scholarly journals Recombinant human epidermal growth factor on oral mucositis induced by intensive chemotherapy with stem cell transplantation

2012 ◽  
Vol 88 (2) ◽  
pp. 107-112 ◽  
Author(s):  
Kyung Im Kim ◽  
Ji-Won Kim ◽  
Hyun Jung Lee ◽  
Byung-Su Kim ◽  
Soo-Mee Bang ◽  
...  
Keyword(s):  
Stem Cell ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Oral Mucositis ◽  
Intensive Chemotherapy ◽  
Human Epidermal Growth Factor ◽  
Epidermal Growth

Interim Analysis of Randomized Phase II Study of Recombinant Human Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy with Stem Cell Transplantation for Hematologic Malignancies

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 905-905
Author(s):  
Ji-Won Kim ◽  
Kyung Im Kim ◽  
Hyun Jung Lee ◽  
Byung-Su Kim ◽  
Soo-Mee Bang ◽  
...  
Keyword(s):  
Stem Cell ◽  
Placebo Group ◽  
Growth Factor ◽  
Oral Mucositis ◽  
Interim Analysis ◽  
Hematologic Malignancies ◽  
Intensive Chemotherapy ◽  
Human Epidermal Growth Factor ◽  
Epidermal Growth ◽  
Grade 3

Abstract Abstract 905 Oral mucositis (OM) develops in 40–80% of patients undergoing intensive chemotherapy with stem cell transplantation (SCT) which is often debilitating and influences the quality of life (QoL). A novel drug, recombinant human epidermal growth factor (rhEGF), recently demonstrated promising efficacy and minimal toxicity in the prevention of OM in patients with head and neck cancer receiving radiotherapy (Wu HG et al, Cancer 2009). To evaluate the efficacy and safety of rhEGF for prevention and treatment of OM during SCT, a prospective randomized double-blind placebo-controlled phase II study is being performed (ClinicalTrials.gov identifier, NCT00845819). In this report, results of the scheduled interim analysis are presented. Patients for whom the procedure of SCT for hematologic malignancies was planned were eligible for this study. Patients were randomly assigned to either the rhEGF group or the placebo group, at a 1:1 ratio. Patients were instructed to spray either the 50 μg/mL rhEGF or the placebo over their entire oral mucosa twice daily and to swallow the residual. The rhEGF was administered at the start of intensive chemotherapy until the time of their recovery from neutropenia (absolute neutrophil count >1000 /μL for 3 consecutive days) and disappearance of OM. The severity of OM was assessed daily using the World Health Organization (WHO) scale. Patients also completed an Oral Mucositis Daily Questionnaire (OMDQ) to assess patient-reported QoL (Stiff PJ et al, J Clin Oncol 2006). A total of 138 patients are planned to be enrolled in this study. This interim analysis was performed after the acquisition of data on the 58 patients who were enrolled between March 2009 and June 2010. Twenty-nine patients were assigned to each group. Patient median age in the rhEGF group was 56 (range, 18–63) years and 51 (range, 19–65) years in the placebo group. Autologous SCT was performed on 26 patients (89.7%) from each group, and allogeneic SCT, in the rest (10.3%). Baseline characteristics were not significantly different between the 2 groups. The difference in the incidence of grade 3 or 4 OM between the 2 groups was not significant (p=0.283). The duration of OM in patients with grade 3 or 4 OM tended to be shorter, however, in the rhEGF group than in the placebo group (8.0 [range, 2.0–23.0] days vs. 18.5 [range, 2.0–34.0] days; p=0.108). This result is also supported by the significantly shorter duration of medication use in patients with grade 3 or 4 OM in the rhEGF group than in the placebo (28.0 [range, 17.0–44.0] days vs. 39.5 [range, 17.0–61.0] days; p=0.050). The OMDQ analysis using area-under-the-curve calculation (with a lower score for milder limitation) for patients with grade 3 or 4 OM also showed that rhEGF significantly reduced limitations in swallowing (26.0 [range, 8.0–75.0] vs. 51.5 [range, 19.0–92.0]; p=0.039) and drinking (25.0 [range, 7.0–73.5] vs. 55.5 [range, 20.0–86.0]; p=0.042) compared to placebo. The duration of administration of total parenteral nutrition (TPN) was significantly shorter in the rhEGF group than in the placebo group (7.0 [range, 0.0–25.0] days vs. 16.5 [range, 10.0–32.0] days; p=0.012) in patients with grade 3 or 4 OM. A similar result was observed for the duration of opioid analgesics use (6.0 [range, 0.0–25.0] days vs. 17.0 [range, 0.0–48.0] days; p=0.117). In patients with grade 3 or 4 OM, the rhEGF group showed a significantly shorter length of hospitalization than the placebo group (27.0 [range, 18.0–65.0] days vs. 41.5 [range, 27.0–94.0] days; p=0.022). Adverse events between the 2 groups were not statistically significant. The adverse events in the rhEGF group were nausea (n=2, 6.9%), oral pain (n=1, 3.4%), and taste alteration (n=1, 3.4%). No grade 3 or 4 adverse events developed. To summarize, in patients who received SCT for hematologic malignancies, rhEGF tended to reduce the duration of grade 3 or 4 OM and significantly reduced limitations in swallowing and drinking. In addition, rhEGF significantly reduced the duration of TPN use and hospitalization, and tended to reduce the duration of opioid analgesics use. The rhEGF was generally well tolerated with a favorable safety profile. The results of this interim report demonstrate that rhEGF has a role in the treatment of OM induced by intensive chemotherapy with SCT, and improves QoL. This study is still ongoing, and the final results are expected to be available within 2 years. Disclosures: Off Label Use: Recombinant human epidermal growth factor is a novel drug, which is officially approved for treatment of diabetic foot in Korea. This drug is currently not approved for treatment of oral mucositis by both the US FDA and the Korean FDA yet. In the present study, we used this drug to evaluate efficacy and safety of this drug for prevention and treatment of oral mucositis induced by intensive chemotherapy with stem cell transplantation.

