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

Minimally Invasive Scoliosis Correction in Parkinson Disease: Retrospective Case Series

2020 ◽  
Author(s):  
Ravi S Nunna ◽  
Richard G Fessler
Keyword(s):  
Minimally Invasive ◽  
Parkinson Disease ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
The United States ◽  
Invasive Technique ◽  
Radiographic Findings ◽  
Presenting Symptoms ◽  
Scoliosis Correction

Abstract BACKGROUND Parkinson disease (PD) is the second most common neurodegenerative disease in the United States. In the context of the disability inherent to PD, the additional physical challenges and pain from scoliosis can be debilitating for these patients. However, the magnitude of surgery required to correct the deformity combined with the medical co-morbidities and frailty in this population of patients makes surgery very risky. OBJECTIVE To investigate clinical presentations and outcomes of patients with PD that underwent minimally invasive long-segment fusion for scoliosis correction. METHODS A retrospective chart review was performed over the years 2007 to 2017 for patients diagnosed with PD undergoing long-segment spinal fusion (5 or more levels) with the use of circumferential minimally invasive spine surgery techniques. Data including age, sex, race, medical co-morbidities, presenting symptoms, radiographic findings, surgical procedure, case history, and complications were collected from the medical record. RESULTS Retrospective chart review revealed three patients that met the inclusion criteria. They included 2 males and 1 female, with a mean age of 68.7 yr (range 63-75 yr). Ability to maintain upright posture, return to activities of daily living, and visual analog scale (VAS)-back improved in all patients at 1-yr follow-up. Results were durable at 2-yr follow-up. No medical complications were observed. CONCLUSION The generally positive results suggest that minimally invasive technique could have significant benefits in this high-risk group of patients.

Treatment patterns and outcomes among patients with microsatellite stable (MSS) advanced endometrial cancer in the United States: Endometrial Cancer Health Outcomes (ECHO) retrospective chart review Study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5581-5581
Author(s):  
Shelby Corman ◽  
Sneha Kelkar ◽  
Shardul Odak ◽  
Jingchuan Zhang ◽  
Vimalanand S. Prabhu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
The United States ◽  
Treatment Patterns ◽  
First Line ◽  
Line Therapy ◽  
The Us ◽  
Review Study

5581 Background: Traditional platinum-based systemic chemotherapy continue to be the SOC for aEC in the first line. Phase 2 clinical trials of chemotherapy (GOG 129 series) and some targeted therapies (229 series) for second line advanced endometrial cancer (aEC) have proved disappointing. Recently the treatment landscape for aEC patients has significantly changed with newer targeted therapies focusing on the microsatellite instability (MSI) status of endometrial tumors. The objective of the ECHO study was to describe real-world treatment patterns and outcomes in non-MSI-high or DNA mismatch repair proficient (pMMR) aEC patients in clinical practice in the United States (US) prior to 2019. Methods: The ECHO study is a multicenter, retrospective chart review study in women diagnosed with aEC in the US. Data were obtained from medical records of adult women (≥18 years) diagnosed with advanced or inoperable aEC (stages III or IV) with known MSI status, who had received at least one prior systemic therapy and progressed between July 1, 2016 – June 30, 2019. De-identified patient data extracted by treating oncologists included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed to estimate real-world progression-free survival (rwPFS) and overall survival (OS). Results: A total of 124 non-MSI-high or pMMR aEC patients who had progression following first line therapy were included in this interim analysis. Average age was 63 years, 62.9% White/Caucasian, 16.9% Hispanic/Latino, and 86% had ECOG ≤1. Metastases were observed in 70% of patients at diagnosis, with the most common metastatic sites being lung (47.6%), liver (32.3%), and distant lymph nodes (29%). As 2nd line therapy, 69% of patients received mono or combination chemotherapy (primarily with doxorubicin), 13% hormonal therapy, and 18% targeted therapy ± chemotherapy. Median duration of 2nd line therapy was 4 months. The majority (86.3%) discontinued 2nd line therapy, with disease progression the most common reason (66.4%). A quarter (26.6%) of patients initiated an additional line of therapy. Median rwPFS from initiation of 2nd line therapy was 5 months (95% confidence interval [CI]: 4-9). Median OS from initiation of 2nd line therapy was 12 months (95%CI: 9-18). Estimated OS rates from initiation of 2nd line therapy at 6, 12, and 24 months were 66%, 47%, and 30%, respectively. Conclusions: In this retrospective, chart review study, patients with non-MSI-high/pMMR aEC in the US who failed at least one systemic therapy had poor prognosis on subsequent therapies. There continues to be a significant unmet need in this group of women. Novel therapies are needed that delay progression and/or improve overall survival and further research is indicated to explore this.

