0.017) in the Cox proportional hazards model analysis. Estimation of technique survival by Kaplan-Meier was 86.7%, 68.8%, 55.7%, and 37.4% at 1, 3, 5, and 10 years, respectively. In the Cox proportional hazards model analysis, age (HR: 1.672 [1.176 – 2.377], p = 0.004) and hypertriglyceridemia (HR: 1.511 [1.050 – 2.174], p = 0.026) predicted technique failure.ConclusionThe PD patients in our center exhibited comparable or even superior patient survival and technical survival rates, compared with reports from other centers in China and other countries.

Prognostic indicators of secondary progression in a paediatric-onset multiple sclerosis cohort in Kuwait

2015 ◽  
Vol 22 (8) ◽  
pp. 1086-1093 ◽  
Author(s):  
Saeed Akhtar ◽  
Raed Alroughani ◽  
Samar F Ahmed ◽  
Jasem Y Al-Hashel
Keyword(s):  
Multiple Sclerosis ◽  
Confidence Interval ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Cox Proportional Hazards Model ◽  
Adjusted Hazard Ratio ◽  
Secondary Progressive ◽  
Hazards Model

Background: The frequency of paediatric-onset multiple sclerosis (POMS) and the precise risk of secondary progression of disease are largely unknown in the Middle East. This cross-sectional cohort study assessed the risk and examined prognostic factors for time to onset of secondary progressive multiple sclerosis (SPMS) in a cohort of POMS patients. Methods: The Kuwait National MS Registry database was used to identify a cohort of POMS cases (diagnosed at age <18 years) from 1994 to 2013. Data were abstracted from patients’ records. A Cox proportional hazards model was used to evaluate the prognostic significance of the variables considered. Results: Of 808 multiple sclerosis (MS) patients, 127 (15.7%) were POMS cases. The median age (years) at disease onset was 16.0 (range 6.5–17.9). Of 127 POMS cases, 20 (15.8%) developed SPMS. A multivariable Cox proportional hazards model showed that at MS onset, brainstem involvement (adjusted hazard ratio 5.71; 95% confidence interval 1.53–21.30; P=0.010), and POMS patient age at MS onset (adjusted hazard ratio 1.38; 95% confidence interval 1.01–1.88; P=0.042) were significantly associated with the increased risk of a secondary progressive disease course. Conclusions: This study showed that POMS patients with brainstem/cerebellar presentation and a relatively higher age at MS onset had disposition for SPMS and warrant an aggressive therapeutic approach.

Comorbidities and Myelodysplatic Syndromes.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2789-2789 ◽  
Author(s):  
Kiran Naqvi ◽  
Guillermo Garcia-Manero ◽  
Sagar Sardesai ◽  
Jeong Oh ◽  
Sherry Pierce ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Median Survival ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Kaplan Meier ◽  
Comorbidity Scores ◽  
Severe Comorbidity

Abstract Abstract 2789 Poster Board II-765 Background: Cancer patients often experience comorbidities that may affect their therapeutic options, prognosis, and outcome (1). Limited studies have evaluated the characteristics and impact of comorbidities in myelodysplastic syndromes (MDS). The aim of this study was to determine the effect of comorbidities on the survival of patients with MDS. Methods: We reviewed the medical records of 500 consecutive MDS patients who presented to MD Anderson Cancer Center from January 2002 to June 2004. The Adult Comorbidity Evaluation-27 (ACE-27), a validated 27-item comorbidity index for cancer patients (2), was used to assess the severity of comorbid conditions. For each patient, we obtained demographic data and specific staging information based on the International Prognostic Scoring System (IPSS). We also collected information on stem cell transplantation (SCT), mortality and survival. Kaplan-Meier methods and log-rank tests were used to assess survival. Multivariate analysis was performed using the Cox Proportional Hazards Model. Results: Of the 500 patients included in this study, 327 (65.4%) were male, and 436 (87.9%) were white; median age at presentation was 66.6 years (17.7, 93.5); mean duration of follow-up was 23.5 months (0, 88). A total of 49% of patients had IPSS intermediate-1 or lower risk. The ACE-27 comorbidity scores were as follows: none, 106 patients (21.2%); mild, 213 (42.6%); moderate, 108 (21.6%); and severe, 73 (14.6%). Three hundred and eighty one (76.2%) patients died, and 44 (8.8%) patients underwent SCT. Overall median survival using the Kaplan-Meier method was 17.6 months. Median survival according to ACE-27 scores was: 27.9 months for no comorbidity, 18.9 months for mild comorbidity, 15.2 months for moderate comorbidity, and 9.7 months for severe comorbidity. This trend reached statistical significance (p < 0.0001). The median survival by IPSS ranged from 40.9 months for patients in the low risk group versus 8.1 months for those in the high risk category (p < 0.0001). The hazards ratio obtained from the multivariate Cox Proportional Hazards Model was 1.5 and 2.0 for moderate and severe comorbidity scores when adjusted for age and IPSS (p < 0.0001). A linear trend was also observed between the severity of comorbidity and having received SCT (p = 0.001). Of the 44 patients who had SCT, 21 (47.7%) died. The median survival of patients who did not undergo stem cell transplantation ranged from 22.7 months for patients with no comorbidity to 9.3 months for patients with severe comorbidity (p = 0.0002). Conclusion: Comorbidities had a significant impact on the survival of patients with myelodysplastic syndrome. Patients with higher ACE-27 comorbidity scores had a shorter survival than those with no comorbidity, independent of their age and the IPSS risk group. Also patients with comorbid conditions received SCT less often than those without comorbidity. A comprehensive assessment of comorbidity is therefore needed to determine the prognosis in patients with MDS. References: (1) Extermann M. Measurement and impact of comorbidity in older cancer patients. Crit Rev Oncol Hematol. 2000;35:181-200. (1) Piccirillo JF, Tierney RM, Costas I, et al. Prognostic importance of comorbidity in a hospital-based cancer registry. JAMA. 2004;291:2441-47. Disclosures: No relevant conflicts of interest to declare.

