Reduced-Dosage Of Three Drugs Combination Of Cyclophosphamide, Bortezomib and Dexamethasone (reduced-CyBorD) Is Suitable For Elderly Frail Patients With Multiple Myeloma

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1963-1963 ◽  
Author(s):  
Hideo Yagi ◽  
Ryosuke Fujiwara ◽  
Keigo Sano ◽  
Keiko Yamazaki ◽  
Hitoshi Hanamoto ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Events ◽  
Conflicts Of Interest ◽  
High Response Rate ◽  
High Dose ◽  
Weekly Schedule ◽  
Old Patients ◽  
High Dose Dexamethasone ◽  
Highly Active ◽  
Frail Patients

Abstract Background The three drugs combination of cyclophosphamide, bortezomib and dexamethasone (CyBorD) is highly active regimen for the treatment of the patients with multiple myeloma (MM). However, twice-weekly schedule of bortezomib and high dose dexamethasone has been shown to cause significant toxicities, including peripheral neuropathy (PN) and thrombotic events. Once-weekly bortezomib induction therapy with reduced dosage of dexamethasone (modified-CyBorD) has shown less toxicity with high response rate equal to original regimen (Reeder, CB et al. Leukemia 2009). However, it was found more than half of the patients still developed bortezomib induced PN (BiPN) in this modification. Thus it was still concerned adverse event for the transplant ineligible patients, especially frail elderly patients because it often caused interruption or withdrawal of the treatments, resulting in fewer efficacies. Under these circumstances, we have studied the reduced-dosage of CyBorD regimen (reduced-CyBorD) in the treatment of transplant ineligible patients with MM to assess response and toxicity. Methods The protocol consisted of bortezomib given intravenously at a dose of 1.3 mg/m2 once a week on days 1, 8, 15, cyclophosphamide orally at a dose of 50 mg daily on days 1-21, and dexamethasone orally or intravenously at a dose of 20 mg daily on days 1,2,8,9,15,16 in 4-week cycles. Total of 32 patients, including 20 newly diagnosed and 12 refractory, were treated with reduced-CyBorD and evaluated its efficacy and safety. Results The median age was 72 years (range from 62 to 88). 14 patients were more than 75 year-old (44 %). 15 patients were female. According ISS, 4 patients were classified in stage I, 10 were in II, and 18 were in III. The overall response (ORR) was 90.6 % with 43.8 % of CR/nCR (6 CR, 8 nCR, 7 VGPR and 8 PR). Hematological adverse events were anemia (18.8%; G1/2 n=7), neutropenia (37.5%; G1/2 n=10, G3/4 n=2), lymphocytopenia (43.8%; G1/2 n=10, G3/4 n=4), thrombocytopenia (12.5%; G1/2 n=1, G3/4 n=3). Non-hematological adverse events were pneumonia (12.5%; G2 n=2, G3 n=2), VZV infection (15.6%; G1/2 n=5), cerebral infarction (3.1%; G2 n=1). Importantly, only 6 patients (18.8%) developed grade 1 PN, and no patient reduced or discontinued bortezomib due to PN. The overall survival (OS) at 1, 2, and 3 years were 81, 63.1, and 45.9 %, respectively. In this study, neither inferior response nor poor survivals were significantly observed between over 75 year-old patients group (n=14) and under 75 year-old group (n=18) (ORR; 100 vs 83.4 %, CR/nCR; 42.9 vs 44.4 %, 1-year PFS 54.6 vs 50 %, and 3-year OS 29.8 vs 55 %). Conclusions Reduced-CyBorD with three times once-weekly bortezomib retained high efficacy seen in standard and modified CyBorD previously reported (ORR; 90.6 vs 88 and 93 %, CR/nCR; 43.8 vs 39 and 43 %). These results showed that our regimen has less toxicity, especially BiPN (18.8 %) compared with those previous regimens (64 % and 57 %), resulting in no discontinuation nor reduction of bortezomib. Furthermore, over 75 year-old patients group did not showed inferior outcomes in comparison with under 75 year-old patients group. Our results suggested that reduced-CyBorD might be suitable for the transplant ineligible patients, especially elderly frail patients (over 75 year-old) with MM. Disclosures: No relevant conflicts of interest to declare.

