scholarly journals Increased Productivity and Efficiency Among Cancer Center Clinical Trials Workforce during the COVID-19 Pandemic

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 41-42
Author(s):  
Kimberly C Jenkins ◽  
Emily C Zabor ◽  
Lindsey A. R. Mooney ◽  
Aaron T. Gerds ◽  
Kerry O'Hop ◽  
...  
Keyword(s):  
Research Funding ◽  
Data Entry ◽  
Median Number ◽  
Working At Home ◽  
Hours Worked ◽  
Work From Home ◽  
Time Period ◽  
Number Of Patients ◽  
Significant Difference ◽  
At Home

Background: Independent of the SARS-CoV-2 pandemic, we developed a pilot program tracking productivity allowing research coordinators (RCs) to work from home. However, with the pandemic's onset all RCs were ordered to work from home starting March 25, 2020. Simultaneously, all in-person clinical trial site monitoring visits were prohibited, forcing sponsors to either halt research monitoring operations (10%) or adapt to remote monitoring (90%). We analyzed the productivity and efficiency of RCs during at home days versus in office days to better understand the impact of the pandemic on clinical trial operations. Methods: During this study period, RCs performed daily productivity tracking in a RedCap database, whether at the office or at home. Productivity was defined as total data fields entered; efficiency was defined as data fields entered in a given time period. Continuous variables were summarized using the median and interquartile range (IQR). To account for the fact that the data are clustered by RC, comparisons between working location were made using a logistic regression model with a random intercept for RC. A p-value <.05 was considered statistically significant. RCs who entered values incorrectly or who entered/exited the team during the tracking period were excluded. The data entry work was also categorized into 16 distinct disease groups for analysis. Results: There were 2,369 observations recorded by 58 RCs between March 2 and June 29, 2020. RCs spent a median of 2.75 hours (IQR 1.50-4.00) performing data entry at home, compared to a median of 3.00 hours (IQR 2.00-5.25) performing data entry in the office (P=.5). All 58 RCs recorded a total of 17,966 hours over 81 days working at home, where 24 of the RCs recorded a total of 1,169 hours over 69 days working from the office (Tables 1 and 2). For all disease groups, the median number of hours worked by RCs from home and the office were 8.00 (IQR 7.92-8.10) and 8.50 (IQR 7.91-10.00), respectively (P=.046). On average, RCs entered significantly more data fields at home (95.5, IQR 32-240) compared to at the office (75, IQR 35-145, P<.001). There was no significant difference in the number of patients for whom data were entered. There was a trend towards an increase in the median number of data fields entered per hour from home (40, IQR 20-72) compared to the office (21, IQR 13-36, P=.064, Tables 3 and 4). Among the hematology group, the median number of hours worked by RCs from home and the office were 8.00 (IQR 7.90-8.05) and 8.02 (IQR 7.92-8.36), respectively (P=.1). The median number of data fields entered by RCs from home and the office were 150 (IQR 47-336) and 74 (IQR 41-164), respectively (P<.001), and the median number of data entry hours for RCs from home and the office were 3.50 (IQR 2-5) and 2.62 (IQR 1.56-3), respectively (P=.004). There was no significant difference in the number of patients for whom data were entered or the number of data fields per hour. Among the solid tumor group, the median number of hours worked by RCs from home and the office were 8.00 (IQR 7.95-8.18) and 9.87 (IQR 7.87-10), respectively (P=.2). There was no significant difference in the number of data fields entered, the number of data entry hours, nor the number of data fields entered per hour. Hematology RCs completed a median of 150 (IQR 47-329) data fields per day while the solid tumor RCs completed a median of 65 (IQR 25-159) data fields per day. The multiple myeloma and leukemia groups completed the most data fields per day, 320 (IQR 200-650) and 202 (IQR 58.5-390), respectively (Tables 5 and 6). Total median time spent on data entry and total median time spent on all other tasks was 2.98 hours and 5.28 hours respectively, meaning 36% of an RCs work was comprised of data entry tasks. With the hematology research RCs bearing the brunt of the data entry workload, per hour, RCs completed nearly double the average amount of data fields when at home (40, IQR 20-72 vs 21, IQR 13-36). This translates into RCs being 17% more efficient overall when working at home. Conclusions: A silver lining to the SARS-CoV-2 pandemic includes increased data entry by RCs, and virtual monitoring and site initiation visits by sponsors and contract research organizations. These have created efficiencies including a greater number of trials opened and a reduction in trial times to open, when compared to a similar time period in 2019. Preliminary employee satisfaction surveys also reveal a high degree of satisfaction when working from home. Disclosures Gerds: Apexx Oncology: Consultancy; Imago Biosciences: Research Funding; AstraZeneca/MedImmune: Consultancy; Roche/Genentech: Research Funding; Gilead Sciences: Research Funding; Incyte Corporation: Consultancy, Research Funding; Sierra Oncology: Research Funding; Celgene: Consultancy, Research Funding; Pfizer: Research Funding; CTI Biopharma: Consultancy, Research Funding. Pennell:Cota: Consultancy; Eli Lilly: Consultancy; Amgen: Consultancy; Genentech: Consultancy; Merck: Consultancy; Astrazeneca: Consultancy; BMS: Consultancy; G1 Therapeutics: Consultancy; Inivata: Consultancy. Sekeres:Takeda/Millenium: Consultancy; BMS: Consultancy; Pfizer: Consultancy.

