Use of Plerixafor in Predicted and Proven Poor Mobilizer (according to GITMO criteria). Experience of Policlinico Universitario Tor Vergata

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4415-4415
Author(s):  
Massimiliano Postorino ◽  
Alessandro Lanti ◽  
Eleonora Fiorelli ◽  
Angelo Salvatore Ferraro ◽  
Oana Marilena Chiru ◽  
...  

Abstract Abstract 4415 BACKGROUND. Autologous stem cell transplantation (ASCT) of PBSCs has become a widely applied treatment for Multiple Mieloma (MM), non- Hodgking's lymphoma (NHL) and Hodgking's lymphoma (HL). Successful engraftment correlates with the number of CD34 hemopoietic progenitors cells infused. However, a part of MM or lymphoma patients (5% to 40%) fail to mobilize adequate numbers of PBSCs and thus cannot undergo to ASCT. The success of PBSCs mobilization is usually assessed by the total number of CD34+ stem cells collected, with a cutoff of 2.0–2.5 ×106 CD34+ cells/kg recipient body weight being considered as a minimum requirement for transplant. Poor mobilization of PBSCs is a major limitation to ASCT. Recently GITMO Working Group worked to define operational criteria for the identification/prediction of the poor mobilizer (PM) patients (Olivieri et al. 2011). Plerixafor, a CXCR4 chemochine antagonist, has been showed to improve significantly PBSC mobilization in PM patients. We present our experience using Plerixafor in PM patients classified according to GITMO criteria. METHODS. Between September 2009 and June 2012, a total of 17 patients (9F-8M) were enrolled. The diagnosis were: 10 MM (5F-5M), 1HL (1M), 6 NHL (4F-2M). The median age was 57 (range 15–66). 7 patients (3MM, 4NHL) were defined “Proven PM” and 10 patients (7MM, 2NHL, 1HL) “Predicted PM” according to GITMO criteria. The mobilization protocol included G-CSF, administered at a dose of 10μg/kg daily on 4 consecutive days. In the evening of the fourth day, patients received subcutaneous plerixafor at a dose of 0,24 mg/kg. Apheresis was initiated on the fifth day, 10–12 h after plerixafor and 1 h after G-CSF administration. Apheresis and daily administration of G-CSF and plerixafor continued until the patient collected enough CD34+ cells for auto- HSCT (> 2 ×106/kg; max 7 plerixafor injections if required). PBSC collection was initiated if peripheral CD34+ cells count was >10μl. A successful mobilization was defined as a total yeld of > 2×106/kg. RESULTS. 13 patients (76,5%) collected the minimum number of CD34 cells > 2×106/kg. The diagnosis were: 8MM, 1HL,1 NHL. 7 patients (2NHL; 4 MM; 1 LH; 7 predicted) were able to collect > 5×106/Kg. Only 4 patients (3 MM; 1 LNH; 4 proven) failed the mobilization because the numbers of cells CD34 were < 10μL and these patients did not undergo to apheresis procedures. The collection target of 2×106/Kg was reached in a median of 2 apheresis session (range 1–3). The technical characteristics of the procedures were (median value): blood volume processed 12 L (range 9–14), total CD34+/Kg collected 3,06 × 106(range 2,21-8,62), procedure efficiency 47,5% (range 35,3–79), duration of the procedure 261 minutes (range 210–309). Plerixafor was well tolerated and mild side effects were: reactions in the injection site, gastrointestinal disturbs, muscle pain. During administration of plerixafor we did not observe any significant laboratory abnormalities of liver or renal function. CONCLUSION. Unsuccessful mobilization represents an important limitation to ASCT in lymphoma and MM. In our experience plerixafor allowed to collect an appropriate amount of CD34 also in patients defined “proven PM” significantly reducing the percentage of patients that could not undergo ASCT (target value obtained in 43% of “proven PM”). Confirming the recent literature plerixafor is well tolerated with minimal side effects. We retrospectively applied GITMO criteria for PM patients and our experience, although limited, confirm that the use of a correct definition of PM allows the appropriate use of new mobilizing agents like plerixafor increasing significantly the therapeutic options also in patients who had no possibilities to receive an ASCT with the traditional mobilizing therapy. Disclosures: No relevant conflicts of interest to declare.

