Degarelix versus LHRH agonists: Differential skeletal and urinary tract outcomes from an analysis of six comparative randomized clinical trials.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 68-68
Author(s):  
E. David Crawford ◽  
Neal Shore ◽  
Kurt Miller ◽  
Bertrand Tombal ◽  
Cathrina Kathrup ◽  
...  
Keyword(s):  
Urinary Tract ◽  
Randomized Clinical Trials ◽  
Disease Stage ◽  
Rank Test ◽  
Lhrh Agonist ◽  
Gnrh Antagonists ◽  
Lhrh Agonists ◽  
Kaplan Meier ◽  
Urinary Infections ◽  
Urinary Tract Symptoms

68 Background: The use of ADT in men with prostate cancer is well established. GnRH antagonists have a mode of action distinct to that of LHRH agonists and comparative trials have shown differences in efficacy and safety between these agents. Adverse events (AE) from the musculoskeletal and renal and urinary systems have now been analysed. Methods: Results were pooled from 6 prospective, comparative randomised trials (n=2328). Most patients (pts) received 1 year of degarelix or LHRH agonist treatment (n=1686); the remaining men had 3–7 months’ treatment (n=642). AEs were analysed using Kaplan Meier plots and a log-rank test for homogeneity on relevant groups of MedDRA terms. Results: Treatment groups (degarelix, n=1491; LHRH agonist, n=837) were balanced for baseline characteristics such as age, testosterone, PSA and disease stage. In men with metastatic disease alkaline phosphatase (ALP) was reduced to a greater extent with degarelix (p=0.0373) throughout the year. Overall probability of fracture (<1% vs. 2%, p=0.0411) and incidence of joint related AEs (4% vs. 6%, p=0.0116) were significantly lower for degarelix-treated men. Incidence of muscle or bone pain was lower for degarelix (9% vs. 12%, p=0.0822). Incidence of urinary infections (UI) was reduced (5% vs. 8% with agonists) and time to first UI was significantly increased (p=0.0010) with degarelix. Overall probability of any renal or urinary tract AEs, including lower urinary tract symptoms (LUTS), was significantly lower in pts receiving degarelix (p<0.0001). Consistent with fewer skeletal and urinary tract AEs indicating better disease control, men with baseline PSA >50 ng/mL had significantly higher PSA PFS compared to agonist treated pts. OS during 1 year of treatment was significantly higher for degarelix pts (98.3% vs. 96.7%, p=0.0329). Conclusions: This analysis of 2,328 men shows degarelix-treated men had lower ALP, significantly fewer fractures, a lower incidence of urinary tract symptoms and higher overall survival than pts receiving an LHRH agonist over one year. Control of such disease symptoms is consistent with previous data on a significantly lower risk of PSA PFS during the first year of treatment.

Outcomes of appendiceal adenocarcinomas compared to right and left-sided colorectal adenocarcinomas: An analysis from the National Cancer Database (NCDB).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 42-42
Author(s):  
Kanika Gupta Nair ◽  
Wei Wei ◽  
Michael Cruise ◽  
Katherine Tullio ◽  
Bassam N. Estfan
Keyword(s):  
Stage Iv ◽  
Stage I ◽  
Disease Stage ◽  
Rank Test ◽  
National Cancer Database ◽  
Kaplan Meier ◽  
Stage Iv Disease ◽  
The Difference ◽  
The Right ◽  
Colorectal Adenocarcinomas

