Prevention of Oral Mucositis with Palifermin in Patients Treated with High-Dose Chemotherapy and Autologous Stem Cell Transplantation. A Single Center Experience.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2974-2974
Author(s):  
Francois Luthi ◽  
Lorenzo Berwert ◽  
Valérie Frossard ◽  
Oscar Marchetti ◽  
Anne Rosselet ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Oral Mucositis ◽  
Conditioning Regimen ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Group A ◽  
Grade 3 ◽  
Group B

Abstract It was demonstrated in a placebo controlled randomized study that Palifemin decrease the severity of oral mucositis in patients (pts) treated with total body irradiation (TBI), high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The benefit of this treatment in pts who are not receiving TBI-containing conditioning regimen is still unclear. We evaluated prospectively the effect of Palifermin on mucositis prevention in 34 consecutive pts treated with HDCT and ASCT compared to an historical group of pts who did not receive Palifermin. Between 03/2005 and 05/2006, 34 pts (Group A) treated with Melphalan 200 (n=15) or BEAM (n=19) gave informed consent and received 6 injections of 0.06 mg/kg of Palifermin (3 days (d.) before HDCT and 3 d. following ASCT). Four were excluded from efficacy analysis, 2 of them due to Melphalan dose reduction and 2 due to early discontinuation of Palifermin. They were compared to 77 pts (Group B) treated with Melphalan 200 (n=43) or BEAM (n=34) from 2003 to 2005. WHO grading was used for toxicity assessment. The median age was 55 years in group A (Range 28–67) and 54 years in group B (Range 19–66). The median count of CD34 cells/kg infused was 4.2 millions (Range 1.96–23.9) in group A and 3.85 millions (Range 1.8–16.2) in group B. The median time for engraftment was the same in both groups and was respectively 11 d. for neutrophils (Range 8–12) and 11 d. for platelets (Range 8–13) in group A, 11 d. for neutrophils (Range 8–13) and 11 d. for platelets (Range 8–18) in group B. Severe oral mucositis (Grade 3 and 4) was lower in group A (17%) than in group B (44%). The incidence of grade 2 or more digestive mucositis was similar in the 2 groups (66% vs.60%) as well as the total opioid use (43% vs 57%). All patients but one in the group B developed fever. Fever of unknown origin were more frequent in group A due to less fever attributed to grade 3 or 4 mucositis.In group A, all but 3 pts developed toxicities. Grade 3 or 4 toxicities consisted in erythematous rash in 15 pts (44%), generalized oedema in 2 and odynophagia in 1. Grade 1 or 2 toxicities were pruritis (24%), rash (32%), localized oedema (26%) and buccal discomfort (41%). 1 pt died at d.12 from an hemophagocytic syndroma and onother at d.90 from a rapidly progressive colorectal cancer. We conclude that the use of Palifermin reduced the incidence of grade 3 or 4 mucositis in our group of pts treated without TBI, but did not decrease either digestive mucositis or the use of morphinic. The benefit of Palifermin on mucositis prevention has still to be balanced again the risk of discomfort and toxicities of this drug. Large randomized studies are still needed before recommending the systematic administration of Palifermin to pts receiving Melphalan 200 or BEAM as conditioning regimen before ASCT.

Multicenter Phase II Trial of 90Y-Ibritumomab Tiuxetan with High-Dose Chemotherapy (Busulfan/Cyclophosphamide/Etoposide) Followed by Autologous Stem Cell Transplantation in Relapsed, Refractoried, or High-Risk B-Cell NHL.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1914-1914
Author(s):  
Byung Woog Kang ◽  
Jae-Cheol Jo ◽  
Shin Kim ◽  
Geundoo Jang ◽  
Sung Sook Lee ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Stem Cell Transplantation ◽  
B Cell ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Conditioning Regimen ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Ibritumomab Tiuxetan

