Long-term survival update of the Scandinavian Prostate Cancer Group 6 study: Bicalutamide 150 mg daily versus placebo in hormone-naïve, non-metastatic prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
Frederik Birkebæk Thomsen ◽  
Klaus Brasso ◽  
Ib Jarle Christensen ◽  
Jan-Erik Johansson ◽  
Anders Angelsen ◽  
...  

2 Background: The optimal timing of endocrine therapy in non-metastatic prostate cancer (PCa) is not clear. There is a need for more data from randomized trials. Methods: A randomized, double-blind, parallel-group trial comparing bicalutamide 150 mg once daily with placebo in addition to standard of care in patients with hormone-naïve, non-metastatic PCa. Kaplain-Meier analysis was used to estimate overall survival (OS) and multivariate Cox proportional hazard model was performed to analyse time-to-event (death). Results: 1,218 patients were included into the SPCG-6 study, 607 patients were randomised to bicalutamide and 611 patients to placebo. The majority (81.4%) were managed on watchful waiting. After median 14.6 years follow-up, 866 (71.1%) patients died, 428 (70.5%) in the bicalutamide arm and 438 (71.7%) in the placebo arm, p=0.87. In patients with localised disease (cT1-2, N0/Nx) survival favoured randomisation to the placebo arm (HR=1.19 (95% CI: 1.00-1.43), p=0.056). Bicalutamide significantly improved OS and reduced the risk of death by 23% relative to the placebo arm in patient with locally advanced disease (cT3-4, any N; or any cT, N+) with a median survival difference of 1.8 years (HR=0.77 (95% CI: 0.63-0.94, p=0.01). The survival benefit of bicalutamide in patients with locally advanced PCa was present throughout the study period. In multivariate Cox proportional hazard model OS was dependent on age (HR 1.55 (95% CI:1.20-1.85)), baseline PSA (localised PCa HR for 2 x increase in PSA 1.09 (95% CI:1.02-1.16), locally advanced PCa HR 1.23 (95% CI:1.14-1.33)), WHO histological grade (moderate vs. well HR 1.27 (95% CI:1.08-1.49), poor vs. well HR 1.92 (95% CI:1.51-2.45)), and randomisation to placebo in locally advanced disease (HR=0.76 (95% CI: 0.61-0.95)). Conclusions: The addition of early bicalutamide to standard of care resulted in a significant OS benefit in patients with locally advanced PCa, whereas patients with localised PCa derived no survival benefit from early bicalutamide. The survival benefit of bicalutamide therapy increased with higher baseline PSA. Clinical trial information: NCT00672282.

2021 ◽  
Vol 12 ◽  
pp. 215013272110002
Author(s):  
Gayathri Thiruvengadam ◽  
Marappa Lakshmi ◽  
Ravanan Ramanujam

Background: The objective of the study was to identify the factors that alter the length of hospital stay of COVID-19 patients so we have an estimate of the duration of hospitalization of patients. To achieve this, we used a time to event analysis to arrive at factors that could alter the length of hospital stay, aiding in planning additional beds for any future rise in cases. Methods: Information about COVID-19 patients was collected between June and August 2020. The response variable was the time from admission to discharge of patients. Cox proportional hazard model was used to identify the factors that were associated with the length of hospital stay. Results: A total of 730 COVID-19 patients were included, of which 675 (92.5%) recovered and 55 (7.5%) were considered to be right-censored, that is, the patient died or was discharged against medical advice. The median length of hospital stay of COVID-19 patients who were hospitalized was found to be 7 days by the Kaplan Meier curve. The covariates that prolonged the length of hospital stay were found to be abnormalities in oxygen saturation (HR = 0.446, P < .001), neutrophil-lymphocyte ratio (HR = 0.742, P = .003), levels of D-dimer (HR = 0.60, P = .002), lactate dehydrogenase (HR = 0.717, P = .002), and ferritin (HR = 0.763, P = .037). Also, patients who had more than 2 chronic diseases had a significantly longer length of stay (HR = 0.586, P = .008) compared to those with no comorbidities. Conclusion: Factors that are associated with prolonged length of hospital stay of patients need to be considered in planning bed strength on a contingency basis.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 947.1-947
Author(s):  
K. S. K. MA ◽  
L. T. Wang