scholarly journals Impact of Induction Treatment on Stem Cell Collection: A COVID Related Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4848-4848
Author(s):  
Brad Rybinski ◽  
Ashraf Z. Badros ◽  
Aaron P. Rapoport ◽  
Mehmet Hakan Kocoglu
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Research Funding ◽  
Median Number ◽  
Cell Transplant ◽  
Cd34 Cells ◽  
Significant Difference ◽  
Number Of Cycles ◽  
Time Required ◽  
Stem Cell Collection

Abstract Introduction: Standard induction therapy for multiple myeloma consists of 3-6 cycles of bortezomib, lenalidomide, and dexamethasone (VRd) or carfilzomib, lenalidomide and dexamethasone (KRd). Receiving greater than 6 cycles of a lenalidomide containing regimen is thought to negatively impact the ability to collect sufficient CD34+ stem cells for autologous stem cell transplant (Kumar, Dispenzieri et al. 2007, Bhutani, Zonder et al. 2013). Due to the COVID-19 pandemic, at least 20 patients at University of Maryland Greenebaum Comprehensive Cancer Center (UMGCC) had transplant postponed, potentially resulting in prolonged exposure to lenalidomide containing induction regimens. Here, in the context of modern stem cell mobilization methods, we describe a retrospective study that suggests prolonged induction does not inhibit adequate stem cell collection for transplant. Methods: By chart review, we identified 56 patients with multiple myeloma who received induction with VRd or KRd and underwent apheresis or stem cell transplant at UMGCC between 10/1/19 and 10/1/20. Patients were excluded if they received more than 2 cycles of a different induction regimen, had a past medical history of an inborn hematological disorder, or participated in a clinical trial of novel stem cell mobilization therapy. We defined 1 cycle of VRd or KRd as 1 cycle of "lenalidomide containing regimen". In accordance with routine clinical practice, we defined standard induction as having received 3-6 cycles of lenalidomide containing regimen and prolonged induction as having received 7 or more cycles. Results: 29 patients received standard induction (Standard induction cohort) and 27 received prolonged induction (Prolonged induction cohort) with lenalidomide containing regimens. The median number of cycles received by the Standard cohort was 6 (range 4-6), and the median number of cycles received by the Prolonged cohort was 8 (range 7-13). The frequency of KRd use was similar between patients who received standard induction and prolonged induction (27.58% vs. 25.93%, respectively). Standard induction and Prolonged induction cohorts were similar with respect to clinical characteristics (Fig 1), as well as the mobilization regimen used for stem cell collection (p = 0.6829). 55/56 patients collected sufficient stem cells for 1 transplant (≥ 4 x 10 6 CD34 cells/kg), and 40/56 patients collected sufficient cells for 2 transplants (≥ 8 x 10 6 CD34 cells/kg). There was no significant difference in the total CD34+ stem cells collected at completion of apheresis between standard and prolonged induction (10.41 and 10.45 x 10 6 CD34 cells/kg, respectively, p = 0.968, Fig 2). Furthermore, there was no significant correlation between the number of cycles of lenalidomide containing regimen a patient received and total CD34+ cells collected (R 2 = 0.0073, p = 0.5324). Although prolonged induction did not affect final stem yield, prolonged induction could increase the apheresis time required for adequate collection or result in more frequent need for plerixafor rescue. There was no significant difference in the total number of stem cells collected after day 1 of apheresis between patients who received standard or prolonged induction (8.72 vs. 7.96 x 10 6 cells/kg, respectively, p = 0.557). However, patients who received prolonged induction were more likely to require 2 days of apheresis (44% vs. 25%, p = 0.1625) and there was a trend toward significance in which patients who received prolonged induction underwent apheresis longer than patients who received standard induction (468 vs 382 minutes, respectively, p = 0.0928, Fig 3). In addition, longer apheresis time was associated with more cycles of lenalidomide containing regimen, which neared statistical significance (R 2 = 0.0624, p = 0.0658, Fig 4). There was no significant difference between standard and prolonged induction with respect to the frequency of plerixafor rescue. Conclusions: Prolonged induction with lenalidomide containing regimens does not impair adequate stem cell collection for autologous transplant. Prolonged induction may increase the apheresis time required to collect sufficient stem cells for transplant, but ultimately clinicians should be re-assured that extending induction when necessary is not likely to increase the risk of collection failure. Figure 1 Figure 1. Disclosures Badros: Janssen: Research Funding; J&J: Research Funding; BMS: Research Funding; GlaxoSmithKline: Research Funding.

