Abstract 220: Early Assessment of Real-world Utilization and Dosing of Sacubitril/Valsartan in the US

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Chun-Lan Chang ◽  
Xue Song ◽  
Tina Willson ◽  
Carol Duffy
Keyword(s):  
Real World ◽  
Maintenance Dose ◽  
Healthcare Providers ◽  
Dose Titration ◽  
Dose Increase ◽  
Early Assessment ◽  
Reduced Ejection Fraction ◽  
Starting Dose ◽  
The Us ◽  
Medicare Patients

Background: Based on the PARADIGM-HF trial, sacubitril/valsartan was approved for the treatment of patients with heart failure and reduced ejection fraction. This study provides an early view of its real-world utilization and dosing in the US before recent guideline updates. Methods: Adult patients with >=1 sacubitril/valsartan claim in 7/7/2015 - 3/31/2016 were selected from a large national claims dataset; their 1st sacubitril/valsartan claim was the index date. Data was required for >=24 months pre-index and >=3 months post-index. Dose at index and the maximum dose achieved post-index were obtained. Dose up-titration, defined as 1st appearance of a sacubitril/valsartan claim with a dose increase from the index strength, and the time to 1st dose increase were reported. Results: Among 981 qualified patients with a mean follow-up of 185 (SD ±81) days, 25% commenced sacubitril/valsartan on the suggested prescribing information (PI) starting dose of 49/51 mg b.i.d.; 58% started on 24/26 mg b.i.d.; 4% started on an even lower dose, and 13% indexed at the target maintenance dose of 97/103 b.i.d.. The target maintenance dose of 97/103 mg b.i.d. was achieved in 30% of patients. For those 856 patients indexing on <=49/51/ mg b.i.d., 58% had no dose up-titration post-index; 31% took >4 weeks to have up-titration initiated and 11% initiated up-titration within 4 weeks. Only 25% of Medicare patients compared to 35% of Commercial patients achieved the target dose of 97/103mg b.i.d.. (Table 1) Conclusion: Most patients commenced sacubitril/valsartan at lower doses than recommended in the PI and were poorly optimized, with the majority of patients having no upward dose titration. Approximately 13% actually indexed at the target maintenance dose. The reasons for these findings need further exploration. Healthcare providers should consider following the appropriate starting doses, with timely dose adjustment of sacubitril/valsartan as recommended in the PI to ensure patients receive the full clinical benefit of this medication as demonstrated in the PARADIGM-HF trial.

Real-world starting dose and outcomes of palbociclib plus an aromatase inhibitor for metastatic breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13021-e13021
Author(s):  
Debra A. Patt ◽  
Xianchen Liu ◽  
Benjamin Li ◽  
Lynn McRoy ◽  
Rachel M. Layman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Aromatase Inhibitor ◽  
Real World ◽  
Metastatic Breast ◽  
Routine Practice ◽  
First Line ◽  
Starting Dose ◽  
The Us

e13021 Background: Palbociclib (PA) has been approved for HR+/HER2–advanced/metastatic breast cancer (mBC) in combination with an aromatase inhibitor (AI) or fulvestrant for more than 6 years. Regardless of the labeled recommended starting dose of 125mg/day, some patients initiate palbociclib at lower doses in routine practice. This study described real-world starting dose, patient characteristics, and effectiveness outcomes of first line PA+ AI for mBC in the US clinical setting. Methods: We conducted a retrospective analysis of Flatiron Health’s nationwide longitudinal electronic health records, which came from over 280 cancer clinics representing more than 2.2 million actively treated cancer patients in the US. Between February 2015 and September 2018, 813 HR+/HER2– mBC women initiated PA+AI as first-line therapy and had ≥ 3 months of potential follow-up. Patients were followed from start of PA+AI to December 2018, death, or last visit, whichever came first. Real-world progression-free survival (rwPFS) was defined as the time from the start of PA+AI to death or disease progression. Real-world tumor response (rwTR) was assessed based on the treating clinician’s assessment of radiologic evidence for change in burden of disease over the course of treatment. Multivariate analyses were performed to adjust for demographic and clinical characteristics. Results: Of 813 eligible patients, 68.3% were white, median age was 65.0 years, and 42.9% had visceral disease (lung and/or liver). Median duration of follow-up was 21.0 months. 805 patients had records of PA starting dose, with 125mg and 75/100mg/day being 86.5% and 13.5%, respectively. Patients who started at 75/100mg/day were more likely to be ≥75 years than those who started at 125mg/day (38.5% vs 17.1%). Other baseline and disease characteristics were generally evenly distributed. Patients who started at 125mg/day had longer median rwPFS (27.8 vs 18.6 months, adjusted HR=0.74, 95%CI=0.52-1.05) and higher rwTR (54.0% vs. 40.4%) than those patients who started 100/75mg/day (adjusted OR=1.76, 95%CI=1.13-2.74). Table presents results in detail. Conclusions: Most patients in this study initiated palbociclib at 125mg/day and dose adjustment was similar regardless of starting dose. These real-world findings may support initiation of palbociclib at a dose of 125mg/day in combination with AI for the first-line treatment of HR+/HER2- mBC. [Table: see text]

