Outcomes of second targeted therapy in metastatic renal carcinoma: A retrospective chart review in the EU.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 558-558
Author(s):  
Daniel Yick Chin Heng ◽  
Jinhee Park ◽  
James E. Signorovitch ◽  
Hongbo Yang ◽  
Jinlin Song ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Chart Review ◽  
Data Entry ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Eligibility Criteria ◽  
Kaplan Meier ◽  
The Uk ◽  
Sites Of Metastases ◽  
The Eu

558 Background: This study describes the real-world outcomes of metastatic renal cell carcinoma (mRCC) patients treated with everolimus (EVE), sorafenib (SOR), and axitinib (AXI) as 2nd targeted therapy in the UK, Germany, and France. Methods: A retrospective chart review was conducted among oncologists and urologists in the UK, Germany and France. Charts were reviewed for adult mRCC patients satisfying the following eligibility criteria: 1) experienced disease progression on 1st targeted therapy with sunitinib or pazopanib; 2) initiated 2nd targeted therapy with EVE, AXI, or SOR between 10/2012 and 6/2013. Kaplan-Meier analysis was used to estimate overall survival (OS) after initiation of 2nd targeted therapy among all patients and stratified by type of 2nd targeted therapy. Results: A total of 281 charts were reviewed, with 99, 91, and 91 mRCC patients receiving EVE, AXI, and SOR as 2nd targeted therapy, respectively. Mean age was 60.6 years old at initial mRCC diagnosis and 65.5% were male. The majority of patients used sunitinib (79.4%), with the rest using pazopanib (20.6%) as 1st targeted therapy. Median duration of 1st targeted therapy was 9.7 months. At the initiation of 2nd targeted therapy, 91.8% of patients had an ECOG score ≤ 2. The most common sites of metastases were lung (71.2%), bone (53.0%), and lymph nodes (47.0%). Median OS from the initiation of 2nd targeted therapy among all patients was 21.8 months (95% CI: 16.5-26.2). The median OS was 23.0, 23.5, and 18.7 for EVE, AXI, and SOR respectively. The majority of patients (87.5%) initiated 2nd targeted therapy on the recommended dose. Patients receiving AXI had a higher rate of dose increase (13.2%), compared to EVE (1.0%) and SOR (0.0%), while patients on EVE had a higher rate of dose decrease (12.1%), compared to AXI (5.5%) and SOR (8.8%). Conclusions: In this retrospective chart review study of several EU countries, the observed median OS was numerically comparable for EVE and AXI, but rates of dose adjustment differed by treatments. Retrospective chart reviews may be subject to selection bias and errors in data entry, and further analysis is underway to address confounding effects of unobserved patient characteristics.

P3674Patient characteristics and treatment patterns in the multicentre, retrospective chart review of first-time Opsumit (macitentan) users in the United States (OrPHeUS)

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V McLaughlin ◽  
R Channick ◽  
K Chin ◽  
P Leary ◽  
C Miller ◽  
...  
Keyword(s):  
Chart Review ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Exposure Period ◽  
The United States ◽  
Treatment Patterns ◽  
Functional Class ◽  
Kaplan Meier ◽  
Real World Evidence

