Comparison of clinical outcomes with sirolimus (SES) and zotarolimus (ZES) stents in real world practice—One-year follow-up data from a single centre

2009 ◽  
Vol 18 ◽  
pp. S204
Author(s):  
A. French ◽  
N. Jepson ◽  
Mark Pitney ◽  
D. Friedman ◽  
A. Lau ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Single Centre ◽  
One Year

Highly selective diversion with proactive leakage management after low anterior resection for rectal cancer

2021 ◽  
Author(s):  
K Talboom ◽  
I Vogel ◽  
R D Blok ◽  
S X Roodbeen ◽  
C Y Ponsioen ◽  
...  
Keyword(s):  
Low Anterior Resection ◽  
Case Series ◽  
Fecal Diversion ◽  
Single Center ◽  
Single Centre ◽  
Diverting Stoma ◽  
Faecal Diversion ◽  
One Year ◽  
Diversion Rate

Abstract In this single center case series with nine percent primary diversion, 86 of 94 patients alive and with complete follow-up at one year had a functioning anastomosis. Seventy-five of the initial 99 patients never had a stoma. Meaning: Highly selective fecal diversion in combination with proactive leakage management, low anastomoses can be preserved safely, and the majority of patients will be spared all disadvantages of a diverting stoma. In this single-centre case series, with a primary diversion rate of 9 per cent, 86 of 94 patients who were alive and had complete follow-up at 1 year had a functioning anastomosis. Seventy-five of the initial 99 patients never had a stoma. The results indicate that, with highly selective faecal diversion in combination with proactive leakage management, low anastomoses can be preserved safely, and the majority of patients will be spared the disadvantages of a diverting stoma.

scholarly journals Real world experience with coronary sinus reducer implantation for the treatment of refractory angina: a single-centre experience

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J P Dias Ferreira Reis ◽  
R Ramos ◽  
P Rio ◽  
A Fiarresga ◽  
D Cacela ◽  
...  
Keyword(s):  
Coronary Sinus ◽  
Real World ◽  
Therapeutic Option ◽  
Objective Evaluation ◽  
Short Version ◽  
Refractory Angina ◽  
Single Centre ◽  
Real World Data ◽  
Serious Adverse Events

Abstract Background Coronary sinus Reducer device (CSF) implantation is a novel therapeutic option to relieve symptoms in patients with refractory angina (RA). There is limited real-world data describing its use outside of clinical trials. Aim To assess the safety and efficacy of this procedure in a real-world setting. Methods This is a report of a single centre prospective registry of consecutive patients with RA (CCS II-IV) deemed unsuitable for revascularization. Between May 2017 and August 2019, 17 patients were referred to CSF implantation. Baseline and follow-up evaluation consisted of clinical assessment, including completion of the short version of the Seattle Angina Questionnaire (SAQ-7) and CCS class evaluation and objective evaluation by transthoracic echocardiography and cardiopulmonary exercise test (CPET). Results A total of 13 patients (70,6±6,5 years, 76,9% male) underwent CSF implantation with a procedural success of 84.6%. No cases of periprocedural serious adverse events were reported. At 12-month follow-up, any reduction in CCS Class was achieved in 72.7% of cases, with 27.2% reducing 2 CCS classes. Baseline CCS score was reduced from 2.8±0.4 to 1.7±0.8 (p=0.009). Quality of life (QoL) was significantly improved as assessed by the improvement seen in all items of SAQ-7 (p<0.017 for all). CPET duration was significantly increased (p=0.034), but no change was noted in the remainder CPET variables. During follow-up, 3 patients suffered myocardial infarction, resulting in 1 death. Conclusion CSF implantation in patients with RA was safe and led to a significant reduction of the angina burden and improvement of QoL at 12-month follow-up. FUNDunding Acknowledgement Type of funding sources: None.