Real-world dosing, management, and clinical outcomes of patients (pts) with metastatic pancreatic adenocarcinoma (mPDAC) treated with liposomal irinotecan.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16780-e16780
Author(s):  
Laith I. Abushahin ◽  
Paul Cockrum ◽  
Andy Surinach ◽  
Bruce Belanger
Keyword(s):  
Real World ◽  
Relative Survival ◽  
The United States ◽  
Duration Of Treatment ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Starting Dose ◽  
The Us ◽  
Liposomal Irinotecan ◽  
To Receive ◽  
Dose Reductions

e16780 Background: Pancreatic cancer remains one of the most lethal cancers in the United States (US) with a 5-year relative survival of 10%. Liposomal irinotecan is a topoisomerase inhibitor indicated, in combination with 5-fluorouracil and leucovorin, for pts with mPDAC following disease progression on gemcitabine-based therapy. This study examines the real-world use and therapeutic management of pts with mPDAC treated with liposomal irinotecan. Methods: This retrospective observational study utilized the Flatiron Health EHR-derived de-identified database from over 280 cancer clinics in the US. Data were analyzed for adult pts with mPDAC treated with liposomal irinotecan based regimens between Nov 2015 and Oct 2019. Pts were categorized into two starting dose groups: 70mg/m2 and < 65mg/m2. Pt characteristics, overall survival (OS), duration of treatment (DOT), and impact of dose reductions (DR, reduction ≥ 7mg/m2) were assessed among pts who received ≥3 cycles of treatment (tx). Results: Of the 532 pts (median age: 69y, IQR: 62-75) included in the study, 95 (18%) had an ECOG score of 2+ at tx initiation. Of the 184 pts (69y, 42 – 84) that did not receive 3 cycles of tx, 47 (25%) had an ECOG score of 2+ and 83 (45%) had two or more prior lines of tx. 348 pts (69y, 43 – 85) received ≥3 cycles of tx. 116 (33%) pts had two or more prior lines of tx, 209 (60%) had an ECOG score of 0-1, 48 (14%) had an ECOG score of 2+, and 91 (26%) had missing scores. 220 (63%) initiated tx at 70mg/m2 and 128 (37%) initiated at < 65mg/m2. 83 (38%) 70mg/m2 and 26 (20%) < 65mg/m2 pts experienced a DR during tx. 43 (52%) and 14 (54%) of the DRs occurred within the first 6 wks of tx in the 70mg/m2 and < 65mg/m2 cohorts, respectively. Median DOT was 12.6 weeks for 70mg/mg2 and 9.1 wks for < 65mg/m2 pts; DOT was longer among pts with a DR: 19.0 wks and 16.1 wks, respectively. Median OS (mOS) was 7.2 months (95% CI: 6.2 – 8.1) and 6.2 mos (5.0 – 7.4) for pts receiving 70mg/m2 and < 65mg/m2, respectively. mOS for pts with a DR was 8.9 mos (7.3 – 10.8) and 7.7 mos (5.0 – 14.9) for pts receiving 70mg/m2 and < 65mg/m2, respectively. mOS for pts with no DR was 6.0 mos (4.8 – 7.2) and 6.0 mos (4.7 - 7.2) for those receiving 70mg/m2 and < 65mg/m2, respectively. Conclusions: In this descriptive study among pts who were able to receive ≥3 cycles of liposomal irinotecan and remain on tx for ≥4 wks, DRs were effective in extending DOT and OS, independent of starting dose. The longest DOT and OS were observed in the pts who received 70mg/m2 with DRs. Pts who received 70mg/m2 and < 65mg/m2 had similar OS in the absence of DRs.