Treatment patterns among patients with advanced/recurrent endometrial cancer in the United States.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 291-291
Author(s):  
Jinan Liu ◽  
Eric M Maiese ◽  
Bruno Émond ◽  
Marie-Hélène Lafeuille ◽  
Patrick Lefebvre ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Treatment Options ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
First Line ◽  
Kaplan Meier ◽  
The Us ◽  
Recurrent Endometrial Cancer ◽  
Third Line

291 Background: Among patients (pts) with endometrial cancer (EC), response rates for platinum-based regimens in the first-line (1L) setting range from 40% to 62% in clinical trials. This study describes patient characteristics, treatment patterns, time to next treatment (TTNT), and overall survival (OS) among pts with advanced/recurrent EC treated with a platinum-based regimen in a real-world setting in the US. Methods: This retrospective study used Optum Clinformatics Extended Data Mart de-identified databases from January 1, 2007, to December 31, 2019. Adult pts with advanced/recurrent EC who initiated a 1L platinum-based regimen and subsequently initiated second-line (2L) antineoplastic therapy were identified. Prior to initiation of 1L, a 12-month washout period of continuous enrollment without use of antineoplastic agents (except hormonal agents) was imposed. Kaplan-Meier (KM) rates were used to report TTNT and OS from 2L, third line (3L), and fourth line (4L), separately. Results: A total of 1878 pts with advanced/recurrent EC initiated 2L therapy following a platinum-based regimen in 1L. Among them, 739 (39.4%) pts initiated 3L and 330 (17.6%) initiated 4L or later (4L+) therapy. Median pt age was 68.0 years. More pts received platinum-based regimens (56.4%) in 2L than other options (Table). Few pts (3.3%) received immunotherapy. Among pts receiving 3L, a similar percentage of pts were treated with platinum-based (33.2%) and other chemotherapy regimens (33.8%); few pts received immunotherapy (3.0%). Among pts receiving 4L+, the most frequent treatment option was other chemotherapy (46.1%). Median TTNT was 17.7, 10.6, and 8.4 months for 2L, 3L, and 4L pts, respectively. KM rates of OS following initiation of 2L therapy at 1, 2, 3, and 4 years were 68.4%, 49.6%, 41.3%, and 33.6%, respectively, with a median OS of 23.5 months. Conclusions: Among pts with advanced/recurrent EC treated with platinum-based therapy in 1L, platinum-based regimens remain prevalent treatment choices in later lines of therapy. In this study, immunotherapy was used infrequently in 2L, 3L, and 4L+. The median TTNT decreased in later lines of therapy. This study highlights a critical need for novel, more effective treatment options in later lines of therapy to optimize outcomes among pts with advanced/recurrent EC.[Table: see text]

Treatment patterns among patients with advanced/recurrent endometrial cancer in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18693-e18693
Author(s):  
Eric M. Maiese ◽  
Bruno Émond ◽  
Jinan Liu ◽  
Marie-Hélène Lafeuille ◽  
Patrick Lefebvre ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Treatment Options ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
First Line ◽  
Kaplan Meier ◽  
The Us ◽  
Recurrent Endometrial Cancer ◽  
Third Line