Clinical features and outcomes of secondary somatic malignancy (SSM) arising from teratoma in late relapse germ cell tumor (GCT).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 518-518
Author(s):  
Nathan Colin Wong ◽  
Shawn Dason ◽  
Lucas W. Dean ◽  
Sumit Isharwal ◽  
Mark Donoghue ◽  
...  
Keyword(s):  
Median Time ◽  
Surgical Resection ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Late Relapse ◽  
Hazards Model ◽  
Kaplan Meier

518 Background: Late relapse (>2 years) GCT is associated with an increased rate of SSM. We report our experience with SSM in the setting of late relapse and determine predictors of overall survival (OS). Methods: From 1985 to 2018, 46 patients with GCT and SSM at late relapse were identified. Clinical and pathologic parameters were reviewed. The Kaplan-Meier method was used to estimate OS from time of relapse and a Cox proportional hazards model to assess predictors of OS. Results: Of 46 men (44 testicular primary, 2 mediastinal primary), median time to late relapse with SSM was 10.4 years (range, 2.3 - 38.1). Most (n=27, 59%) were symptomatic at presentation but 11 were detected by elevated tumor markers (AFP 8, HCG 2, both 1) and 8 by surveillance imaging. SSMs were adenocarcinoma (25), sarcoma (14), poorly differentiated neoplasm (3), Wilms (2), PNET (1) and glioma (1). Median time to relapse was longer for adenocarcinoma vs other histotypes of SSM (14.6 vs 4.1 years, p < 0.001). The initial site of relapse was the retroperitoneum (RP, 26), pelvis (7), lung (6), retrocrural space (3), mediastinum (2), neck (1) and duodenum (1). Only 10 of 26 men with late relapse in the RP had undergone prior RPLND (all at outside institutions; variable templates) with histology in 7/10 showing teratoma. The other 16 men had received chemotherapy only (8), orchiectomy only for stage I (3), RPLND aborted due to cardiac arrest (1), and unknown (4). All 46 late relapses were managed with surgical resection; 26 also received chemotherapy (16 SSM-directed, 10 GCT-directed). Overall, 12 patients died and the median OS was 14.2 years. On univariable analysis, symptomatic presentation (HR = 3.1), SSM at multiple sites (HR = 3.9), extra-RP disease (HR: 3.9), and incomplete/no resection of SSM (HR = 3.6) predicted mortality. On multivariable analysis, only extra-RP disease was independently associated with inferior OS (5-year OS, 82 vs 52%, p = 0.017). Conclusions: SSM is an important potential complication of late relapse GCT and seems to be associated with the lack of resection of retroperitoneal metastases. Early identification and complete surgical resection prior to SSM arising in extra-RP sites is critical to optimizing outcomes.

scholarly journals Impact of Prior Cancer History on Outcomes in Thymoma

2020 ◽  
Author(s):  
Shilong Wu ◽  
Mengyang Liu ◽  
Weixue Cui ◽  
Guilin Peng ◽  
Jianxing He
Keyword(s):  
Overall Survival ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Cancer History ◽  
Treatment Methods ◽  
Hazards Model ◽  
Kaplan Meier ◽  
The Impact