Real-World Ponatinib Prescribing Patterns and Outcomes in US Patients

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1591-1591
Author(s):  
Michael J. Mauro ◽  
Lisa J. McGarry ◽  
Mo Yang ◽  
Stephanie Lustgarten ◽  
Hui Huang
Keyword(s):  
Dose Reduction ◽  
Real World ◽  
Dose Adjustment ◽  
Prescribing Patterns ◽  
Employment Equity ◽  
Line Therapy ◽  
Starting Dose ◽  
The Us ◽  
Equity Ownership ◽  
Over Time

Abstract Background: In Jan 2014, ponatinib was reintroduced to the US market after an 11 week withdrawal to review data on arterial thrombotic events, revise US prescribing information (USPI) and implement a risk evaluation and mitigation strategy (REMS). The USPI was revised to narrow the indicated population and recommend a starting dose of 45 mg, with consideration of 1) lower doses in patients with selected comorbidities or to manage adverse events, 2) dose reduction in chronic phase (CP) and accelerated phase (AP) chronic myeloid leukemia (CML) patients achieving major cytogenetic response, and 3) discontinuation if response has not occurred at 3 months. In the US, ponatinib is available exclusively through a specialty pharmacy that maintains prescribing data for all US ponatinib-treated patients since reintroduction. Examining these data provides insight into practitioners' patient selection and prescribing patterns, and real-world ponatinib outcomes. Methods: We performed a retrospective analysis of patients starting treatment with ponatinib between 01 January 2014 and 25 March 2015 using data from referring physicians, patient intake forms and pharmacy dispensing records. Patient and prescriber characteristics, and dosing and dose modifications were documented. Clinical, demographic and physician characteristics were examined as predictors of initial dose and dose modification using logistic regression; therapy duration was assessed using Kaplan-Meier techniques and proportional hazard regression. Results: 758 US patients initiated treatment with ponatinib over this 15-month period, (58% male; median age 55 years [range: 11-98]). Among 730 patients with a specified diagnosis, 80% had CML and 4% Philadelphia chromosome positive (Ph+) acute lymphocytic leukemia (ALL); the remainder had unspecified ALL (10%), other hematologic malignancies (3%), and solid tumors (3%). Of 411 CML patients reporting disease phase, 61% were in CP, 18% AP and 21% blast phase (BP). 12% of CML and 8% of Ph+ ALL patients had a reported T315I mutation. 21% of CP, 34% of AP, 12% of BP and 31% of Ph+ ALL patients were receiving ponatinib as 2nd-line therapy, with the remainder in 3rd line or later. Most recent prior TKI was dasatinib for 48%, nilotinib for 23%, bosutinib for 17%, and imatinib for 12% of patients in all therapy lines. 50% received 45 mg as their initial dose, 33% 30 mg and 17% 15 mg. Prescribers' practice setting was 49% community and 51% academic. Most prescribers (82%) had only 1 ponatinib patient; only 7% had 3 or more. Prescribers with >1 ponatinib patient were less likely to prescribe 45 mg starting dose (OR=0.53 for those with 2 patients; OR=0.25 for 3+ patients.) 23% of patients had at least one dose adjustment, including 17% with dose reduction. Among CP patients initially on 45 mg, with at least 6 months of therapy, 42% reduced dose (29% to 30 mg; 13% to 15 mg). Dose reduction decreased significantly for later therapy lines in CP, but did not differ by disease phase. Median time on therapy was >15 months for CP, 10.6 months for AP, 7.0 months for BP, and >14 months for Ph+ ALL. CP patients' time on therapy was longer for those started on 15 mg, although this difference was not significant (p=0.14) (Figure.) Reasons for dose adjustment and discontinuation were not well documented, but they appeared to occur at a relatively constant rate over time rather than at time points recommended for response monitoring. Conclusions: Real-world US data shows ponatinib is prescribed across disease phase, therapy line, and mutation status. While a majority of patients were in their 3rd line of therapy or later, a substantial proportion of patients, especially in AP CML and Ph+ ALL, received ponatinib as 2nd line therapy. Physicians appear to be selecting patients who are younger than those enrolled in registrational trial for ponatinib (55 years vs. PACE trial median age, 64 years), and mitigating against potential risk using lower starting doses and dose reduction. Most prescribers have only 1 ponatinib patient, but physicians with >1 ponatinib patient favor lower starting doses. Dose reduction and discontinuation occurred steadily over time rather than clustered at routine response milestone time points. CP CML Patients starting at 15 mg appear to have similar or better treatment duration compared with those started at higher doses. Disclosures Mauro: Ariad: Consultancy; Pfizer: Consultancy; Novartis Pharmaceutical Corporation: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy. McGarry:ARIAD: Employment, Equity Ownership. Yang:ARIAD Pharmaceuticals, Inc: Employment. Lustgarten:ARIAD Pharmaceuticals Inc.: Employment, Equity Ownership, Other: Stock. Huang:ARIAD: Employment, Equity Ownership.

