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Maximilian Stahl - One of the best experts on this subject based on the ideXlab platform.
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Leukapheresis for the management of hyperleukocytosis in acute myeloid leukemia a systematic review and meta analysis
Transfusion, 2020Co-Authors: Jan Philipp Bewersdorf, Martin S Tallman, Smith Giri, Amer M Zeidan, Maximilian StahlAbstract:Background Up to 20% of patients with acute myeloid leukemia (AML) present with hyperleukocytosis, usually defined as a white blood cell (WBC) count greater than 100 × 109 /L. Given the high early mortality rate, emergent cytoreduction with either Leukapheresis, hydroxyurea, or chemotherapy is indicated, but the optimal strategy is unknown. Study design and methods For this systematic review and meta-analysis we searched MEDLINE and EMBASE via Ovid, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science from inception through March 2020 for multiarm studies comparing early mortality rates of patients with AML treated with Leukapheresis and those who were not. The risk ratio (RR) of early death for patients who received Leukapheresis vs patients who did not was estimated using a sum of the log-ratio of individual study estimates weighted by sample size. Results Among 13 two-arm, retrospective studies with 1743 patients (486 Leukapheresis and 1257 nonLeukapheresis patients), Leukapheresis did not improve the primary outcome of early mortality compared to treatment strategies in which Leukapheresis was not used (RR, 0.88; 95% confidence interval [CI], 0.69-1.13; P = .321) without statistically significant heterogeneity between studies (Cochran's Q, 18; P = .115; I2 , 33.4%). Patients presenting with clinical leukostasis tended to be more likely to undergo Leukapheresis (odds ratio, 2.01; 95% CI, 0.99-4.08; P = .052). Conclusion As we did not find evidence of a short-term mortality benefit and considering the associated complications and logistic burden, our results argue against the routine use of Leukapheresis for hyperleukocytosis among patients with AML.
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management of hyperleukocytosis and impact of Leukapheresis among patients with acute myeloid leukemia aml on short and long term clinical outcomes a large retrospective multicenter international study
Leukemia, 2020Co-Authors: Maximilian Stahl, Mikkael A Sekeres, Rory M Shallis, Wei Wei, Pau Montesinos, Etienne Lengline, Judith Neukirchen, Vijaya Raj Bhatt, Amir T Fathi, Heiko KonigAbstract:Hyperleukocytosis in acute myeloid leukemia (AML) is associated with inferior outcomes. There is limited high quality evidence to support the benefits of Leukapheresis. We retrospectively collected data from patients with newly-diagnosed AML who presented with a white cell count (WBC) >50 × 109/L to 12 centers in the United States and Europe from 2006 to 2017 and received intensive chemotherapy. Logistic regression models estimated odds ratios for 30-day mortality and achievement of composite complete remission (CRc). Cox proportional hazard models estimated hazard ratios for overall survival (OS). Among 779 patients, clinical leukostasis was reported in 27%, and Leukapheresis was used in 113 patients (15%). Thirty-day mortality was 16.7% (95% CI: 13.9-19.3%). Median OS was 12.6 months (95% CI: 11.5-14.9) among all patients, and 4.5 months (95% CI: 2.7-7.1) among those ≥65 years. Use of Leukapheresis did not significantly impact 30-day mortality, achievement of CRc, or OS in multivariate analysis based on available data or in analysis based on multiple imputation. Among patients with investigator-adjudicated clinical leukostasis, there were statistically significant improvements in 30-day mortality and OS with Leukapheresis in unadjusted analysis, but not in multivariate analysis. Given the significant resource use, cost, and potential complications of Leukapheresis, randomized studies are needed to evaluate its value.
