The role of post granulocyte colony-stimulating factor white blood cell counts in predicting the mobilization adverse events and yields Shu-Huey Chen1,2.

Slides:



Advertisements
Similar presentations
Brown JR et al. Proc ASH 2013;Abstract 523.
Advertisements

Correlation of Leukocyte Count with Clinical Outcomes in Hospitalized Patients with Community-Acquired Pneumonia: Results from Rapid Empiric Treatment.
Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3 LONESTAR-2 Phase 2 Treatment Experienced Lawitz E, et.
Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1b PEARL-II.
Comparison of INSTI vs PI  FLAMINGO  GS  ACTG A5257.
TMC125 Safety and Tolerability: 24-week Results of the Pooled DUET-1 and -2 Trials R Haubrich, M Schechter, S Walmsley, M Peeters, M Janssens, G De Smedt.
Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in Liver Transplant.
Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 and HIV Coinfection ION-4 Phase 3 Treatment Naïve and Treatment Experienced.
Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Phase 2 Curry MP, et al. Gastroenterology. 2015;148:100-7.
Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Recurrence Following Liver Transplantation Phase 2 Charlton M, et al. Gastroenterology.
Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir + RBV in Sofosbuvir-Experienced HCV GT1 Retreatment of Sofosbuvir Failures Phase 2 Treatment.
Hepatitis web study Hepatitis web study 3D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Phase 2 Treatment Naïve and Treatment Experienced.
Hepatitis web study Hepatitis web study 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) +/- RBV in GT1b PEARL-II Phase 3 Treatment Experienced Andreone.
1 Journal Club Alcohol, Other Drugs, and Health: Current Evidence July–August 2012.
In the name of God. Celecoxib as a pre-emptive analgesia in arthroscopic knee surgery; a triple blinded randomized controlled trial Mohsen Mardani-Kivi,
Association of ABO Incompatibility with RBC Indices of Cord Blood Unit Shu-Huey Chen, Marie Lin, Kuo-Liang Yang, Teng-Yi Lin, His-Hsiu Tsai, Shang-Hsien.
Use of 12 weekly doses of isoniazid and rifapentine for the treatment of latent tuberculosis − Connecticut , Kelley Bemis, MPH CDC/CSTE Applied.
MANAGEMENT OF MANTLE CELL LYMPHOMA IN TUNISIA R BEN LAKHAL, L KAMMOUN, K ZAHRA, S KEFI Sousse 25 MAY 2012.
Q FEVER IN THE PANHANDLE THE SAGA CONTINUES James L. Alexander, DSHS Kelly Fitzpatrick, CDC Lindsay Oliver, CDC Gilbert Kersh, CDC Robert Massung, CDC.
ATOMIC  Design  Objective –SVR 24 by ITT-analysis, detection of a 30% or 25% difference between two treatment groups, 2-sided significance level of 5%,
Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 and HIV Coinfection ION-4 Phase 3 Treatment Naïve and Treatment Experienced.
The Impact of Circulation Access in Allogeneic Peripheral Blood Stem Cell Harvest Shang-Hsien Yang1, Tso-Fu Wang2,3, Shu-Hui Wen4, Sung-Chao Chu3, Ruey-Ho.
FISSION  Design  Objective –Non inferiority of SOF + RBV : SVR 12 (2-sided significance level of 5%, lower margin of the 95% CI for the difference =
A Phase II Study with Carfilzomib, Cyclophosphamide and Dexamethasone (CCd) for Newly Diagnosed Multiple Myeloma Bringhen S et al. Proc ASH 2013;Abstract.
Taiwan Unrelated Donor PBSC Harvest Experience Shu-Huey Chen Hualien Tzu-Chi General Hospital.
Reportedly from hospital records: ‘On the second day the knee was better, and on the third day it had disappeared’
Collection of peripheral blood stem cells Dr Kacem Karima Department of clinical haematology -HAO CMH - 26/05/2012.
ION-4  Design LDV/SOF Open-label ION-4 Study: LDV/SOF in HIV co-infection W12 ≥ 18 years Chronic HCV infection Genotype 1 or 4 HCV RNA ≥ 10,000 IU/ml.
Second Donation from Volunteer Hematopoietic Stem Cell Donors in Taiwan Tso-Fu Wang(1), Shu-Huey Chen(1), Shang-Hsien Yang(1), Chu-Yu Chang(2), Ya-Wen.
