Efficacy and Safety of Micafungin as An Empirical Antifungal Agent for Febrile Neutropenic Patients with Hematological Diseases.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4661-4661
Author(s):  
Joon Seong Park ◽  
Dong Hwan Kim ◽  
Chul Won Choi ◽  
Seong Hyun Jeong ◽  
Jin-Hyuk Choi ◽  
...  
Keyword(s):  
Fungal Infection ◽  
Success Rate ◽  
Antifungal Agent ◽  
Conflicts Of Interest ◽  
Multicenter Trial ◽  
Base Line ◽  
Efficacy And Safety ◽  
Hematological Disorders ◽  
Neutropenic Patients ◽  
Grade 3

Abstract Abstract 4661 Introduction Invasive or possible fungal infection is often fatal and its incidence is increasing in febrile neutropenic patients with hematological malignancies. Thus, empirical antifungal agent should be carefully selected for those patients. Patients and Methods The study was conducted as a prospective multicenter trial to document the efficacy and safety of micafungin (Mycamine®), a class of echinocandin, as an empirical antifungal agent in febrile neutropenic patients. Micafungin was administrated for sustained fever (>38.4°C) on day 3 - 5 after initiation of empirical antibiotic therapy. The overall success rate according to the composite score (no breakthrough fungal infection, survival for seven days beyond the end of therapy, did not discontinue therapy prematurely, had resolution of fever during the period of neutropenia, and successfully treated a documented base-line fungal infection) and side effects were evaluated. Results A total of 47 patients with AML, ALL, MDS or lymphomas were enrolled. The overall success rate was 61.7% (29/47). Three patients (6.4 %) experienced grade 3/4 elevated aspartate aminotransferase and ten patients (21 %) showed grade 3/4 hyperbilirubinemia and nine of which resolved, and four patients died of septic shock. Patients with young age (< 50 yr) and ALL rather than AML showed a better response to micafungin. Less profoundly neutropenic (≥50 /mm3) patients revealed a better response, as did the patients who recovered from fever or neutropenia. Conclusions Micafungin has been reported to have an excellent efficacy (61.7 %) and safety profile when used as an empirical antifungal agent to treat febrile neutropenic patients with hematological disorders. Disclosures: No relevant conflicts of interest to declare.

Safety and Efficacy of 90Y Ibritumomab Tiuxetan (Zevalin®) for Untreated FollicularNon-Hodgkin's Lymphoma (FL) Patients, An Italian Cooperative Study

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 100-100
Author(s):  
G. Pica ◽  
S. Nati ◽  
Umberto Vitolo ◽  
Sara Galimberti ◽  
Pier Luigi Zinzani ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Remission Rate ◽  
Bone Marrow Involvement ◽  
Single Agent ◽  
Multicenter Trial ◽  
Hematologic Toxicity ◽  
Ibritumomab Tiuxetan ◽  
Highly Effective ◽  
Grade 3 ◽  
Treatment Safety

Abstract Abstract 100 90Y ibritumomab tiuxetan (Zevalin®) combines the targeting advantage of monoclonal antibody with the radiosensitivity of FL. Previous studies showed that Zevalin resulted safe and highly effective in relapsed/refractory indolent NHL, irrespective to prior treatment with rituximab. Based on these results, we designed a multicenter trial to evaluate the safety and the efficacy of “upfront” single-agent Zevalin in FL. The primary endpoint was the incidence of responses in terms of overall remission rate (ORR) and complete remissions (CR). The secondary endpoints were the treatment safety by monitoring hematology and biochemistry parameters as well as adverse events. Fifty patients, with a median age of 59 years (range, 35–81), were treated. Forty-eight percent had bone marrow involvement (<25%) and 14% an elevated LDH. Thirty-four percent of patients had high risk FLIPI. Forty-six patients were also assessed by qualitative and quantitative PCR for Bcl2/IgH or IgH clonal rearrangement, for total 30 cases PCR-positive (65.2%). Results: The ORR was 93% (45/48) with a CR rate of 82% (41/48). Twenty-six patients, who were PCR-positive at diagnosis, were assessed at week 14. Twenty out of 26 (77%) became PCR-negative. After a median follow up of 24 months, the 2-year EFS for all patients was 85%; moreover, 15 patients (55%), who were PCR-positive at diagnosis, maintain PCR negativity. As expected, the main toxicity was moderate myelosuppression, with 30% and 26% of patients developing Grade 3/4 neutropenia and thrombocytopenia, respectively. Very few patients required platelets transfusion (4%) or growth factor use (6%). None of the patients experienced grade 3/4 non hematologic toxicity. In conclusion, Zevalin is highly effective and safe treatment for newly diagnosed FL patients. In the next future, the role of radioimmunotherapy - i.e. including optimal sequencing with chemotherapy - should be established in randomized studies. Disclosures: No relevant conflicts of interest to declare.

