scholarly journals POS0227 SHOULD ALL PATIENTS TRIAL SUBCUTANEOUS METHOTREXATE PRIOR TO COMMENCING BIOLOGIC THERAPY – A REAL WORLD STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 333.1-333
Author(s):  
A. Mirza ◽  
M. K. Nisar
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Biologic Therapy ◽  
Economic Benefits ◽  
University Teaching ◽  
Limiting Factor ◽  
Published Data ◽  
Low Disease Activity ◽  
Oral Preparation

Background:Methotrexate (MTX) is the bed rock of inflammatory arthritis management. However intolerance is a major limiting factor for drug optimisation and retention. There is data to suggest that subcutaneous (SC) MTX is tolerated better and is now being recommended in several guidelines including ACR’s. It is less clear though whether this strategy is effective in those where oral preparation is inefficacious and its potential to avoid escalation to biologic therapy.Objectives:Our aim was to analyse the reasons for switching to SC formulation in a real world setting, clinical outcomes achieved and proportion requiring biologic prescription.Methods:We undertook a retrospective survey of all patients prescribed SC MTX in a large university teaching hospital between 1983 and Apr 2019. We had access to full patient records including details on co-morbidities, drugs and disease management. We analysed demographics, reasons for SC MTX initiation, clinical outcomes and impact on biologic prescription.Results:352 patients were identified during the study period. The mean age of the cohort was 54 yrs (3-87). 192 (70%) were women. 260 (74%) were Caucasian, 64 (18%) Asian, 21 (6%) Afro-Caribbean and remaining of other ethnicity. Two most common diagnoses were RA [n=243 (69%)] and pSpA [n=66 (18%)]. Average disease duration was 74 months (11-324) with mean of three comorbidities (0-11).284 (80%) had switched from oral to SC MTX. 137 (49%) stopped oral MTX due to side effects. Mean duration of oral MTX prior to switching was 26 months (0.25-167). Follow up period for SC MTX ranged from two to 132 months (mean 29) until the data cut-off date of Apr 2019. 103 (29%) patients progressed to biologic therapy.Amongst RA patients, DAS28 improved from mean 4.16 (0.63-8.06) to 2.83 (0.14-7.32) following the switch. pSpA cohort’s mean TJC and SJC improved from mean seven (0-42) and two (0-26) to two (0-25) and one (0-6) respectively.Conclusion:Our study confirms that SC MTX is an effective solution irrespective of whether oral MTX is inefficacious or intolerable. This applies to people with both RA and pSpA. In accordance with prior published data, our findings support the utility of SC MTX for those intolerant of enteral option. Additionally, it shows that even in instances where oral MTX was ineffective, a switch to SC formulation achieved low disease activity despite multi-morbidity, long disease course and protracted oral MTX exposure. This intervention also prevented over two-thirds of patients progressing to biologic therapy with significant financial savings. SC MTX therefore remains a durable strategy with excellent disease outcomes and confers substantial economic benefits to healthcare.Disclosure of Interests:None declared

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 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.

scholarly journals Clinical outcomes and complications following primary total elbow arthroplasty using the Latitude prosthesis

2018 ◽  
Vol 11 (5) ◽  
pp. 359-371 ◽  
Author(s):  
David Cinats ◽  
Aaron J Bois ◽  
Kevin A Hildebrand
Keyword(s):  
Range Of Motion ◽  
Clinical Outcomes ◽  
Total Elbow Arthroplasty ◽  
Published Data ◽  
Mayo Elbow Performance Score ◽  
Elbow Arthroplasty ◽  
Radiographic Outcomes ◽  
Flexion Extension ◽  
Functional Outcome Measures