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beliefs and patterns of practice in the management of hyperleukocytosis and leukostasis among health care providers for patients with acute leukemia a large north american web based survey
Blood, 2017Co-Authors: Maximilian Stahl, Alexander B Pine, Selina M Luger, Harry P. Erba, David P Steensma, Richard Stone, Mikkael A Sekeres, Mark R. Litzow, Jeanne E. Hendrickson, Rami S KomrokjiAbstract:Introduction: Hyperleukocytosis and leukostasis in acute leukemia are associated with high risks of organ failure and early death. The best management approach for hyperleukocytosis and the role of Leukapheresis are poorly defined due to the lack of high quality evidence. We sought to study beliefs and patterns of practice in the management of hyperleukocytosis and Leukapheresis among providers in North America. Methods: We developed a 38-question survey to query providers caring for acute leukemia patients with hyperleukocytosis. The survey was approved by the NCI-funded oncology cooperative group chairs and was administered through a Web-based platform. A link to the survey was distributed via email to all members of the ECOG-ACRIN Cancer Research Group, Alliance for Clinical Trials in Oncology (Alliance) and Southwest Oncology Group (SWOG) by the ECOG-ACRIN Clinical Education and Awareness Team on 6/21/2017 with 3 subsequent weekly reminders. Responses were anonymous, and no incentives were provided to survey respondents. Descriptive statistics were used to analyze responses. Results: There were 142 participants with a median age of 48 years (range, 30-75). Most responders (97%) were from North America representing 36 states. While 42% were clinicians, 26%, 23%, 2% and 6% of participants identified themselves as clinical researchers, research coordinators, basic scientists and others, respectively. Practice site included: 50%, 32%, 13% and 6% university hospital, community hospital, private practice, and other settings, respectively. Most responders (45%) defined hyperleukocytosis in acute myeloid leukemia as a white blood cell count (WBC) >100x109/L, while 18% and 4% of responders used a WBC of >50 x109/L and >30 x109/L as the cut-off; 23% did not indicate a specific threshold. Most responders (82%) indicated they would use Leukapheresis in some patients. The responders who did not use Leukapheresis most commonly cited lack of availability of the procedure at their facility (48%) or lack of perceived benefit (20%) as the primary reason; 6% cited unacceptable time required to consult transfusion medicine, while 32% cited other reasons. The majority of responders (77%) would use clinical evidence of leukostasis to initiate Leukapheresis [Figure 1A]; 72% would avoid using Leukapheresis if symptoms of leukostasis were not present [Figure 1B]. Others stated they did not decide based on signs of leukostasis but rather on WBC count [Figure 2A and B]. The majority (82%) did not indicate the upper age limit for using Leukapheresis; 10% used 80 years as a cut-off. Most participants believed acute promyelocytic leukemia (62%) and hemodynamic instability (72%) to be contraindications, whereas only 20%, 30% and 40% of participants considered significant coronary artery disease, significant heart failure and disseminated intravascular coagulation (DIC) to be contraindications, respectively. Focusing on thrombocytopenia, 25%, 46%, 21% and 8% cited a platelet count >10, >20, >30 and >50 x 109/L as the minimal threshold required before initiating Leukapheresis. For patients with severe symptomatic anemia and hyperleukocytosis, 41% did not transfuse red blood cells (RBCs) in patients with leukostasis (regardless of the WBC count) whereas 27% use a WBC in considering RBCs transfusions; 32% of responders would transfuse RBCs regardless of the presence of hyperleukocytosis or leukostasis. Only 18% of participants had guidelines available at their institutions when and how to use Leukapheresis, while 60% indicated it was solely the attending physician9s decision. Most responders felt that Leukapheresis only had a beneficial effect on early mortality if leukostasis symptoms were present; however, about one third of responders were not sure whether Leukapheresis influenced early mortality in patients with or without leukostasis [Figure 3A]. When asked about long-term survival, 67% of responders did not believe there is a benefit with Leukapheresis in the absence of leukostasis; about one third of responders were unsure [Figure 3B]. Conclusions: This survey demonstrates significant variability in the definition and management of hyperleukocytosis and perceptions regarding indications and contraindications of Leukapheresis. The findings emphasize the need for randomized clinical trials to define the role of Leukapheresis in the management of hyperleukocytosis. Disclosures Stone: Celgene: Consultancy; Astellas: Consultancy; Jazz: Consultancy; Fuji Film: Consultancy; Arog: Consultancy; Agios: Consultancy; Abbvie: Consultancy; Sumitomo: Consultancy; Amgen: Consultancy; Pfizer: Consultancy; Ono: Consultancy; Novartis: Consultancy. Erba: Juno: Other: all research support paid to University of Alabama, Research Funding; Seattle Genetics: Consultancy, Other: all research support paid to University of Alabama, Research Funding; Sunesis: Consultancy; Millennium/Takeda: Consultancy, Other: all research support paid to University of Alabama, Research Funding; Glycomimetics: Other: Chair, Data and Safety Monitoring Committee; Agios: Other: all research support paid to University of Alabama, Research Funding; Celgene: Consultancy, Other: Chair, Scientific Steering Committee , Speakers Bureau; Incyte: all research support paid to University of Alabama, Consultancy, Speakers Bureau; Jazz: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Amgen: Consultancy, Other: all research support paid to University of Alabama, Research Funding; Daiichi Sankyo: Consultancy, Other: all research support paid to University of Alabama, Research Funding; ImmunoGen: Consultancy, Other: all research support paid to University of Alabama, Research Funding; MacroGen: Consultancy; Ono: Consultancy; Pfizer: Consultancy; Astellas: Other: all research support paid to University of Alabama, Research Funding; Celator: Other: all research support paid to University of Alabama, Research Funding; Janssen: Other: all research support paid to University of Alabama, Research Funding. Sekeres: Celgene: Membership on an entity9s Board of Directors or advisory committees. Steensma: Novartis: Consultancy, Membership on an entity9s Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity9s Board of Directors or advisory committees; Pfizer: Consultancy; Janssen: Consultancy, Research Funding; Pfizer: Consultancy, Membership on an entity9s Board of Directors or advisory committees; Onconova: Consultancy; Incyte: Equity Ownership; Celgene: Consultancy; Takeda: Consultancy; H3 Biosciences: Consultancy. Komrokji: Celgene: Honoraria; Novartis: Honoraria, Speakers Bureau. Zeidan: AbbVie, Otsuka, Pfizer, Gilead, Celgene, Ariad, Incyte: Consultancy, Honoraria; Takeda: Speakers Bureau; Otsuka: Consultancy.