Safety and efficacy of hematopoietic stem cell collection from mobilized peripheral blood in unrelated volunteers: 12 years of single-center experience.
Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3 LONESTAR-2 Phase 2 Treatment Experienced Lawitz E, et.
Safety and effectiveness of granulocyte-colony stimulating factor in advanced chronic heart failure Jacob Joseph, MD Veterans Affairs Healthcare System-
Taipei Medical University The correlation between Geriatric Nutritional Risk Index and nutritional status in hemodialysis patients I ntroduction O bjective.
Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Phase 2 Curry MP, et al. Gastroenterology. 2014;September.
Neurologic Effects Associated With Efavirenz Generally Mild, Transient Slideset on: Clifford DB, Evans S, Yang Y, et al. Impact of efavirenz on neuropsychological.
Efavirenz Use Not Associated With Depressive Episodes, According to Analysis of Randomized Clinical Trial Outcomes Slideset on: Journot V, Chene G, De.
Colony-Stimulating Factors for Febrile Neutropenia during Cancer Therapy N ENGL J MED 2013;368: (Mar 21, 2013) Charles L. Bennett, M.D., Ph.D., Benjamin.
COMPARISON OF ADVERSE EFFECT PROFILES OF PAIN REGIMENS WITH AND WITHOUT INTRAVENOUS ACETAMINOPHEN IN TOTAL HIP AND KNEE ARTHROPLASTY PATIENTS Alyssa J.
Kantarjian HM et al. Proc ASH 2012;Abstract Long-Term Follow-Up of Ongoing Patients in 2 Studies of Omacetaxine Mepesuccinate for Chronic Myeloid.
Comparison of INSTI vs PI  FLAMINGO  GS  ACTG A5257.
Phase 3 Treatment-Naïve and Treatment-Experienced
Phase 3 Treatment-Naïve and Treatment-Experienced
Discontinued group (n=33)
CCO Independent Conference Highlights
Cryopreservation of Stem Cells Using Human Serum Albumin and
Five Years of Real World Pirfenidone Experience
Sex and Body Mass Index but Not CXCL12 801 G/A Polymorphism Determine the Efficacy of Hematopoietic Cell Mobilization: A Study in Healthy Volunteer Donors 
Efficacy and Side Effects of Granulocyte Collection in Healthy Donors
Dorina Onoya1, Tembeka Sineke1, Alana Brennan1,2, Matt Fox1,2
Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program by Michael.
Switch to BIC/FTC/TAF GS-US GS-US GS-US
Recovery and Safety Profiles of Marrow and PBSC Donors: Experience of the National Marrow Donor Program  John P. Miller, Elizabeth H. Perry, Thomas H.
Donor demographic and laboratory predictors of allogeneic peripheral blood stem cell mobilization in an ethnically diverse population by Sumithira Vasu,
Figure 2 Components of each transplantation platform
Grövdal M et al. Blood 2008;112:Abstract 223.
Basal CD34+ Cell Count Predicts Peripheral Blood Stem Cell Mobilization in Healthy Donors after Administration of Granulocyte Colony–Stimulating Factor:
Related PBSC Donors Experience Higher Levels of Pain and Donation-Related Symptoms and Less Complete Rates of Recovery Compared to Unrelated Donors:
ALT-803 administration increases peripheral blood cell counts of lymphocyte subsets in cynomolgus monkeys. ALT-803 administration increases peripheral.
Pollyea DA et al. Proc ASCO 2011;Abstract 6505.
Phase I/II Study of Intravenous Plerixafor Added to a Mobilization Regimen of Granulocyte Colony–Stimulating Factor in Lymphoma Patients Undergoing Autologous.
Factors Associated with Peripheral Blood Stem Cell Yield in Volunteer Donors Mobilized with Granulocyte Colony-Stimulating Factors: The Impact of Donor.
Recovery of Unrelated Donors of Peripheral Blood Stem Cells versus Recovery of Unrelated Donors of Bone Marrow: A Prespecified Analysis from the Phase.
Campbell FM, et al. Pediatr Diabetes. 2018;19(7):1294–1301
Tips on using ruxolitinib
Phase 3 Treatment-Naïve and Treatment-Experienced
Successful hematopoietic stem cell mobilization and apheresis collection using plerixafor alone in sickle cell patients by Erica B. Esrick, John P. Manis,
Donation Activities and Product Integrity in Unrelated Donor Allogeneic Hematopoietic Transplantation: Experience of the National Marrow Donor Program 
ARV-trial.com Switch to DTG/ABC/3TC STRIIVING NEAT
Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program.
