Impact of bodyweight (BW)-based starting doses on safety and efficacy of lenvatinib (LEN) in patients (pts) with hepatocellular carcinoma (HCC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16119-e16119
Author(s):  
Takuji Okusaka ◽  
Masatoshi Kudo ◽  
Kenji Ikeda ◽  
Masafumi Ikeda ◽  
Kiwamu Okita ◽  
...  
Keyword(s):  
Treatment Duration ◽  
Ad Hoc ◽  
Small Sample Size ◽  
Small Sample ◽  
Comparable Efficacy ◽  
Safety And Efficacy ◽  
Median Treatment ◽  
Median Treatment Duration ◽  
Starting Dose ◽  
Dose Reductions

e16119 Background: In Study 202, pts received LEN 12 mg/d for treatment of unresectable (u)HCC, irrespective of BW. Correlations between early dose adjustments and BW in Study 202 led to BW-adjusted dosing in the phase 3 REFLECT study of LEN in uHCC. In REFLECT, pts <60 kg received LEN 8 mg/d and pts ≥60 kg received LEN 12 mg/d. While improvements in safety were expected by reducing the LEN starting dose to 8 mg/d in pts <60 kg, any differences in safety and efficacy of BW-adjusted dosing vs standard dosing among pts with lower BW have yet to be determined. Herein, we compare safety and efficacy of LEN based on pts’ BW (<60 kg vs ≥60 kg) in Study 202 (LEN 12 mg/d irrespective of BW) and in Japanese pts in REFLECT (dose adjusted by BW). Methods: This ad hoc analysis included all pts from Study 202 (n=46; all Asian, 43 Japanese) and Japanese pts from REFLECT (n=81). Safety and efficacy were assessed in Study 202 and REFLECT according to pt BW (<60 kg vs ≥60 kg). Tumors were assessed using mRECIST, by independent radiologic review. Results: In Study 202, pts in the <60 kg group had a median treatment duration of 5.8 mos and received 57% of the LEN planned starting dose (PSD); pts in the ≥60 kg group had a median treatment duration of 9.4 mos and received 78.6% of the LEN PSD. Among Japanese pts in REFLECT, median treatment duration was 5.7 mos in both treatment groups; pts in the LEN 8 mg group received 79.1% of the PSD and pts in the LEN 12 mg group received 70.7% of the PSD. In Study 202, treatment-related adverse events (TRAEs) led to dose reduction in 80.8% of pts in the <60 kg group and 55% of pts in the ≥60 kg group. In REFLECT, TRAEs led to dose reductions in 52.5% of pts in the LEN 8 mg group and 70.7% of pts in the LEN 12 mg group. Serious TRAEs occurred at incidences of 46.2% and 10.0% in Study 202 in the <60 kg and ≥60 kg groups, and 15.0% and 22.0% in REFLECT in the LEN 8 mg and LEN 12 mg groups, respectively. Efficacy results are in the Table. Conclusions: Despite the small sample size, this comparison of Study 202 pts and Japanese pts from REFLECT indicates that BW-adjusted LEN dosing in pts with uHCC yielded comparable efficacy between pts <60 kg who received LEN 8 mg and pts ≥60 kg who received LEN 12 mg. The safety profile was favorable in pts <60 kg who received LEN 8 mg in REFLECT vs those who received LEN 12 mg in Study 202. Fewer serious TRAEs and dose reductions due to TRAEs were observed in pts with lower BW who received the LEN 8 mg starting dose in REFLECT. These data suggest that by reducing the starting dose from LEN 12 mg to 8 mg in pts with uHCC and lower BW (<60 kg), safety is improved without compromising efficacy. Clinical trial information: NCT00946153; NCT01761266. [Table: see text]

scholarly journals Continuous Clindamycin Infusion, an Innovative Approach to Treating Bone and Joint Infections