Thomas H Price - One of the best experts on this subject based on the ideXlab platform.
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an analysis of Leukapheresis and central venous catheter use in the randomized placebo controlled phase 3 impact trial of sipuleucel t for metastatic castrate resistant prostate cancer
The Journal of Urology, 2013Co-Authors: Robert C Flanigan, Anthony J Polcari, Neil Shore, Thomas H Price, Robert B Sims, Johnathan Maher, J B Whitmore, John M CormanAbstract:Purpose: Sipuleucel-T is an autologous cellular immunotherapy. We review the safety of the Leukapheresis procedure required for sipuleucel-T preparation and complications related to venous catheter use in the randomized, placebo controlled phase 3 IMPACT (IMmunotherapy for ProstAte Cancer Trial) study (NCT 00065442).Materials and Methods: A total of 512 patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer were enrolled in the study. All patients were scheduled to undergo 3 standard 1.5 to 2.0 blood volume Leukapheresis procedures at 2-week intervals. Leukapheresis related adverse events and those related to venous catheter use were reviewed. Immune cell counts were examined throughout the treatment course.Results: Of 512 enrolled patients 506 underwent 1 or more Leukapheresis procedures and were included in this analysis. Adverse events were comparable between the sipuleucel-T and control arms. Leukapheresis related adverse events were primarily associated with...
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augmented mobilization and collection of cd34 hematopoietic cells from normal human volunteers stimulated with granulocyte colony stimulating factor by single dose administration of amd3100 a cxcr4 antagonist
Transfusion, 2005Co-Authors: Conrad W Liles, Thomas H Price, Elin Rodger, Hal E Broxmeyer, Christine Dehner, Karin Badel, Gary Calandra, Jeffrey Christensen, Brent L Wood, David C DaleAbstract:BACKGROUND: AMD3100, a selective antagonist of CXCR4, rapidly mobilizes CD34+ hematopoietic progenitor cells (HPCs) from marrow to peripheral blood with minimal side effects. STUDY DESIGN AND METHODS: To further investigate potential clinical utility of AMD3100 for CD34+ cell mobilization and collection, a Phase I study in normal volunteers was performed examining single-dose administration of AMD3100 alone and in combination with a standard 5-day granulocyte–colony-stimulating factor (G–CSF) regimen. RESULTS: AMD3100 (160 µg/kg × 1 on Day 5) significantly increased both G–CSF-stimulated (10 µg/kg/day) mobilization of CD34+ cells (3.8-fold) and Leukapheresis yield of CD34+ cells. Moreover, collection of CD34+ cells was comparable between individuals mobilized by a single-dose regimen of AMD3100 (240 µg/kg) and individuals mobilized with a 5-day regimen of G–CSF. AMD3100-mobilized Leukapheresis products contained significantly greater numbers of T and B cells compared to G–CSF-stimulated Leukapheresis products. CONCLUSION: These findings indicate that AMD3100 can be used alone or as an adjunct to G–CSF to mobilize cells for HPC transplantation.