Impact of Molecular Mutations on Treatment Response to Hypomethylating Agents in MDS

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 461-461 ◽  
Author(s):  
Fabiola Traina ◽  
Anna M Jankowska ◽  
Valeria Visconte ◽  
Yuka Sugimoto ◽  
Hadrian Szpurka ◽  
...  
Keyword(s):  
Treatment Response ◽  
Predictive Value ◽  
Research Funding ◽  
Myeloproliferative Neoplasms ◽  
Progression Free Survival ◽  
Predictive Biomarker ◽  
Median Number ◽  
Categorical Variables ◽  
Hypomethylating Agents ◽  
Significant Difference

Abstract Abstract 461 Aberrant DNA methylation is a hallmark of myelodysplastic syndromes (MDS), MDS/myeloproliferative neoplasms (MDS/MPN) and secondary acute myeloid leukemia (sAML). It provides a rationale for treating these malignancies with hypomethylating agents like 5-azacitidine (AZA) and decitabine (DAC). However, treatment outcomes remain limited and heavily weighed on morphologic/cytogenetic results. The discovery of novel mutations has provided important insight into the pathogenesis of MDS and related disorders. Genes implicated in epigenetic regulation, including DNMT3A, TET2, IDH1/IDH2, EZH2, ASXL1 and UTX have been found mutated in MDS, while others have also been implicated in MDS pathogenesis. There is limited data on the predictive value of these genetic defects for treatment response and disease outcome. We hypothesized that these defects are important biomarkers predictive of response to hypomethylating agents. We studied 88 patients with MDS (RCUD=2, RARS=6, RCMD=11, MDS-U=3, RAEB-1/2=29, CMML1/2=16, MDS/MPN-U=5, RARS-T=5, AML from MDS=11) who received hypomethylating agents (AZA=53, DAC=24, both=11). The median number of cycles was 7 [range 1–35], median age was 69 years (range 42–82) and median follow-up was 18 months (range 0–76). Responses were scored according to IWG criteria. DNMT3A, TET2, IDH1/2, EZH2, ASXL1, UTX, KRAS, NRAS, CBL, RUNX1, TP53 and SF3B1 were sequenced using standard techniques. Categorical variables were analyzed using Chi-square statistics. Overall survival (OS) was analyzed using Kaplan-Meier; p-values ≤ 0.05 were considered statistically significant. Mutated patients were older than wild type (WT) cases (72 vs. 68 years, p=.01) but were well matched for marrow blast %, cytogenetic risk group and cycles of hypomethylating agents received. We found mutations in 40/88 (45%) patients. Mutations were most frequent in SF3B1 (6/11; 55%), ASXL1 (13/50; 26%), TET2 (18/88; 20%), KRAS (3/34; 9%), and DNMT3A (7/88; 8%). Less common were mutations in EZH2 (2/43; 5%), TP53 (1/23; 4%), IDH1 (4/88; 5%), IDH2 (3/88; 3%), and UTX (1/36;3%). No mutations were found in CBL, NRAS or RUNX1. Based on single mutations, overall response rate (ORR) was higher in mutated vs WT patients for DNMT3A (6/7 [86%] vs 33/81 [41%]; p=.02), ASXL1 (11/13 [85%] vs 14/37 [38%]; p=.003), and TET2 (12/18 [67%] vs. 27/70 [39%]; p=.03). All heterozygous DNMT3A mutants responded to hypomethylating agents. Differences remained significant when stratified to AZA treatment alone for DNMT3A (6/7 [86%] vs 21/56 [38%]; p=.01) and ASXL1 (9/11 [82%] vs 12/29 [41%]; p=.02) but not TET2 (6/10 [60%] vs 21/53 [40%]; p=0.22). The predictive value of combined mutations were analyzed for DNMT3A, TET2 and/or IDH1/2, showing better response to hypomethylating therapy in patients who had a mutation; ORR (mutated: 18/28 (64%) vs WT: 21/60 (35%); p=.01). This difference remained significant in patients receiving only AZA (n=53); ORR was 11/18 (61%) in mutant and 11/35 (31%) in WT patients (p=.03). No differences in ORR were noted for KRAS, EZH2 and IDH1/2 mutant and WT patients. No SF3B1 mutants responded to treatment while both patients with UTX and TP53 mutations responded. The frequency of AML evolution was also analyzed and showed no difference between mutant and WT cases for TET2 (7/18 [39%] vs 22/70 [31%];p=.52), ASXL1 (4/10 [40%] vs 11/35 [31%]; p=.61), and DNMT3A (3/7 [43%] vs 26/81 [32%];p=.56). No differences in OS and progression free survival (PFS) were noted between responders and non-responders to hypomethylating therapy (28 vs 17 mos, p=.25; 16 vs 8 mos, p=.54). Comparison of survival outcomes for mutant and WT patients showed no significant difference for DNMT3A (OS: 30 vs 21 mos, p=0.43; PFS: 20 vs 11, p=.53), ASXL1 (OS: 28 vs 22, p=.68; PFS: 16 vs 10, p=.88), and TET2 (OS: 30 vs 20 mos, p=.30). PFS was better in TET2 mutants compared to WT (19 vs 9, p=.03). No survival differences were noted between mutant and WT cases who responded to hypomethylating agents for DNMT3A (OS: 25 vs 28,p=.84; PFS: 14 vs 16, p=.78), ASXL1 (OS: 10 vs 18, p=.48; PFS: 10 vs 6, p=.76) TET2 (OS: 27 vs 16, p=.79; PFS: 18 vs10, p=.19). In conclusion, DNMT3A, ASXL1 and TET2 mutations were independently associated with a better response to hypomethylating drugs. Moreover, combined mutations in DNMT3A/TET2/IDH1/IDH2 may influence the response to hypomethylating agents, especially AZA supporting its role as a predictive biomarker in MDS treatment. Disclosures: Maciejewski: Celgene and Eisai, NIH, AA&MDS Foundation: Research Funding. Tiu:MDS Foundation Young Investigator Award: Research Funding.