Reduced-Dosage of Three Drugs Combination of Cyclophosphamide, Bortezomib and Dexamethasone (reduced-CyBorD) Retains High Response Rate with Less Toxicities in Elderly Patients with Multiple Myeloma

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1865-1865 ◽  
Author(s):  
Hideo Yagi ◽  
Ryosuke Fujiwara ◽  
Keigo Sano ◽  
Fujita Mariko ◽  
Takashi Iizuka ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Events ◽  
Elderly Patients ◽  
Response Rate ◽  
Conflicts Of Interest ◽  
High Response Rate ◽  
High Response ◽  
High Dose ◽  
Weekly Schedule ◽  
High Dose Dexamethasone

Abstract Abstract 1865 Background: The three drugs combination of cyclophosphamide, bortezomib and dexamethasone (CyBorD) has been proven to be a powerful regimen for the treatment of the patients with multiple myeloma (MM). However, twice-weekly schedule of bortezomib and high dose dexamethasone has been shown to cause significant toxicities, including severe peripheral neuropathy (PN). Recently, once-weekly bortezomib induction therapy with CyBorD (modified-CyBorD) has shown less toxicity with high response rate equal to original regimen (Reeder, CB et al. Leukemia 2009). However, more than half of the patients developed bortezomib induced PN (BiPN) in modified-CyBorD. Thus it was still concerned adverse event for the transplant ineligible patients, especially frail elderly patients because it often caused interruption or withdrawal of the treatments, resulting in fewer efficacies. Under these circumstances, we introduced the reduced-dosage of CyBorD regimen (reduced-CyBorD) in the transplant ineligible patients with multiple myeloma for continuation of the treatment. Methods: The protocol consisted of bortezomib given intravenously at a dose of 1.3 mg/m2once a week on days 1, 8, 15, cyclophosphamide orally at a dose of 50 mg daily on days 1–21, and dexamethasone orally or intravenously at a dose of 20 mg daily on days 1,2,8,9,15,16 in 4-week cycles. Total of 20 patients, including 12 newly diagnosed and 8 refractory, were treated with reduced-CyBorD and evaluated its efficacy and safety. Results: The median age was 72 years (range from 62 to 81). 14 patients were more than 70 year-old (70%). A half of the patients were female. According ISS, 3 patients were classified in stage I, 6 were in II, and 11 were in III. The overall response was 86.6 % with 26.7 % CR/nCR (1 CR, 3 nCR, 5 VGPR and 4 PR). Hematological adverse events were neutropenia (35%; G1/2 n=7), lymphocytopenia (35%; G1/2 n=1, G3/4, n=1), thrombocytopenia (10%; G1/2 n=2). Non-hematological adverse events were pneumonia (20%; G2 n=2, G3 n=2), VZV infection (15%; G2 n=3), cerebral infarction (5%; G2 n=1). Importantly, only three patients (15%) developed grade 1 PN, and no patient reduced or discontinued bortezomib due to PN. Conclusions: Reduced-CyBorD with three times once-weekly bortezomib retained high efficacy seen in standard and modified CyBorD (4 times bortezomib administration). Furthermore, it was found that this regimen obviously revealed less toxicity, especially BiPN compared with those previous regimens (See Table). Our results suggested that reduced-CyBorD might be safe and effective approach to the transplant ineligible patients, especially elderly frail patients with MM. Disclosures: No relevant conflicts of interest to declare.

Bortezomib-Containing Regimens for Multiple Myeloma Maintenance Therapy: a Meta-Analysis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3473-3473
Author(s):  
Yucai Wang ◽  
Wenwen Zhang ◽  
Fang Yang ◽  
Xiaoxiang Guan ◽  
Neil Kothari ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Conflicts Of Interest ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
High Dose ◽  
Vascular Events ◽  
Cardiac Disorders ◽  
Grade 3