2009 ◽  
Vol 54 (1) ◽  
pp. 88-92 ◽  
Author(s):  
Valérie Zeller ◽  
Arnaud Dzeing-Ella ◽  
Marie-Dominique Kitzis ◽  
Jean-Marc Ziza ◽  
Patrick Mamoudy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Duration ◽  
Innovative Approach ◽  
Safety And Efficacy ◽  
Median Treatment ◽  
Median Treatment Duration ◽  
Joint Infections ◽  
Bone And Joint Infections ◽  
Median Serum

ABSTRACT The feasibility, safety, and efficacy of prolonged, continuous, intravenous clindamycin therapy were retrospectively evaluated for 70 patients treated for bone and joint infections, 40% of whom were treated as outpatients. The median treatment duration was 40 days, the median daily clindamycin dose was 2,400 mg, and three moderate-grade adverse events occurred. The median serum clindamycin concentrations on days 3 to 14 and days 8 to 28 were 5 and 6.2 mg/liter, respectively; the median concentration was significantly lower (P < 0.02) in patients treated with rifampin (5.3 mg/liter) than in those not treated with rifampin (8.9 mg/liter). Among 53 patients with a median follow-up of 30 months (range, 24 to 53 months), 49 (92%) were considered cured (1 patient had a relapse, and 3 patients had reinfections).

scholarly journals 110. Clinical Outcomes of Patients with Secondary Bacteremia in the Omadacycline Phase 3 Acute Bacterial Skin and Skin Structure Infections and Community-Acquired Bacterial Pneumonia Studies

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S86-S87
Author(s):  
George Sakoulas ◽  
Paul B Eckburg ◽  
Amy Manley ◽  
Evan Tzanis ◽  
Lynne Garrity-Ryan ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Treatment Duration ◽  
Bacterial Pneumonia ◽  
Clinical Success ◽  
Small Sample ◽  
Phase 3 ◽  
Skin Structure ◽  
Median Treatment ◽  
Median Treatment Duration ◽  
Common Pathogen

Abstract Background Low serum concentrations of tetracycline antibiotics may raise concerns on their efficacy in patients with secondary bacteremia, especially in comorbid patients and in those with higher acuity of illness. Omadacycline (OMC), an aminomethylcycline antibiotic, showed noninferiority to linezolid (LZD) in two acute bacterial skin and skin structure infections (ABSSSI) studies (Omadacycline in Acute Skin and skin structure Infections Study [OASIS]-1 and -2), or to moxifloxacin (MOX) in a community-acquired bacterial pneumonia (CABP) study (Omadacycline for Pneumonia Treatment In the Community study [OPTIC]). This analysis considers clinical outcomes in patients with secondary bacteremia identified in these studies. Methods Baseline blood cultures were taken from adult patients enrolled in Phase 3 randomized, double-blind clinical studies of OMC. Patients received ≥1 treatment dose: N = 1,347 ABSSSI (OMC n = 676; LZD n = 671); N = 774 CABP (OMC n = 386; MOX n = 388). Efficacy was evaluated by investigator assessment of clinical response at a post-treatment evaluation (PTE) 7–14 days (ABSSSI) or 5–10 days (CABP) after the last dose. Results Bacteremia was confirmed in 63 patients (3%) across the three studies. Staphylococcus aureus was the most common pathogen in patients with ABSSSI (N = 30: OMC n/N = 7/13; LZD n/N = 9/17), with a median treatment duration of median 9 days (OMC) and median 10 days (LZD). Streptococcus pneumoniae was the most common pathogen in patients with CABP (N = 33; OMC n/N = 11/15; MOX n/N = 11/18), with a median treatment duration of 11 days (OMC) and 14 days (MOX). Clinical success was numerically comparable between treatment groups within each study (figure) after completion of therapy. Conclusion The clinical successes of patients receiving OMC for ABSSSI or CABP with secondary bacteremia were comparable to results for LZD and MOX, respectively. Although limited by the small sample size, data from ABSSSI and CABP study patients with secondary bacteremia provide reassurance for the use of OMC. Real-world OMC data in patients with ABSSSI and CABP will be needed to assess outcomes in patients with additional comorbidities and/or higher acuity of illness. Disclosures All authors: No reported disclosures.