e18693 Background: Among patients (pts) with endometrial cancer (EC), response rates for platinum-based regimens in the first-line (1L) setting range from 40% to 62% in clinical trials. This study describes patient characteristics, treatment patterns, time to next treatment (TTNT), and overall survival (OS) among pts with advanced/recurrent EC treated with a platinum-based regimen in a real-world setting in the US. Methods: This retrospective study used Optum Clinformatics Extended Data Mart de-identified databases from January 1, 2007, to December 31, 2019. Adult pts with advanced/recurrent EC who initiated a 1L platinum-based regimen and subsequently initiated second-line (2L) antineoplastic therapy were identified. Prior to initiation of 1L, a 12-month washout period of continuous enrollment without use of antineoplastic agents (except hormonal agents) was imposed. Kaplan-Meier (KM) rates were used to report TTNT and OS from 2L, third line (3L), and fourth line (4L), separately. Results: A total of 1878 pts with advanced/recurrent EC initiated 2L therapy following a platinum-based regimen in 1L. Among them, 739 (39.4%) pts initiated 3L and 330 (17.6%) initiated 4L or later (4L+) therapy. Median pt age was 68.0 years. More pts received platinum-based regimens (56.4%) in 2L than other options (Table). Few pts (3.3%) received immunotherapy. Among pts receiving 3L, a similar percentage of pts were treated with platinum-based (33.2%) and other chemotherapy regimens (33.8%); few pts received immunotherapy (3.0%). Among pts receiving 4L+, the most frequent treatment option was other chemotherapy (46.1%). Median TTNT was 17.7, 10.6, and 8.4 months for 2L, 3L, and 4L pts, respectively. KM rates of OS following initiation of 2L therapy at 1, 2, 3, and 4 years were 68.4%, 49.6%, 41.3%, and 33.6%, respectively, with a median OS of 23.5 months. Conclusions: Among pts with advanced/recurrent EC treated with platinum-based therapy in 1L, platinum-based regimens remain prevalent treatment choices in later lines of therapy. In this study, immunotherapy was used infrequently in 2L, 3L, and 4L+. The median TTNT decreased in later lines of therapy. This study highlights a critical need for novel, more effective treatment options in later lines of therapy to optimize outcomes among pts with advanced/recurrent EC.[Table: see text]

scholarly journals F.09 Neurosurgical Outcomes in patients with Multiple Sclerosis related Trigeminal Neuralgia

2016 ◽  
Vol 43 (S2) ◽  
pp. S20-S20
Author(s):  
S Krishnan ◽  
AM Kaufmann
Keyword(s):  
Multiple Sclerosis ◽  
Trigeminal Neuralgia ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Time Interval ◽  
Recurrent Pain ◽  
Kaplan Meier ◽  
Glycerol Injection

Background: The aim of this study was to assess the outcomes of surgery for multiple sclerosis-related trigeminal neuralgia (MS-TN). Methods: All Manitobans undergoing first surgery for medically refractory MS-TN between 2000 and 2014 were identified. The time interval until additional surgeries were required for recurrent pain, defined as the time to fail (TTF), was determined from a retrospective chart review. Kaplan-Meier analyses were performed and outcomes compared. Results: Twenty-one patients (26 sides) underwent first rhizotomy by GammaKnife (GK, 13), glycerol injection (PGR, 10) or balloon compression (BCR, 3). Second procedures were required in 88% at 15±13 months, including GK (24), PGR (19), BCR (25), microvascular decompression (2) and open surgical partial rhizotomy (Dandy, 4) for an overall total of 99 surgeries (1-12 per side). The additional GK, PGR, and BCR eventually failed and required further surgeries in 40%, 60% and 70% at 1, 2, and 3 years respectively with a trend to longer TTF compared to first surgeries (ns). Follow up of Dandy procedures, however, identified no pain recurrence at 4 to 110 months. Conclusions: The minimally invasive rhizotomies for MS-TN were associated with high rates of recurrence and reoperation. Long term pain relief was best achieved with a Dandy procedure, even after multiple prior rhizotomies.

scholarly journals Neonatal Follow Up Study: A Retrospective Chart Review of Developmental Outcomes

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Heather Wolfe, MD ◽  
Denise Gilham, NP ◽  
Susan Stace, RN, CPN ◽  
Uchechukwu Emili, BS
Keyword(s):  
Preterm Birth ◽  
Infant Development ◽  
Chart Review ◽  
Turning Point ◽  
Retrospective Chart Review ◽  
The United States ◽  
Ages And Stages Questionnaire ◽  
Preterm Group ◽  
Preterm Babies