Simultaneous care in Italy’s Veneto Region Health District 8: Integrated assistance to provide better outcomes in end-of-life care.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19595-e19595
Author(s):  
Fabio Girardi ◽  
Paola Paiusco ◽  
Paolo Manente ◽  
Michela Bortolin ◽  
Maria Grazia Ruggeri ◽  
...  
Keyword(s):  
Palliative Care ◽  
Advanced Cancer ◽  
Hospital Admissions ◽  
Palliative Care Unit ◽  
Health District ◽  
Care Plan ◽  
Veneto Region ◽  
Time Period ◽  
Number Of Patients ◽  
At Home

e19595 Background: The number of cancer patients requiring active treatment and palliation for symptoms relief is progressively increasing, due to the possibility to significantly prolong survival even in persons affected by metastatic disease. Italian Board of Health, within the National Oncological Plan 2010-2012, gave “simultaneous care” the recognition as the most qualified model to ensure the best result regarding life expectation, quality of life, adherence to therapies. Methods: In Italy’s veneto region health district 8 a unit dedicated to palliative care works in cooperation with oncology clinic, medical wards, general practitioner, social services; periodical meetings are scheduled to review all the requests; each patient is given a multidimensional evaluation, to assess the care needs. The Unit is able to provide a daily home-care, with total parenteral nutrition if needed, management of infusional devices, invasive procedures such as paracentesis, in order to minimize the number of intervening hospital admissions. We considered the percentage of patients who received a simultaneous care approach between 2008 and 2010, the number of patients who died at home or in a hospice, the average time-period of care, the number of elapsing hospital admissions. Results: In 2008 268 new patients received assistance by the Palliative Care Unit, 273 new patients in 2009 and 434 new patients in 2010; 82 (31,3%), 70 (25,6%) and 111 (25,6%) were affected by advanced cancer, respectively; in 2008 208 patients out of 262 (79,4%) died at home or in a hospice, in 2009 224 patients out of 273 (82,1%), in 2010 376 patients out of 434 (86,7%); in 2008 the average time-period of care was 93 days (calculated as the ratio between the total number of days of assistance to patients as a whole and the number of patients), 88 days in 2009; in 2008 the average number of intervening hospital admissions was 0,26 (calculated as the ratio between the number of admissions and the number of patients), 0,28 in 2009. Conclusions: Our data show that the earlier the patient affected by advanced cancer is evaluated by Palliative care Unit, the higher is the likelihood to develop an adequate home- or hospice-base care plan.

scholarly journals Data on an Austrian Company's Productivity in the Pre-Covid-19 Era, During the Lockdown and After Its Easing: To Work Remotely or Not?