A first-in-human phase I/II study of HL-085, a MEK Inhibitor, in Chinese patients with NRASm advanced melanoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10047-10047
Author(s):  
Xuan Wang ◽  
Lu Si ◽  
Lili Mao ◽  
Chuanliang Cui ◽  
Zhihong Chi ◽  
...  
Keyword(s):  
Phase I ◽  
Treatment Duration ◽  
Malignant Tumors ◽  
Mek Inhibitor ◽  
Advanced Melanoma ◽  
Chinese Patients ◽  
Median Treatment ◽  
Median Treatment Duration ◽  
Anti Cancer ◽  
Cancer Activity

10047 Background: MEK inhibitors have confirmed effects on malignant tumors, especially for those induced by RAS/RAF dysfunction. There is no effective drug in clinic for NRASm advanced melanoma. HL-085 is a selective MEK inhibitor, showing good safety and efficacy in preclinical studies. This study is a phase I/II study to evaluate the safety, tolerability, pharmacokinetic and preliminary anti-cancer activity of HL-085 in patients(pts) with NRASm advanced Melanoma. Methods: The phase I/II study is conducted using a “3+3” regimen for dose escalation. The pts are treated with HL-085 at a starting dose of 0.5mg BID to 18mg BID. Adverse events (AEs) are reported per NCI CTCAE version 5.0. Preliminary anti-cancer activity is evaluated by ORR, DCR, PFS and DoR. Results: Total 33 pts were enrolled in the study. The histologic types were acral (51.4%), mucosal (27.2%) and other (21.2%). The NRAS mutation types were Q61 (72.7%), G12 (18.2%) with half for G12D, and G13 (9.1% ). Most AEs were G1 or G2, and the most common drug-related AEs were rash, increased creatine phosphokinase, peripheral edema, increased alanine aminotransferase and aspartate aminotransferase. No dose-limited toxicity was observed. PK analysis was shown linear PK profile with no obvious accumulation. Among 12 evaluable pts over 9 mg, 4 pts were at the stage of M1c with 1 liver metastasis. Average targeted tumor size was 74.6mm with the largest 184 mm. 10 pts achieved tumor shrinkage [ 60% with Q61, 20% with G12D, 10% each with G12S and G13R]. 4 pts ( 2 acral, 1 mucosal and 1 other, each pt has mutaiton type of Q61R,Q61L, Q61K and G12S respectively ) had confirmed partial response(PR) [median treatment duration 26.6 weeks (wks) with longest 47.6 wks]). 6 pts achieved stable disease (SD) (median treatment duration 15.72 wks with longest 24 wks), and 66.7% were over 14 wks . The median PFS was 17.4 wks, and confirmed best ORR was 33.3% with DCR 83.3% . Conclusions: Our data demonstrated that HL-085 is well tolerated, with manageable side-effects and promising anti-cancer activity in pts with NRASm advanced melanoma. Clinical trial information: NCT 03973151.

Workplace Satisfaction Before and After Move to an Open Plan Office - Including Interactions with Gender and Introversion

2017 ◽  
Vol 61 (1) ◽  
pp. 455-459 ◽  
Author(s):  
Nathan Bos ◽  
Kylie Molinaro ◽  
Alexander Perrone ◽  
Kelly Sharer ◽  
Ariel Greenberg
Keyword(s):  
Ad Hoc ◽  
Additional Data ◽  
Small Sample Size ◽  
Small Sample ◽  
Workplace Satisfaction ◽  
Flexible Support ◽  
Before And After ◽  
Open Plan ◽  
Data Source ◽  
Insight Into

Open plan offices are both popular and controversial. We studied the response of a group moving from shared, but closed offices to an open plan office. The main data source reported here is a workplace satisfaction survey given pre-move, post-move, and to a lab baseline comparison group at the same organization, with some additional data from observations and interviews. Workers moving to the open plan office appreciated the flexible support for collaboration and the space’s appearance. There was lower satisfaction related to space for private concentrated work, temperature control, and ability to have private conversations. There were also some statistical interactions suggesting more positive responses by males and less positive responses by introverts; analysis was limited by small sample size. Observations and interviews gave further insight into open plan “neighborhoods” and the design of ad hoc spaces.