scholarly journals Regorafenib pharmacokinetics and its association with real-world treatment outcomes

2021 ◽  
Author(s):  
Masahide Fukudo ◽  
Keiko Asai ◽  
Chikayoshi Tani ◽  
Masashi Miyamoto ◽  
Katsuyoshi Ando ◽  
...  
Keyword(s):  
Real World ◽  
Plasma Concentrations ◽  
Progression Free Survival ◽  
Japanese Patients ◽  
Dose Titration ◽  
Efficacy And Safety ◽  
Active Metabolites ◽  
Exposure Response ◽  
Starting Dose ◽  
Liquid Chromatography Tandem Mass

Abstract Purpose Despite the established activity of regorafenib in metastatic colorectal cancer (CRC), gastrointestinal stromal tumor (GIST), and hepatocellular carcinoma (HCC), its toxicity profile has limited clinical use. We aimed to evaluate the pharmacokinetics of regorafenib and its active metabolites M-2/M-5, and to clarify the relationships between total drug-related exposure and clinical outcomes in real-world practice.Methods Blood samples were obtained at steady state in Cycle 1 in patients treated with regorafenib. Plasma concentrations of regorafenib and its metabolites were measured by liquid chromatography–tandem mass spectrometry. The efficacy and safety endpoints were progression-free survival (PFS) and dose-limiting toxicities (DLTs), respectively. The exposure–response relationships were assessed.Results Thirty-four Japanese patients with advanced cancers were enrolled (CRC, n = 26; GIST and HCC, each n = 4). Nine patients started regorafenib treatment at the recommended dose of 160 mg once daily (3 weeks on / 1 week off), while the other patients received a reduced starting dose to minimize toxicities. The median PFS was significantly longer in patients achieving total trough concentrations (Ctrough) of regorafenib and M-2/M-5 ≥2.9 µg/mL than those who did not (112 vs. 57 days; p = 0.044). Furthermore, the cumulative incidence of DLTs during the first 2 cycles was significantly higher in patients with summed Ctrough levels ≥4.3 µg/mL than in others (p = 0.0003).Conclusions Dose titration of regorafenib to achieve drug-related Ctrough levels in Cycle 1 between 2.9 and 4.3 µg/mL may improve the efficacy and safety, warranting further investigation in a larger patient population.

scholarly journals Real-World Dosing Patterns of Ruxolitinib in Patients with Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4192-4192
Author(s):  
Ivy Altomare ◽  
Anna Nguyen ◽  
Shreekant Parasuraman ◽  
Dilan Paranagama ◽  
Jonathan K. Kish ◽  
...  
Keyword(s):  
Real World ◽  
Treatment Duration ◽  
Chart Review ◽  
Dose Increase ◽  
Employment Equity ◽  
Skin Ulcers ◽  
Starting Dose ◽  
Equity Ownership ◽  
Dose Modifications ◽  
Dosing Patterns