scholarly journals Yttrium-90 Ibritumomab Tiuxetan Is Feasible and Efficient in Unselected Patients. Definitive Results of a Large Retrospective Phase IV Study

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5108-5108
Author(s):  
Valentine Richez ◽  
Julie Abraham ◽  
Sandy Amorim ◽  
Charles Herbaux ◽  
Laure Philippe ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Median Time ◽  
Oral Mucositis ◽  
Intensive Chemotherapy ◽  
Hematopoietic Stem ◽  
Grade 3 ◽  
Time To Onset ◽  
Yttrium 90

Abstract In July 2004 in Europe, radioimmunotherapy (RIT) with Yttrium-90 Ibritumomab Tiuxetan ((90)Y-IT) obtained marketing authorization (MA) for follicular lymphoma (FL) in consolidation treatment in front line or relapse after rituximab treatment. Additional results also showed the potential interest of high-dose ((90)Y-IT) in monotherapy or in combination with intensive chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation. Due to its particular toxicity profile (extended cytopenia and high rate of oral mucositis), the use of RIT in unselected patients is still debated. The aim of this retrospective cohort study was to evaluate the toxicity and efficacy of (90)Y-IT) in unselected consecutive adult patients treated for CD20+ B-type lymphoma. Between January 2013 and December 2014, 102 patients at 25 Francophone centers were treated with at least one injection of (90)Y-IT. Median age was 62 years (range 32-87) and 36% were female. Sixty-one percent of patients had a low-grade B lymphoma. More than 80% of patients presented an advanced stage with bone marrow involvement in 25% of cases. ECOG performance status was <2 for 94 (92%) patients and 72 (78%) patients had a prognostic score >1. Nearly two thirds of diffuse large B-cell lymphomas (DLBCL) were GC-like. About half of the patients (51%) were treated with ((90)Y-IT) combined with high-dose BEAM chemotherapy (carmustine, etoposide, cytarabine and melphalan) or BeEAM (bendamustine, etoposide, cytarabine and melphalan) followed by autologous stem cell transplantation (autoSCT). Median prior therapies was 1 (range 0-3). Eight (8%) patients were treated with ((90)Y-IT) combined with intensive chemotherapy (fludarabine, busulfan) and allogeneic stem cell transplantation (alloSCT): median prior therapies was 2 (range 1-4). Forty-two (41%) patients were treated with RIT in monotherapy: median prior therapies was 1 (range 0-3). Among the 42 patients treated with ((90)Y-IT) as consolidation, 6 (14%) did not receive chemotherapy before administration of RIT, 8 (19%) received R bendamustine, 12 (29%) RCHOP, 14 (33%) R DHAox and 2 (5%) received RFC regimen before RIT. The median time between diagnosis and first administration of ((90)Y-IT) was 22 months (range 1-281) and the median time between the last treatment received and the start of RIT regimen was 1 month (range 0-75). In the autoSCT group, ((90)Y-IT) combined with BEAM or BeEAM, the post-RIT evaluation showed 45 (86%) complete responses (CR), 2 (4%) partial responses (PR), 4 (8%) stable disease (SD) and 1 (2%) progression (PG). The median time to onset of grade 3 or 4 anemia, thrombopenia and neutropenia was, respectively, 6 (range 1-90), 8 (range 3-90) and 10 days (range 6-90). Grade 3 or 4 oral mucositis occurred in 29 patients (56%). Interestingly, among patients treated with Z-Beam associated with amifostine (n=6), only one patient suffered from severe oral mucositis (17%). In the group of patients who underwent alloSCT, ((90)Y-IT) injection combined with fludarabine and busulfan, the post-RIT evaluation showed 4 (50%) CR, 1 (12.5%) PR, 1 (12.5%) SD and 2 (25%) PG. The median time to onset of grade 3 or 4 anemia, thrombopenia and neutropenia was, 12 (range 10-35), 15 (range 11-240) and 23 days (range 15-48), respectively. Severe oral mucositis (grade 3-4) occurred in 3 patients (37%). In the group of patients who underwent consolidation treatment, ((90)Y-IT) injection in monotherapy, the post-RIT evaluation showed 25 (60%) CR, 9 (21%) PR and 8 (19%) PG. The median time to onset of grade 3-4 anemia, thrombopenia and neutropenia was 70 (range 4-150), 80 (range 6-100) and 45 days (range 6-120), respectively. Grade 3/4 oral mucositis occurred in 1 patient (2%). The median follow-up time was 11 months (range 1-30). Median progression-free survival (PFS) and overall survival (OS) were 9 months (range 1-30) and 11 months (range 1-120), respectively. These results confirmed, on a large retrospective series of unselected patients, the safety and efficacy of ((90)Y-IT) administered in monotherapy or in combination with intensive chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation, without increased toxicity. For autologous bone marrow transplant, the use of amisfostine could lower the high-grade mucositis rate. However, further analysis of long-term outcome criteria such as PFS, OS and toxicities will be of interest in this series of patients. Disclosures Off Label Use: In this study, Yttrium-90 Ibritumomab Tiuxetan is administred in monotherapy for follicular lymphoma (MA) and in monotherapy or combination with intensive chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation for CD20+ B-type lymphoma..

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