scholarly journals Management of Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Proteasome Inhibitor Based Therapy at First Relapse in Routine Clinical Practice in Germany

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1953-1953 ◽  
Author(s):  
H. Tilman Steinmetz ◽  
Moushmi Singh ◽  
Andrea Lebioda ◽  
Aurelien Mantonnier ◽  
Leah Fink ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Practice ◽  
Treatment Duration ◽  
Employment Equity ◽  
Available N ◽  
Median Treatment ◽  
Median Treatment Duration ◽  
Refractory Multiple Myeloma ◽  
Equity Ownership ◽  
Patient Profiles

Abstract Background: Proteasome inhibitors (PI) represent an important therapeutic advance in the treatment of patients with relapsed/refractory multiple myeloma (RRMM). In 2017, three distinct PIs (bortezomib [BTZ], carfilzomib [CFZ] and ixazomib [IXA]) were available in Germany but real-world data describing their usage was scarce. Aim: To describe characteristics and treatment experience of PI-treated patients with RRMM in Germany. Methods: A national retrospective medical chart review included consecutive patients treated with at least one dose of PI-based regimen in participating hospitals/centers across Germany between January and June 2017. The following data were extracted until April 2018 or death of patient, whichever occurred first: patient demographics, disease characteristics and treatment history at diagnosis and at initiation of PI-based therapy. Physician assessed treatment response were also collected. Results: Physicians from 44 participating centers extracted 302 patient charts, including 219 patients in 2nd line (2L) and 83 in 3rd line treatment (3L), as shown in Figure 1. Results for 2L patients are described below (Table 1, Figure 2): BTZ-treated patients represented 42% of patients (n=92) with a PI-based therapy in 2L. BTZ was often combined with dexamethasone (dex) alone (77%). Median age was 74 years and 56.5% had an ECOG status ≥2 at 2L initiation. Most patients (86%) did not receive a prior transplant. Median treatment duration was 6 months among 40 patients who completed 2L; based on 38 narratives, 2L was ended as planned (47.4%). Where response was available (n=83), 25% of patients achieved a complete response/very good partial response [CR/VGPR]. Median time to next treatment (TTnT) was 7.5 months for 12 patients who moved to 3L. Patient profiles differed in terms of prior treatment exposure: 22% of patients had been treated with a BTZ-based therapy in both 1L and 2L and 62% switched therapies from 1L lenalidomide (len) to BTZ. None of the patients receiving len in 1L were transplanted. A CR/VGPR was achieved by 65% of prior BTZ-treated patients (13/20) and 30% of patients with prior len therapy (17/57). CFZ-treated patients: 48% (n=106) of patients received CFZ-based therapy in 2L. Of those, 56% (n=59) received CFZ in combination with len/dex (KRd) and 44% (n=47) with dex alone (Kd). Median age was 68 years, 60.4% had an ECOG status of 0-1 at 2L initiation and 49% had received a transplant. In 1L, 82% had received a BTZ-based regimen. Where response was mentioned (n=89), a CR/VGPR was reached in 53% of CFZ-treated patients. Median treatment duration was 6.5 months (24/106). Based on 21 narratives, the main reason for discontinuing CFZ in 2L was disease progression (47.6%). Median TTnT was 9.5 months for 10 patients who moved to 3L. The patient profiles by KRd or Kd combination were as follows: at KRd initiation, median age was 65 years, 10.2% of patients had an ECOG status ≥2 and 72.9% were transplanted. At Kd initiation, median age was 71 years, 76.6% of patients had an ECOG ≥2 and 19.1% were transplanted. IXA-treated patients (n=21) represented only 10% of PI-treated patients in 2L. Median age was 66 years, 71.4% had an ECOG status of 0-1 at 2L initiation, 33% were transplanted, and 72% had received a BTZ combination in 1L. Information on response was premature as it was only available for 13 patients with no CR reached (VGPR 77%). Median treatment duration was 4 months (n=9) and median TTnT was 10 months for 4 patients who moved into 3L. Limitation: The main limitation of the study was the sample size of IXA-treated patients due to open inclusion criteria to select patient charts. This analysis was not powered to compare between PIs. Hence, results are descriptive of the clinical experience with PI-based therapy to date and reflect current treatment practices in Germany in 2017. Conclusion: In Germany, distinct patient characteristics are observed in clinical practice by selected PI-based therapy. Patients treated with novel PI agents in 2L are generally younger and more transplanted than bortezomib-treated patients; these appear to be important considerations when tailoring therapy in RRMM. In addition, the choice between triplet or doublet therapy for CFZ-based combinations seems to reflect prior transplant status and patients' overall functional performance. Evidence suggests that use of novel PI agents such as CFZ can translate into deeper response in 2L. Disclosures Steinmetz: Amgen, Celgene, Novartis, Vifor: Research Funding; Amgen; BMS, Celgene, Hexal-Sandoz, Medice, Novartis; Janssen-Cilag; Pharmacosmos; Pfizer, Vifor; Ariad: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Alexion, Amgen, Bayer, Celgene, Janssen-Cilag, Novartis: Other: Travel grants. Singh:Amgen: Employment, Equity Ownership. Lebioda:Amgen: Employment, Equity Ownership. Mantonnier:Kantar Health: Employment, Other: Received funding to conduct this research. Fink:Kantar Health: Employment, Other: Received funding to conduct this research. Rieth:Amgen: Employment, Equity Ownership. Suzan:Amgen: Employment, Equity Ownership. Gonzalez-McQuire:Amgen: Employment, Equity Ownership.