Background The Latitude total elbow arthroplasty (TEA) is an implant with limited published data on its performance and outcomes. The aim of this study was to report the short-term outcomes of the Latitude TEA as well as to describe the radiographic outcomes and complications. Methods The Latitude was implanted in 20 patients (23 elbows) in a linked configuration. Patients were recalled to clinic for the assessment of their range-of-motion and compared to preoperative values. Administration of functional outcome measures was also performed. Results Mean follow-up was 4.7 years (range, 1 to 7.5 years) with four elbows requiring revision. The flexion–extension arc improved from 86.6 to 101.3 (range, 76 to 126) postoperatively (p = 0.04). The average Disabilities of the Arm, Shoulder, and Hand score was 28.1 (range, 5.8 to 50.4) and the average Mayo Elbow Performance Score was 89.6 (range, 76 to 100), with 83% of elbows scoring in the good or excellent range. Radiolucencies were detected in 60% of patients and 31% of these lucencies progressed in size at the time of follow-up. Conclusions The Latitude prosthesis provides patients with favorable clinical outcomes with improvements in their range-of-motion and a complication rate comparable to other elbow arthroplasty implants.

scholarly journals Economic Burden of Hospitalizations for Patients with Newly Diagnosed Acute Myeloid Leukemia in Remission in the United States: Retrospective Analysis of an Administrative Claims Database

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4976-4976
Author(s):  
Clara Chen ◽  
Eros Papademetriou ◽  
Zephirin Kiendrebeogo ◽  
Ravi Potluri
Keyword(s):  
Real World ◽  
Myeloid Leukemia ◽  
Healthcare Resource ◽  
Economic Benefits ◽  
Healthcare Resource Utilization ◽  
Newly Diagnosed ◽  
Systemic Induction ◽  
Claims Database ◽  
Acute Myeloid

Abstract INTRODUCTION : Managing patients with acute myeloid leukemia (AML) requires extensive healthcare resource utilization and costs; hospitalization is the largest component of medical costs for AML. In the phase 3 QUAZAR AML-001 trial, oral azacitidine (Oral-AZA [CC-486]) was associated with significant improvements in overall survival and relapse-free survival (RFS) vs. placebo (Wei, 2020). Prolonged RFS with Oral-AZA may translate into substantial economic benefits, with lower hospitalization-related costs due to reduced rates of hospitalization and days in hospital (Oliva, ASH 2020). Real-world economic benefits of prolonged remission remain insufficiently studied. OBJECTIVE: This study aimed to examine the economic burden of hospitalizations among patients with newly diagnosed AML in remission from a retrospective analysis of real-world data from a US claims database. METHODS: Using a retrospective cohort design, adult patients were selected from the IBM MarketScan TM Commercial and Medicare Supplemental Databases, with ≥2 outpatient claims or 1 inpatient claim with a primary International Classification of Disease 9th/10th Revision (ICD-9/ICD-10) code for AML between July 1, 2012, and September 30, 2019. Patients were required to have 1) at least 6 months of continuous enrollment, with pharmacy benefits, prior to diagnosis, 2) received systemic induction therapy as first-line (1L) therapy for AML on or after the index diagnosis date, and 3) attained remission from 1L systemic therapy. Patients were followed from remission after systemic induction therapy, with or without consolidation, until the end of the follow-up period. Eligible patients were organized into cohorts based on their duration of remission (DOR): Cohort A included patients with < median DOR and Cohort B had patients with ≥ median DOR. Hospitalization incidence and duration during the follow-up period were calculated using a per-patient per-year (PPPY) metric. Hospitalization-related costs were compared using a generalized linear model (GLM) with gamma distribution and log-link function. Generalized estimating equations (GEE) clustered on the patient were used to compare incidence and duration of hospitalizations. All costs were adjusted for inflation and reported in 2019 US dollars (USD). RESULTS: In all, 693 patients met all selection criteria and were assessed for DOR. The median DOR for all patients was 167 days; cohorts A and B included 346 and 347 patients, respectively, with median times from remission to end of follow-up of 106.5 and 460 days. Baseline characteristics were comparable between cohorts; mean [SD] age was 55.1 [14.4] years, 49.4% of patients were male, and mean [SD] Charlson comorbidity index [CCI] was 0.8 [1.2]. The PPPY number of hospitalizations was higher in Cohort A than in Cohort B (4.56 vs 2.09, respectively), as was the PPPY total length of hospital stay (51.1 vs 19.7 days). The PPPY hospitalization-related costs were $345,728 in Cohort A and $125,018 in Cohort B; the cumulative hospitalization cost per patient was $148,430 higher in Cohort A at 12 months and $177,500 higher at 18 months (Figure). Multivariate GEE and GLM models with adjustment for patient characteristic covariates (eg, age, sex, CCI) identified prolonged remission was significantly associated with reduced number, duration, and cost of hospitalization (P < 0.001, all comparisons). CONCLUSIONS: In a real-world setting, prolonged AML remission was associated with significantly lower rates and durations of hospitalization, which were estimated to result in substantial cumulative cost savings. These data underscore the importance of active maintenance therapies that delay relapse for patients with AML. While the costs of long-term therapy face increasing scrutiny, these costs should be weighed relative to the potential economic benefit of prolonged remission and reduced burden of healthcare resource utilization. Figure 1 Figure 1. Disclosures Chen: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Papademetriou: SmartAnalyst Inc.: Current Employment. Potluri: Bristol Myers Squibb: Consultancy.