The Efficacy and Safety of Immunomodulatory Drugs in Multiple Myeloma Maintenance Therapy: Results of a Meta-Analysis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3477-3477
Author(s):  
Yucai Wang ◽  
Fang Yang ◽  
Wenwen Zhang ◽  
Xiaoxiang Guan ◽  
Neil Kothari ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Conflicts Of Interest ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Immunomodulatory Drugs ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Grade 3

Abstract Objective: To evaluate the efficacy and safety of immunomodulatory drugs (IMiDs) in maintenance therapy of multiple myeloma through meta-analysis of randomized controlled trials (RCTs). Patients and methods: PubMed, Web of Science, ASCO, ESMO and ASH databases were searched for RCTs that investigated the treatment outcomes (overall survival [OS], progression-free survival [PFS] and/or event-free survival [EFS] and/or time to progression [TTP]) of maintenance therapy with IMiDs in patients with multiple myeloma. Study endpoints included OS, PFS/EFS/TTP, 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). The random-effect model was utilized in view of clinical heterogeneity in the study population. Results: Eighteen RCTs comprising a total of 6562 patients were included in this meta-analysis. IMiDs used in the RCTs included thalidomide (14 trials) and lenalidomide (4 trials). Overall, IMiD-based maintenance therapy significantly improved OS (HR = 0.91, 95% CI = 0.84 - 0.99, P = 0.027) and PFS (HR = 0.63, 95% CI = 0.60 - 0.68, P < 0.001). Notably, IMiDs maintenance therapy increased OS in the setting of ASCT but showed no OS prolongation without ASCT. On further stratification, thalidomide-based maintenance therapy demonstrated OS benefit only in the setting of ASCT, while lenalidomide-based maintenance therapy did not show OS benefit regardless of transplantation status. For PFS however, both thalidomide- and lenalidomide-based maintenance therapies demonstrated significant survival benefits, regardless of transplantation status (Table 1). IMiD-based maintenance therapy increased the risk of developing grade 3 or 4 neutropenia (RR = 3.04, 95% CI = 2.49 - 3.70, P < 0.001), thrombocytopenia (RR = 2.68, 95% CI = 1.90 - 3.79, P < 0.001), anemia (RR = 1.97, 95% CI = 1.23 - 3.15, P = 0.005), infection (RR = 1.53, 95% CI = 1.22 - 1.92, P < 0.001), fatigue (HR = 1.71, 95% CI = 1.24 - 2.36, P = 0.001), constipation (RR = 2.04, 95% CI = 1.15 - 3.62, P = 0.015), and peripheral neuropathy (RR = 2.02, 95% CI = 1.20 - 3.39, P = 0.008). Conclusions: IMiD-based maintenance therapy results in significant improvement in OS and PFS in multiple myeloma patients but increased the risk of developing some grade 3 or 4 adverse events. While thalidomide-containing maintenance therapy regimens showed OS benefits in the setting of ASCT, lenalidomide-containing maintenance therapy did not prolong OS regardless of transplantation status. Both thalidomide- and lenalidomide-based maintenance therapies increased PFS in multiple myeloma patients independent of transplantation status. When more data on lenalidomide and the newer agent pomalidomide become available, further analysis will be warranted to analyze the efficacy and safety of IMiDs in multiple myeloma maintenance therapy. Table 1. Effects of IMiD-based maintenance therapy on OS and PFS in multiple myeloma patients IMiD ASCT status Survival Number of trials HR 95% CI P value Thalidomide/Lenalidomide combined OS 18 0.91 0.84 - 0.99 0.027 with ASCT OS 10 0.88 0.78 - 0.99 0.036 without ASCT OS 9 0.94 0.83 - 1.06 0.299 Thalidomide combined OS 14 0.92 0.84 - 1.01 0.090 with ASCT OS 8 0.87 0.77 - 1.00 0.049 without ASCT OS 7 0.97 0.85 - 1.10 0.640 Lenalidomide combined OS 4 0.84 0.67 - 1.04 0.102 with ASCT OS 2 0.89 0.66 - 1.20 0.457 without ASCT OS 2 0.78 0.57 - 1.06 0.114 Thalidomide/Lenalidomide combined PFS 17 0.63 0.60 -0.68 < 0.001 with ASCT PFS 9 0.62 0.57 - 0.67 < 0.001 without ASCT PFS 9 0.66 0.60 - 0.73 < 0.001 Thalidomide combined PFS 13 0.67 0.63 - 0.72 < 0.001 with ASCT PFS 7 0.66 0.60 - 0.72 < 0.001 without ASCT PFS 7 0.69 0.62 -0.77 < 0.001 Lenalidomide combined PFS 4 0.50 0.43 - 0.58 < 0.001 with ASCT PFS 2 0.49 0.41 - 0.58 < 0.001 without ASCT PFS 2 0.52 0.40 - 0.67 < 0.001 Disclosures No relevant conflicts of interest to declare.