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4051-4051
Author(s):  
Ahmed Y Abuabdou ◽  
Eric R Rosenbaum ◽  
Saad Usmani ◽  
Bart Barlogie ◽  
Michele Cottler-Fox

Abstract Abstract 4051 Introduction: What constitutes an acceptable mobilization regimen for collecting CD34+ cells depends on whether the goal of collection is to obtain a minimum number versus optimal number of cells. When treating patients with high-risk myeloma it may be important to obtain an optimal number. Here we compare retrospectively our earlier mobilization regimen, VTD-PACE, with MVTD-PACE in newly diagnosed, previously untreated multiple myeloma patients. Materials and Methods : We reviewed data for all patients who collected hematopoietic progenitor cells on Total Therapy protocols TT3a/TT3b with VTD-PACE (n=394) from February 2004 to September 2008 (138 females and 256 males, median age 59y; range 31–75), and on TT4/TT5 with MVTD-PACE (n=188) from August 2008 to May 2011 (78 females and 110 males, median age 61y, range 30–76). Based on their predicted first day collection with a large volume leukapheresis (30L processed), using our center's predictive formula (Blood 2010; 116(21):1182a), patients were stratified into 4 mobilizer types: poor (<2×106 CD34+ cells/kg), intermediate (≥2 to 10×106), good (>10 to 20×106) and excellent (>20×106). Variables examined included number of CD34+ cells/μl blood on day 1 and day 2 of collection (we have a minimum 2 day collection requirement), number of collection days to reach our minimum goal of 20×106 CD34+ cells/kg, and total CD34+ cells/kg collected for both chemotherapy groups. Variables for both groups stratified by mobilizer type were compared using two-tailed student's t-tests, except for the poor mobilizer group, where population size was too small for formal statistical analyses (VTD-PACE n=7, MVTD-PACE n=4), although averages were calculated. Results : There was no significant difference between VTD-PACE and MVTD-PACE for CD34+ cells/μl blood on day 1 of collection among the excellent [mean 368.9 (n=184) vs. 434.6 x106 (n=92); p-value 0.07], good [mean 138.6 (n=102) vs. 128.6 x106 (n=40); p-value 0.19], and intermediate [mean 60.1 (n=100) vs. 55.9 x106 (n=52); p-value 0.39] groups. A statistically significant difference between VTD-PACE and MVTD-PACE was found for CD34+ cells/μl blood on day 2 of collection for excellent mobilizers [mean 333.8 (n=184) vs. 460 ×106 (n=92); p-value <0.001], but not for the good [mean 165.7 (n=102) vs. 189.5×106 (n=40); p-value 0.21] and intermediate [mean 80.1 (n=101) vs. 102.3 ×106 (n=52); p-value 0.07] groups. When CD34+ cell/kg collection totals with VTD-PACE and MVTD-PACE were compared, a significant difference was seen for the intermediate mobilizer group only [mean 23.6 (n=101) vs. 26.3 ×106 (n=52); p-value 0.03]. For the poor mobilizer group, VTD-PACE had an average CD34+ cells/μl blood of 13.5×106 for day 1 of collection and 17.0 ×106 for day 2, with a total of 14.5×106 CD34+cells/kg collected; while MVTD-PACE had an average of 13.2×106 CD34+ cells/μl blood for day 1 of collection, 24.9×106 for day 2, with a total of 24.2×106CD34+ cells/kg collected. The number of collection days was similar between VTD-PACE and MVTD-PACE in the excellent mobilization group (2 days), but was slightly more for VTD-PACE compared to MVTD-PACE for the good (2.1 vs. 2 days), intermediate (3.2 vs. 2.9 days), and poor (6.1 vs. 5.8 days) groups. Conclusion : Both regimens allow more than minimum collections, but MVTD-PACE provides a higher peak number of CD34+ cells/μl blood, resulting in a slightly lower mean number of days of collection than VTD-PACE to reach an optimal collection. Disclosures: No relevant conflicts of interest to declare.