scholarly journals Safety and efficacy of BAY1436032 in IDH1-mutant AML: phase I study results

Leukemia ◽  
2020 ◽  
Vol 34 (11) ◽  
pp. 2903-2913 ◽  
Author(s):  
Michael Heuser ◽  
Neil Palmisiano ◽  
Ioannis Mantzaris ◽  
Alice Mims ◽  
Courtney DiNardo ◽  
...  
Keyword(s):  
Treatment Duration ◽  
Overall Response Rate ◽  
Response Rate ◽  
Maximum Tolerated Dose ◽  
Dose Escalation Study ◽  
Median Treatment ◽  
Median Treatment Duration ◽  
Overall Response ◽  
Investigational Agent ◽  
Study Results

Abstract The mutant IDH1 (mIDH1) inhibitor BAY1436032 demonstrated robust activity in preclinical AML models, supporting clinical evaluation. In the current dose-escalation study, BAY1436032 was orally administered to 27 mIDH1 AML subjects across 4 doses ranging from 300 to 1500 mg twice-daily. BAY1436032 exhibited a relatively short half-life and apparent non-linear pharmacokinetics after continuous dosing. Most subjects experienced only partial target inhibition as indicated by plasma R-2HG levels. BAY1436032 was safe and a maximum tolerated dose was not identified. The median treatment duration for all subjects was 3.0 months (0.49–8.5). The overall response rate was 15% (4/27; 1 CRp, 1 PR, 2 MLFS), with responding subjects experiencing a median treatment duration of 6.0 months (3.9–8.5) and robust R-2HG decreases. Thirty percent (8/27) achieved SD, with a median treatment duration of 5.5 months (3.1–7.0). Degree of R-2HG inhibition and clinical benefit did not correlate with dose. Although BAY1436032 was safe and modestly effective as monotherapy, the low overall response rate and incomplete target inhibition achieved at even the highest dose tested do not support further clinical development of this investigational agent in AML.