Abstract The need of new effective regimen for high-dose chemotherapy followed by autologous stem cell transplantation (ASCT) in aggressive B-cell non-Hodgkin’s lymphoma (NHL) patients and promising results observed so far in trials with 90Y-Ibritumomab tiuxetan containing regimens in ASCT strongly warrants the investigation of 90Y-Ibritumomab tiuxetan combined busulfan/cyclophosphamide/etoposide (Z-BuCyE) high-dose chemotherapy with ASCT for relapsed, refractoried, or high-risk B-cell NHL. We evaluated efficacy and safety of the combination of Z-BuCyE and ASCT in patients with relapsed, refractoried, or high-risk B-cell NHL. Treatment consisted of two doses of Rituximab (250 mg/m2, IV, day -21, -14) and a single dose of 90Y-Ibritumomab (0.4 mCi/kg, IV, day -14). All patients received conditioning regimen: busulfan (3.2 mg/kg, IV, day -7, -6, -5), etoposide (200 mg/m2, IV, day -5, -4), and cytoxan (50 mg/kg, IV, day -3, -2) followed by ASCT (day 0). Thirteen patients were entered the trial. The median age was 46.1 years (range: 25–60), and 6 (46%) patients were male. Histology was diffuse large B-cell (n=10), follicular (n=1), Burkitt (n=1), and mantle cell lymphoma (n=1). The objective overall response rate (ORR) was 76.9% (10/13): continued CR, 38.5% (5/13); induced CR, 23.1% (3/13); continued or induced PR, 15.4% (2/13). Three patients (23.1%) had a PD after transplantation and two of these patients died of progression. Median follow-up duration was 6.0 months. Median progression-free survival (PFS) and median overall survival (OS) has not yet been reached. Toxicity was principally non-hematologic. Grade 2 toxicity included mucositis (53.8%), nausea (61.5%), vomiting (15.4%), diarrhea (23.1%), and elevation of liver enzyme (7.7%). Grade 3 toxicity included mucositis (15.4%), nausea (23.1%), and diarrhea (23.1%). There was no grade 4 toxicity. Infection occurred in ten patients, bleeding in one patient, and there was no treatment related mortality. This preliminary analysis shows that the combination of Z-BuCyE and ASCT has excellent efficacy and is well-tolerated treatments for relapsed, refractoried or high-risk B-cell NHL. This study will be continued till 20 patients enrollment.

High-Dose Rituximab In The Conditioning Regimen Before Allogeneic Stem Cell Transplantation Decreases Deaths Related To Gvhd Without Affecting The Anti-Lymphoma Effect

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2059-2059 ◽  
Author(s):  
Anna Dodero ◽  
Francesco Spina ◽  
Barbara Sarina ◽  
Cristiana Carniti ◽  
Francesca Patriarca ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
B Cell ◽  
Immune Reconstitution ◽  
Acute Gvhd ◽  
Chronic Gvhd ◽  
Conditioning Regimen ◽  
High Dose ◽  
Group A ◽  
Group B

Abstract Introduction Allogeneic stem cell transplantation (alloSCT) is an effective salvage therapy for relapsed B-cell lymphomas. Different studies have shown that Rituximab (R) is implicated in the pathophysiology of acute and chronic GVHD. Methods: We analyzed 153 adult patients who received alloSCT for relapsed/refractory B-cell lymphomas. All patients received the same preparative conditioning consisting of thiotepa/cyclophosphamide/fludarabine, and GVHD prophylaxis consisting in cyclosporine and short course methotrexate. ATG (7 mg/kg) was added to patients allografted from class I antigen mismatched sibling or unrelated donors. Eighty-two patients (group A) received high-dose Rituximab (R 500 mg/ms on day -6) and were enrolled in a prospective multicenter study, whereas 71 consecutive patients (group B, control group) were part of a previous study without R. The two groups were not significantly different in terms of diagnosis (p=0.10), donor types (p=0.74), rate of complete remission at transplant (p=0.51). Results: The cumulative incidence (CI) of non-relapse mortality (NRM) at 2-years was 16% in group A and 18% in group B (p=0.84). Main cause of death were infections without GVHD in group A (7/13) and extensive GVHD in group B (6/14). Deaths associated to acute or chronic GVHD were significantly lower in group A (5 of 13) as compared to group B (13 of 14) (p=0.004). The CI of grade II-IV and III-IV acute GVHD was 23% versus 35% (p=0.11) and 7% versus 14% (p=0.11) in group A versus B, respectively. The CI of chronic GVHD was 48% versus 47% (p=0.73) in group A versus group B, respectively. The CI of acute GVHD and chronic GVHD in unrelated recipients was 20% versus 31% (p=0.41) and 32% versus 40% (p=0.83) in patients who received R in the conditioning comparing to group B. A delayed immune reconstitution of B-cells was still evident at 2 years after alloSCT in group A versus B [median value CD19+: 126/µL versus 300/µL with a significant higher percent of IgD+CD27- in group A and reduced immunoglobulin production: 502 versus 778 mg/dL of IgG (p=0.04)]. Progression free survival (PFS) and overall survival (OS) at 3-years were similar in group A and group B [PFS: 54% versus 58% (p=0.50); OS: 64% versus 67% (p=0.51)]. PFS at 3-years in indolent and aggressive lymphomas was 66% versus 75% and 42% versus 43% with and without R; OS at 3-years in indolent and aggressive lymphomas was 74% versus 78% and 55% versus 57% with and without R. In multivariate analysis, acute GVHD, extensive chronic GVHD and aggressive hystotype were associated to a lower OS [HR=3.6, p=0.0003; HR=2.3,p=0.03;HR=2.1,p=0.01] and only acute GVHD and aggressive hystotype to lower PFS [HR=2.7, p=0.002; HR=2.3, p=0.001]. Rituximab in the conditioning regimen, year of transplant and donor type did not influence the outcome. Conclusions: Rituximab administration in the setting of alloSCT is associated with reduced GVHD-related deaths and increased infection-related deaths, likely due to delayed B-cell immune-reconstitution. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Atypical Neurologic Complications Post Autologous Stem Cell Transplantation