10.12737/5011 ◽  
2014 ◽  
Vol 21 (2) ◽  
pp. 104-109 ◽  
Author(s):  
Кодяков ◽  
A. Kodyakov ◽  
Груздев ◽  
D. Gruzdev ◽  
Федоров ◽  
...  

This paper is devoted to the actual problem of cosmetology - the procedures of filament rejuvenation of face and neck, which become popular every year. Literature data on the efficacy of these methods are controversial. The authors of most works indicate the minimum number of complications in the practical absence of negative appraisal methodology. The issues of development of the indication for use of some types of filaments and optimal criteria of evaluation of the expected effect in clinical practice are relevant and are discussed in this paper. Taking into account the absence of objective information about long-term consequences, other practical aspects of filament rejuvenation, the authors on the basis of many years of research and experience has specified evaluation criteria and suggested own classification of cosmetic filaments used in the method of filament rejuvenation of face and neck. Installation of filaments with different cosmetic features allows to reaching three different anti-aging effects: lifting, reinforcing and bio-stimulation. The degree of manifestation of these effects depends on the installation method of the thread, but first of all - on the design of conductive filament and needle or cannula. Based on the above data, the authors propose to divide all known cosmetic filaments on the basis of their purpose, proceeding from the achieved effect for three species - lifting, reinforcing and bio-stimulating. The new classification can be used in practice to optimize the selection of filaments for rejuvenation of face and neck and to reduce unintended side effects. The proposed classification of filaments has the purpose of definition of a fundamental criterion for their beauty opportunities. The practical application of this classification contributes to ensure adequate choice of filaments to perform the procedure, reduce side effects and create realistic expectations of doctors and patients from the procedures of the rejuvenation of face and neck.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4563-4563
Author(s):  
Giuseppe Milone ◽  
Salvatore Leotta ◽  
Giuseppe Avola ◽  
Massimo Poidomani ◽  
Maria Grazia Camuglia and Andrea Spadaro