Subspinal impingement: clinical outcomes of arthroscopic decompression with one year minimum follow up

2018 ◽  
Vol 28 (9) ◽  
pp. 2756-2762 ◽  
Author(s):  
Frankl Michal ◽  
Eyal Amar ◽  
Ran Atzmon ◽  
Zachary Sharfman ◽  
Barak Haviv ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
One Year

scholarly journals P705 Switching from originator to biosimilar infliximab—real-world data from 18 months prospective follow-up of a single-centre IBD population

2018 ◽  
Vol 12 (supplement_1) ◽  
pp. S467-S468
Author(s):  
M L Hoivik ◽  
L C Buer ◽  
N Bolstad ◽  
B Moum ◽  
A W Medhus
Keyword(s):  
Real World ◽  
Single Centre ◽  
Real World Data ◽  
World Data

scholarly journals Longitudinal clinical outcomes in a real-world population of patients with idiopathic pulmonary fibrosis: the PROOF registry

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Wim A. Wuyts ◽  
Caroline Dahlqvist ◽  
Hans Slabbynck ◽  
Marc Schlesser ◽  
Natacha Gusbin ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Pulmonary Function ◽  
Clinical Outcomes ◽  
Real World ◽  
Lung Transplant ◽  
World Population ◽  
Duration Of Treatment

Abstract Background The PROOF registry is an observational study initiated in October 2013 with the aim to monitor disease progression in a real-world population of patients with idiopathic pulmonary fibrosis (IPF). Here, we present longitudinal clinical outcomes from the PROOF registry. Methods Patients with IPF were enrolled across eight centers in Belgium and Luxembourg. For all patients, clinical outcomes data were collected, including mortality, lung transplant, acute exacerbations, and pulmonary hypertension. For patients treated with pirfenidone at any time during follow-up (2013–2017), for any duration of treatment (the pirfenidone-treated population): pirfenidone treatment patterns were collected; changes in pulmonary function (forced vital capacity [FVC] and carbon monoxide diffusing capacity [DLco]) were reviewed up to 24 months post-inclusion; and time-to-event analyses from the time of registry inclusion were performed. Results The PROOF registry enrolled a total of 277 patients. During follow-up, 23.1% of patients died, 5.1% received a lung transplant, 5.4% experienced an acute exacerbation, and 6.1% had comorbid pulmonary hypertension. In the pirfenidone-treated population (N = 233, 84.1%), 12.9% of patients had a temporary dose discontinuation and 31.8% had a temporary dose reduction; 4.3% of patients permanently discontinued pirfenidone due to an adverse drug reaction. Mean percent predicted FVC was 81.2% (standard deviation [SD] 19.0) at Month 0 and 78.3% (SD 25.0) at Month 24, and mean percent predicted DLco was 47.0% (SD 13.2) and 45.0% (SD 16.5), respectively. Rates of ≥ 10% absolute decline in percent predicted FVC and ≥ 15% absolute decline in percent predicted DLco over 24 months were 31.0% and 23.2%, respectively. Mean times from registry inclusion to categorical absolute decline in percent predicted FVC and percent predicted DLco were 20.1 (standard error [SE] 0.6) months and 23.4 (SE 0.5) months, respectively; mean time from registry inclusion to death was 31.0 (SE 0.9) months. Conclusions The PROOF registry is a source of European data characterizing longitudinal clinical outcomes of patients with IPF. Over 12 months of follow-up, pulmonary function remained largely stable in patients with IPF who received pirfenidone for any duration of treatment. Pulmonary function remained similar at 24 months of follow-up, although patient numbers were lower. Trial registration PROOF is registered with the relevant authorities in Belgium and Luxembourg, with registration to Comité National d’Éthique et de Recherche (CNER) N201309/03–12 September 2013 and a notification to Comité National de Protection des Données (CNDP) for Luxembourg.