Background Polycythemia vera (PV) is a myeloproliferative neoplasm affecting >100,000 people in the United States annually. Patients (pts) with PV are at risk for thromboembolic events (TEs), premature death, and high symptom burden. Hydroxyurea (HU) is recommended for high-risk pts with PV; however, up to 40% of pts become resistant and/or intolerant to the drug (Demuynck T, et al. Ann Hematol. 2019;98:1421-1426). Ruxolitinib (RUX), a Janus kinase (JAK) 1/JAK2 inhibitor, is currently the only FDA-approved treatment option for pts with PV who are resistant to or intolerant of HU. We conducted a retrospective chart review to characterize the reasons pts were switched from HU to RUX and to describe the real-world dosing patterns of RUX in pts with PV. Methods This retrospective medical chart review was conducted at US community hematology/oncology practices in the Cardinal Health Oncology Provider Extended Network. Eligible pts were ≥18 y old, initiated RUX therapy during the index period (January 1, 2015, to December 31, 2016), were previously treated with HU for ≥3 mo, and were seen at least twice during the 6 mo following RUX initiation. Data were collected for the 12 mo prior to RUX initiation (including near the time of HU discontinuation), near the time of RUX initiation (index), and up to the last provider visit. Pt and clinical characteristics were collected, including blood counts, symptoms, TEs, cardiovascular disease risk factors, phlebotomy, and HU and RUX treatment patterns. Target enrollment was 250 pts; interim results are presented here. Results Providers identified 99 pts for inclusion; mean (SD) age was 64 (9.9) y, 56% were male, and 68% had high-risk PV (ie, age ≥60 y and/or history of TE). All pts had been tested for the JAK2V617F mutation, and 99% were positive. At the time of HU discontinuation, 28% of pts had reached an HU dose of ≥2 g/d; median (range) HU treatment duration was 9.7 (3.6-182.4) mo. Causes of HU discontinuation were resistance (63%), intolerance (17%), resistance and intolerance (11%), and other reasons (9%; Table). The most frequent reasons for HU discontinuation due to resistance were hematocrit (Hct) ≥45% (79%), symptoms (45%), leukocytosis (32%), thrombocytosis (31%), and splenomegaly (22%). The most frequent intolerance signs and symptoms were nausea (43%), stomatitis (25%), fever (18%), and skin ulcers (14%). With respect to the RUX starting dose, 44 pts (44%) initiated RUX at the US package insert-recommended dose of 10 mg twice daily (BID); median (range) treatment duration for these pts was 26.4 (3.2-52.0) mo (Table). During the first 6 mo of RUX treatment, dose modification was noted in 19 pts (43%) who initiated at 10 mg BID (dose increase, n=13 [30%]; dose decrease, n=5 [11%]; dose interruption, n=1 [2%]). The most common reasons for dose increase were continued need for phlebotomy (39%) and symptoms (39%). Five pts required a dose reduction; the most common reason was low hemoglobin levels (n=3). Overall, pts starting at 10 mg BID had more dose modifications in the first 6 mo of RUX treatment (43%), with fewer dose modifications needed after 6 mo (25%). Hct control (Hct <45%) at initiation and after 6 mo of RUX treatment was 14% and 75%, respectively. At the time of the last visit, 48% of pts were still taking RUX. The majority of pts (65%) who discontinued RUX had no dosing changes from the time of initiation to discontinuation. Conclusions In this interim analysis of real-world data pertaining to pts with PV who discontinued HU and were subsequently treated with RUX, the most common resistance events leading to HU discontinuation were Hct ≥45%, uncontrolled symptoms, leukocytosis, thrombocytosis, and splenomegaly. Discontinuations due to intolerance were most commonly attributed to nausea, stomatitis, fever, and skin ulcers. Of pts who were switched from HU to RUX, the duration of HU treatment was shorter and the proportion of pts treated with HU doses of ≥2 g/d was higher than has been reported for all pts discontinuing HU, irrespective of their next line of therapy (Grunwald MR, et al. ASH Annual Meeting 2017. Poster 1633). Less than half of pts initiated RUX at the recommended dose of 10 mg BID; 41% of pts dosed in accordance with the recommended starting dose experienced dosing modifications (primarily dose increases); however, the majority of pts who discontinued RUX had no dosing modifications during their treatment. Results from the entire cohort of 250 pts will be presented. Disclosures Altomare: Amgen: Consultancy; Incyte: Consultancy, Speakers Bureau; Novartis: Consultancy; Rigel: Consultancy. Nguyen:Incyte: Employment, Equity Ownership. Parasuraman:Incyte: Employment, Equity Ownership. Paranagama:Incyte: Employment, Equity Ownership. Kish:Cardinal Health: Employment. Lord:Cardinal Health: Employment, Equity Ownership. Colucci:Incyte: Employment, Equity Ownership.