2021 ◽  
Vol 6 ◽  
Author(s):  
Michal Beno ◽  
Jozef Hvorecky
Keyword(s):  
Home Schooling ◽  
Academic Standards ◽  
Online Surveys ◽  
Home Office ◽  
Working At Home ◽  
Service Employees ◽  
Work From Home ◽  
The Face ◽  
Three Stages ◽  
At Home

The Covid-19 crisis across the world has increased the proportion of e-working. The transition from cubicles to the home office raised many questions in connection with companies adopting the new working conditions. Our paper provides recent evidence on the extent of this move, its impact on workplace evolution, productivity and the future prevalence of the face-to-display workplace after the easing of the lockdown. It uses data from 154 service employees of an Austrian sports and leisure product company obtained using online surveys on employees' opinions on e-working. By a coincidence, we conducted the first of them shortly prior to the epidemic. We decided to modify our planned research goals and decided to study their opinions during different Covid-19 stages. As a result, our findings do not follow all the academic standards. First, they are almost impossible to replicate due to the specific coincidence. Then, the shift in our aims leads us to minor changes in the content of the questionnaire. There are not only significant differences in the proportion of workers in the office and at home during the different periods of the lockdown. After its end, there was a significant increase in the number of those who had started working at home—more than one half. Compared to the period prior to the lockdown, they have a tolerant attitude to their work from home and believe that their productivity might remain the same. For many of them the change was an unavoidable obligation so they would prefer to return to the traditional workplace. The results suggest that more than one fifth want to continue working from home permanently, about one third more frequently than before, more than a quarter sometimes and just one seventh not at all. We studied the issues related to their productivity and its limits during all three stages. There are three important reasons for the fall in productivity related to e-working: (1) Providing childcare/home schooling, pet sitting and/or care for others while working (>one-fourth); (2) Work-from-home routine (>one-fourth); and (3) Having less work to do (>one-fifth).

Comparing the outcomes of noninferiority (NI) and superiority phase III trials.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e13055-e13055
Author(s):  
Everardo D. Saad ◽  
Marc E. Buyse
Keyword(s):  
Progression Free Survival ◽  
Median Number ◽  
Phase Iii ◽  
Experimental Therapy ◽  
Tumor Type ◽  
Margin Width ◽  
Number Of Patients ◽  
Significant Difference ◽  
Phase Iii Trials ◽  
Superiority Trials

e13055 Background: We compared the outcomes of NI and superiority trials on advanced breast cancer (BC), non-small-cell lung cancer (NSCLC), and colorectal cancer (CRC). Methods: We searched PubMed for phase III trials on systemic antineoplastic treatments for advanced BC, NSCLC and CRC published between 1/1998 and 12/2009 in 11 leading journals. We categorized primary endpoints (PEP) as time-to-event (overall survival or any variant of progression-free survival), response rate, or other (quality of life or toxicity). We used the PEP (defined as the one stated explicitly, used for N calculation, or cited first) to ascertain trial positivity. Results: We retrieved a total of 262 trials (93 on BC, 102 on NSCLC, and 67 on CRC), 36 of which (13.7%) used a NI design (12 in each tumor type). There was no significant trend in the proportion of NI trials in the two 6-year periods compared (1998-2003 vs 2004-9). The median number of patients/arm for NI and superiority trials were 284 and 164, respectively (p<0.001). There was no significant difference in the distribution of the PEP categories between NI and superiority trials. We could ascertain trial positivity in all but six trials: 24 (66.7%, 95% confidence interval [CI], 49.1% to 81.2%) NI trials were positive, compared with 89 (39.4%, 95% CI, 33.0% to 46.1%) superiority trials (p<0.001). NI trial positivity could be determined by finding a CI for the estimated treatment effect that excluded the NI margin in 15 of 27 trials (otherwise, positivity was based on authors’ conclusions, or the experimental therapy was superior to control for the PEP). The overall rates of trial positivity varied across tumor types: 48.4% for BC, 31.4% for NSCLC, and 53.7% for CRC (p=0.002). When adjusted for trial size, NI design (vs. superiority; odds ratio [OR]=4.2; 95% CI, 1.7 to 10.3) and tumor type (BC [OR=2.2; 95% CI, 1.2 to 4.0] and CRC [OR=2.8; 95% CI, 1.4 to 5.5] vs. NSCLC as reference) remained significantly associated with trial positivity. Conclusions: NI trials are more likely than superiority trials to yield positive results. The influence of NI margin width on trial results should be investigated.