Abstract Introduction The OPsumit® Historical USers cohort (OrPHeUS) is a multicentre, US, retrospective medical chart review conducted to supplement the OPsumit® USers (OPUS) Registry to fulfil the FDA request to characterise the safety of macitentan in clinical practice. Purpose To describe patient characteristics, treatment patterns, hepatic safety and survival in patients with pulmonary hypertension (PH) newly treated with macitentan. Methods OrPHeUS (NCT03197688) aimed to include 2200 new users of macitentan, between October 2013 and March 2017, who were not enrolled in OPUS. Here we present patients with follow-up data, including characteristics and treatment patterns at macitentan initiation, hepatic adverse events (HAEs) identified using preferred terms in chart entries and pharmacovigilance reporting, hospitalisations and survival. Results OrPHeUS included 2982 patients newly treated with macitentan and with follow-up data; the reason for macitentan prescription was pulmonary arterial hypertension (PAH) in 2362 (79.3%) patients, other PH aetiologies in 612 (20.6%) patients and 8 patients with other/unknown reasons. At macitentan initiation, the median (Q1, Q3) age of the patients was 62 (51, 72) years and 73.9% were female. WHO functional class (FC) was documented in 654 (21.9%) patients, 35.6% of patients were in FC I/II and 64.4% in FC III/IV; median (Q1, Q3) 6-minute walk distance, documented in 411 (13.8%) patients, was 293 (200, 383) metres. At macitentan initiation, 41.5% (n=1239) of patients were not receiving PAH therapy, 46.3% (n=1382) were already receiving one PAH therapy and 11.9% (n=356) were already receiving two PAH therapies. The median (Q1, Q3) exposure to macitentan was 14.9 (5.6, 27.1) months; 57% and 43% of patients had exposures of >12 and >18 months. During the exposure period, 933 (31.3%) patients discontinued treatment, including 474 (15.9%) patients who discontinued due to an adverse event (AE), 6 (0.2%) due to a HAE, 449 (15.1%) for reasons other than an AE/HAE, and 4 (0.1%) for unknown reasons. There were 275 (9.2%) patients who experienced ≥1 HAE (incidence rate [IR]: 0.07 [95% CI, 0.06, 0.08] per 1 person-year); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN) were experienced by 113 (3.8%) patients (IR: 0.028 [95% CI, 0.023, 0.033] per 1 person-year); ALT/AST ≥x3 ULN and bilirubin ≥2x ULN was experienced by 33 (1.1%) patients (IR: 0.008 [95% CI, 0.006, 0.011] per 1 person-year). There were 1148 (38.5%) patients who experienced at least one hospitalisation (IR: 0.36 [95% CI, 0.34, 0.39] per 1 person-year). The 12-month Kaplan-Meier survival estimate was 92% (95% CI, 91, 93). Conclusion OrPHeUS provides additional real-world evidence in patients newly treated with macitentan, confirming the hepatic safety profile of macitentan. Acknowledgement/Funding Actelion Pharmaceuticals Ltd

Patient characteristics and outcomes of an interdisciplinary menopause clinic: a retrospective chart review

Maturitas ◽  
2015 ◽  
Vol 81 (1) ◽  
pp. 178-179
Author(s):  
Beate C. Sydora ◽  
Nicole Veltri ◽  
Christoph P. Sydora ◽  
Justin Marillier ◽  
Lori Battochio ◽  
...  
Keyword(s):  
Chart Review ◽  
Retrospective Chart Review ◽  
Patient Characteristics

Outcomes in AML patients receiving HMA + venetoclax combination with prior HMA exposure.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19011-e19011
Author(s):  
Bakos Keegan Jonathan ◽  
Dena Blanding ◽  
Christopher Andrew Rangel ◽  
Sarah Pasyar ◽  
Elizabeth Goodwin Hill ◽  
...  
Keyword(s):  
Overall Survival ◽  
Tp53 Mutation ◽  
Clinical Laboratory ◽  
Retrospective Chart Review ◽  
Progression Free Survival ◽  
Poor Response ◽  
Patient Characteristics ◽  
Entire Cohort ◽  
Kaplan Meier ◽  
Poor Outcomes

e19011 Background: Venetoclax (Ven) is a BCL-2 inhibitor approved in combination with hypomethylating agents (HMAs) in newly diagnosed AML patients who are not candidates for intensive induction based on impressive response rates (CR+CRi of 66.4%) and median overall survival (14.7 months) compared to HMA therapy alone (DiNardo CD, NEJM, 2020). Ven was also used in combination with 10 days of a HMA (Decitabine) in a phase II study. In the subgroup of patients with relapsed AML, some of which previously received HMA, the ORR, CR+CRi, and median OS were 62%, 42%, and 7.8 months respectively. (DiNardo CD, Lancet, 2020). To our knowledge there are no studies specifically looking at patients with AML receiving HMA + Ven with previous exposure to a HMA agent. Methods: We conducted a single center retrospective study of AML patients who received HMA + Ven therapy after previously receiving a HMA agent. Baseline demographic, clinical, laboratory, pathology, and outcomes data were collected by retrospective chart review. Response criteria was determined by 2017 ELN recommendations. Kaplan Meier was constructed to summarize time to event data. Results: A total of 17 patients were identified that met these criteria. 7 patients (41%) had progressed on prior HMA treatment, 11 patients (65%) received prior intensive chemotherapy, and 5 patients (29%) received previous Allogenic SCT prior to HMA+Ven therapy. 10 patients (59%) had either a TP53 mutation or 17p deletion and 11 patients (65%) had complex cytogenetics (≥ 3 cytogenetic abnormalities). Other patient characteristics are included in table below. For the entire cohort, the ORR (CR, CRi, PR) was 41% and the CR/CRi rate was 6%; The ORR in the following subgroups for previous HMA failure, TP53 mutation/17p deletion, and complex cytogenetics were 14%, 30%, and 36% respectively. The median Progression free survival and overall survival for the entire cohort was 2 months (1-4 months 95% CI) and 3 months (1-5 months, 95% CI) respectively. 15 patients (88%) were deceased and all deaths were attributed to AML (12/15) or infection (3/15). None of the patients went on to receive an Allogenic SCT. Conclusions: Although a limited sample size which includes many patients with a TP53/17p aberration, complex cytogenetics, Allogenic SCT relapse, and/or heavily pre-treated AML, this data describes poor outcomes in patients receiving HMA+Ven after previous HMA exposure. Patients with previous HMA failure in particular had a poor response rate. None of the patients received 10 day decitabine and it is unclear if this had any effect on the results. It would be beneficial to supplement this data with experience from multiple centers. Patient Characteristics (N = 17).[Table: see text]