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neutrophil transfusions kinetics and functions of neutrophils mobilized with granulocyte colony stimulating factor and dexamethasone
Transfusion, 1998Co-Authors: David C Dale, W C Liles, C Llewellyn, Elin Rodger, Thomas H PriceAbstract:BACKGROUND: The collection of adequate numbers of neutrophils (polymorphonuclear leukocytes, PMNs) from normal donors has long hampered the development of neutrophil transfusion therapy. The stimulation of donors with granulocyte-colony-stimulating factor (G- CSF) plus dexamethasone is a promising way of improving PMN collections. STUDY DESIGN AND METHODS:Sixteen normal subjects received G-CSF (600 micrograms subcutaneously) and dexamethasone (8 mg by mouth) 12 hours before Leukapheresis. Measurements included PMN morphology, immunophenotype analysis, chemiluminescence, bactericidal activity, in vivo kinetics, and adverse effects. RESULTS:A mean of 77.4 +/− 6.4 × 10(9) PMNs was collected with each Leukapheresis; 14 percent were bands. PMNs had increased surface expression of CD11b, CD18, CD14, CD32, and CD64. Bactericidal capacity against Staphylococcus aureus was normal. Inducible respiratory burst was maintained, although the responses to some agonists were diminished. Returned Leukapheresis cells labeled with 3H-diisopropylfluorophosphate had a modestly decreased percentage of recovery and circulated with a prolonged half- life. Migration of these cells to skin chambers was approximately equal to that of the subjects' own blood PMNs. Adverse effects included transient bone pain, headache, hunger, and insomnia. CONCLUSIONS:Precollection treatment of Leukapheresis donors with G-CSF plus dexamethasone is an effective way to enhance the collection of PMNs with normal or near-normal functional properties for PMN transfusion therapy.
David C Dale - One of the best experts on this subject based on the ideXlab platform.
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augmented mobilization and collection of cd34 hematopoietic cells from normal human volunteers stimulated with granulocyte colony stimulating factor by single dose administration of amd3100 a cxcr4 antagonist
Transfusion, 2005Co-Authors: Conrad W Liles, Thomas H Price, Elin Rodger, Hal E Broxmeyer, Christine Dehner, Karin Badel, Gary Calandra, Jeffrey Christensen, Brent L Wood, David C DaleAbstract:BACKGROUND: AMD3100, a selective antagonist of CXCR4, rapidly mobilizes CD34+ hematopoietic progenitor cells (HPCs) from marrow to peripheral blood with minimal side effects. STUDY DESIGN AND METHODS: To further investigate potential clinical utility of AMD3100 for CD34+ cell mobilization and collection, a Phase I study in normal volunteers was performed examining single-dose administration of AMD3100 alone and in combination with a standard 5-day granulocyte–colony-stimulating factor (G–CSF) regimen. RESULTS: AMD3100 (160 µg/kg × 1 on Day 5) significantly increased both G–CSF-stimulated (10 µg/kg/day) mobilization of CD34+ cells (3.8-fold) and Leukapheresis yield of CD34+ cells. Moreover, collection of CD34+ cells was comparable between individuals mobilized by a single-dose regimen of AMD3100 (240 µg/kg) and individuals mobilized with a 5-day regimen of G–CSF. AMD3100-mobilized Leukapheresis products contained significantly greater numbers of T and B cells compared to G–CSF-stimulated Leukapheresis products. CONCLUSION: These findings indicate that AMD3100 can be used alone or as an adjunct to G–CSF to mobilize cells for HPC transplantation.
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neutrophil transfusions kinetics and functions of neutrophils mobilized with granulocyte colony stimulating factor and dexamethasone
Transfusion, 1998Co-Authors: David C Dale, W C Liles, C Llewellyn, Elin Rodger, Thomas H PriceAbstract:BACKGROUND: The collection of adequate numbers of neutrophils (polymorphonuclear leukocytes, PMNs) from normal donors has long hampered the development of neutrophil transfusion therapy. The stimulation of donors with granulocyte-colony-stimulating factor (G- CSF) plus dexamethasone is a promising way of improving PMN collections. STUDY DESIGN AND METHODS:Sixteen normal subjects received G-CSF (600 micrograms subcutaneously) and dexamethasone (8 mg by mouth) 12 hours before Leukapheresis. Measurements included PMN morphology, immunophenotype analysis, chemiluminescence, bactericidal activity, in vivo kinetics, and adverse effects. RESULTS:A mean of 77.4 +/− 6.4 × 10(9) PMNs was collected with each Leukapheresis; 14 percent were bands. PMNs had increased surface expression of CD11b, CD18, CD14, CD32, and CD64. Bactericidal capacity against Staphylococcus aureus was normal. Inducible respiratory burst was maintained, although the responses to some agonists were diminished. Returned Leukapheresis cells labeled with 3H-diisopropylfluorophosphate had a modestly decreased percentage of recovery and circulated with a prolonged half- life. Migration of these cells to skin chambers was approximately equal to that of the subjects' own blood PMNs. Adverse effects included transient bone pain, headache, hunger, and insomnia. CONCLUSIONS:Precollection treatment of Leukapheresis donors with G-CSF plus dexamethasone is an effective way to enhance the collection of PMNs with normal or near-normal functional properties for PMN transfusion therapy.