Pharmacogenetics as predictor of sunitinib and mTOR inhibitors toxicity in patients with metastatic renal cell carcinoma (mRCC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4570-4570
Author(s):  
Yuksel Urun ◽  
Kathryn P. Gray ◽  
Sabina Signoretti ◽  
David F. McDermott ◽  
Michael B. Atkins ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Treatment Duration ◽  
Mtor Inhibitor ◽  
Mtor Inhibitors ◽  
European Ancestry ◽  
Wild Type ◽  
Median Treatment ◽  
Median Treatment Duration ◽  
Increased Risk ◽  
Grade 3

4570 Background: Single nucleotide polymorphisms (SNPs) in major pharmacokinetics (PK) and pharmacodynamics (PD) pathways of targeted agents may affect the incidence of drug toxicities. Methods: Germline DNA was extracted fromwhole blood or normal kidney parenchyma frommRCC pts of European ancestry in two cohorts: those treated with VEGF-targeted therapy (sunitinib) (n=159) or with an mTOR inhibitor (everolimus or temsirolimus) (n=62). Ten SNPs in 6 candidate genes: CYP3A4 (rs2242480, rs4646437, rs2246709), CYP3A5 (rs15524), ABCB1 (rs2032582, rs1045642), VEGFR2 (rs2305948), NR1I3 (rs2307424, rs2307418), FLT3 (rs1933437) were genotyped using Sequenom iPlex Gold platform. Logistic regression model tested the association of genotype variants with adverse events of 1) grade 3/4 (G3/4) toxicity and G3/4 hypertension (for sunitinib cohort) and 2) grade 3/4 toxicity and all grade pneumonitis (for mTOR inhibitors cohort), adjusted for clinical factors associated with toxicity outcomes. Results: In the sunitinib cohort, median treatment duration was 7.7 months (IQR=3-15.5), 83 (52%) pts had grade 3/4 toxicities and 22 (14%) had grade 3/4 hypertension. Rare variant (AG) of CYP3A4 rs464637 was associated with the reduced risk of grade 3/4 toxicities (4 events/17 cases) vs. wild-type (GG, 73 events/134 cases), (Odds Ratio (OR) = 0.27, 95%CI: 0.08-0.88, p=0.03). No association between SNPs and hypertension was observed. In the mTOR inhibitor cohort, median treatment duration was 3.4 months (IQR=1.4-6), 21(34%) pts had G3/4 toxicities and 27 (43%) had all grade pneumonitis. No association between SNPs and G3/4 toxicities was observed. Rare homozygote (GG) of FLT3 SNP rs1933437 was associated with increased risk of all grade pneumonitis (7 events/ 9 cases) vs. wild-type (AA, 4 events/12 cases), however, given the very small variant group size, further investigation is required to verify the association. Conclusions: The minor allele of SNP rs464637 in the gene CYP3A4 may influence sunitinib toxicity. Further validation is needed to determine if the marker could be used for in targeted therapy dosing strategies and direct patient care. (IQR=Interquartile Range).

Outcomes of second-targeted therapy for mRCC: A retrospective chart review of community practices in the United States.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 424-424
Author(s):  
Eric Jonasch ◽  
James E. Signorovitch ◽  
Peggy L. Lin ◽  
Zhimei Liu ◽  
Kenneth W. Culver ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Targeted Therapies ◽  
Treatment Duration ◽  
Dose Adjustment ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Common Reason ◽  
Median Treatment ◽  
Median Treatment Duration ◽  
Imaging Test

424 Background: Sequential use of targeted therapies has become standard practice for the treatment of metastatic renal cell carcinoma (mRCC). This study describes treatment outcomes of the 2nd-targeted therapy among patients with mRCC treated in the community setting. Methods: A retrospective chart review and survey was conducted during May through June 2012 among community-based oncologists or hematologists. Charts were reviewed for adult mRCC patients initiated on 2nd -targeted therapy on or after January 1, 2010. Abstracted data included patient demographics, disease characteristics, treatment duration, dose adjustment, progression, mortality, and imaging test patterns. Kaplan-Meier analysis was used to estimate treatment duration, overall survival (OS) and progression-free survival (PFS) during 2nd-targeted therapy. Patients were censored at the most recent contact. Results: Charts were reviewed for 433 mRCC patients. Mean age was 63 years at initial mRCC diagnosis and 64% were male. The most commonly used 2nd targeted therapies were everolimus (36% of patients), temsirolimus (17%), pazopanib (15%), and sunitinib (14%). The median duration of 2nd -targeted therapy was 10.5 months (95% CI: 8.8-11.5). The majority of patients (73%) had no dose adjustment on 2nd-targeted therapy; the most common reason for adjustment was drug toxicity (70%). Among the 44% of patients who discontinued 2nd-targeted therapy, disease progression was the most common reason for discontinuation. The proportion of patients who received imaging test within 3, 6, and 12 months after 2nd-line treatment initiation was 57%, 92%, and 99%, respectively. Routine monitoring (83%) was the most common reason for imaging tests. Median durations of OS and PFS after initiation of the 2nd-targeted therapy were 30.4 months (95% CI: 23.5-not reached) and 10.7 months (95% CI: 8.4-12.2), respectively. Conclusions: In this large, retrospective chart review study, median treatment duration of 2nd -targeted therapy was 10.5 months, median OS was 30.4 months, and median PFS was 10.7 months. Median treatment duration in community practice was longer than in clinical trials for targeted therapies in mRCC.