scholarly journals Real-World Practice Patterns with Carfilzomib in Patients with Relapsed and Refractory Multiple Myeloma

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5765-5765
Author(s):  
R. Donald Harvey ◽  
Ze Cong ◽  
Winifred Werther ◽  
Jan L. Lethen ◽  
Sagar Lonial
Keyword(s):  
Multiple Myeloma ◽  
Clinical Practice ◽  
Dose Escalation ◽  
Real World ◽  
Research Funding ◽  
Clinical Characteristics ◽  
Patient Demographics ◽  
The Third ◽  
Starting Dose ◽  
The Us

Abstract Background: Single-agent carfilzomib (CFZ), a selective proteasome inhibitor, received accelerated approval in the US (July 2012) for the treatment of patients with relapsed and refractory multiple myeloma (MM). The approved dosing schedule is a 2–10 minute intravenous infusion on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. The starting dose is 20 mg/m2 during cycle 1; if well tolerated, it should be escalated to a target dose of 27 mg/m2 during cycles 2 and beyond, as CFZ dose-escalation may be associated with improved responses. To date, adherence to this schedule in a real-world setting has not been evaluated. We present results from a retrospective analysis that assessed the frequency of CFZ dose escalation in routine clinical practice and its association with patient demographics, clinical characteristics, concomitant medications, and duration of therapy (DOT). Methods: This study was a retrospective analysis of clinical practice data with CFZ in the US. Data were obtained from the OSCER electronic medical record (EMR) database, which collates information on patient demographics, clinical characteristics, and treatment from multiple hematology/oncology practices. Patients were included if they were diagnosed after January 1, 2005 and received CFZ between July 20, 2012 and March 1, 2014 after previous exposure to bortezomib and an immunomodulatory agent. In the primary analysis, patients were classified as escalators if they received an increased dose of CFZ within 29 days (start of cycle 2) of initiation and non-escalators if they did not receive an increased dose of CFZ within 29 days. The Kaplan-Meier method with death as a competing risk and end of follow-up as right censored was used to compare DOT between escalators and non-escalators. To test the sensitivity of the analysis to the criteria for classifying patients by presence of dose escalation, calculations were repeated with patients classified as escalators if they received an increased dose of CFZ by the third cycle of treatment and non-escalators if they did not receive an increased dose of CFZ by the third cycle. Results: A total of 281 patients in the OSCER EMR database met inclusion criteria. Data regarding dose escalation within 29 days or 3 cycles of starting treatment with CFZ was obtained for 244 and 153 patients, respectively; the majority (75%) were treated in practices in the southern region of the US. Fifty-five percent of patients received an increased dose of CFZ within 29 days of initiating treatment and 80% received an increased dose by the third cycle. Demographics (age and sex) and clinical characteristics (Eastern Cooperative Oncology Group performance status and presence of renal failure or chronic kidney disease) were similar between escalators and non-escalators (p>0.08). Although a greater proportion of non-escalators received granulocyte-colony stimulating factors (G-CSF) compared with escalators (<29 days: 16% vs 4%, respectively; <3 cycles: 19% vs 10%), a significant proportion of patients who did not receive G-CSF were also non-escalators (<29 days: 42%; <3 cycles: 18%). The median DOT was significantly higher in patients who were escalated within 29 days compared with patients who were not (160 vs 114 days, respectively; p=0.02; Fig. 1). Patients who were escalated within 3 cycles had a trend for increased median DOT compared to those who were not (184 vs 163 days, respectively; p=0.07; Fig. 2). Among patients who did not receive G-CSF, escalators had a longer DOT compared with non-escalators, consistent with results in the overall population. Conclusion: A non-trivial proportion of patients (20%) who received CFZ were not dose-escalated by the third cycle of treatment. The demographics and clinical characteristics examined did not appear to distinguish escalators from non-escalators, and concomitant use of G-CSF did not fully explain why some patients were not escalated. As escalators had a longer DOT compared with non-escalators, there may be consequent differences in disease progression outcomes between escalators and non-escalators. Further investigation of demographics and disease characteristics (e.g. high-risk disease) in escalators and non-escalators is needed to understand the reasons behind the practice of continuing the starting dose, but not escalating, in those patients who do not receive target doses of CFZ, and what effect this practice has on disease progression outcomes. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Harvey: Onyx: Consultancy, Research Funding; Millennium: Consultancy, Research Funding; Novartis: Research Funding; Celgene: Research Funding; Acetylon: Research Funding; Amgen: Research Funding. Cong:Onyx Pharmaceuticals: Employment. Werther:Onyx Pharmaceuticals: Employment, Equity Ownership. Lethen:Amgen. Inc.: Employment. Lonial:Millennium: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Onyx: Consultancy, Research Funding.