Abstract Objective: To evaluate the efficacy and safety of bortezomib-containing regimens in maintenance therapy of multiple myeloma through meta-analysis of randomized controlled trials (RCTs). Patients and methods: PubMed, Web of Science and ASH databases were searched for RCTs that investigated the treatment outcomes (progression-free survival [PFS] and overall survival [OS]) of maintenance therapy with bortezomib-containing regimens in patients with multiple myeloma. Study endpoints included PFS, OS, and grade 3 or 4 adverse events. Pooled hazard ratios (HRs) for survival outcomes and risk ratios (RRs) for dichotomous data with 95% confidence interval (CI) were calculated using Comprehensive MetaAnalysis (v2). Results: Three RCTs comprising 1396 patients were included in this meta-analysis. Compared with maintenance therapy without bortezomib and/or no maintenance therapy, bortezomib-based maintenance therapy regimens significantly prolonged PFS (HR = 0.66, 95% CI = 0.58 - 0.76, P < 0.001) and OS (HR = 0.74, 95% CI = 0.62 - 0.88, P = 0.001) in multiple myeloma patients. In patients who received high-dose chemotherapy followed by autologous stem cell transplantation (ASCT), bortezomib-based maintenance therapy increased both PFS (HR = 0.73, 95% CI = 0.61 - 0.86, P < 0.001) and OS (HR = 0.76, 95% CI = 0.61 - 0.95, P = 0.016). For transplant ineligible patients, maintenance therapy with bortezomib-containing regimen also increased PFS (HR = 0.58, 95% CI = 0.47 - 0.71, P < 0.001) and OS (HR = 0.70, 95% CI = 0.52 - 0.92, P = 0.012). However, bortezomib-based maintenance therapy increased the risks of grade 3 or 4 adverse events including thrombocytopenia (RR = 1.37, 95% CI = 1.01 - 1.87, P = 0.046), infections (RR = 1.29, 95% CI = 1.02 - 1.64, P = 0.035), cardiac disorders (RR = 2.01, 95% CI = 1.17 - 3.47, P = 0.012), and vascular events (RR = 2.02, 95% CI = 1.15 - 1.45, P= 0.015). Conclusions: Bortezomib-based maintenance therapy results in significant improvement in PFS and OS in multiple myeloma patients, but may increase the risk of developing some grade 3 or 4 adverse events, such as thrombocytopenia, infections, cardiac disorders, and vascular events. Further studies are needed to corroborate the above findings given the limited data on proteasome inhibitor based maintenance therapy for multiple myeloma. Disclosures No relevant conflicts of interest to declare.

Effectiveness of Lenalidomide and Dexamethasone for the Treatment of Extramedullary Plasmacytoma in Patients with Multiple Myeloma: Report of Two Cases

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5760-5760
Author(s):  
Katarína Masárová ◽  
Zdenka Stefanikova ◽  
Martin Mistrik ◽  
Angelika Batorova
Keyword(s):  
Multiple Myeloma ◽  
Complete Remission ◽  
Conflicts Of Interest ◽  
Bone Marrow Involvement ◽  
Progression Free Survival ◽  
Primary Diagnosis ◽  
Extramedullary Plasmacytoma ◽  
High Dose ◽  
Solitary Plasmacytoma ◽  
High Dose Dexamethasone

Abstract Extramedullary plasmacytoma (EMP) can occur at the time of primary diagnosis of multiple myeloma (MM), during the disease, or as solitary plasmacytoma without bone marrow involvement. The presence of EMP at any time in the course of disease is associated with significantly shorter overall survival and progression-free survival. We report a series of two patients with EMP who were successfully treated with lenalidomide and dexamethasone. The first patient was diagnosed in 2006 with EMP in the spine without presence of MM at the time of diagnosis. Reconstruction surgery followed by high dose dexamethasone treatment led to stabilization of patient’s condition. Patient received zoledronic acid for prevention of skeletal fractures. In 2011 the patient was diagnosed with MM and two new EMP lesions in the spine were discovered. The patient received bortezomib and achieved a partial remission. In 2012 a significant growth of EMP in retroperitoneum was observed. Tumor was surgically removed, plasmacytoma was confirmed histologically. Patient was treated with lenalidomide and dexamethasone with subsequent autologous peripheral blood stem cell transplantation (APBSCT) and achieved complete remission. Patient Two had advanced stage of MM at the time of diagnosis, without presence of EMP. She was treated with induction therapy followed by APBSCT. EMP in the area of clivus, diagnosed three years after initial diagnosis of MM was successfully managed with conventional chemotherapy and radiotherapy. In 2010 another EMP in the left sphenoid sinus progressed during relapse of MM. Treatment with lenalidomide and dexametazone led to remission of MM and disparition of EMP. Both patients are in complete remission at the time of submitting this abstract. Our clinical experience strongly suggests that lenalidomide with dexamethasone is an effective agent for treating EMP in patients with MM. The treatment was well tolerated with manageable side effects. Disclosures No relevant conflicts of interest to declare.