Background and Hypothesis: According to the CDC, Preterm birth is defined as a baby born before 37 weeks of gestation. 1 In 2016 preterm birth affected 1 in every 10 infant born in the United States.1 Preterm birth has been known to cause many birth defects along with developmental delays and has attributed to 17% of all infant death. Neonatal Follow Up clinics or programs have been instrumental in helping infants catch up developmentally.3 We believe that with the NFC, we will be able to develop a standard for preterm babies and the normalization of their development. Experimental Design or Project Methods: A retrospective chart review was conducted to determine the developmental outcome of infants that were born prior to 37 weeks’ gestation. Infants were divided into extreme, very, and moderate preterm cohorts. Test of Infant Motor Performance (TIMP), Ages and Stages Questionnaire (ASQ), Bayley Scales of Infant Development (BSID) and Modified Checklist for Autism in Toddlers (M-CHAT) scores were used to determine a standard for when preterm babies in each cohort normalize developmentally. Results: Analysis of the data showed that the developmental turning point for each cohort varies. Within the extreme preterm cohort, one can see that there was no clear turning point for development. For the very preterm group, by TIMP 2, one could see a turning point and a decrease in delays. Lastly, moderately preterm cohort, the number of delays was seen tot decrease from the administration of TIMP 2 and continue in this trend. Conclusion and Potential Impact: Through the administration of these developmental tests, physicians are able to track the development of preterm babies. We concluded that with the proper follow up, one can see an improvement in development as early as the administration of TIMP 2. 1) Preterm Birth https://www.cdc.gov/reproductivehealth/MaternalInfantHealth/PretermBirth.htm 2) Suave, R., & Lee, S. K. (2006). Neonatal follow-up programs and follow-up studies: Historical and current perspectives. Paediatrics and Child Health. http://doi.org/10.1093/pch/11.5.267 3) Voller, S. M. B. (2018). Follow-Up Care for High-Risk Preterm Infants. Pediatric Annals, 47(4). http://doi.org/10.3928/19382359-20180325-03

scholarly journals Real World Evidence in Relapsed/Refractory Classical Hodgkin Lymphoma Patients Who Are Ineligible for Stem Cell Transplant in the United States (US)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2268-2268
Author(s):  
Joseph Feliciano ◽  
Nate Way ◽  
Gerald Engley ◽  
Nilanjan Ghosh
Keyword(s):  
Real World ◽  
Systemic Therapy ◽  
Research Funding ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
Cell Transplant ◽  
Real World Evidence ◽  
The Us ◽  
Line Of Therapy