scholarly journals Predictors of Ponatinib Therapy Duration Among Real-World Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients in the US

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3081-3081 ◽  
Author(s):  
Michael J. Mauro ◽  
Lisa J. McGarry ◽  
Stephanie Lustgarten ◽  
Hui Huang
Keyword(s):  
Real World ◽  
Kinase Inhibitor ◽  
Chronic Phase ◽  
Academic Community ◽  
Employment Equity ◽  
Starting Dose ◽  
The Us ◽  
T315i Mutation ◽  
Equity Ownership ◽  
Line Of Therapy

Abstract Background: Ponatinib is a potent oral tyrosine kinase inhibitor (TKI) active against native and mutant forms of BCR-ABL. It is approved for patients with resistant or intolerant CML or Ph+ ALL, or with the T315I mutation, which renders other TKIs ineffective. The USPI recommends a starting dose of 45 mg/day, with consideration of lower starting doses in patients with selected comorbidities. In the US, ponatinib is available exclusively through a specialty pharmacy that maintains prescribing data for all US ponatinib-treated patients. Analyses of dispensed ponatinib prescriptions for CP-CML patients show that median therapy duration exceeds 1.5 years but is variable across groups; examination of demographic, clinical and physician characteristics may reveal predictors of therapy duration. Methods: We performed a retrospective analysis of patients starting treatment with ponatinib over the 2.5-year period from 01 January 2014 and 30 June 2016 using data from referring physicians, patient intake forms and pharmacy dispensing records. Gender (M/F), age (</≥65 years), reported T315I status (Y/N), line of therapy (2nd-5th), most recent prior TKI (imatinib, nilotinib, dasatinib, or bosutinib), starting dose (15, 30 or 45 mg/day), prescribing physician practice type (academic/community), and number of ponatinib patients treated by physician (1, 2, 3 or more) were examined as predictors of therapy duration using Kaplan-Meier (K-M) techniques and log-rank tests; multivariable, stepwise, proportional-hazard regression was used to generate adjusted hazard ratios and identify primary drivers of therapy duration. Results: 475 US patients identified with CP-CML initiated treatment with ponatinib over this 2.5-year period; K-M median time on therapy was 20.7 months. About one-half of patients were male (Table) and most were aged <65 years. Only 10% were reported to have the T315I mutation, most were in their 3rd or 4th line of therapy, and had most commonly switched from dasatinib; nearly one-half had a starting dose of 45 mg/day. Slightly more than one-half of prescribing physicians were in academic settings, and more than three-quarters had only one ponatinib patient. When examining each predictor individually, only gender was a significant predictor of time on therapy (Table), with women having significantly shorter duration than men. There was also a trend for T315I patients to have longer duration than non-T315I. In analyses adjusted for other covariates, non-T315I patients had significantly shorter duration (hazard ratio [HR]: 2.09; p=0.033), as did those whose most recent TKI was not imatinib (HR nilotinib v imatinib: 3.61; dasatinib v imatinib 4.72; bosutinib v imatinib 1.85; overall p=0.001). Women had a borderline significantly shorter duration than men (HR: 1.40; p= 0.085) and versus 2nd line, patients in 3rd (HR: 0.67) and 4th (HR: 0.68) line had longer duration, while 5th line had shorter (HR: 1.45; overall p=0.054). Conclusions: Real-world US data for CP-CML patients receiving ponatinib show that a number of subgroups have median duration on ponatinib exceeding 2 years, but suggest drivers of therapy duration may be complex including both disease (e.g. T315I, prior line of tx) and patient (e.g. sex) related factors. Study sponsor: ARIAD Pharmaceuticals, Inc. Disclosures Mauro: Novartis: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria; ARIAD: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria. McGarry:ARIAD: Employment, Equity Ownership. Lustgarten:ARIAD: Employment, Equity Ownership. Huang:ARIAD: Employment, Equity Ownership.