A. Tunalı - One of the best experts on this subject based on the ideXlab platform.
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successful pregnancy and delivery in a patient with chronic myelogenous leukemia cml and management of cml with Leukapheresis during pregnancy a case report and review of the literature
Japanese Journal of Clinical Oncology, 2004Co-Authors: Ridvan Ali, F. Özkalemkaş, V. Özkocaman, T. Özçelik, Ü. Ozan, Y. Kimya, A. TunalıAbstract:Although infrequently seen, the management of cancer during pregnancy can be difficult for patients, their families and physicians. The concomitant occurrence of pregnancy and chronic myelogenous leukemia is uncommon. We describe the successful management of a 26-year-old woman in the first trimester of her pregnancy with chronic myelogenous leukemia (CML) in chronic phase by using only Leukapheresis. She was treated with Leukapheresis until her delivery at 36 weeks of gestation. The procedure was without significant adverse effects on the patient or fetus. We applied a total of 15 Leukapheresis treatments throughout the pregnancy. The patient gave birth vaginally to a healthy 2800 g boy at 36 weeks of gestation. We conclude that Leukapheresis may provide an alternative treatment to chemotherapy, alpha-interferon or imatinib in pregnant patients with CML, particularly with concern over their potential teratogenic and other adverse effects.
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Successful labor in the course of chronic lymphocytic leukemia (CLL) and management of CLL during pregnancy with Leukapheresis
Annals of Hematology, 2004Co-Authors: F. Özkalemkaş, V. Özkocaman, E. Bülbül-başkan, T. Özçelik, Ü. Ozan, Y. Kimya, A. TunalıAbstract:We describe the successful management of a 30-year-old woman in the second trimester of her pregnancy with chronic lymphocytic leukemia (CLL) in stage IV by using only Leukapheresis. We applied three sessions (courses) of Leukapheresis throughout the pregnancy. The procedure did not have any significant adverse effect on the patient and the fetus. The patient gave birth vaginally to a healthy boy, weighing 3100 g, at 39 weeks of gestation. Seven months after delivery, Richter's syndrome developed in the patient. We conclude that Leukapheresis may provide an alternative for palliative treatment to chemotherapy in pregnant patients with CLL. To our knowledge, this is the fourth reported case of CLL in pregnancy, and the first management of CLL during pregnancy with Leukapheresis.
Karsten Spiekermann - One of the best experts on this subject based on the ideXlab platform.
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the role of therapeutic Leukapheresis in hyperleukocytotic aml
PLOS ONE, 2014Co-Authors: Friederike Pastore, Alessandro Pastore, Georg Wittmann, Wolfgang Hiddemann, Karsten SpiekermannAbstract:Purpose: Hyperleukocytosis in AML with leukostasis is a serious life-threatening condition leading to a high early mortality which requires immediate cytoreductive therapy. Therapeutic Leukapheresis is currently recommended by the American Society of Apheresis in patients with a WBC>100 G/l with signs of leukostasis, but the role of prophylactic Leukapheresis before clinical signs of leukostasis occur is unclear. Patients: We retrospectively analyzed the role of Leukapheresis in 52 patients (median age 60 years) with hyperleukocytotic AML with and without clinical signs of leukostasis. Since Leukapheresis was performed more frequently in patients with signs of leukostasis due to the therapeutic policy in our hospital, we developed a risk score for early death within seven days after start of therapy (EDd7) to account for this selection bias and to independently measure the effect of Leukapheresis on EDd7. Results: 20 patients received Leukapheresis in combination to chemotherapy compared to 32 patients who received chemotherapy only. In a multivariate logistic regression model for the estimation of the probability of EDd7 thromboplastin time and creatinine remained as independent significant parameters and were combined to create an EDd7 risk score. The effect of Leukapheresis on EDd7 was evaluated in a bivariate logistic regression together with the risk score. Leukapheresis did not significantly change early mortality in all patients with a WBC >= 100 G/l. Discussion: Prophylactic Leukapheresis in hyperleukocytotic patients with and without leukostasis did not improve early mortality in our retrospective study. Larger and prospective clinical trials are needed to validate the risk score and to further explore the role of Leukapheresis in AML with hyperleukocytosis.