Efficacy and Safety of Bortezomib Based Regimens Retreatment in Relapsed Multiple Myeloma Patients: Results from a Retrospective Study.

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5387-5387
Author(s):  
Wenjun Wu ◽  
Gaofeng Zheng ◽  
Xiaoyan Han ◽  
Yi Zhao ◽  
Donghua He ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Partial Response ◽  
Confidence Interval ◽  
Incidence Rate ◽  
Conflicts Of Interest ◽  
Progression Free Survival ◽  
Initial Therapy ◽  
Efficacy And Safety ◽  
Grade 3 ◽  
Group 1

Abstract Objective: To evaluate the efficacy and safety of bortezomib retreatment in relapsed multiple myeloma (MM) patients, who previously responded to bortezomib. Methods: This retrospective observational study included data from 45 patients and evaluated the efficacy and safety of bortezomib based retreatment in these patients, who had achieved at least a partial response (PR) on initial bortezomib therapy in our hospital from May 2006 to May 2013. Results: The overall response rate (ORR) was 71.2%, among them 9% patients achieved CR, 11.1% patients achieved very good partial response (VGPR), 51.1% patients achieved PR. All patients were divided into 3 groups according to the response of initial bortezomib therapy, including CR group, VGPR group and PR group. After bortezomib retreatment, the ORR of the 3 groups was 76.9%, 75% and 62.5%, respectively. According to the response of bortezomib retreatment, the patients were divided into 2 groups: group 1 who at least achieved PR, group 2 who showed no response. The median progression-free survival (PFS) after bortezomib retreatment for group 1 and 2 was 9( 95% confidence interval 7.947~10.051) and 10 (95% confidence interval 8.381∼11.619) months, respectively (P>0.05), while the median overall survival (OS) after bortezomib retreatment was 71 (95% confidence interval 66.694∼75.306)) and 37 (95% confidence interval 1-28) months, respectively (P<0.05). In patients with bortezomib retreatment had different degrees of adverse events (AE) , the most AE for grade 1~2. The most common grade ≥3 AE was thrombocytopenia, neutropenia and anemia. The incidence rate of grade ≥3 AE peripheral neuropathy bortezomib was 15%. Conclusion: Bortezomib based regimens retreatment was effective and tolerable in relapsed MM patients, who had achieved at least a partial response (PR) on initial therapy. The incidence rate of AE was not significantly increased. Disclosures No relevant conflicts of interest to declare.