42 Background: Appendiceal carcinomas (AC) account for 1-2% of colorectal cancers (CRC) and are generally treated like other CRC. However, there is limited data to guide treatment. While AC originate on the right side of the colon, it is unclear if they behave like as right-sided CRC (R-CRC). We seek to learn how AC differ from right versus left-sided CRC (L-CRC). Methods: We identified histologically confirmed cases of appendiceal and colorectal adenocarcinomas with information about stage and overall survival (OS) diagnosed between 2004 and 2016 from the National Cancer Database. Kaplan-Meier method and log-rank test were used to estimate and compare OS. Results: 833,939 patients met our inclusion criteria: 15,138 (1.8%) AC, 447,551 (53.7%) L-CRC, 308,794 (37.0%) R-CRC, and 62,456 (7.5%) transverse CRC (T-CRC). Median age at diagnosis of all patients was 68 years (range:18-90); AC was lowest at 61 years for stage I-III disease and 58 years for stage IV disease. Stage IV AC was more common in females 3628/5739 (63.22%). AC had the best OS among site groups in stage I-III. Median OS for stage I-III AC was 128.8 months (95% CI: 117.9-139.0), with 5-year OS rate of 0.69 (95% CI: 0.67-0.70); L-CRC median OS was 111.6 months (95% CI: 110.9-112.4), with 5-year OS rate of 0.681 (95% CI: 0.680-0.683); R-CRC median OS was 88.5 months (95% CI: 87.8-89.1), with 5-year OS rate of 0.613 (95% CI: 0.611-0.615); and T-CRC median OS was 86.2 months (95% CI: 84.7-87.6), with 5-year OS rate of 0.608 (95% CI: 0.604-0.613) (p <0.0001) (Table). Similar difference was observed in stage IV patients (Table). Conclusions: Patients with AC had significantly better OS for stages I-III and stage IV compared to patients with L-CRC, R-CRC, and T-CRC, though outcomes were more similar to L-CRC. The difference is more evidence for patients with stage IV disease. T-CRC had similar OS to R-CRC, as anticipated. [Table: see text]

scholarly journals Independent validation of a predictive nomogram for risk of reinfection in women with recurrent non-complicated urinary tract infections

2020 ◽  
Vol 12 ◽  
pp. 175628722092242
Author(s):  
Marcelo Gonzales Favoreto ◽  
Emerson Pereira Gregorio ◽  
Marcio Augusto Averbeck ◽  
Silvio Henrique Maia de Almeida
Keyword(s):  
Urinary Tract ◽  
Statistical Significance ◽  
External Validation ◽  
Rank Test ◽  
Multivariate Logistic Regression Model ◽  
Predictive Capacity ◽  
Time To Recurrence ◽  
Kaplan Meier ◽  
History Of ◽  
Tract Infections

Aims: Independent external validation of a predictive nomogram for risk of reinfection in women with a history of non-complicated recurrent urinary tract infection (UTI). Methods: A retrospective longitudinal study was conducted to validate the LUTIRE nomogram in a Brazilian female cohort. The nomogram was applied to 81 women presenting non-complicated recurring UTI screened at a urological clinic. External validation was performed using the nomogram variables in patients followed up from January 2014 to December 2016 at a urological clinic. Accuracy of the nomogram was obtained by analyzing the predictive capacity observed in the area under the receiver operating characteristic (ROC) curve. A multivariate logistic regression model was used to assess the ability of the nomogram variables to predict the recurrence of UTI over 12 months. The time to recurrence of infection was calculated using a Kaplan–Meier curve and the log-rank test with calculation of the hazard ratio. Results: The mean age of the study population was 42.8 years; 57 women (70.37%) had recurrence. The independent variables with statistical significance in the multivariate analysis were gram-negative bacteria [odds ratio (OR) 18.38; p = 0.03897] and number of UTIs in the past 12 months (OR 25.11; p = 0.00006). The accuracy of the nomogram for discriminating patients who had UTI recurrence was 82.6% (95% CI = 72.5–90.1). Conclusion: The LUTIRE nomogram showed good accuracy among Brazilian women with recurrent UTI.

Comparision of the risk of cardiovascular events and death in patients treated with degarelix compared with LHRH agonists.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 42-42 ◽  
Author(s):  
Peter C. Albertsen ◽  
Jan Nilsson ◽  
Laurence Klotz ◽  
Heather Payne ◽  
Egbert van der Meulen ◽  
...  
Keyword(s):  
Gnrh Antagonist ◽  
First Year ◽  
Lhrh Agonist ◽  
Event Analysis ◽  
Cvd Risk ◽  
Lhrh Agonists ◽  
Kaplan Meier ◽  
Increased Risk ◽  
Treatment Data ◽  
Cv Disease