Working at Home

2008 ◽  
pp. 3229-3245
Author(s):  
Tracy L.M. Kennedy
Keyword(s):  
Business Organizations ◽  
Working At Home ◽  
Effective Work ◽  
Work From Home ◽  
Organizational Perspective ◽  
The Social ◽  
Household Members ◽  
Work Family ◽  
The Relationship ◽  
At Home

This chapter explores the work-family interface by investigating home as a potential work space that must still accommodate the social and leisure needs of household members. By examining spatial patterns of household Internet location, this chapter investigates the prevalence of paid work in Canadian homes, illustrates how household spaces are reorganized to accommodate the computer/Internet, and examines how the location of Internet access is situated within sociocultural contexts of the household and how this might affect potential work-from-home scenarios. Data collected from a triangulation of methods—surveys, interviews and in-home observation—also illustrate the relevance of household Internet location from an organizational perspective. The relationship between individuals and business organizations is interactive and integrative, and the home workplace is complex and blurred with other daily social realities, which influence effective work-at-home strategies and potentially shapes productivity and efficiency.

Working at Home

2007 ◽  
pp. 257-279
Author(s):  
Tracy L.M. Kennedy
Keyword(s):  
Business Organizations ◽  
Working At Home ◽  
Effective Work ◽  
Work From Home ◽  
Organizational Perspective ◽  
The Social ◽  
Household Members ◽  
Work Family ◽  
The Relationship ◽  
At Home

This chapter explores the work-family interface by investigating home as a potential work space that must still accommodate the social and leisure needs of household members. By examining spatial patterns of household Internet location, this chapter investigates the prevalence of paid work in Canadian homes, illustrates how household spaces are reorganized to accommodate the computer/Internet, and examines how the location of Internet access is situated within sociocultural contexts of the household and how this might affect potential work-from-home scenarios. Data collected from a triangulation of methods—surveys, interviews and in-home observation—also illustrate the relevance of household Internet location from an organizational perspective. The relationship between individuals and business organizations is interactive and integrative, and the home workplace is complex and blurred with other daily social realities, which influence effective work-at-home strategies and potentially shapes productivity and efficiency.

Cost Analysis of Stored Autologous Peripheral Blood Stem Cells for a Second Autologous Transplantation in Multiple Myeloma Patients: A Markov Model

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1184-1184
Author(s):  
Anca Prica ◽  
Vinita Dhir ◽  
Nuchanan Areethamsirikul ◽  
Christine Chen ◽  
Donna Reece ◽  
...  
Keyword(s):  
Stem Cells ◽  
Multiple Myeloma ◽  
Stem Cell ◽  
Cost Analysis ◽  
Research Funding ◽  
Median Number ◽  
Time Period ◽  
The Mean ◽  
The Cost ◽  
Cell Storage

Abstract Background: Autologous stem cell transplantation (ASCT) is a standard part of first-line therapy for pts <70 years of age with multiple myeloma. If remission length is ≥ 2 years, our policy is to offer a salvage transplant upon relapse if the patient is eligible. Many centers, including ours, collect adequate CD34+ cells for two transplantations, as there is concern for poor mobilization post-therapy, including lenalidomide. However, no good data truly quantifies this rate, given plerixafor availability. The advent of novel therapies has reduced the use of second salvage ASCT (ASCT2), and the prolonged storage of cryopreserved stem cells imposes a significant economic burden. We performed a cost analysis to compare the cost of mobilizing and storing stem cells for ASCT2 in all patients versus remobilizing and collecting for ASCT2 upon relapse in eligible patients. Methods: We developed a Markov decision-analytic model to compare the two strategies in a hypothetical cohort of 60 year old patients newly-diagnosed with multiple myeloma. The model simulates the clinical course of 10,000 patients over a 10 year time horizon, with the end point of costs per patient per strategy. Baseline probabilities were derived from published studies as well as analysis of multiple myeloma patients who underwent ASCT1 at Princess Margaret Cancer Centre between January 2003 and December 2012. Key health states include probability of progression (pPD) and death in the 1st 2 years post-ASCT1, pPD >2 years post-transplantation, probability of having an ASCT2 upon relapse vs. a non-ASCT approach. Direct costs were collected from a Canadian public health payer's perspective. Costs were obtained from hospital and provincial databases, as well as the literature and presented in 2016 Canadian dollars. Key costs collected were the cost of mobilization for 2 transplants vs. 1, the cost of remobilization and the cost of stem cell storage. Costs were discounted at 3%. All patients were assumed ASCT2 eligible at relapse. In the re-mobilization arm, all patients were successfully remobilized, with an assumed >50% rate of plerixafor use. Results: 938 patients underwent ASCT1 at Princess Margaret Cancer Centre during this time period, with stem cells stored for a salvage transplant. The mean age of transplanted patients at ASCT1 was 58.4 yrs. The mean number of aphaeresis days required to collect enough cells for 2 stem cell transplants was 1.53 days. The calculated mean aphaeresis days required to collect for 1 transplant was 1.15 days. The median number of bags processed for 2 ASCT was 4, as such, after ASCT1, the median number of bags stored per person was 2. 74 patients (7.9%) underwent ASCT2 over the 10 year period. Most (73%) occurred early, 2-5 yrs post-ASCT1, with only 27% beyond this time period. Over the 10 yr horizon, the total mobilization and storage cost of the stored stem cells strategy was C$9702, versus C$7229 for the re-mobilization strategy, thus storing stem cells for a potential ASCT2 costs an extra C$2473 per patient. Our centre collects such stem cells in >100 pts/yr, at a cost of approximately $250,000. The model was robust to one-way sensitivity analyses of all variables. Storing stem cells only becomes the less costly strategy if the storage costs are less than C$125/6mo or C$10/bag/month (figure 1). Conclusions: The use of salvage ASCT for patients who sustain at least a 2 yr remission with their first is low (less than 10%), and it is associated with significant costs to the system unless the costs of stem cell storage are minimal. With the availability of plerixafor, the cost savings would justify a re-mobilization approach for the minority of patients that are eligible for a salvage ASCT. Figure 1 Figure 1. Disclosures Prica: Janssen: Honoraria; Celgene: Honoraria. Chen:Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Takeda: Research Funding. Reece:Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Merck: Research Funding; Novartis: Honoraria, Research Funding; Otsuka: Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; BMS: Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding. Trudel:Glaxo Smith Kline: Honoraria, Research Funding; Celgene: Honoraria; Novartis: Honoraria; Oncoethix: Research Funding. Tiedemann:Takeda Oncology: Honoraria; Celgene: Honoraria; Janssen: Honoraria; Novartis: Honoraria; Amgen: Honoraria; BMS Canada: Honoraria. Kukreti:Celgene: Honoraria; Lundbeck: Honoraria; Amgen: Honoraria.