Efficacy and safety of micafungin, an echinocandin antifungal agent, on invasive fungal infections in patients with hematological disorders

2009 ◽  
Vol 50 (1) ◽  
pp. 92-100 ◽  
Author(s):  
Kazuo Tamura ◽  
Akio Urabe ◽  
Minoru Yoshida ◽  
Akihisa Kanamaru ◽  
Yoshihisa Kodera ◽  
...  
Keyword(s):  
Antifungal Agent ◽  
Fungal Infections ◽  
Invasive Fungal Infections ◽  
Efficacy And Safety ◽  
Hematological Disorders

Medical Costs Analysis for Antifungal Prophylaxis in Neutropenic Patients with Hematological Malignancies: A Systematic Review Analysis.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3334-3334
Author(s):  
Takamichi Shintani ◽  
Osamu Imataki ◽  
Hiroaki Ohnishi ◽  
Akira Kitanaka ◽  
Yoshitsugu Kubota ◽  
...  
Keyword(s):  
Fungal Infection ◽  
Antifungal Agent ◽  
Hematological Malignancies ◽  
Antifungal Agents ◽  
Single Agent ◽  
Medical Costs ◽  
Antifungal Prophylaxis ◽  
Candida Spp ◽  
Expected Cost ◽  
Neutropenic Patients

Abstract Purpose Invasive fungal infection (IFI) is one of the leading causes of mortality and morbidity in neutropenic patients with hematological malignancies (HM). Randomized studies and followed by metanalysis suggest the prophylactic effects of antifungal agents for chemotherapy-induced neutropenia. The purpose of this study is to estimate the medical costs on each antifungal agent for prophylaxis of antifungal infection in neutropenic patients in Japan. Method PubMed was searched for articles, which reported antifungal prophylaxis in neutropenic patients with HM, published after 1999, using 3 keywords; ’prophylaxis ’, ’hematological malignancy’ and ’fungal infection’. Fifteen articles that met the criteria were selected; randomized controlled trial, more than 100 cases overall, prospective study, and single agent used in each study arm. Antifungal agents were limited to the 4 drugs; fluconazole (FLCZ) capsules or tablets, itraconazole (ITCZ) capsules or oral solution, micafungin (MCFG), and liposomal amphotericin B (L-AMB). We assumed 3-week-prophylaxis after chemotherapy and 2-week-target therapy for the occurrence of the breakthrough infection, and designed the decision tree models in which a breakthrough fungal infection occurred in certain incidence of proven and probable IFI. The incidences of IFI from the 15 studies were applied to our model. MCFG, voriconazole (VRCZ) and L-AMB were applied as target therapies to the assumed Candida spp., Aspergillus spp., and other fungal infections, respectively. An average expected cost for prophylaxis on each antifungal agent was calculated and compared. Sensitive analysis was performed for the parameter of the incidence of breakthrough IFI. Results In each prophylaxis agent, the collected study population was 1061 cases in FLCZ, 1510 in ITCZ, 425 in MCFG, and 219 in L-AMB. The incidence of proven and probable IFI was 4.3% (46/1061) in FLCZ, 2.7% (41/1510) in ITCZ, 1.6% (7/425) in MCFG, and 3.7% (8/219) in L-AMB. Causative fungi were revealed in table 1 below. The mean duration to the breakthrough fungal infection was 20 days (95CI, 13–26) after chemotherapy. The average expected cost for prophylaxis in each drug was $1,098 for FLCZ, $532 for ITCZ, $1,313 for MCFG, and $2297 for L-AMB. Conclusion In our review, the prophylactic failure seems be comparable in the 4 antifungal agents. However, cost-effectiveness was the superior in the prophylaxis by ITCZ than the other agents in neutropenic patients with HM in Japan. The incidence of proven and probable IFI and its causes. Agents for prophylaxis Proven and probable IFI Prophylactic success (%) (95% CI) Candida spp. (%) Aspergillus spp. (%) Other fungus (%) Number of the causative fungus is indicated as the proportion among prophylactic failure cases. FLCZ 4.3% (46/1061) 95.7 (94.3–96.7) 23.7 63.2 13.2 ITCZ 2.7% (41/1510) 97.3 (96.3–98.0) 23.5 58.8 17.6 MCFG 1.6% (7/425) 98.4 (96.6–99.2) 57.1 14.3 28.6 L-AMB 3.7% (8/219) 96.3 (93.0–98.1) 75.0 25.0 0.0