Abstract Introduction: Treatment of relapsed or refractory classical Hodgkin lymphoma (R/R cHL) in patients considered ineligible for stem cell transplant (SCT) in the United States (US) has evolved since 2011. It is important to understand the current treatment landscape and the outcomes associated with current standards of care as new treatment options have been introduced. This analysis provides recent real-world evidence on patient characteristics, treatment patterns, and outcomes in R/R cHL patients in the US who are initially considered ineligible for SCT and are treated with or without brentuximab vedotin (BV). Methods: Hematologists and oncologists (N=205) from the US retrospectively identified patients diagnosed with R/R cHL who received at least two lines of therapy and received their most recent line of therapy between January 2014 and May 2018. The physicians were responsible for abstracting data and completing response forms for variables of interest. The current analysis focused on patients who were considered ineligible for SCT by their physician: descriptive statistics on patient demographics/clinical characteristics, treatment patterns, and outcomes by line of therapy; bivariate analyses (chi-square) comparing treatment modalities by line of therapy. Results: Physicians retrospectively identified 297 patients that they considered ineligible for SCT. Mean (SD) age at initial cHL diagnosis was 53.0 (18.5), most patients were male (69.4%) and Caucasian (61.3%). The most common cHL subtype at diagnosis was nodular sclerosis HL (40.4%), and patients had either Stage I/II (45.8%) or Stage III/IV (54.2%) cHL at initial diagnosis. Median follow-up time for the cohort included here was 15.96 months from initiation of 1L treatment. The majority of the cohort (N = 297) received systemic therapy alone (84.5%) compared to those who received systemic therapy in combination with radiation therapy (RT) (15.5%) in 1L. 1L systemic regimens included regimens that contained ABVD alone or ABVD in combination with other regimens (69.4%). Of those who used ABVD alone or in combination with another regimen (N = 206), 24.8% used a PET adapted approach and deescalated to AVD (N = 51) and 11% escalated to be BEACOPP (N = 18). Other systemic regimens included AVD (10.1%), BEACOPP (7.4%) and ICE (5.7 %). The majority of patients achieved a complete response (CR) or partial remission (PR) after 1L therapy (41.4%, 38% respectively) while 34.1% (N = 61) failed to achieve remission or progressed while on therapy. The most common systemic regimens in 2L (N = 293) were BV monotherapy or in combination with bendamustine (34.6%), salvage regimens [including ICE, DHAP, ESHAP or gemcitabine based combinations] (33%), re-challenge with a previous 1L regimen (19.5%), and PD-1 inhibitors (10.8%). Very few patients received systemic therapy in combination with RT (6.7%) in 2L.The most common systemic regimens used in 3L (N = 21) for the selected cohort of patients not eligible for SCT were BV monotherapy (28.6%) and PD-1 inhibitors (33.3%). Median (range) number of cycles in 2L and 3L was four (1-18) and two (1-14), respectively. Treatment outcomes were variable for patients in 2L and 3L. In 2L, 27.6% achieved a CR, 25.6% achieved a PR, while 24.2% and 15.8% were refractory or progressed on treatment. There were no CRs reported in 3L (N = 21). 26 patients died in 2L and 3L combined. Conclusion/Summary: Given the rapid evolution of therapies used to treat R/R cHL, these findings fill a crucial data gap in real-world evidence on patient characteristics, treatment patterns, and outcomes of patients deemed SCT ineligible in the US. Disclosures Feliciano: Seattle Genetics: Employment. Way:Kantar Health: Employment; Seattle Genetics: Research Funding. Engley:Seattle Genetics: Employment. Ghosh:Juno: Consultancy, Research Funding; SGN: Consultancy, Research Funding, Speakers Bureau; PCYC: Consultancy, Research Funding, Speakers Bureau; Celgene: Consultancy; Spectrum: Consultancy; Gilead: Consultancy, Speakers Bureau; Pharmacyclics, an Abbvie Company: Consultancy, Research Funding, Speakers Bureau; Genentech: Research Funding; F. Hoffman-La Roche Ltd: Research Funding; Abbvie: Consultancy, Speakers Bureau; Forty seven Inc: Research Funding; TG Therapeutics: Honoraria, Research Funding.

scholarly journals Treatment Patterns and Outcomes of 159 Ibrutinib-Treated MCL Patients in the United States: A Retrospective Electronic Medical Record Database and Chart Review Study

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4163-4163
Author(s):  
Jeff Sharman ◽  
Shaum Kabadi ◽  
Jamyia Clark ◽  
E Susan Amirian ◽  
David J. Andorsky
Keyword(s):  
Real World ◽  
Research Funding ◽  
Chart Review ◽  
Kinase Inhibitor ◽  
Stage Iv ◽  
The United States ◽  
Treatment Patterns ◽  
Discontinuation Rate ◽  
Real World Data