scholarly journals P047: Emergency department practice patterns of UTI investigation among the delirious elderly: a retrospective chart review

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S81-S81
Author(s):  
R. Pinnell ◽  
P. Joo
Keyword(s):  
Emergency Department ◽  
Elderly Patients ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Urinary Symptoms ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Indwelling Catheter ◽  
Exact Test

Introduction: Delirium is a common emergency department (ED) presentation in elderly patients. Urinary tract infection (UTI) investigation and treatment are often initiated in delirious patients in the absence of specific urinary symptoms, despite a paucity of evidence to support this practice. The purpose of this study is to describe the prevalence of UTI investigation, diagnosis and treatment in delirious elderly patients in the ED. Methods: We performed a retrospective chart review of elderly patients presenting to the ED at The Ottawa Hospital between January 15-July 30, 2018 with a chief complaint of confusion or similar. Exclusion criteria were pre-existing and current UTI diagnosis, Glasgow Coma Scale <13, current indwelling catheter or nephrostomy tube, transfers between hospitals, and leaving without being seen. The primary outcome was the proportion of patients for whom urine tests (urinalysis or culture) or antibiotic treatment were ordered. Secondary outcomes were associations between patient characteristics, rates of UTI investigation, and patient outcomes. Descriptive values were reported as proportions with exact binomial confidence intervals for categorical variables and means with standard deviations for continuous variables. Comparisons were conducted with Fischer's exact test for categorical variables and t-tests for continuous variables. Results: After analysis of 1039 encounters with 961 distinct patients, 499 encounters were included. Urine tests were conducted in 324 patients (64.9% [60.6-69.1]) and antibiotics were prescribed to 176 (35.2% [31.1-39.6]). Overall 57 patients (11.4% [8.8-14.5]) were diagnosed with UTI, of which only 12 (21.1% [11.4-33.9]) had any specific urinary symptom. For those patients who had no urinary symptoms or other obvious indication for antibiotics (n = 342), 199 (58.2% [52.8-63.5]) received urine tests and 62 (18.1% [14.2-22.6]) received antibiotics. Patients who received urine tests were older (82.4 ± 8.8 vs. 78.3 ± 8.4 years, p < 0.001) but did not differ in sex distribution from those than those who did not. Additionally, patients who received antibiotics were more likely to be admitted (OR = 2.6 [1.48-4.73]) and had higher mortality at 30 days (OR = 4.2 [1.35-12.91]) and 6 months (OR = 3.2 [1.33-7.84]) than those who did not. Conclusion: Delirious patient without urinary symptoms in the ED were frequently investigated and treated for UTI despite a lack of evidence regarding whether this practice is beneficial.

Darbepoetin alfa Maintains Hemoglobin Levels in Patients with Myelodysplastic Syndromes (MDS) after Therapeutic Interchange from Epoetin alfa: Results of a Retrospective Chart Review.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4708-4708 ◽  
Author(s):  
Jeffrey Patton ◽  
Yong Mun ◽  
Joel Wallace
Keyword(s):  
Darbepoetin Alfa ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Epoetin Alfa ◽  
Minor Response ◽  
Therapeutic Substitution ◽  
Kaplan Meier ◽  
Major Response ◽  
A Minor ◽  
The Impact