Stratified Intense-Dose- Yttrium-90 Ibritumumab Tiuxetan (90YIT ) with Bendamustine+Fludarabine Nonmyeloablative Conditioning for Allogeneic Stem Cell Transplantation in b-Cell Malignancies

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 662-662
Author(s):  
Issa F. Khouri ◽  
Bill Erwin ◽  
Alison M Gulbis ◽  
Francesco Turturro ◽  
S Cheenu Kappadath ◽  
...  
Keyword(s):  
Cord Blood ◽  
Research Funding ◽  
Conditioning Regimen ◽  
Median Number ◽  
Whole Body ◽  
Fixed Dose ◽  
Patient Specific ◽  
Organ Doses ◽  
Significant Difference

Abstract Background: Nonmyeloablative allogeneic transplantation has the potential to induce long-term remissions in patients with relapsed lymphoma. However, a non-intense conditioning regimen enhances the risk of early relapse. Anti-CD20 antibody radioimmunotherapy (90YIT) delivers radiation dose not only to the tumor cells that bind the antibody but also to inaccessible neighboring cells as a result of the cross-fire effect. Thus, we hypothesized that the addition of escalated 90YIT dose to the recently published bendamustine+fludarabine conditioning regimen (Khouri et al. Blood 2014) would facilitate early cytoreduction in such patients and promote improved long-term disease control by the allogeneic graft. Organ doses from a 90YIT weight-based activity prescription (mCi/kg) vary considerably, which justifies a dosimetry-based strategy for mCi/kg escalation. Methods and patients: On days -22 and -14, rituximab was given at 250 mg/m2 preceding 111In ibritumumab and 90YIT administration, respectively. Organ dosimetric assessment was performed based on serial 111In ibritumumab whole body scanning (0, 4, 24, 72 and 144 hours) , to select from among five 90YIT mCi/kg prescriptions (0.5, 0.75, 1, 1.25 or 1.5) that would result in an estimated 10 - 12 Gy dose to the liver, lungs or kidneys. Organ dose was corrected for patient-specific mass, based on a CT volume estimate times 1.03 g/cc for liver and kidneys, and a variable specific gravity for lungs (Simon, J Clin Monit Comput, 2000). Bendamustine 130 mg/m2 plus 30 mg/m2 of fludarabine IV were given daily on days -5 to - 3 prior to transplantation. Tacrolimus and mini-methotrexate (Mycophenolate mofetil in case of cord blood transplantation) were used for GVHD prophylaxis. In addition, thymoglobulin 1 mg/kg IV was given on days -2, and -1 in patients receiving an unrelated donor transplant. Results: Twenty patients were studied. The median age was 58 years (range, 37-71). Lymphoma histologies included: indolent (n=8, 40%), diffuse large cell (n=6; 30%), double-hit (n=2; 10%) and mantle cell (n= 4, 20%). The median number of prior chemotherapies received was 4 (range, 2-7). At study entry, 8 patients (40%) were in complete remission following salvage therapy, 7 (35%) were in partial response, and 5 (25%) had refractory disease. Six of 16 (37.5%) patients tested were PET+. Dosimetry: The most exposed organ was either liver (16 patients) or lungs (4 patients). The distribution among the five 90YIT mCi/kg prescriptions (smallest to largest) was 2, 4, 12, 1 and 1, with a mean of 0.94 ± 0.23 mCi/kg. If all twenty patients were treated at 1 mCi/kg (the most common prescription), the 20 Gy limit employed for 90YIT clinical trials prior to approval would have been exceeded in only one patient for the liver (22.9 Gy) or lungs (20.9 Gy). The maximum liver and lung doses at 0.75 mCi/kg would have been 17.2 and 15.7 Gy, respectively. Transplant outcomes: Fifteen patients (75%) received their transplants from unrelated donors (including 1 mismatched and 2 cord blood), and only 5 (25%) from HLA-compatible siblings. The median number of CD34+ cells infused was 6.2 × 106/kg. Neutrophil counts recovered to > 