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Moreb JS ◽  
◽  
Elliott K ◽  
Verenes M ◽  
◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Conditioning Regimen ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Neurological Improvement ◽  
General Weakness ◽  
One Year

We describe the case of a patient with high grade, triple hit, Non-Hodgkin’s Lymphoma (NHL) who underwent high-dose chemotherapy and Autologous Stem Cell Transplantation (ASCT) as a consolidation. Patient received BEAM conditioning regimen. She engrafted after usual post ASCT course. However, 2 months post ASCT she developed atypical neurologic symptoms and findings leading to general weakness mainly in the lower extremities with multiple falls, mental status changes and high CSF protein with severe sensorimotor neuropathy. She initially failed treatment with IVIg but responded to high dose steroids. More than one year after transplant, she has maintained her neurological improvement, but unable to walk, while her NHL continues to be in remission.

High-dose chemotherapy followed by autologous stem-cell transplantation for Hodgkin disease using CVB as conditioning regimen

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17505-17505
Author(s):  
R. A. Avila ◽  
J. A. Valdéz ◽  
G. Caeiro ◽  
A. L. Basquiera ◽  
A. G. Sturich ◽  
...  
Keyword(s):  
Stem Cell ◽  
Complete Remission ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Hodgkin's Disease ◽  
Hodgkin’S Disease ◽  
Conditioning Regimen ◽  
High Dose Chemotherapy ◽  
High Dose

17505 Background: Autologous stem-cell transplantation has become a widely used therapy in Hodgkin's disease. We analysed outcome, overall survival (OS) and time to progression (TTP) in relapsed patients with Hodgkin's disease undergoing autologous stem-cell transplantation (ASCT) in a single institution. Methods: Between 1996 and 2006, 28 patients (19 males and 9 females; median age 31 years old, range 10–63) underwent high dose chemotherapy with CVB regimen (cyclophosphamide 6 gr/m2, VP-16 2.400 mg/m2, and BCNU 450 mg/m2) with autologous stem-cell support. Before transplantation, 20 patients had received two lines of chemotherapy and 8 patients, three lines or more. At time of transplantation 12 (42.8%) patients were in complete remission and 16 (57.2%) in partial remission after rescue chemotherapy. The graft consisted of bone marrow (n: 6) or peripheral blood stem cells (n: 22). Results: The 100-day mortality rate was 3.57 %. With a median follow-up of 36 months for the surviving cohort, the median time of TTP and OS was of 31.4 and 55.63 months respectively and the five years TTP and OS were of 45% and 47% respectively. The most common toxicities presented were febrile neutropenia (100%) and mucositis (92%), both of them resolved completely before discharged. Patients who achieved complete response (n=20) after transplantation (evaluated at 100-day) had a better OS than patients who achieved partial response (n=8) (HR: 0.11; CI: 95% 0.03–0.49; p:0. 0036). Conclusions: High dose chemotherapy using CBV as conditioning regimen followed by ASCT is an effective treatment to achieve complete remission, which is associated with better survival in our series. This regimen presented acceptable toxicity and low mortality. No significant financial relationships to disclose.

Sign in / Sign up

Export Citation Format

Share Document