Shifting Treatment Patterns and Clinical Outcomes in Veterans Diagnosed with Waldenstrom Macroglobulinemia from 2006 to 2018

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 12-12
Author(s):  
Hsu-Chih Chien ◽  
Deborah Kay Morreall ◽  
Vikas Patil ◽  
Kelli M Rasmussen ◽  
Christina Yong ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Outcomes ◽  
Real World ◽  
Research Funding ◽  
Practice Patterns ◽  
Treatment Patterns ◽  
Clinical Settings ◽  
Treatment Groups ◽  
Treatment Regimens

Background Waldenström's Macroglobulinemia (WM) is a rare indolent lymphoma with an estimated 1,500 new cases diagnosed each year in the United States (US). Over the last decade, several treatments have been introduced into the WM therapeutics landscape including, bendamustine, bortezomib, and most recently oral Bruton's kinase inhibitor (ibrutinib). There is limited information in the adoption of these WM treatments in real-world clinical settings in the US. We describe the practice patterns and clinical outcomes of first-line (1L) treatment of WM in a nationwide cohort of Veterans. Methods Using Veteran Affairs electronic health records (EHR) data, we identified Veterans who were diagnosed and received 1L treatment for WM between January 2006 and December 2018 in the Veterans Health Administration (VHA). Human annotation of EHR clinical records confirmed the diagnosis and 1L treatment regimens. Patients with another cancer diagnosis or patients with documentation that 1L treatment was received outside the VHA were excluded. Eligible patients were followed until loss to follow-up, death, or the end of the study period (June 30, 2019). Patient demographics, disease characteristics, and treatment patterns were identified. Local polynomial regression model curves were generated to demonstrate treatment changes over time. Unadjusted progression-free survival (PFS) and the unadjusted overall survival (OS) are also provided. Results We identified 505 patients diagnosed with WM in VHA between January 2006 thru December 2018. Of these, 318 patients received 1L treatment, with a median time from diagnosis to 1L treatment of 1.2 months (95% confidence interval [CI]: 0.5-5 months). The median age of WM patients was 69.9 years (standard deviation [SD]: 9.4 years), with approximately 73% of WM patients ≥65 years old. Prior to 1L treatment, the median hemoglobin and platelets observed were similar across all treatment groups, regardless of first 1L treatment. However, the median immunoglobulin M (IgM) was substantially lower in patient's treated with ibrutinib (2,570 mg/dL [range: 422-9,001 mg/dL]) and single-agent rituximab (R), 2,855 mg/dL (range: 84-7,880 mg/dL) when compared to those treated with chlorambucil +/- rituximab (4,416 mg/dL [range: (9-8,130 mg/dL]) and bortezomib/dexamethasone +/- rituximab (BDR), 4,086 mg/dL (range: 16-9,944 mg/dL). MYD88 testing occurred in 40 (13%) of patients, with testing most frequently occurring in patients treated with bendamustine +/- rituximab (BR), ibrutinib, and BDR- likely reflecting increased adoption in later periods. Hepatitis C testing occurred in 61 (19%) of patients, with testing most frequently occurring in patients treated with dexamethasone, rituximab, and cyclophosphamide (DRC), BDR, and BR. Over the study observation period, 1L practice patterns shift significantly with increased adoption of BR, BDR and ibrutinib and de-adoption of chemotherapy (Figure 1). The median follow-up time for all patients was 44 months (range: 1-147 months), although a shorter median follow-up time was observed in patients treated with therapeutics in recent years, such as ibrutinib (18 months [range: 2-53 months]) and BR (23 months [range: 4-86 months]). The median unadjusted PFS for all WM patients was 44 months (95% CI: 37-58 months) and the median unadjusted overall survival (OS) was 94 months (95% CI: 82-117 months). Conclusions The introduction of numerous therapeutic options throughout the past decade has profoundly altered the treatment landscape for WM, suggesting a shift in 1L practices from chlorambucil to BDR, BR, and most recently ibrutinib which has been increasingly adopted, since its approval in 2015, especially in older patients, suggesting that it may provide an effective therapeutic option for patients who may not be able to tolerate more aggressive treatment regimens. Limitations of this study include the differences observed in follow-up time as well as the limited number of patients in some 1L treatment groups. Further research is required to establish the long-term benefits and potential treatment-related toxicities of WM treatments in real-world clinical settings. Disclosures Sauer: Roche: Research Funding; Genentech, Inc.: Research Funding; Pharmacyclics: Research Funding; AbbVie: Research Funding. Halwani:AbbVie: Research Funding; Takeda: Research Funding; Roche: Research Funding; Genentech, Inc.: Research Funding; Miragen: Research Funding; Immunedesign: Research Funding; Kyowa Hakko Kirin: Research Funding; Seattle Genetics: Research Funding; Amgen: Research Funding; Pharmacyclics: Research Funding; Bristol Myers Squibb: Research Funding.