Abstract Abstract 4563 AML patients having a high apheretic yield in CD34+ cells during mobilization have a poor prognosis, independently from cytogenetic risk (Feller 2004, Keating 2004). It is however not known if prognostic value of PBSC mobilization is retained after different post remissional treatment and clinical usefullness of this prognostic information in dealing with intermediate cytogenetic group patients, the more represented AML subgroup in which post remissional therapy is still a controversial issue. METHODS A group of 64 AML adult patients in 1st CR was prospectively studied. PBSC mobilization was attempted following first consolidation course. Cytogenetic assessment at diagnosis was available in 95% of patients. Post remissional treatment was chosen based on cytogenetic risk, sibling donor availability and presence of others prognostic factors, MUD transplants were proposed in cytogenetic high risk patients or in selected young patients with intermediate cytogenetic, Autologous HSC Transplantation was proposed when allogeneic transplant was felt not indicated, no further therapy was administered in patients deemed ineligible for any kind of transplantation. Prognostic significance of CD34+ cells was evaluated measuring DFS in groups of patients identified from value of CD34+ peak in respect to 50th percentile (CD34 peak: 65×10e6/L) and 75th percentile (197×10e6/L). Those patients having a CD34+ cell peak below median value (65×10e6/L) were categorised as LOW MOBILIZER, those having a CD34+ peak between 65 and 197 ×10e6/L were categorised as GOOD MOBILIZER, and those having a CD34+ peak over 75th percentiles (197 ×10e6/L) were categorised as SUPERMOBILIZER. RESULTS In our serie 40% of patients received an Allogeneic transplant after a myeloablative treatment, 49% an autologous transplant while 11% no further chemotherapy. Disease Free Survival (DFS) was 60%. CD34+ peak during mobilization, evaluated as a continuous variable, in a Cox regression model resulted important for DFS (hazard ratio:1.001; p=0.01). Importance of CD34+ peak was maintained also when the stratum of patients with intermediate cytogenetic risk was analysed (DFS: p=0.002). POOR MOBILIZER, GOOD MOBILIZER and SUPERMOBILIZER patients had statistically different DFS when cases were analysed as a whole (DFS: POOR M.: 70%; GOOD M. 50%; SUPER M: 30%; log rank: p=0.05); mobilizing efficiency was important for DFS also in intermediate cytogenetic group (DFS: POOR M. 70%; GOOD M. 40% DFS; SUPER M. 28%; log rank p= 0.02), importance was maintained also in patients treated by allogeneic transplantation or with autologous transplantation (fig.1). When allogeneic transplantation was compared to the group of patients receiving autologous transplantation or other post remissional strategies both in the cases as a whole and in the stratum of intermediate cytogenetic (table 1), the group of POOR mobilizer had after autologous transplants results non different from patients receiving allogeneic transplantation, however, the group of GOOD mobilizer patients had after allogeneic transplants a DFS significantly better compared to other treatment while SUPER mobilizer patients had poor results also when allogeneic transplantation was employed. In conclusion in AML in 1st CR, evaluation of CD34 peak during mobilization is a parameter providing prognostic informations useful also within intermediate cytogenetic group. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5575-5575
Author(s):  
George Zacharia ◽  
Ali M. Ameri

Abstract Background: One of the basic goals of an oncologist is to educate patients as to the purpose of treatment and possible side effects of chemotherapy. Evidence suggests that patients who gain knowledge perform better self-care, cope better, and have better symptom control (Dodd, Res Nurs Health 1984; Williams et al, Oncol Nurs Forum 2004). However, we have found that in our clinic, patients frequently misunderstand the information presented to them regarding cancer treatment. This can lead to difficulties on both ends of the patient-physician spectrum. In our institution, it is standard policy for patients commencing chemotherapy as an outpatient to have a lengthy discussion with their oncologist regarding their diagnosis, type of chemotherapy, and side effects of chemotherapy 1-2 weeks before treatment. These patients then receive a handout in our outpatient infusion center from a nurse which contains the names of all the chemotherapeutic agents and possible side effects. The nurse also personally reviews the medications with the patients prior to administration. We have observed that despite receiving verbal and written education, cancer patients often cannot recall the names of the chemotherapeutic agents and side effects of treatment. We are investigating whether physician-directed handouts (PDH), in addition to education provided by nurses, prior to commencement of chemotherapy compared to our current practice could improve cancer drug education in our patients. Methods: We randomized 13 patients starting chemotherapy to receive either PDH or no PDH. The PDH included the name of the chemotherapy as well as 3-5 major and common side effects, which were highlighted. The handouts also contained the patient's chemotherapy cycle (i.e. how often they would be receiving chemotherapy). Patients then continued to receive handouts and education from the nurses at the outpatient infusion center as previously described. Four to six weeks after starting chemotherapy, patient took a multiple choice quiz which tested knowledge in three areas: names of the chemotherapeutic drugs or regimen they received, major side effects, and how often they were receiving chemotherapy. Eight to ten weeks after starting chemotherapy, patients again took the same quiz. Results: Of 13 patients randomized (6 to PDH and 7 to no PDH), 12 completed the study (5 PDH patients, 7 no PDH patients). Demographics: median age 63 years (20-89 years); 5 male; 8 female. At 4-6 weeks, patients in the PDH group and in the no PDH group scored 86% and 77%, respectively. At 8-10 weeks, patients in the PDH group and in the no PDH group scored 84% and 77%, respectively. With the exception of knowledge of chemotherapy cycles at 8-10 weeks (80% vs 100%), patients in the PDH group scored the same or better across all three of the main areas tested in the quizzes (first quiz: chemotherapy names 83% vs 73%, side effects 82% vs 71%, chemotherapy cycles 100% vs 100%; second quiz: chemotherapy names 91% vs 81%, side effects 78% vs 64%, chemotherapy cycles 80% vs 100%). Conclusions: Patients receiving PDH scored higher overall compared to patients that did not receive PDH. Dedicated education by physicians with handouts highlighting the most important aspects of treatment, in addition to education provided by chemotherapy nurses, may be beneficial to patients undergoing chemotherapy. Given the limitations of this small sample size, larger studies are warranted to evaluate these findings. Figure 1. Patients were either given a physician-directed handout (PDH) or no PDH prior to commencement of chemotherapy. Four to six weeks after starting chemotherapy, they took their first quiz. Eight to ten weeks after initiation of chemotherapy, patients took a second quiz. Figure 1. Patients were either given a physician-directed handout (PDH) or no PDH prior to commencement of chemotherapy. Four to six weeks after starting chemotherapy, they took their first quiz. Eight to ten weeks after initiation of chemotherapy, patients took a second quiz. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5640-5640
Author(s):  
Kishore Kumar ◽  
Kishore Kumar ◽  
Chezhian Subash