Pain. Pain. (A) Skeletal pain experienced by bone marrow (BM) and peripheral blood stem cell (PBSC) donors at baseline, during the pericollection period,
Presentation transcript:

The role of post granulocyte colony-stimulating factor white blood cell counts in predicting the mobilization adverse events and yields Shu-Huey Chen1,2 Shang-Hsien Yang1 Chu-Yu Chang2, Ya-Wen Chiu2, Sung-Chao Chu1, Kuo-Liang Yang2, Tso-Fu Wang1,2 (1)Hualien Tzu-Chi General Hospital Taiwan; (2)Buddhist Tzu-Chi Stem Cell Center Background To evaluate the incidences of adverse events of granulocyte colony-stimulating factor (G-CSF) and the impacts of post G-CSF white blood cell (WBC) counts on adverse events and mobilization yields in healthy peripheral blood stem cell donors. Materials and methods Four hundred seventy-six healthy donors were given G-CSF of 10  g/kg/day for 5-6 consecutive days. The WBC counts were determinated at baseline, after third dose (before the fourth dose on Day4) and after fifth dose (before leukapheresis on Day5) of G-CSF administration. Performance status and symptoms were recorded everyday before G-CSF injection. The incidences of adverse events and mobilization yields were compared between different donor characteristic groups. Multivariate analysis was used to analyze the correlations between the adverse events and donor factors. Results Bone pain (64.9%), myalgia/arthralgia (58.2%), fatigue (44.1%) and headache (33.0%) were the most common side effects(Table 1). The third day and fifth day median WBC counts were 35,050/µL and 45,905/µL. Donors with WBC ≧ 50x103/µL after 3 doses of G-CSF experienced more fatigue, myalgia/arthralgia and chills (p=0.0314, and ) but post G-CSF CD34+ cells were similar (72.6/µL vs 68.7/µL, p=0.5916). Although the CD34+ cells were higher in donors with WBC ≧ 50x103/µL after 5 doses of G-CSF (89.3/µL vs 59.1/µL, p<0.0001), the incidences of side effects were similar. Female donors more frequently had headache, nausea/anorexia, vomiting, fever (p=0.003, <0.0001, and ) and lower post G-CSF CD34+ cell count than male donors did (78.0/µL vs 59.0/µL, p<0.0001). Donors with body mass index ≧ 25 had higher incidences of sweat and insomnia (p= and ) and also higher CD34+ cell count (79.9/µL vs 64.9/µL, p<0.0001). Donor receiving G- CSF ≧ 10µg/kg tended to have bone pain, headache and chills (p=0.0085, and ). The side effects and CD34+ cells were not different between young and old donors. In multivariate analysis, female donor experienced more fatigue, nausea, vomiting, bone pain, myalgia/arthragia, headache, fever and insomnia(Table 2). Higher BMI donor had more fatigue, myalgia/arthragia and sweats. G-CSF dose was associated with bone pain and the WBC count post the third G-CSF was associated with fatigue only. Table 2 Multivariate analysis of the side effects and the possible factors Conclusions Table 1. Selected studies about the incidences of adverse events during G-CSF mobilization. Female and high BMI donors are associated with higher risk of side effects of PBSC mobilization by G-CSF. Routine monitor of the post G-CSF WBC count provide minimal benefit in predicting side effects. Reducing dose or discontinuation of G-CSF should mainly base on the clinical severity of adverse events. Side effect percentage Tzu-Chi (n=476) Murata M et al 17 (n=94) Martino M et al 18 (n=184) Anderlini P et al 23 (n=341) Horowitz MM et al 5 (n = 1080) ECOG > 114.1%-- Fatigue44.1%33.0%19.0%31%49% Nausea/anorexia13.9%10.6%12.0%13%11% Vomiting5.9%10.6%-- 2% Bone pain64.9%71.3%71.2%84%-- Myalgia/arthralgia58.2%-- 54% Headache33.0%27.7% 54%52% Sweats9.5%-- 14% Fever9.5%2.1%5.4%<5%6% Chills5.3%-- 6% Insomnia16.6%13.8%22.3%<5%28% p value AgeG-CSF doseBMIGenderD3 WBC ECOG > Fatigue Nausea/anorexia < Vomiting Bone pain Myalgia/arthralgia Headache Sweats Fever Chills Insomnia