Renal Impairment in Patients With Multiple Myeloma: A Consensus Statement on Behalf of the International Myeloma Working Group

2010 ◽  
Vol 28 (33) ◽  
pp. 4976-4984 ◽  
Author(s):  
Meletios A. Dimopoulos ◽  
Evangelos Terpos ◽  
Asher Chanan-Khan ◽  
Nelson Leung ◽  
Heinz Ludwig ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Function ◽  
Renal Impairment ◽  
Light Chain ◽  
Renal Injury ◽  
High Dose ◽  
Acute Renal Injury ◽  
High Dose Dexamethasone ◽  
Cast Nephropathy ◽  
High Dose Melphalan

Renal impairment is a common complication of multiple myeloma (MM). The estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula is the recommended method for the assessment of renal function in patients with MM with stabilized serum creatinine. In acute renal injury, the RIFLE (risk, injury, failure, loss and end-stage kidney disease) and Acute Renal Injury Network criteria seem to be appropriate to define the severity of renal impairment. Novel criteria based on eGFR measurements are recommended for the definition of the reversibility of renal impairment. Rapid intervention to reverse renal dysfunction is critical for the management of these patients, especially for those with light chain cast nephropathy. Bortezomib with high-dose dexamethasone is considered as the treatment of choice for such patients. There is limited experience with thalidomide in patients with myeloma with renal impairment. Thus, thalidomide can be carefully administered, mainly in the context of well-designed clinical trials, to evaluate if it can improve the rapidity and probability of response that is produced by the combination with bortezomib and high-dose dexamethasone. Lenalidomide is effective in this setting and can reverse renal insufficiency in a significant subset of patients, when it is given at reduced doses, according to renal function. The role of plasma exchange in patients with suspected light chain cast nephropathy and renal impairment is controversial. High-dose melphalan (140 mg/m2) and autologous stem-cell transplantation should be limited to younger patients with chemosensitive disease.

High-dose dexamethasone for refractory or relapsing multiple myeloma

1991 ◽  
Vol 36 (3) ◽  
pp. 171-175 ◽  
Author(s):  
William R. Friedenberg ◽  
Robert A. Kyle ◽  
William H. Knospe ◽  
John M. Bennett ◽  
Anastasios A. Tsiatis ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
High Dose ◽  
High Dose Dexamethasone

Lenalidomide Plus High-Dose Dexamethasone Provides Improved Overall Survival Compared to High-Dose Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma (MM): Results of 2 Phase III Studies (MM-009, MM-010) and Subgroup Analysis of Patients with Impaired Renal Function.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3547-3547 ◽  
Author(s):  
Donna Weber ◽  
Michael Wang ◽  
Christine Chen ◽  
Andrew Belch ◽  
Edward A. Stadtmauer ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Renal Function ◽  
Creatinine Clearance ◽  
Subgroup Analysis ◽  
Impaired Renal Function ◽  
Phase Iii ◽  
High Dose ◽  
High Dose Dexamethasone ◽  
Duration Of Response