42 Background: LHRH agonists are used to treat patients (pts) with advanced prostate cancer and have been associated with an increased risk of cardiovascular (CV) events and related deaths. Degarelix is a GnRH antagonist that appears to mitigate this risk. Methods: Results were pooled from 2328 pts participating in 6 prospective randomised trials. Most pts (n=1,686) received 1 year of GnRH antagonist or LHRH agonist treatment; the remainder (n=642) had 3–7 months’ treatment. Data were classified based on the MedDRA system and analysed using Kaplan Meier plots and a Cox proportional hazard model. Event analysis was based on death from any cause or CV event defined as arterial embolic/thrombotic; haemorrhagic or ischemic cerebrovascular; myocardial infarction or other ischemic heart disease. High risk pts were defined as men with a baseline CV disease (CVD) history. Results: Treatment groups (GnRH antagonist, n=1,491 [degarelix]; LHRH agonist, n=837 [goserelin, n=458; leuprolide, n=379]) were balanced for baseline characteristics and CVD history (31% vs. 29%). Characteristics associated with CVD (e.g. statin medication, elevated blood pressure, diabetes, cholesterol >6.2 mmol/L) were similar between groups. The risk of a CV event or death was significantly lower in pts receiving degarelix during the first year of treatment (see Table). In pts with baseline CVD the findings remained significant. In pts with no baseline CVD, there was no difference in subsequent CVD events or death in either group. In analysis by time to CV event only in all pts and pts with baseline CVD (see Table), men receiving GnRH antagonist had a significantly lower risk of CV events. Conclusions: In all pts treated with a GnRH antagonist (degarelix) risk of a CV event or death was significantly lower than in pts receiving an LHRH agonist over a treatment period of up to 1 year. In pts with baseline CVD, risk reduction remained significant at ~50%. [Table: see text]

Selecting patients with stage II/III colorectal cancer for 5-fluorouracil-based adjuvant chemotherapy using proteomic analysis.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 708-708
Author(s):  
Dongyao Yan ◽  
Ji Hyung Hong ◽  
Hee Yeon Lee ◽  
Jae Ho Byun ◽  
Fabiola Cecchi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Mass Spectrometry ◽  
Cohort Analysis ◽  
Tumor Stage ◽  
Stage Ii ◽  
Disease Stage ◽  
Rank Test ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Student’S T

708 Background: 5-fluorouracil (5-FU) is a common adjuvant treatment for stage III and high-risk stage II colorectal cancer (CRC). However, about 20% of patients relapse within 48 months of treatment with 5-FU, even when combined with oxaliplatin. To improve patient selection, tumor biomarkers that predict sensitivity to 5-FU have been proposed. These include proteins involved in 5-FU activation or metabolism such as uridine-cytidine kinase 2 (UCK2) and thymidylate synthase (TYMS). We used multiplexed mass spectrometry to evaluate the utility these biomarkers in the archived tumor samples of patients with stage II/III CRC. Methods: Tumor samples were from 143 patients with stage II/III CRC who received adjuvant 5-FU, folinic acid, and oxaliplatin during 2000-2014; 83% of patients received 12 cycles and the others received ≤ 11 cycles. Tumor cells were microdissected and solubilized, and 67 candidate biomarkers were quantitated using mass spectrometry. Overall survival (OS) and relapse-free survival (RFS) were assessed using the Kaplan-Meier method and log-rank test. Protein expression by tumor stage, lymph node (LN) status, tumor sidedness was compared using the Student’s t-test. Results: Of 143 patients, 45 had recurrence and 98 patients did not. UCK2 was detected in all samples, ranging from 187 to 1606 attomoles per microgram of total protein (amol/µg). Patients with UCK2 expression above 335 amol/μg (n = 109) had significantly longer OS than patients with lower expression (n = 34; HR: 0.42; p= 0.009). There was no significant difference in RFS (HR: 0.6; p= 0.088). UCK2 expression did not differ by disease stage, LN metastasis status, or tumor sidedness. TYMS expression was not associated with survival in this cohort. Analysis of other biomarkers associated with response to 5-FU and platinum is in progress. Conclusions: In stage II/III CRC, UCK2 expression above 335 amol/μg identifies a subgroup of 5-FU-treated CRC patients with longer survival, suggesting that quantitated UCK2 has potential for use in selecting patients for treatment. These findings warrant validation in larger cohorts.