Aims & Objectives: The aim of the study is to check the safety and feasibility of using Plerixafor in healthy donors who have failed to mobilise > 2 x 10 6/kg of CD34 cells on day 1 of aphresis. The indication at present remains off label. Patients/Materials & Methods: Seventeen healthy donors, all more than 18 years of age were enrolled in this study after a proper written informed consent who failed to mobilise adequately on day 1 collection. The dose of Plerixafor used was 0.24mg/kg body weight of donor, 10-11 hours before the aphresis procedure. The GCSF was given from day -5 and the last dose was given 4 hours before the second day aphresis. CD34 was done in pre-aphresis peripheral blood and in product bag and compared with day 1 data. Results: The median donor bw was 54 kg (IQR, 42 kg to 69 kg) and the median recipient bw was 58 kg (IQR, 44 kg to 76 kg).The median CD34+ count in peripheral blood was 11.2/µl on day 4 after G-CSF alone and 24.7.0/µl on day 5 after G-CSF plus Plerixafor. The use of Plerixafor increased the number of circulating CD34 cells in peripheral blood by 2.2 fold.There were no major side effects except for the manageable bone pains which can be attributed to GCSF also. There were no differences in the engraftment statistics and rates of GVHD in comparison to historical cases. Though this is not a randomised control study to compare with second day high dose GCSF cases, the amount of increase in stem cells were statistically significant comparing with historical controls(p< 0.05). After a median followup of six months, no adverse effects were noted in donors. Discussion & Conclusion: Plerixafor is well tolerated in healthy donors and can be used safely in situations of poor mobilisers or when there is a significant difference in weight of donor to receipient. Its a small pilot study. We need a proper randomised control study and a longer follow up to look infor the side effects on healthy donor. Disclosures No relevant conflicts of interest to declare.


2021 ◽  
pp. 088626052098548
Author(s):  
Chanelle Wilson ◽  
Lorraine Sheridan ◽  
David Garratt-Reed