Abstract Lenalidomide is a novel, orally administered immunomodulatory drug (IMiD) that has single-agent activity against multiple myeloma (MM) and additive effects when combined with dexamethasone. We have previously reported improved response (OR), time to progression (TTP) and overall survival (OS) with lenalidomide-dexamethasone (Len-Dex) compared to dexamethasone-placebo (Dex) based on the results of 2 phase III trials (MM-009, North American, 353 pts; MM-010, Europe, Australia, and Israel, 351 pts). In both trials patients with relapsed or refractory MM not resistant to dexamethasone, were treated with dexamethasone 40 mg daily on days 1–4, 9–12, and 17–20 every 28 days and were randomized to receive either lenalidomide 25 mg daily orally on days 1–21 every 28 days or placebo. Beginning at cycle 5, Dex was reduced to 40 mg daily on days 1–4 only, every 28 days. Patients were also stratified with respect to B2M (≤2.5 vs. > 2.5 mg/mL), prior stem cell transplant (none vs. ≥ 1), and number of prior regimens (1 vs > 1). At a median follow-up from randomization of 17.1 mos (MM-009) and 16.5 mos (MM-010), both studies continue to show significant improvement with Len-Dex compared to Dex in OR (MM-009: 61% vs 20.5%, p<.001; MM-010: 59.1% vs. 24%, p<.001, respectively), TTP (MM-009: 11.1mos vs. 4.7mos, p<.001; MM-010: 11.3mos vs. 4.7mos, p<.001, respectively), and OS (MM-009: 29.6mos vs. 20.5mos, p<.001; MM-010: not estimable vs 20.6mos, p<.001, respectively). Pooled data from both trials demonstrates a significant improvement in duration of response for pts achieving ≥ PR with 122/216 pts (56.5%) who received Len-Dex continuing in remission (med. duration of response not reached but > 68.1 wks) compared to only 22/76 pts (28.9%) treated with dexamethasone alone (med. duration of response 22.1 wks, p<.001). An additional subgroup analysis was performed on pts with impaired creatinine clearance (cr cl). No significant difference in response rate, TTP, or OS was noted for patients with cr cl above or below 50 ml/min who were treated with Len-Dex, but for 16 pts with cr cl <30ml/min, med. TTP and OS was shorter than for those with cr cl >30ml/min, but still significantly higher than for pts treated with Dex. Grade 3–4 thrombocytopenia was significantly higher in pts with impaired renal function (<50ml/min, 13.8%; >50ml/min 4.6%, p<.01; <30ml/min, 18.8%, >30 ml/min, 5.5%, p<.05), but there was no difference for G3–4 neutropenia at either cutoff. Phase I–II evaluation to establish appropriate dosing in pts with cr cl < 30ml/min, particularly with respect to thrombocytopenia is warranted, but should not underscore improved OR, TTP, and OS for pts treated with Len-Dex regardless of creatinine clearance.

Cytomegalovirus Infection in Patients with Acute Leukemia and MDS.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4167-4167
Author(s):  
Hiromi Yuasa ◽  
Taiichi Kyo ◽  
Noriaki Yoshida ◽  
Yuta Katayama ◽  
Hideki Asaoku
Keyword(s):  
Acute Leukemia ◽  
Induction Chemotherapy ◽  
Cytomegalovirus Infection ◽  
Conflicts Of Interest ◽  
High Dose ◽  
Consolidation Chemotherapy ◽  
Old Patients ◽  
Chemotherapy Induction ◽  
Cmv Reactivation ◽  
Support Treatment

Abstract Abstract 4167 [Background] It is important for the progress of the support treatment for AML. It is possible for more than seventy years old patients to cure AML actively. [Purpose] We examined the CMV reactivation after chemotherapy of AML, MDS, and ALL. [Methods] The study design planned to enroll 195 patients. Diagnoses included AML (121), MDS (56), ALL (18). Patients received induction chemotherapy. Induction regimens consisted of IDA (12 mg/m2 per day, day 1, 3, 5 and 8) and BHAC (350 mg/ m2 per day, day 1-10)(= Ara-C 200 mg/ m2 per day, day 1-10). Patients received consolidation chemotherapy. Consolidation chemotherapy comprised of High-dose Ara-C Therapy-containing regimens. We examined the CMV reactivation when patients have fever but they were recovered from the leukocyte decrease term after chemotherapy. [Results] About 10% of patients experienced CMV reactivation. Thirteen of 121 AML patients experienced CMV reactivation. Three of 56 MDS patients experienced CMV reactivation. Four of 18 ALL patients experienced CMV reactivation. [Conclusion] It is important to be careful for CMV reactivation in patients receiving High-dose Ara-C Therapy. Disclosures: No relevant conflicts of interest to declare.