Efficacy and Safety of Micafungin as An Empirical Antifungal Therapy for Suspected Fungal Infection in Patients with Hematological Disorders.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1939-1939
Author(s):  
Minoru Yoshida ◽  
Kazuo Tamura ◽  
Masahiro Imamura ◽  
Yoshiro Niitsu ◽  
Takeshi Sasaki ◽  
...  
Keyword(s):  
Fungal Infection ◽  
Antifungal Therapy ◽  
Clinical Symptoms ◽  
Fungal Infections ◽  
Efficacy And Safety ◽  
Hematopoietic Stem ◽  
Persistent Fever ◽  
Hematological Disorders ◽  
Study Results ◽  
Empirical Antifungal Therapy

Abstract Background: Invasive fungal infections (IFIs) are of serious concern in the management of immunocompromised patients (pts) with hematological disorders. Empiric antifungal therapy is recommended for neutropenic pts with persistent fever, because treatment after confirmation of fungal infection often produces poor outcomes. Micafungin (MCFG), one of the echinocandin families, was launched first in Japan in 2002, and has now been approved in more than 11 countries and areas including the USA and the EU. Although the efficacy and safety of MCFG against both Candida and Aspergillus infections has been shown in many clinical trials, there are few clinical study reports on the empiric therapy of a suspected fungal infection. Here, we report the multi-center study results of MCFG for the empiric antifungal therapy, which were conducted from April 2005 to September 2006 in Japan. Objective: This prospective study was performed to clarify the efficacy and safety of MCFG for the empirical antifungal therapy on suspected fungal infection in pts with hematological disorders and neutropenia. Methods: Study design: A multiple-center, open, uncontrolled study. The investigator registered pts with neutropenia (&lt; 1,000/μl) who met the following criteria to the Subject Registration Center. Suspected fungal infections were divided into two categories: possible fungal infection defined by positive clinical symptoms/findings and serological testing (beta-D-glucan or galactomannan) or diagnostic imaging (chest X-ray or CT scan), refractory fever defined by unexplained persistent fever (an axillary temperature higher than 37.5 °C) after the antibacterial treatment over 2 days and by positive clinical symptoms/findings. IFIs categorized as proven or probable were not included in this study. Efficacy evaluation was performed using an algorithm based on each of the evaluation of clinical symptoms/findings, imaging study findings, and serological tests. Results: 388 pts (M:234, F:154, mean age:57.8 years old) were registered. The mean dosage and duration of treatment with MCFG were 154.6±55.3 mg/day and 14.0±6.9 days, respectively. The main underlying hematological disorders were acute leukemia (61.3%), non-Hodgkin’s lymphoma (18.3%) and myelodysplastic syndrome (10.8%). The number of pts with hematopoietic stem cell transplantation (HSCT) was 76 (19.6%). The clinical response rate (CRR), excluding 4 non-evaluable pts was 63.3% (243/384): 60.1% (89/148) for pts with possible fungal infection and 65.3% (154/236) for pts with refractory fever, respectively. Even in persistent neutropenic pts whose neutrophil counts were &lt; 500/μL throughout the treatment with MCFG, the CRR was high enough: 46.9% (61/130). No difference was observed in the CRR among the main underlying hematological disorders. The CRR in pts with HSCT and other conditions were 63.2% (48/76) and 63.3% (195/308), respectively. Drug-related adverse events (DAEs) were observed in 16.8% (65/388). Serious DAEs such as elevation of serum bilirubin and renal dysfunction was observed in 0.52% (2/388). Conclusion: MCFG was confirmed to have high clinical efficacy and be safe for the treatment of suspected fungal infection in pts with hematological disorders and neutropenia.