Real World Data In Myeloma: Experiences From The Swedish Population-Based Registry On 2494 Myeloma Patients Diagnosed 2008-2011

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1972-1972 ◽  
Author(s):  
Cecilie Blimark ◽  
Erik Holmberg ◽  
Gunnar Juliusson ◽  
Hareth Nahi ◽  
Forsberg Karin ◽  
...  
Keyword(s):  
Plasma Cell ◽  
Real World ◽  
Clinical Intervention ◽  
Population Based ◽  
Plasma Cell Leukemia ◽  
Cell Leukemia ◽  
First Report ◽  
One Year ◽  
The Impact

Abstract Introduction The Swedish Myeloma Registry (SMR) is a prospective observational registry designed to document real-world management and outcomes in newly diagnosed myeloma, with the purpose to improve the quality of the management of patients in Sweden. Population-based registries may provide complementary information on the management of patients to that of clinical intervention trials. With high representation and excellent data quality we can present valuable information in a whole population and reduce the impact of selection on outcome and reduce the subsequent problem with extrapolating data from clinical intervention studies on non-study populations. Methods The registry comprises web-reported data on all patients diagnosed with myeloma, plasmocytoma, and plasma cell leukemia from 2008 in Sweden, at time of diagnosis and after one year of follow-up. Coverage is analyzed through the compulsory Swedish Cancer Registry. Survival is achieved from the Swedish Tax Agency. Missing data are actively requested. This first report contains data on patients diagnosed between 2008 and 2011 with follow-up after one year on patients with symptomatic disease 2008-2010, with a follow-up through the end of 2012. Analyses of incidence, patient characteristics at baseline, proportion of patients given intensive treatment, obtaining very good partial remission (VGPR) and overall survival (OS) were estimated. Results Clinical data at baseline was available for 2494 patients (96% coverage)and 1- year follow-up data on 1427 patients (90% of all symptomatic cases initially reported), from 70 different centers in Sweden. The age adjusted incidence was 6.5 myeloma cases per 100 000 inhabitants and year. The median age was 70 years for men, and 73 years for women (34% younger than 66 years). At diagnosis, 76% were reported as symptomatic myeloma, 18% as smouldering myeloma, 5% plasmocytoma and 1% plasma cell leukemia. IgG-myeloma was most common (59%), followed by IgA (21%), Bence-Jones (13%), non-secretory (4%), IgD and IgM both less than 1%. Among symptomatic myeloma (n=1910), 76% had osteolytic lesions or compression fractures at diagnosis. Anemia (defined as hemoglobin levels below 10 g/dl) was seen in 33%, impaired kidney function (s-creatinin levels above 173 mmol/l) in 18%, and hypercalcemia in 21% at the time of diagnosis. In patients were ISS was available, 23%, 45% and 32% were in stage I, II, and III, respectively. Previous MGUS was known in 13 % of patients. Overall, 81 % of patients 65 years or younger received autologous stem cell transplantation (ASCT) and 4% of the elderly population. In the patients aged 65 years and younger, 63% of patients received one of the newer drugs in the first year of treatment, for the patients 66 to 80 years the number was 56%, and 25% of patients above 80 years. Throughout the study period, an increase in VGPR-rate on initial treatment was observed, more pronounced in younger patients (<66 years), from 35% in 2008 to 46% in 2010. For patients >65 years, the VGPR-rate increased from 17 to 27%. After a median of follow-up time of three years, OS was 63%. There was a significant difference in absolute and relative survival between younger and older patients. In symptomatic myeloma, patients 65 years or younger had an expected 3-year survival of 76% and in patients 66 years and above it was 50% (Figure). The relative 3-year survival for patients with asymptomatic patients was 81%. Discussion SMR is an instrument for increased quality in the management of plasma cell neoplasms in Sweden. This first report from the registry shows very high coverage and good adherence to guidelines in all regions of Sweden, both in diagnostics and treatment. A great effort is made to make the SMR complete and to present population-based data on management and outcome in Sweden. Longer follow-up is needed to address the question of the impact of new treatment options on the survival. The registry gives a great opportunity to perform population-based research of high quality based on the acceptance of the registry among treating physicians. Disclosures: Turesson: Celgene Corp: Honoraria.