Allogeneic Transplant Outcomes in Imatinib-Refractory Chronic Myeloid Leukaemia (CML) Are Similar to Transplant Outcomes in Imatinib-Responsive/Imatinib-Naïve CML and Appear To Be Predicted by the EBMT Risk Score.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3155-3155
Author(s):  
Steven Stylian ◽  
Eileen T. Fennelly ◽  
Jason P. Butler ◽  
James P. Morton ◽  
Robyn Western ◽  
...  
Keyword(s):  
Chronic Myeloid Leukaemia ◽  
Myeloid Leukaemia ◽  
Risk Score ◽  
Survival Data ◽  
Cytogenetic Response ◽  
Disease Stage ◽  
Risk Scores ◽  
Rank Test ◽  
Transplant Outcomes ◽  
Kaplan Meier

Abstract Aims: To review the outcome of allogeneic stem cell transplantation (SCT) in imatinib refractory chronic myeloid leukaemia (CML). Methods: Outcomes of all allogeneic transplants performed after January 2001 for CML at our institution were retrospectively reviewed. Imatinib-refractory CML was defined as either lack of any cytogenetic response (CGR) after at least 6mths of imatinib, loss of CGR or progression to a more advanced disease stage (accelerated or blast phase) during imatinib therapy. Using the EBMT risk score (Lancet1998; 352: 1087), transplant outcomes for imatinib refractory CML were compared with all other CML transplants performed during the same time period. Survival analysis was performed using the Kaplan-Meier product-limit and comparison of survival data via the log-rank test. Results: Of 31 allogeneic transplants (19M; 12F) performed for CML, 12 had been performed for imatinib refractory CML (no CGR to imatinib n=3; loss of CGR n=3; progression to AP n=3; progression to BC n=3), 5 in patients with imatinib responsive CML, and 14 in patients never exposed to imatinib. Median age at SCT was 40yrs (range 19–63yrs). Donor source included HLA-matched unrelated donors in 14 cases, HLA-identical siblings in 16 and other matched family donors in 1. Conditioning regimens included Cy/TBI (20 cases), Bu/Cy (8 cases), Flu/Mel (2 cases) and Flu/Cy (1 case); CsA + MTX was used as standard GVHD prophylaxis. EBMT risk scores were 1 (4 cases), 2 (6 cases), 3 (8 cases), 4 (5 cases), 5 (3 cases) and 6 (5 cases). At median follow-up post-SCT of 37mths (range 6–64mths), median PFS and OS are not reached; at 2yrs PFS, EFS and OS are 81%, 58% and 61% respectively. For patients with EBMT risk scores of 1–2 versus 3–4 versus 5–6, OS at 2 yrs post-SCT is 80%, 62% and 38% respectively (p=0.03). Based on EBMT risk score, no significant differences in PFS, EFS or OS were observed when comparing SCT for imatinib-refractory versus imatinib-responsive / imatinib-naïve CML. Conclusion: Our experience suggests that survival post-SCT for imatinib-refractory CML is similar to SCT for imatinib-responsive / imatinib-naïve CML. The EBMT risk score appears to remain useful in predicting survival post-SCT in imatinib-refractory CML.

scholarly journals Association Between Osteoarthritis and Urinary Tract Infection in Older Adults: A Nationwide Population-Based Cohort Study

2021 ◽  
Author(s):  
Wei-Hung Wang ◽  
Tian-Hoe Tan ◽  
Chung-Han Ho ◽  
Yi-Chen Chen ◽  
Chien-Chin Hsu ◽  
...  
Keyword(s):  
Older Adults ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Older Patients ◽  
Population Based ◽  
Rank Test ◽  
Research Database ◽  
Kaplan Meier ◽  
Increased Risk

Abstract Background: Osteoarthritis (OA) may increase urinary tract infection (UTI) in older adults. However, this issue remains unclear.Methods: We identified 8599 older patients (≥65 years) with OA, and an equal number of older patients without OA, matched by age, sex, and index date from the Taiwan National Health Insurance Research Database between 2001 and 2005. Past histories, including UTI and underlying comorbidities, were included in the analyses. Comparisons for any UTI, ≥1 hospitalization for UTI, and ≥3 hospitalizations for UTI between the two cohorts by following up until 2015 were performed.Results: In both cohorts, the percentages of age subgroups were 65–74 years (65.7%), 75–84 years (30.1%), and ≥85 years (4.2%). The male sex was 42.4%. Patients with OA had an increased risk of any UTI compared with those without OA after adjusting for all past histories (adjusted hazard ratio [AHR]: 1.72; 95% confidence interval [CI]: 1.64–1.80). The Kaplan–Meier curve and log-rank test showed that OA increased any UTI (p <.001). Compared with patients without OA, patients with OA also had an increased risk of ≥1 hospitalization for UTI and ≥3 hospitalizations for UTI (AHR: 1.13; 95% CI: 1.06–1.19 and AHR: 1.25; 95% CI: 1.13−1.38, respectively). In addition to OA, older age, female sex, history of UTI, benign prostatic hyperplasia, indwelling urinary catheter, cerebrovascular disease, diabetes, dementia, and urolithiasis were independent predictors for any UTI.Conclusions: OA increased UTI in older adults. We suggest appropriately managing OA and controlling underlying comorbidities to prevent subsequent UTI.