scholarly journals Clinical Efficacy and Safety of TPO in Combination with Eltrombopag in Patients with Solid Tumor Chemotherapy-Induced Thrombocytopenia

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 11-11
Author(s):  
Fuling Zhou ◽  
Shuai Liu ◽  
Yin Liu
Keyword(s):  
Solid Tumor ◽  
Muscle Soreness ◽  
Adverse Reactions ◽  
Conflicts Of Interest ◽  
Classification Criteria ◽  
Efficacy And Safety ◽  
Kidney Dysfunction ◽  
Liver And Kidney ◽  
Grade 3 ◽  
Time Required

Aim: To evaluate the efficacy and safty of TPO in combination with eltrombopag in the treatment of solid tumor chemotherapy-induced thrombocytopenia (CIT). Methods: 7 patients with thrombocytopenia after standard solid tumor chemotherapy were enrolled in this study, including gastric cancer(n=1), breast cancer(n=1), lung cancer(n=3) and liver cancer(n=2). They were treated with TPO (15000IU q.i.d.) in combination with eltrombopag (25mg t.i.d.) until the platelet count was recovered to 100 × 109 / L or the medication time was up to 14 days. The time required for platelets to recover to &gt; 50 × 109 / L and ≥ 100 × 109 / L, platelet transfusion times and adverse reactions were observed. Results: After the treatment, the platelet counts of all patients were recovered to &gt; 50 × 109 / L, and 3 of them ≥ 100 × 109 / L. The adverse reactions include muscle soreness(n=1), liver and kidney dysfunction(n=1), no case of them was above grade 3 according to WHO classification criteria for adverse reactions. Conclusion: TPO in combination with eltrombopag is an effective and safe method for the treatment of solid tumor chemotherapy-induced thrombocytopenia (CIT). Disclosures No relevant conflicts of interest to declare.

A Multicenter, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Posaconazole Vs Fluconazole in the Prophylaxis of Invasive Fungal Infection in a Chinese Population

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4916-4916
Author(s):  
Shen Yang ◽  
Xiaojun Huang ◽  
Jianxiang Wang ◽  
Jie Jin ◽  
Jianda Hu ◽  
...  
Keyword(s):  
Fungal Infection ◽  
Failure Rate ◽  
Invasive Fungal Infection ◽  
Conflicts Of Interest ◽  
Statistical Significance ◽  
Randomized Study ◽  
Treatment Phase ◽  
Clinical Failure ◽  
Open Label ◽  
Neutropenic Patients

Abstract Abstract 4916 Background Invasive fungal infection (IFI) is a common and fatal complication in neutropenic patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Methods In this multicenter, randomized study, we enrolled patients with persistent neutropenia resulting from chemotherapy for the treatment of AML and MDS. Prophylaxis with either posaconazole or fluconazole was given to the patients to compare the efficacy and safety of the 2 drugs. The treatment was given with each cycle of chemotherapy until the patient recovered from neutropenia and had complete remission, an IFI occurred, or until the patient had received a maximum of 12 weeks of treatment. The primary end point was the incidence of possible, proven, or probable diagnosis of IFI during the treatment phase in *the 2 groups; clinical failure rate, all-cause mortality, and time to first systemic antifungal treatment were secondary end points. Results A total of 252 patients were included in this study, and 7 patients were excluded due to withdrawal of informed consent or deviation of eligible criteria. Finally, 124 patients from the posaconazole group and 121 patients from the fluconazole group were included; and 234 patients (117 in each group) entered into statistical analysis, respectively. The incidence of proven, probable, and possible IFI was 9.4% (11/117) and 22.2% (26/117) in the posaconazole and fluconazole groups, respectively (P = 0.0114). The clinical failure rate was lower in the posaconazole group (31.6% [95% CI: 23.3–40.9], 37/117) than in the fluconazole group (41.88% [95% CI: 32.8–51.4], 49/117); however, statistical significance was not reached (P = 0.168). The patients receiving posaconazole had a later onset of first systematic antifungal therapy than those receiving fluconazole (P = 0.0139). The most common clinical adverse reactions were liver function abnormalities, with 11 cases (9.4%) in the posaconazole group and 6 cases (5.1%) in the fluconazole group (P = 0.221). Conclusions Posaconazole demonstrates efficacy as prophylaxis against IFI in high-risk neutropenic patients with AML and MDS undergoing chemotherapy and is well tolerated during long-term use. (ClinicalTrials.gov number, NCT00811928) Disclosures: No relevant conflicts of interest to declare.