scholarly journals P002 Real-world experiences of biologic tapering

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Zoe Rutter-locher ◽  
Yik Long Man ◽  
Lydia Marsh ◽  
Scott Mercer ◽  
Bina Menon ◽  
...  
Keyword(s):  
Real World ◽  
Biologic Therapy ◽  
Small Sample Size ◽  
Significant Proportion ◽  
Small Sample ◽  
Patient Choice ◽  
Treat To Target ◽  
Improvement Project ◽  
Real World Setting

Abstract Background/Aims  Biologic therapy and treat to target have significantly improved patient outcomes and we now have a proportion of patients on biologic therapy who remain in clinical remission. NICE guidance suggests “cautiously reducing drug doses or stopping drugs in those who have maintained the treatment target”. Despite this guidance, little is known about current clinical practice of biologic tapering in UK rheumatology centres. We aimed to illustrate current practice and success rates in biologic tapering in a real-world setting in patients with rheumatoid arthritis (RA), psoriatic arthritis (PSA) and ankylosing spondylitis (AS). Methods  We identified patients who were potentially suitable for biologic tapering 1 week prior to their follow up appointment using the following criteria - any anti-TNFα biologic ≥ 1 year, RA patients (DAS28 CRP<3.2, CRP normal), PSA patients (no swollen joints, CRP normal, no extra-articular manifestations), AS patients (BASDAI<4, CRP normal). We then analysed how many patients were successfully tapered at one year. Tapering schedule was decided by the supervising rheumatologist. Results  From December 2018 to February 2019, 66 patients were identified as being suitable for biologic tapering. 3 patients did not attend and were excluded from further analysis. Tapered group: 20 (32%) patients were tapered. Based on the retrospective review of clinic letters, the “tapering schedule” was inconsistent and the information provided to patients if they flared was also inconsistent - 9 (45%) patients were advised to return to their normal dose and only 1 (5%) patient was advised to contact the helpline. After 12 months of follow up, 11 (55%) patients remained on the tapered dose, 7 (35%) patients returned to their prior dose and 2 (10%) patients were lost to follow up. Non-tapered group: 43 (68%) patients were not tapered. The reasons for not tapering were divided into 6 broad categories: active disease (n = 15, 35%), patient choice (n = 5, 12%), DMARD was tapered instead (n = 5, 12%), discuss at next visit (n = 3, 7%), reason not mentioned (n = 12, 28%), other (n = 3, 7%) Conclusion  This Quality Improvement Project has highlighted the inconsistencies in biologic tapering in a UK real-world setting. In response to this inconsistency, we have developed a departmental guideline which provides stringent criteria to identify patients at lowest risk of flaring and standardises a tapering schedule and clinical pathway. We also created a patient information leaflet that could be distributed. Only half of the patients remained on the tapered dose after 1 year, suggesting a significant proportion of patients flare following dose reduction. However, our findings may be limited by small sample size. National guidance and a thorough audit based on this guidance is welcomed. Disclosure  Z. Rutter-locher: None. Y. Long Man: None. L. Marsh: None. S. Mercer: None. B. Menon: None. A. Cope: None.