The absence of a widely accepted definition of cyberstalking has resulted in studies operationalizing it in various ways, reducing the comparability and generalizability of findings. The present work examined the most common behaviors and criteria used to operationalize cyberstalking within the quantitative literature. The definitions employed by the studies were evaluated in respect of (a) whether they included a minimum requirement for the number of times the behaviors needed to be repeated in order to be considered “cyberstalking”; (b) whether victim fear was required for the behaviors to be considered “cyberstalking”; (c) the timeframe within which the cyberstalking behavior needed to have occurred; and (d) the behaviors identified as indicating cyberstalking. The results demonstrated considerable variation in the specificity of criteria used. Of the 33 studies examined, 45% specifically defined a minimum number of behavioral repetitions required to classify the behaviors as “cyberstalking,” although there were some discrepancies in the number of behaviors specified across studies. Only 30% of studies included victim fear as a criterion and 70% of studies did not include specific timeframe requirements in which the behaviors needed to have occurred within. The number and description of behaviors included within scales used to measure “cyberstalking” varied widely. Some instruments utilized as many as 24 different items, whilst others identified cyberstalking through the use of two items. A series of recommendations are advanced aimed at providing criteria for defining and operationalizing cyberstalking that can be employed by future studies, with the ultimate aim of allowing greater comparability between results. From this a consistent knowledge base can be developed, and with it a deeper understanding of cyberstalking and how to counter it.


Author(s):  
Katharina Diehl ◽  
Tatiana Görig ◽  
Charlotte Jansen ◽  
Maike Carola Hruby ◽  
Annette B. Pfahlberg ◽  
...  

Pharmacists and pharmaceutical technicians play an important role in counselling customers regarding sunscreen use and sun protection measures. A potentially helpful tool that can be used during counselling is the ultraviolet index (UVI), which informs individuals when and what sun protection measures are needed at a specific place and time. Our aim in this qualitative study was to explore awareness, knowledge, and use of the UVI during counselling in pharmacies. We used semi-structured interviews with pharmacists and pharmaceutical technicians (n = 20) to answer our research questions. Interviews were audiotaped, transcribed verbatim, and analyzed using qualitative content analysis. During the interviews pharmacists and pharmaceutical technicians revealed a lot of uncertainty and lack of knowledge regarding the UVI. Eight professionals were able to give a correct definition of UVI. Amongst others, the UVI was confused with sun protection factor. Overall, the UVI was hardly used during the counselling of customers. The UVI was developed to provide guidance when which type of sun protection is required to avoid detrimental effects of ultraviolet radiation. For effective implementation, both the general population and health professionals (e.g., pharmacists) have to increase their knowledge about the UVI. This would strengthen its use during professional counselling in pharmacies and may help to reduce the incidence of skin cancer over the long term.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Shamima Yesmin ◽  
S.M. Zabed Ahmed

Purpose The purpose of this paper is to investigate Library and Information Science (LIS) students’ understanding of infodemic and related terminologies and their ability to categorize COVID-19-related problematic information types using examples from social media platforms. Design/methodology/approach The participants of this study were LIS students from a public-funded university located at the south coast of Bangladesh. An online survey was conducted which, in addition to demographic and study information, asked students to identify the correct definition of infodemic and related terminologies and to categorize the COVID-related problematic social media posts based on their inherent problem characteristics. The correct answer for each definition and task question was assigned a score of “1”, whereas the wrong answer was coded as “0”. The percentages of correctness score for total and each category of definition and task-specific questions were computed. The independent sample t-test and ANOVA were run to examine the differences in total and category-specific scores between student groups. Findings The findings revealed that students’ knowledge concerning the definition of infodemic and related terminologies and the categorization of COVID-19-related problematic social media posts was poor. There was no significant difference in correctness scores between student groups in terms of gender, age and study levels. Originality/value To the best of the authors’ knowledge, this is the first time an effort was made to understand LIS students’ recognition and classification of problematic information. The findings can assist LIS departments in revising and improving the existing information literacy curriculum for students.


2016 ◽  
Author(s):  
Valerio De Biagi ◽  
Maria Lia Napoli ◽  
Monica Barbero ◽  
Daniele Peila

Abstract. With reference to the rockfall risk estimation and the planning of rockfall protection devices one of the most critical and most discussed problems is the correct definition of the design block taking into account its return period. In this paper, a methodology for the assessment of the design block linked with its return time is proposed and discussed, following a statistical approach. The procedure is based on the survey of the blocks already detached from the slope and accumulated at the foot of the slope and the available historical data.


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