scholarly journals Efficacy and Safety of Pemetrexed Combined with Lenalidomide in the Treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 2-3
Author(s):  
Jingjing Ma ◽  
Bobin Chen ◽  
Lin Zhiguang ◽  
Qing Li ◽  
Hui Kang ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Adverse Events ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Conflicts Of Interest ◽  
Central Nervous System Lymphoma ◽  
Ventricular Premature Beat ◽  
Efficacy And Safety ◽  
Grade 3

ABSTRACT BACKGROUND/PURPOSE: There is currently no standard effective treatment for patients with relapsed/refractory primary central nervous system lymphoma (PCNSL). The prognosis is poor, so more studies are needed. Pemetrexed is similar to methotrexate in structure and can cross the blood-brain barrier. Compared with methotrexate, it has more targets and fewer side effects. Lenalidomide is a second generation immunomodulator with multiple functions, such as regulating immunity, anti-tumor and tumor microenvironment. A prospective observational study was conducted to explore the efficacy and safety of pemetrexed combined with lenalidomide in the treatment of relapsed/refractory primary central nervous system lymphoma. METHODS: This is a prospective observational study, we collected patients who had undergone whole brain radiotherapy and two or more chemotherapy regimens between January 2018 and December 2019 but still experienced disease progression or recurrence. each patient was treated with pemetrexed at a dose of 900mg/m2 and lenalidomide 25mg over 3 weeks as salvage chemotherapy, and one cycle consists of 4 weeks. Folic acid, vitamin B12 and dexamethasone were used to induce toxicities to pemetrexed given before chemotherapy. Oral aspirin was used to prevent thrombosis caused by lenalidomide. Adverse events were recorded in each patient during inpatients, outpatient or telephone follow-up. RESULTS: A total of 38 patients with recurrent/refractory PCNSL were enrolled in our study, including 26 males and 12 females with a median age of 57 (range from 33 to 73) years old. After treatment, the overall response rate was 68.4%(Table 1). The median progression free survival (PFS) time was 6 months and median overall survival (OS) time was 14 months (Figure1, Figure2). The adverse events mainly included fatigue, gastrointestinal reaction, myelosuppression, thrombocytopenia, fever and infection. After long-term or short-term chemotherapy, the patients had different degrees of myelosuppression symptoms presented as leukopenia (six cases in grade 1 and one case in grade 3), neutropenia (six cases in grade 1 and two cases in grade 3), anemia (6 cases in grade 1), thrombocytopenia (1 case in grade 2 and 3 cases in grade 3). Nausea and vomiting, as the common gastrointestinal reaction, appeared in two (grade 1) and one (grade 2) cases, respectively. One patient died of severe pneumonia infection. Three cases developed grade 1 cardiac disorder, including asymptomatic sinus bradycardia and asymptomatic ventricular premature beat, respectively. In addition, other reactions including fatigue (four cases in grade 1 and one case in grade 2), fever (four cases). All patients had no abnormal liver function, kidney function, constipation and leukoencephalopathy (Table 2). CONCLUSION: This study has been the first prospective clinical study of pemetrexed combined with lenalidomide in the treatment of patients with relapsed/refractory PCNSL in international. The results indicate that chemotherapy with pemetrexed combined with lenalidomide may be an effective therapy for the treatment of relapsed/refractory PCNSL with modest toxicity. KEYWORDS: Primary central nervous system lymphoma; Relapse/refractory; Pemetrexed combined with lenalidomide; Efficacy; Safety Disclosures No relevant conflicts of interest to declare.

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