scholarly journals Real-World Treatment Results for Ruptured Blood-blister Aneurysm of the Internal Carotid Artery: Analysis of a Japanese Nationwide Multi-Center Study

2021 ◽  
Author(s):  
Yusuke Egashira ◽  
Yukiko Enomoto ◽  
Noriyuki Nakayama ◽  
Miki Fujimura ◽  
Yuichiro Kikkawa ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Internal Carotid Artery ◽  
Endovascular Treatment ◽  
Clinical Outcomes ◽  
Real World ◽  
Internal Carotid ◽  
Treatment Results ◽  
Reconstructive Procedures ◽  
The Real

Abstract Objective. Ruptured blood-blister aneurysm (BBA) of the internal carotid artery (ICA) remains a challenging lesion, even in the age of modern neurosurgery and endovascular treatment. This retrospective multicenter study aimed to investigate the real-world treatment choice and treatment results.Methods. We included 182 ruptured BBAs of the ICA treated at 51 neurosurgical centers in Japan between 2013 and 2017. The baseline patient characteristics, radiological features of the aneurysm, treatment modality, details of treatment, complications of treatment, treatment results were retrospectively collected. The treatment strategy was divided into deconstructive and reconstructive procedures. Primary clinical outcomes were evaluated using the modified Rankin Scale (mRS) at final follow-up.Results. Direct surgery was performed in 144 (79%) cases, and the remaining 38 (21%) cases received endovascular treatment. The majority of treatment selections were deconstructive and reconstructive procedures in the direct surgery group and endovascular treatment group, respectively. Overall, favorable clinical outcomes (mRS 0 to 2) were achieved in 66% of cases, and the mortality rate was 15% at the final follow-up (mean 23 months). There was no significant difference in clinical outcome between direct and endovascular treatment groups. Conclusion. Our large nationwide study compared the real-world treatment options for ruptured BBAs and their results. Our findings may offer beneficial information for treatment decision and for future studies investigating ruptured BBAs.

Axitinib and avelumab (AA) as first-line treatment of metastatic renal cell carcinoma (mRCC): A real-world outcome review in the Northwest of England, United Kingdom.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 294-294
Author(s):  
Jennifer Allison ◽  
Natalie Charnley ◽  
Robert Stevenson ◽  
Tom Waddell ◽  
Manon Rhys Pillai
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Kinase Inhibitor ◽  
Checkpoint Inhibitor ◽  
Risk Scores ◽  
Published Data ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