Real-world outcomes in patients (pts) with metastatic urothelial carcinoma (mUC) who received first- or second-line immunotherapies (IO) in the United States (US).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 457-457
Author(s):  
Marley Boyd ◽  
Srinivas Annavarapu ◽  
Gurjyot K. Doshi ◽  
Kentaro Imai ◽  
Eric Sbar ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Performance Status ◽  
The United States ◽  
Future Research ◽  
Second Line ◽  
Ecog Performance Status ◽  
Using Data ◽  
Line Of Therapy

457 Background: Benefit of IO (PD1 and PD-L1 inhibitors) for mUC was observed in clinical trials but real-world evidence for benefit and clinical outcomes is limited. Methods: This was a retrospective study of adult pts with mUC who initiated IO regardless of PD-L1 expression in the first- (1L cohort) or second-line (2L cohort) setting between 5/1/2016-1/31/2019 in the US Oncology Network (USON), a network of community oncology practices. Descriptive and Kaplan-Meier analyses to evaluate baseline characteristics, treatment patterns and clinical outcomes were conducted using data from USON’s electronic heath record. Results: Among 393 pts in the 1L cohort, median (range) age at IO initiation was 77 (42, 90+), 74% were male, 69% were White, and 19.1% and 4.1% had ECOG performance status (PS) 2 and 3/4, respectively. Among the 366 pts in the 2L cohort, median (range) age at IO initiation was 70 (29, 90+), 74% were male, 71% were White, and 19.7% and 1.4% had ECOG PS 2 and 3, respectively. Median (range) follow-up durations from IO initiation were 4.2 (0, 34.1; 1L cohort) and 4.1 (0, 31.3; 2L cohort) months (mo), during which time 43.1% (1L cohort) and 44.4% (2L cohort) of pts died. Median overall survival (OS) from IO initiation (95% confidence interval [CI]) was 10.6 (9.7, 13.2) mo for the 1L cohort and 9.4 (7.1, 11.5) mo for the 2L cohort; 1-year survival probabilities (95% CI) were 46.6% (40.1%, 52.8%; 1L cohort) and 43.4% (36.8%, 49.8%; 2L cohort). By the end of the follow-up, 48.1% of 1L pts and 47.8% of 2L pts were alive and did not advance to next line of therapy, and 13.5% of 1L and 13.4% of 2L cohort pts advanced to the next line of therapy. Median (95% CI) treatment durations were 2.6 (2.1, 2.9) and 2.8 (2.2, 3.5) mo for the 1L and 2L cohorts, respectively; 6-mo ongoing treatment probabilities (95% CI) were 26.6% (22.2%, 31.2%; 1L cohort) and 31.4% (26.4%, 36.4%; 2L cohort). Conclusions: OS of pts in the real world receiving 1L and 2L IO appears consistent with clinical trial results, although survival follow-up is limited. A minority of pts received post-IO therapy. Future research should examine influence of pt characteristics and PD-L1 expression on treatment choice and outcomes.

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