A usability study of taxonomy visualisation user interfaces in digital repositories

2014 ◽  
Vol 38 (2) ◽  
pp. 284-304 ◽  
Author(s):  
Paulo Alonso Gaona García ◽  
David Martín-Moncunill ◽  
Salvador Sánchez-Alonso ◽  
Ana Fermoso García
Keyword(s):  
User Interfaces ◽  
Ad Hoc ◽  
Small Sample Size ◽  
Scientific Basis ◽  
Resource Discovery ◽  
Small Sample ◽  
Digital Learning ◽  
Digital Collections ◽  
Content Type ◽  
Visual Interfaces

Purpose – This paper aims to analyse user interfaces for search and collection visualisation and navigation from a usability perspective. The final aim is to offer repository owners a scientific basis to support their decisions when they have to choose an interface that can really help users to effectively locate and visualise resources over large digital collections. Design/methodology/approach – This HCI study is divided into two parts: perception and usability. The first one analysed three perceptual abilities required to use interfaces: attention, retention of information and understanding. The second one was run on an ad hoc generated collection including more than 40,000 European digital resources collected and classified according to a given branch of knowledge in the Art & Architecture Thesaurus. Findings – Although visual interfaces proved useful for certain tasks related to resource discovery and search, and despite the overall good general user opinion, the authors found it necessary to conduct another thorough study to know more about the target users and the amplitude of the collection, as well as to determine the ideal type of interface to implement. All these factors are important for increasing user acceptance and avoiding unnecessary implementation costs. Research limitations/implications – This research was run on a relatively small sample size of users from Spain and Latin America, which may not be representative of the general population. In similar studies previous knowledge about usability has been reported to introduce bias in the results, so the authors tried to avoid this when selecting the participants. Originality/value – There are no previous usability studies for the development and implementation of interfaces in digital learning or cultural repositories. The authors' experience highlights the importance of addressing usability aspects a priori, to prevent users from ceasing to use visual interfaces over time, because they do not perceive any benefit from using them.

scholarly journals Real-World Treatment Patterns and Transfusion Burden Among US Patients with Newly Diagnosed Myelodysplastic Syndromes (MDS)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3499-3499
Author(s):  
Sudipto Mukherjee ◽  
S. Lane Slabaugh ◽  
Ronda Copher ◽  
Jonathan Johnson ◽  
Paul Buzinec ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Treatment Duration ◽  
Research Funding ◽  
Index Date ◽  
Treatment Patterns ◽  
Newly Diagnosed ◽  
Advisory Committees ◽  
Median Treatment ◽  
Medical Claims ◽  
Median Treatment Duration