scholarly journals Perceived Barriers to COVID-19 Testing

2021 ◽  
Vol 18 (5) ◽  
pp. 2278
Author(s):  
Pearl A. McElfish ◽  
Rachel Purvis ◽  
Laura P. James ◽  
Don E. Willis ◽  
Jennifer A. Andersen
Keyword(s):  
Analytical Approach ◽  
Nasal Swab ◽  
Healthcare Providers ◽  
Research Participant ◽  
Perceived Barriers ◽  
Lower Income ◽  
The Us ◽  
Qualitative Descriptive ◽  
Descriptive Method ◽  
Background Prior

(1) Background: Prior studies have documented that access to testing has not been equitable across all communities in the US, with less testing availability and lower testing rates documented in rural counties and lower income communities. However, there is limited understanding of the perceived barriers to coronavirus disease 2019 (COVID-19) testing. The purpose of this study was to document the perceived barriers to COVID-19 testing. (2) Methods: Arkansas residents were recruited using a volunteer research participant registry. Participants were asked an open-ended question regarding their perceived barriers to testing. A qualitative descriptive analytical approach was used. (3) Results: Overall, 1221 people responded to the open-ended question. The primary barriers to testing described by participants were confusion and uncertainty regarding testing guidelines and where to go for testing, lack of accessible testing locations, perceptions that the nasal swab method was too painful, and long wait times for testing results. (4) Conclusions: This study documents participant reported barriers to COVID-19 testing. Through the use of a qualitative descriptive method, participants were able to discuss their concerns in their own words. This work provides important insights that can help public health leaders and healthcare providers with understanding and mitigating barriers to COVID-19 testing.

scholarly journals Stethoscope hygiene: A call to action. Recommendations to update the CDC guidelines

2021 ◽  
pp. 1-3
Author(s):  
Sarathi Kalra ◽  
Alpesh Amin ◽  
Nancy Albert ◽  
Cindy Cadwell ◽  
Cole Edmonson ◽  
...  
Keyword(s):  
Healthcare Providers ◽  
Acoustic Properties ◽  
Patient Encounter ◽  
Call To Action ◽  
The Us ◽  
Cdc Guidelines ◽  
Control And Prevention ◽  
Healthcare Acquired Infections ◽  
Current Guidance ◽  
Tremendous Challenge

Abstract Healthcare-acquired infections are a tremendous challenge to the US medical system. Stethoscopes touch many patients, but current guidance from the Centers for Disease Control and Prevention does not support disinfection between each patient. Stethoscopes are rarely disinfected between patients by healthcare providers. When cultured, even after disinfection, stethoscopes have high rates of pathogen contamination, identical to that of unwashed hands. The consequence of these practices may bode poorly in the coronavirus 2019 disease (COVID-19) pandemic. Alternatively, the CDC recommends the use of disposable stethoscopes. However, these instruments have poor acoustic properties, and misdiagnoses have been documented. They may also serve as pathogen vectors among staff sharing them. Disposable aseptic stethoscope diaphragm barriers can provide increased safety without sacrificing stethoscope function. We recommend that the CDC consider the research regarding stethoscope hygiene and effective solutions to contemporize this guidance and elevate stethoscope hygiene to that of the hands, by requiring stethoscope disinfection or change of disposable barrier between every patient encounter.

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