Background:Juvenile Idiopathic Arthritis (JIA), an autoimmune disease, has been proposed to be comorbid with obstructive sleep apnea (OSA).Objectives:We aimed at identifying the relationship between JIA and OSA.Methods:We performed a cohort study including JIA and OSA patients from 1999 to 2013. A total of 2791 patients diagnosed with OSA after JIA onset were recruited, which 11,164 eligible individuals without JIA history were selected as matched-controls. A Cox proportional hazard model was developed to estimate the risk of OSA in JIA patients. A cumulative probability model was adopted to assess the time-dependent effect of JIA on OSA development, implying the casual link of the association. To identify whether JIA patients have higher risks for developing temporomandibular joint (TMJ) disorders, craniofacial anomalies and deformities than non-JIA individuals, subgroup analyses was conducted. Finally, Ingenuity Systems Pathway Analysis (IPA) was conducted to identify underlying mechanisms of the above disease correlation among peripheral blood mononuclear cells (PBMCs) from rheumatic factor (RF)-positive and RF-negative JIA patients, and subcutaneous fat tissues from OSA patients, using p-value visualization for RNA-seq analyses.Results:The Cox proportional hazard model showed that JIA patients were more likely to have OSA than non-JIA individuals (adjusted hazard ratio =1.949, 95% CI =1.264–3.005). The incidence of developing OSA was particularly high among patients who developed JIA aged 18-30 years old (aHR= 2.034, 95% CI=1.305-3.169) and males (aHR=1.82, 95% CI=1.121-2.954). The risk of developing OSA increased within 0-36 months (aHR = 2.216, 95% CI = 1.001 – 4.907) and over 60 months (aHR = 2.558, 95% CI = 1.346 – 4.860) of follow-up duration after JIA onset. Subgroup analyses showed that JIA patients were more likely to have TMJ disorders (relative risk = 2.047, 95% CI = 1.446-2.898) and to receive treatment for craniofacial deformities (RR = 1.722, 95% CI = 1.38-2.148) than non-JIA controls. IPA analyses suggested that the underlying mechanisms involved activation of antigen presentation pathway followed by antigen presentation to CD4+ and CD8+ T lymphocytes, as well as B cell development.Conclusion:Our findings identified high risks of developing OSA, TMJ disorders, and craniofacial deformities following JIA onset, which the underlying mechanisms may involve both cellular and humoral immunity.Disclosure of Interests:None declared


2017 ◽  
Vol 05 (04) ◽  
pp. E291-E296
Author(s):  
Nobuhiko Fukuba ◽  
Shunji Ishihara ◽  
Hiroki Sonoyama ◽  
Noritsugu Yamashita ◽  
Masahito Aimi ◽  
...  

Abstract Background and study aims Recurrence of common bile duct stones (CBDS) in patients treated with endoscopic sphincterotomy (ES) can lead to deterioration in their quality of life. Although the pathology and related factors are unclear, we speculated that proton pump inhibiter (PPI) administration increases the risk of CBDS recurrence by altering the bacterial mixture in the bile duct. Patients and methods The primary endpoint of this retrospective study was recurrence-free period. Several independent variables considered to have a relationship with CBDS recurrence including PPI use were analyzed using a COX proportional hazard model, with potential risk factors then evaluated by propensity score matching analysis. Results A total of 219 patients were analyzed, with CBDS recurrence found in 44. Analysis of variables using a COX proportional hazard model demonstrated that use of PPIs and ursodeoxycholic acid (UDCA), as well as the presence of periampullary diverticula (PD) each had a hazard ratio (HR) value greater than 1 (HR 2.2, P = 0.007; HR 2.0, P = 0.02; HR 1.9, P = 0.07; respectively). Furthermore, propensity score matching analysis revealed that the mean recurrence-free period in the oral PPI cohort was significantly shorter as compared with the non-PPI cohort (1613 vs. 2587 days, P = 0.014). In contrast, neither UDCA administration nor PD presence was found to be a significant factor in that analysis (1557 vs. 1654 days, P = 0.508; 1169 vs. 2011 days, P = 0.121; respectively). Conclusion Our results showed that oral PPI administration is a risk factor for CBDS recurrence in patients who undergo ES.