Incidence of Febrile Episodes During Stem Cells Mobilization After High Dose Cyclophosphamide Chemotherapy and G-CSF (filgrastim or lenograstim) Administration in Multiple Myeloma Patients: Preliminary Final Results.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4560-4560
Author(s):  
Enrico Orciuolo ◽  
Gabriele Buda ◽  
Emerenziana Marturano ◽  
Elisa Mauro ◽  
Giuseppe Milone ◽  
...  
Keyword(s):  
Stem Cells ◽  
Multiple Myeloma ◽  
Conflicts Of Interest ◽  
Treatment Plan ◽  
High Dose ◽  
Absolute Count ◽  
Functional Block ◽  
Grade 3 ◽  
Febrile Episodes

Abstract Abstract 4560 Introduction The G-CSF, primary regulator of granulopoiesis, has shown its efficacy in reducing duration of neutropenia after chemotherapy or myelosuppressive therapy. In these situations G-CSF, accelerating the granulocytous reconstitution, may enable a significant reduction of the incidence, duration and severity of infection. Commercially formulations of rHu-G-CSF include lenograstim, a glycosylated form, and filgrastim, a non-glycosylated form. Glycosylation of the molecule contribute to pharmacokynetis advantages and to higher affinity to specific receptor. Additionally, lenograstim exposed neutrophils maintain unchanged all their functions in vitro, while filgrastim exposed neutrophils present functional defects due to higher adhesivity, cytoscheletric alterations and a more immature phenotype. Aim On these bases, we hypotized that lenograstim may prevent febrile episodes (FE) and reduce their lasting in patients with chemotherapy derived neutropenia more efficiently than filgrastim. Primary endpoint is the incidence of FE (ClinicalTrials.gov ID: NCT00932217). Patients and methods starting from April 2005, 180 multiple myeloma patients achieving high dose cyclophosphamide for stem cells mobilization were enrolled in 11 Italian Centers. Treatment plan consisted in: high dose cyclophosphamide (3 or 4 g/sqm) on day 1, G-CSF (random 1:1 on the base of a generated random list: filgrastim or lenograstim) 30 MU/day from day +4 to +9, 60 MU/day from day +10 to the achievement of an optimal CD34+ cell count for staminoapheresis. FE, significant if equal or higher than 38 °C for at least 2 different determinations, were recorded till day +30. Results 176 of 180 patients received scheduled treatment and are eligible for final analyses. All 176 patients underwent post-chemo grade 4 neutropenia and G-CSF was administered starting from day +4. FE were recorded in 26 pts, 16 in the filgrastim arm (89 total patients) and 10 in the lenograstim arm (87 total patients). The global fever incidence was 14.77%, 17.98% with filgrastim and 11.49% with lenograstim. However, to demonstrate functional block of filgrastim exposed neutrophils, FE have been related to neutrophil absolute count. Related to the neutropenia grade, 8 FE are recorded with filgrastim (8.99%) and 1 FE with lenograstim (1.15%) with absolute neutrophil count >500/μL (grade 3) (chi square test with Yates' correction: p=0.0436); this difference is still evident when neutrophils are >1000/μL (grade 2), with 7 episodes with filgrastim (7.87%) versus 1 (1.15%) with lenograstim. Conclusions Lenograstim is associated with a reduced global incidence of FE in multiple myeloma patients undergoing to high dose cyclophosphamide and stem cells mobilization when compared to filgrastim. Additionally, excluding the time frame when neutrophils are not yet recovered (neutrophils <500/μL; grade 4 neutropenia) and G-CSF effects may not be demonstrated, filgrastim treated patients present, when compared to lenograstim treated patients, an higher FE incidence at neutrophil absolute count recovery (both with grade 3 and grade 2 neutropenia), confirming the functional block of filgrastim exposed neutrophils described in vitro. On the contrary, lenograstim allows to recovery normally functional neutrophils as demonstrated by the very low incidence of FE (1.15% with neutrophils >500/μL) in treated patients. Disclosures: No relevant conflicts of interest to declare.

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