294 Background: The combination of the immune checkpoint inhibitor avelumab and VEGF-targeted, antiangiogenic tyrosine kinase inhibitor axitinib (AA) has demonstrated superior PFS and ORR compared to sunitinib in patients with mRCC and is an option for first line treatment across all IMDC risk scores. In this retrospective review we report our real world experience of this combination in three cancer centres in the Northwest of England. Methods: Treatment naïve mRCC patients receiving AA through the Early Access to Medicine Scheme at 3 cancer sites in the UK between May 2019 and July 2020 were identified. Primary outcomes of interest include overall response rate (ORR), adverse events (AEs) and preliminary survival observations. Results: A total of 44 patients were identified with a median follow up of 6.9 months (0.8-13.5 mo). Median age was 68 (48-81); 68% were male. The patients’ adult comorbidity evaluation score (ACE-27) was calculated: 0 = 43%, 1 = 30%, 2 = 7% and 3 = 20% . 45%, 48% and 7% of patients had favourable (F), intermediate (I) and poor (P) IMDC risk scores respectively. All had clear cell histology with 16% demonstrating sarcomatoid change. Most patients had undergone a nephrectomy (70%) and 36% had a single organ site of metastatic disease. ORR in the whole cohort was 60% (CR 5%, PR 55%, SD 25%, PD 2%, NE 13 %). Median time to first response was 2.6 months (0.6- 8.2mo). At time of data cut-off, 64% of patients remain on treatment (80% F, 48% I and 67% P). 14% of patients discontinued treatment due to disease progression while 22% stopped due to toxicity. The majority of patients (68%) continued axitinib at the starting dose of 5mg BD. Dose escalation of axitinib was possible in 9% patients while 23% needed a dose reduction due to toxicities. AEs were observed in 36 (82%) patients (G3 36%); the commonest being mucositis 30%; hypertension 23% (G3 11%); fatigue 25%; thyroid dysfunction 18%; diarrhoea 20% (G3 5%); hepatitis 20% (G3 11%). 9% of patients experienced an infusion reaction to avelumab. Overall, 9 (20%) patients received steroids for suspected immune related adverse events (irAEs); 6 (14%) were managed as G3≤ irAEs. 9 (20%) patients required inpatient admission due to AEs; 5 (11%) were associated with irAEs. Of the patients who discontinued AA treatment, 50% received subsequent therapy (12.5%, 75% and 12.5% receiving combination checkpoint inhibitor therapy, other VEFG TKi and TKi/MTOR combination respectively). 4 patients remain on active surveillance with no evidence of progression. Conclusions: Our early experience of AA in this real world setting reports comparable clinical responses to the published data. Treatment is well tolerated, with lower than expected levels of G3 or above AEs which is reassuring in a non-trial selected population. Follow-up is ongoing and updated efficacy and safety outcomes will be presented.

Abstract 2538: Long-Term (up to 6 years) Clinical Outcomes of Patients with Impact of Chronic Kidney Disease in the Treated with Drug-eluting Stents. Insights from the Drug Eluting Stents In the REal World(DESIRE) Registry

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Adriana Moreira ◽  
Amanda Sousa ◽  
José Costa ◽  
Ricardo Costa ◽  
Manuel Cano ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Outcomes ◽  
Real World ◽  
Negative Impact ◽  
Chronic Renal Disease ◽  
Drug Eluting Stents ◽  
Group I ◽  
Drug Eluting

Background: Chronic renal disease has been consistently shown to be an independent predictor of poorer long-term clinical outcomes after percutaneous treatment of coronary artery disease, even in DES era. We sought to evaluate the very long-term clinical outcome after DES implantation in this high risk subset in a real world cenario. Methods and Results: Between May/2002 and Jan/2007, 2,043 pts treated exclusively with DES were consecutively enrolled in the non-randomized, single-center DESIRE Registry. Recent myocardial infarction (72h), saphenous venous graft and patients with < 6months follow-up were excluded. The remaining pts (n=1500) were divided into 2 groups according to their creatinine clearence: Group I -Clearance ≤ 60 (n= 490) and Group II- clearance >60 (n= 1010). Primary endpoint included combined MACE and stent thrombosis (ST) rate. ST was classified according to ARC definitions. Clinical follow-up was obtained at 1, 3 and 6 months and then annually up to 6 years. Follow-up was achieved in 98% of the eligible cohort (median 3.6 years). Baseline characteristics and late outcomes are displayed in the table . Conclusions: In the DESIRE registry the negative impact of renal dysfunction was considerably minimized by the use of DES, resulting in very low and equivalent rates of myocardial infarction, TLR and ST when compared to patients with preserved renal condition. We especulate that the higher mortality among these very complex pts may reflect the severity of their comorbities.

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