Author(s):  
Nida Sajid Ali Bangash ◽  
Natasha Hashim ◽  
Nahlah Elkudssiah Ismail

  Objective: Adenocarcinoma (AC) of the lung is now the most common histologic type of non-small cell lung cancer (NSCLC) worldwide since the past 20 years. This study was conducted to investigate survival difference among smoker and non-smoker lung AC patients.Methods: A retrospective observational study was conducted for 81 advanced NSCLC adult Malaysian patients in Radiotherapy and Oncology Clinic at Hospital Kuala Lumpur, Malaysia. A total of adult 30 Malaysian smokers and 51 non-smokers with lung AC were included. Ex-smokers were not included in the study. Demographic and clinical data were collected and described. For survival analysis, Kaplan–Meier test and log-rank test were used to calculate overall survival (OS) and analyse the difference in the survival curve. Cox proportional hazard model was used to identify prognostic significance of smoking status.Results: Non-smokers showed a significant association with female gender and Stage IV NSCLC. The median OS was higher for non-smokers (493 days) as compared to smokers (230 days). The Cox proportional hazard model showed higher hazard ratio for smokers.Conclusion: Non-smoking is an independent positive prognostic factor in lung AC.


Author(s):  
Melissa Wright ◽  
Shantini Paranjothy ◽  
David Fone ◽  
Sinead Brophy ◽  
Joanne Demmler

ABSTRACTObjectiveTo explore whether children with pelvicalyceal dilatation (PCD, a marker detected during the 18-20 week gestation ultrasound scan in which there is enlargement of tubes that collect urine in the kidney) have more hospital admissions for kidney problems in childhood compared to children without the marker. Approach We were funded by NISCHR to study outcomes associated with markers of uncertain significance at the second trimester anomaly scan (Welsh Study of Mothers and Babies). Data collected in the WSMB was uploaded to the Secure Anonymised Information Linkage (SAIL) databank and record linked to hospital activity data. Patterns of hospital admissions for renal causes were described and compared between those with no markers and those with PCD. Children were followed up from birth until 31st December 2014 or until the age of 5. A Cox Proportional Hazard Model was used to investigate the impact of PCD on time to first presentation. Results (Preliminary)Of the WSMB cohort, 20,834 children were eligible for inclusion in analyses. Those with PCD had 6.29 times the hazard of a renal admission compared to those without the marker (95% CI: 3.69 to 10.72). Children with PCD were more likely to have multiple renal admissions to hospital - median (interquartile range) number of renal admissions, 2.5 (1 to 5) compared to 1 (1 , 1) in children without markers. ConclusionPreliminary analysis suggests there is increased childhood renal morbidity associated with the presence of a PCD marker detected on the 18-20 week gestation ultrasound scan. These findings will inform the discussions clinicians have with parents when discussing the implications of this marker for the health of the chid.


2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Zhiying Yin ◽  
Canjie Zheng ◽  
Quanjun Fang ◽  
Xiaoying Gong ◽  
Guoping Cao ◽  
...  

Mumps is a vaccine-preventable disease caused by the mumps virus, but the incidence of mumps has increased among the children who were vaccinated with one-dose measles-mumps-rubella (MMR) in recent years. In this study, we analyzed the influence of different doses of mumps-containing vaccine (MuCV) against mumps using Cox-proportional hazard model. We collected 909 mumps cases of children who were born from 2006 to 2010 and vaccinated with different doses of MuCV in Quzhou during 2006-2018, which were all clinically diagnosed. Kaplan-Meier survival methods and Cox-proportional hazard model were used to estimate the hazard probabilities. Kaplan–Meier curves showed that the cumulative hazard of male and female has no difference; lower hazards were detected among those who were vaccinated with two-dose MuCV, born in 2006, and infected after supplementary immunization activities (SIA). Cox-proportional hazard regression suggested that onset after SIA, born in 2006, and vaccinated with two-dose MuCV were protective factors against infection even after adjusting for potential confounding effects. Our study showed that it was necessary to revise the diagnostic criteria of mumps and identify RT-PCR as the standard for mumps diagnosis in China. We suggested that routine immunization schedule should introduce two doses of MMR and prevaccination screening should be performed before booster immunization in vaccinated populations.


Sign in / Sign up

Export Citation Format

Share Document