Abstract Patients with MDS often receive erythropoietic therapy for the treatment of anemia resulting from the disease. This retrospective chart review examined the impact of switching patients from their current dosing regimens of epoetin alfa (Procrit®) to darbepoetin alfa (Aranesp®) 200 mcg every two weeks (Q2W) following the implementation of therapeutic substitution guidelines in September 2003. Key eligibility criteria included: ≥ 18 years old with a diagnosis of MDS, and treatment with epoetin alfa therapy between May 2003 and January 2004. Patients receiving epoetin alfa therapy were either switched to darbepoetin alfa, or allowed to remain on epoetin alfa, depending on whether their treating physician had adopted therapeutic substitution guidelines. To ensure full characterization of the patient population, in the 16 weeks prior to the time of the therapeutic substitution, detailed demographic and disease characteristics were collected, in addition to dose requirements, transfusion status and hemoglobin profiles. To assess the impact on clinical outcomes, data were collected for 16 weeks after the therapeutic substitution guidelines were implemented (defined as the treatment period). Patients identified in the chart review who received at least one dose of study drug during both time periods were included in the analysis. Response was defined according to the international working group on MDS definitions (Cheson et al., Blood, 2000; 96(12):3671–4). Kaplan-Meier estimates (95% CL) for the percentage of patients with a major response (hemoglobin [Hb] change ≥ 2 g/dL over baseline or transfusion independence) or a minor response (Hb increase ≥ 1 g/dL to < 2 g/dL or a 50% reduction in transfusion requirements) during the treatment period were calculated. Data were abstracted from 142 patient charts, 112 (62 darbepoetin alfa; 50 epoetin alfa) of whom had confirmatory evidence of MDS available in their records (a documented bone marrow biopsy, French-American-British [FAB] classification, or karyotype [confirmed MDS population]). Baseline demographics for the confirmed MDS population were similar between the two cohorts. For those patients with data available, the majority had a FAB classification of refractory anemia with ≤ 5% bone marrow blasts. Mean baseline Hb was 11.0 g/dL for the darbepoetin alfa cohort (n=61) and 11.3 g/dL for the epoetin alfa cohort (n=48). The Kaplan-Meier percentage (95% CL) of patients with a major response was 27% (15, 39) for the darbepoetin alfa cohort and 19% (7, 30) for the epoetin alfa cohort; a minor response was noted for 46% (33, 59) and 47% (31, 63) of patients in the darbepoetin alfa and epoetin alfa cohorts, respectively. The Kaplan-Meier (95% CL) proportion of patients receiving red blood cell transfusions was similar between the groups: 8% (1, 15) for the darbepoetin alfa cohort and 12% (3, 22) for the epoetin alfa cohort. This study indicates that darbepoetin alfa achieved comparable clinical outcomes with epoetin alfa for the treatment of anemia in patients with confirmed MDS.

scholarly journals The Low Fresh Gas Flow Anesthesia and Hypothermia in Neonates Undergoing Digestive Surgeries: A Retrospective Before-After Study

2020 ◽  
Author(s):  
Yu Cui ◽  
Yu Wang ◽  
Rong Cao ◽  
Gen Li ◽  
Lingmei Deng ◽  
...  
Keyword(s):  
Gas Flow ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Surgical Time ◽  
Eligibility Criteria ◽  
Mean Body Temperature ◽  
Digestive Surgery ◽  
Intraoperative Hypothermia

Abstract Background Based on the previous investigation in our institution, the incidence of intraoperative hypothermia in neonates was high. Since September 1st, 2019, the recommendation had been launched to utilize ≤ 1 L/min fresh gas flow during the neonates’ surgical procedure. We therefore intended to evaluate the association between low fresh gas flow anesthesia and the occurrence of hypothermia in neonates undergoing digestive surgeries.Methods A retrospective chart review, before-after study was conducted for neonates who underwent digestive surgeries. The primary outcomes were the incidence of hypothermia. The secondary outcomes included hospital mortality, the value of lowest temperature, blood loss, mean body temperature during the surgery, the length of hypothermia during the surgery and postoperative hospital length-of- stay (PLOS).Results 249 neonates fulfilled the eligibility criteria. The overall incidence of intraoperative hypothermia was 81.9%. The low fresh gas flow anesthesia significantly reduced the odds of hypothermia [routine group: 149 (87.6%) versus low group: 55 (69.6); p ༜ 0.01]. Moreover, the low fresh gas flow anesthesia could reduce the length of hypothermia [routine group: 104 (50, 156) versus low group: 30 (0,100); p ༜ 0.01], as well as elevate the value of lowest temperature for neonates [routine group: 35.1 (34.5, 35.7) versus low group: 35.7(35.3, 36); p ༜ 0.01]. After adjustment for confounding, low fresh gas flow anesthesia and the length of surgical time were independently associated with intraoperative hypothermia.Conclusions Low fresh gas flow anesthesia is an effective way to alleviate hypothermia in neonates undergoing open digestive surgery.

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