Introduction: Symptomatic anemia transfusion support represents a significant problem for patients with MDS. The principal strategy in managing these patients remains supportive care with erythropoiesis-stimulating agents (ESAs) and red blood cell (RBC) transfusions. However, there is paucity of real-world data regarding patterns of use of ESA and other therapies, and its impact on transfusion needs in these patients early in their clinical course. To address this question, we performed a retrospective claims-based study to characterize treatment patterns and transfusion burden in patients with MDS. Methods: In this retrospective claims analysis of a large national health insurance plan, all patients aged ≥ 18 years with newly diagnosed MDS (≥ 2 medical claims with an International Classification of Diseases, 9th or 10th Revision [ICD-9 or ICD-10] diagnosis codes ≥ 30 days apart) identified between January 2012 and May 2018 were included. Index date was defined as date of first diagnosis. Continuous health plan enrollment for ≥ 6 months pre- and 3 months post-index date was required. RBC transfusion status was evaluated during the 16 weeks prior to first diagnosis as well as 16 weeks prior to and immediately following line of therapy (LOT) 1 and LOT2. Transfusion burden categories were adapted and modified from the proposed International Working Group 2018 revised criteria (Platzbecker U, et al., Blood. 2019;133(10):1096-1107). Categories included transfusion independence (TI), defined as patients receiving no transfusions during the observation period; low (LTB), moderate (MTB), and high transfusion burden (HTB) were defined by patient's having 1-3, 4-7, and ≥ 8 unique dates for a transfusion during the observation periods, respectively. Therapies in each LOT were captured using pharmacy and medical claims data. The end of a LOT was defined after ≥ 60-day gap in therapy, a claim for any new or additional MDS therapy, or patient death; LOT durations are described for non-censored patients. Results: Among the 3,587 patients identified (mean age = 74.9 years, 44.3% female), transfusion burden during 16 weeks prior to index was: 78.8% TI, 19.2% LTB, 1.9% MTB, and 0.2% HTB. Among the 1,935 patients who received LOT1, transfusion burden in the 16 weeks preceding LOT1 was: 57.0% TI, 36.3% LTB, 5.6% MTB, and 1.1% HTB. The top 5 regimens in LOT1 were ESA monotherapy (61.9%), hypomethylating agent (HMA) monotherapy (19.2%), white blood cell growth factor (WBCGF) monotherapy (3.5%), immunomodulators (3.3%), and HMA + ESA (2.7%) (Figure). Of 824 patients who received LOT2, transfusion burden prior to LOT2 was: 49.4% TI, 28.6% LTB, 16.5% MTB, and 5.5% HTB. The top 5 regimens in LOT2 were ESA monotherapy (44.2%), HMA monotherapy (12.1%), HMA + ESA (9.2%), WBCGF + ESA (6.9%), and WBCGF monotherapy (6.4%) (Figure). In LOT1, the median treatment duration for ESA monotherapy was 2.8 months (mean = 5.2 months, standard deviation [SD] = 6.8) whereas in LOT2, the median treatment duration was 2.0 months (mean = 3.7 months, SD = 5.0). Amongst patients receiving ESA monotherapy as LOT2, 90.4% had prior ESA monotherapy as LOT1. In patients treated with HMA monotherapy in LOT1 that also experienced a LOT2, 39.1% moved on to a variety of LOT2 regimens (Table), while in 15.5% ESAs were combined with HMA (Table). Conclusions: Our results show that at the time of diagnosis, 20% of MDS patients were transfusion dependent, but up to 50% require treatment. The high rate of ESA use is likely due to anemia-related symptoms. In those treated with ESA monotherapy, approximately 50% have a LOT1 duration that is &lt; 3 months, and interestingly, the majority of patients restart a second LOT with an ESA as the most common regimen. Additional analyses are necessary to determine whether this indicates a switch in ESA agent, escalation in dose of prior ESA, treatment cycling due to elevated hemoglobin, or other reasons. Considering the short median treatment duration and worsening of transfusion dependency beyond first line, there remains a high unmet need for MDS therapy that more effectively slows the progression of transfusion dependence. Disclosures Mukherjee: Bristol-Myers Squibb: Speakers Bureau; Takeda: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Projects in Knowledge: Honoraria; Celgene Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Partnership for Health Analytic Research, LLC (PHAR, LLC): Consultancy; McGraw Hill Hematology Oncology Board Review: Other: Editor. Slabaugh:Celgene Corporation: Employment, Equity Ownership. Copher:Celgene Corporation: Employment. Johnson:Optum: Employment; Celgene Corporation: Consultancy. Buzinec:Optum: Employment. Mearns:Celgene Corporation: Employment.

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