Abstract Introduction Ibrutinib, a Bruton's tyrosine kinase inhibitor, was approved in the U.S. for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in November of 2013. However, real-world data on ibrutinib use for the treatment of MCL is limited. The purpose of this study was to examine ibrutinib use, dosages, and reasons for treatment discontinuation among MCL patients treated in a community oncology practice setting. Methods The study population consisted of adult (≥18 year old) MCL patients treated with ibrutinib between November 1, 2013 and October 31, 2016, who were not enrolled in a clinical trial and had at least 2 visits to a US Oncology Network (USON) clinic. Patients with other primary cancers were excluded. Patient data were sourced from the USON's electronic health records system, iKnowMed (iKM)™. The structured iKM database provided information on demographics and clinical and treatment characteristics. Manual chart review was used to confirm ibrutinib treatment patterns. Duration of ibrutinib therapy (DOT), overall survival (OS), and progression-free survival (PFS) from systemic treatment initiation were estimated using Kaplan-Meier methods. Events were defined as death in the OS analysis, and progression or death in the PFS analysis. Patients were censored if their treatment was ongoing for DOT. Censors for OS and PFS were patients lost to follow up or those who did not experience a failure event within the study period. Results 159 eligible MCL patients were identified through iKM. The majority of patients were Caucasian (n=141, 88.7%), male (n=121, 76.1%), and diagnosed with Stage IV disease (n=117, 73.6%). Median follow-up for the population was 16.1 months. Approximately 7.5% (n=12) of patients received ibrutinib as first-line therapy (1L), compared to 54.1% (n=86) in 2L and 38.4% (n=61) in 3L or beyond. Median ibrutinib dose at initiation was 560mg (range: 140-700). During ibrutinib treatment, 16.4% (n=26) of patients experienced a dose reduction. Dose holds occurred in 30.2% (n=48), 66.7% (n=32) due toxicities. The overall discontinuation rate was 83.6% The primary reason for discontinuation was disease progression (n=46, 34.6%) followed by toxicities (n=34, 25.6%). Median DOT was higher for patients initiating treatment in 3L+ (14.9: 95% CI 8.8-17.1) compared to other lines. Median PFS was 19.6 (95% CI: 16.5-24.3) for the overall population and median OS was 25.8 months (95% CI: 19.9-not reached). Conclusions Our real-world findings on survival are consistent with those from clinical trials on ibrutinib in relapsed/refractory MCL, although our observed discontinuation rate (~84%) was higher than that of the trial (~58%), which had a similar median follow-up time (16.1 months vs. 15.3 months, respectively). Our findings provide additional data on MCL treatment patterns and patient outcomes in clinical practice. Disclosures Sharman: Acerta: Consultancy, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding. Kabadi:AstraZeneca: Employment. Clark:McKesson Specialty Health: Employment, Equity Ownership. Amirian:McKesson Specialty Health: Employment. Andorsky:Celgene: Research Funding; CTI BioPharma: Consultancy, Research Funding; AstraZeneca: Consultancy; Genentech: Consultancy.

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.

Prosthetic management of children in the Netherlands with upper limb deficiencies

2001 ◽  
Vol 25 (3) ◽  
pp. 228-234 ◽  
Author(s):  
M-A. Kuyper ◽  
M. Breedijk ◽  
A. H. M. Mulders ◽  
M. W. M. Post ◽  
A. J. H. Prevo
Keyword(s):  
The Netherlands ◽  
Upper Limb ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Congenital Defects ◽  
Rehabilitation Centre ◽  
Follow Up Study ◽  
Limb Deficiencies

The aim of the study was to assess which children with congenital and acquired upper limb deficiencies were fitted with prostheses, what types of prostheses were prescribed as first, second and third prostheses, at what age prostheses were first prescribed and how long the children wore their prostheses.The design was a retrospective chart review at De Hoogstraat Rehabilitation Centre, Utrecht (The Netherlands). Medical files of all patients with congenital or acquired upper limb deficiencies who visited the outpatient clinic between 1972 and 1996 were reviewed, collecting data on patient characteristics, prosthesis prescription and use of prostheses.The group included 224 children, of whom 206 (92%) had congenital deficiencies. Of all children with unilateral congenital deficiencies, 54% had been fitted with prostheses, against 3% of all children with bilateral congenital deficiencies and 67% of all children with acquired deficiencies. In the congenital group, it was children with transverse defects of one-third or two-thirds of the forearm who had most frequently had prostheses fitted (85% of the children). Most of the children with unilateral congenital deficiencies had received passive prostheses as their first prostheses (80 of the 90 prescribed prostheses); children with acquired defects usually had active prostheses (8 of the 12 prescribed prostheses). Body-powered prostheses were most commonly prescribed as the second type of prosthesis.In the group of 119 children who had been seen before the age of 4 years and had been followed for at least three years, 63 had been fitted with one or more prostheses at a mean age of 2.6 (SD 2.5) years. Of the 46 children with congenital defects, 30 had been fitted with prostheses, and at the age of 12, two-thirds of them still used their prostheses (63%, 19/30).“De Hoogstraat” rehabilitation centre uses a restrained prosthesis prescription policy, depending on the type of deficiency and the expected functional benefits. Data on prosthesis use are encouraging, although a follow-up study is required to determine the functional outcome for prosthesis users and non-users.

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