0.5 × 109/L after a median of 12 days (range, 0-24 days). Platelet counts recovered to > 20 × 109/L after a median of 19 days (range, 9-30 days). By day 30, median donor myeloid and T-cells were 100% (range, 98-100). The cumulative incidence of acute grade 2-4 GVHD and chronic extensive GVHD were 25% (5% for acute grade 3-4) and 32%, respectively. Treatment-related mortality (TRM) rates at day 100 and 1 year after transplantation were 0% and 10%, respectively. The 2 cord blood transplants engrafted with 100% donor cells and none had GVHD. With a median follow-up duration of 14 months (range, 3-34 months), the overall survival and progression-free survival rates were 85% and 70%, respectively. No significant difference in survival or TRM could be detected by age, donor type, histology, disease status, PET status or number of prior therapies. Conclusions: Our results indicate that dose-intense 90YIT combined with fludarabine and bendamustine is a well-tolerated nonmyeloablative allogeneic conditioning for lymphoid malignancies, with promising results of engraftment, GVHD and survival. Our stratified 90YIT prescription results suggest that future studies with a fixed dose of 1 mCi/kg level without dosimetry would have an acceptable radiation risk to vital organs in this setting. Disclosures Jabbour: ARIAD: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Novartis: Research Funding; BMS: Consultancy.

scholarly journals Factors Associated with the Maintenance of Breastfeeding at One Year among Women in Chiang Mai, Thailand

2021 ◽  
Vol 18 (17) ◽  
pp. 9224
Author(s):  
Krongporn Ongprasert ◽  
Penprapa Siviroj
Keyword(s):  
Multivariable Logistic Regression Analysis ◽  
Sources Of Information ◽  
Chiang Mai ◽  
Cross Sectional ◽  
Working At Home ◽  
Factors Associated ◽  
Work From Home ◽  
Baby Clinic ◽  
One Year ◽  
At Home

This study aimed to investigate factors associated with breastfeeding for at least one year among women in Chiang Mai, Thailand. We conducted a cross-sectional study of 451 mothers with children aged between 12 and 24 months who visited the well-baby clinic among women who visited the well-baby clinic in secondary and tertiary hospitals. The data collected included maternal sociodemographic information, employment status, reasons contributing to continued breastfeeding, primary sources of information, and influential people affecting continued breastfeeding. Multivariable logistic regression analysis was used to investigate the relationship between explanatory variables and continued breastfeeding at one year. Reporting “easier to bond with baby” as a reason to continue breastfeeding (AOR 3.118, 95% CI: 2.022, 4.809) and multiparous status (AOR 1.588, 95% CI: 1.042, 2.420) were positive predictors of mothers who had breastfeeding at least one year postpartum while mothers with undergraduate education level (AOR 0.635, 95% CI: 0.404, 0.997) were more likely to discontinue breastfeeding. Our study highlighted that working mothers have lower odds of continued breastfeeding than stay-at-home mothers (SAHMs), which was found for work with day shifts (AOR 0.437, 95% CI: 0.261, 0.731), work with rotational shifts (AOR 0.481, 95% CI: 0.247, 0.934), and work from home jobs with a flexible schedule (AOR 0.439, 95% CI: 0.229, 0.838). These findings showed that both employment outside home and work from home were strong risk factors for discontinuing breastfeeding before 12 months. We suggest that a breastfeeding-friendly workplace policy is essential to enhance the continuance of breastfeeding. Additionally, working at home requires more research to explore breastfeeding barriers and establish more support strategies.

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