scholarly journals Primary colorectal lymphomas

2009 ◽  
Vol 66 (4) ◽  
pp. 295-301 ◽  
Author(s):  
Goran Stanojevic ◽  
Miroslav Stojanovic ◽  
Milan Jovanovic ◽  
Miodrag Stojanovic ◽  
Miroslav Jeremic ◽  
...  
Keyword(s):  
Adjuvant Therapy ◽  
Disease Stage ◽  
Rank Test ◽  
Kaplan Meier ◽  
Gastrointestinal Lymphomas ◽  
The Difference ◽  
Colorectal Lymphoma ◽  
Disease Stages ◽  
Type Of Surgery

Background/Aim. Colorectal lymphoma is a rare tumor representing 1.4% of human lymphomas, 10-20% of gastrointestinal lymphomas, namely 0.2-0.6% of all malignancies in the colon. The aim of this study was to review clinical characteristics of primary colorectal lymphoma and overall survival. Methods. A detailed analysis of 16 surgically treated patients included patients age, symptoms and signs, tumor site, type of surgery, histopathologic findings, diagnosis of the disease, disease stage, type of surgery related to the degree of emergency (elective or urgent), applied adjuvant therapy, patient follow-up and treatment outcomes. Survival was expressed by the Kaplan-Meier curve, while the difference in survival among the two groups by the Log-rank test. Results. The all patients were on an average followed-up for a median of 29 months (range 2-60 months), while those with chemotherapy 48 months (range 4-60 months). An overall mean survival time was 38.65 months. Conclusion. Primary colorectal lymphoma is a rare malignant tumor of the large bowel. Therapy usually involves resection of the affected colon or rectum and regional lymphovascular structures, followed by adjuvant therapy. Survival period is short and, therefore, timely diagnosis is crucial in early disease stages when the probability of cure is high.

scholarly journals Influence of marital status on overall survival in adult chordoma patients: A SEER-based study

2020 ◽  
Author(s):  
Chao Tang ◽  
Ruiliang Wang ◽  
Qingguo Lu ◽  
Shantao Wang ◽  
Gen Jia ◽  
...  
Keyword(s):  
Overall Survival ◽  
Marital Status ◽  
Cox Regression ◽  
Prognostic Indicator ◽  
Primary Site ◽  
Disease Stage ◽  
Rank Test ◽  
Primary Bone Tumor ◽  
Risk Of Death ◽  
Kaplan Meier

Abstract Background. As a rare primary bone tumor, no studies have reported the relationship between prognosis and marital status in patients with chordoma. Methods. We classified chordoma patients identified from the Surveillance, Epidemiology, and End Results (SEER) database from 1975 to 2016 into four groups: married, divorced/separated, widowed and single groups. Kaplan-Meier curves with log-rank test and Cox regression were used to analyse the effect of marital status on overall survival (OS). Results. A total of 1,080 patients were included in the study, 700 (64.8%) were married, 88 (8.1%) were divorced/separated, 78 (7.2%) were widowed and 214 (19.8%) were single. Among the four groups, the 5-year OS (45.2%), 10-year OS (12.5%) and median OS (56.0 months) were the lowest in the widowed group. After including age, sex, primary site, marital status, disease stage, tumor size, histological type, and treatment pattern, multivariate analysis showed that marital status was still an independent risk factor for chordoma patients, widowed patients have the lowest OS (hazard ratio [HR]: 1.71; 95% confidence interval [CI]: 1.25–2.33, p<0.001) compared with married patients. Similar results were observed after stratifying the primary site and disease stage. Conclusion. Marital status was an independent prognostic indicator for adult chordoma patients, and marital status was conducive to patient survival. Compared with married patients, widowed patients have a higher risk of death.

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