Abstract Background Thymoma is an uncommon intrathoracic malignant tumor and has a long natural history. It is uncertain whether the survival of thymoma patient is affected by prior cancer history. Finding out the impact of a prior cancer history on thymoma survival has important implications for both decision making and research. Method The Surveillance, Epidemiology, and End Results (SEER) database was queried for thymoma patients diagnosed between 1975 and 2015. Kaplan-Meier methods and Cox proportional hazards model were used to analyze overall survival across a variety of stages, age, and treatment methods with a prior cancer history or not. Results A total of 3604 patients with thymoma were identified including 507 (14.1%) with a prior cancer history. The 10-year survival rate of patients with a prior cancer history (53.8%) was worse than those without a prior cancer history (40.32%, 95%CI 35.24-45.33, P < 0.0001). However, adjusted analyses showed that the impact of a prior cancer history was heterogenous across age and treatment methods. In subset analyses, prior cancer history was associated with worse survival among patients who were treated with chemoradiotherapy (HR: 2.80, 95% CI: 1.51-5.20, P = 0.001) and age ≤ 65 years (HR: 1.33, 95%CI: 1.02-1.73, P = 0.036). Conclusions Prior cancer history provides an inferior overall survival for patients with thymoma. But it does not worsen the survival in some subgroups and these thymoma patients should not be excluded from clinical trials.

Results of the randomized phase II portion of NRG Oncology/RTOG 0848 evaluating the addition of erlotinib to adjuvant gemcitabine for patients with resected pancreatic head adenocarcinoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4007-4007 ◽  
Author(s):  
Howard Safran ◽  
Kathryn A Winter ◽  
Ross A. Abrams ◽  
William Regine ◽  
Karyn A. Goodman ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Pancreatic Head ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Adjuvant Radiation ◽  
Pancreatic Head Cancer ◽  
Hazards Model ◽  
Kaplan Meier

4007 Background: NRG/RTOG 0848 is a 2-step study designed to determine whether erlotinib (E) added to gemcitabine (G) (randomized Ph II) &/or adjuvant radiation with concurrent 5-FU or capecitabine following 6 months of systemic chemotherapy (Ph III), improve survival in patients (pts) with resected pancreatic head adenocarcinoma. The erlotinib results are reported here. Methods: Eligible pts include those with resected pancreatic head adenocarcinoma, pathologic stage T1-T3, N0-1, M0; PS 0-1, & CA19-9 ≤ 180 IU/L. Pts in Arms 1 & 2 received G 1 gm/m2 weekly for 3 weeks in a 28-day cycle for 6 cycles. Pts in Arm 2 also received E 100 mg/day. The primary hypothesis for the E portion was that G+E would increase overall survival (OS) compared to G alone. With a 1-sided alpha of 0.15, 200 OS events provide 80%/90% power to detect a signal for an increase in median OS from 22 to 28.8/30.6 months (mos). OS was estimated by the Kaplan-Meier method & arms compared using the log rank test. The Cox proportional hazards model was used to analyze treatment effect. Results: 336 pts were randomized from 11/17/2009 to 2/28/2014, with 163 pts evaluable for G and 159 for G+E. Median age was 63 years (39-86). Most pts had pathologic T3 disease (78%) & CA19-9 ≤ 90 (93%). There are 32 pts (20%) with grade 4 adverse events (AEs) & 2 pts (1%) with grade 5 AEs on G and 27 (17%) & 3 (2%) on G+E arm, respectively. There are fewer grade ≥ 3 GI AEs on the G arm (22%) as compared to the G+E arm (28%), and 110 (69.2%) & 93 (59.6%) pts received at least 85% of planned G dose for the G & G+E arms, respectively. 58% of E pts received at least 85% of planned E dose. The median follow-up for alive pts is 42.5 mos (min-max: < 1-75). With 203 deaths, median & 3-yr OS (95% CI) are 29.9 mos (21.7-33.4) & 39% (30, 45) for G and 28.1 mos (20.7-30.9) & 39% (31, 47) for G+E; log-rank p = 0.62. The hazard ratio (95% CI) comparing OS of G+E to G is 1.04 (0.79- 1.38). Conclusions: The addition of adjuvant E to G did not provide a signal for increased OS in pts with resected pancreatic head cancer compared to G alone. Accrual to the trial is continuing to answer the Ph III radiation question. Clinical trial information: NCT01013649.

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