Safety of Intrathecal Liposomal Cytarabine (Depocyte®) Injection Given Prophylactically in Patients with High-Risk Diffuse Large B-Cell Lymphoma: A Report of 22 Patients in Spain.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4459-4459
Author(s):  
Miguel A. Canales ◽  
A. Salar ◽  
J.A. Diaz ◽  
J.J. Ferreiro ◽  
S. Ferrer ◽  
...  
Keyword(s):  
High Risk ◽  
B Cell ◽  
Cell Lymphoma ◽  
Prospective Trial ◽  
B Cell Lymphoma ◽  
Median Number ◽  
Liposomal Cytarabine ◽  
Large B Cell Lymphoma ◽  
Grade 3 ◽  
Large B Cell

Abstract Patients with diffuse large B-cell lymphoma (DLBCL) who develop lymphomatous meningitis (LM) during or after first-line treatment have a poor prognosis, with CNS relapse occurring within 1 year in approximately 80%. Risk factors have been defined and prophylaxis is recommended in patients with high-risk DLBCL. Liposomal cytarabine (DepoCyte®), a sustained-release preparation of cytarabine for intrathecal (IT) injection, has been shown to be well tolerated and effective in the treatment of LM. Its long CSF half-life allows liposomal cytarabine to be given less frequently than conventional therapy, reducing discomfort for patients and the risks associated with repeated lumbar punctures. The potential of liposomal cytarabine to improve the outcome of prophylaxis against LM is being investigated into a multicenter and prospective trial in patients with high-risk DLBCL in Spain. Preliminary safety results are reported in 22 patients (median age 67 years; range 18–79; 14 male) with newly diagnosed DLBCL at high risk of developing LM (defined as the presence of at least one of the following criteria: retroperitoneal mass >10 cm, Waldeyer’s ring or paranasal involvement, involvement of >30% bone marrow, testicular involvement) who received prophylactic IT liposomal cytarabine during treatment with R-CHOP14 regimen between June 2006 and July 2007 at 10 centers in Spain. Liposomal cytarabine 50 mg was administered during the first day of treatment at first, second and sixth cycles of R-CHOP14 scheme (study days 1, 15 and 71). The median number of doses administered was 3 (range 1–3). Seventeen patients received corticosteroid as prophylaxis for chemical arachnoiditis: 16 dexamethasone (4 mg IT [n = 9] or PO at varying dosages [n = 7]); and 1 patient received IT hydrocortisone (20 mg). The remaining patients did not receive specific corticosteroid prophylaxis for chemical arachnoiditis. Overall, liposomal cytarabine was well tolerated. Six patients experienced minor side effects including headache (Grade 1/2, n = 4; grade 3/4, n = 2) and nausea/vomiting (Grade 3/4, n = 1). No signs of neurological progression or relapsed were observed. These preliminary observations indicate that IT injection of liposomal cytarabine (DepoCyte®) is well tolerated and can be administered safely in combination with dose-dense regimens. Longer-term follow-up will be needed to confirm these encouraging observations.

Efficacy and Safety of Liposomal Cytarabine as Intrathecal Prophylaxis in Patients with Diffuse Large B Cell Lymphoma at High Risk of CNS Involvement: A Multicentric Study Including 80 Patients in Spain.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1663-1663
Author(s):  
Adolfo de la Fuente ◽  
Antonio Salar ◽  
Carlos Panizo ◽  
Belen Navarro ◽  
Teresa Olave ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Retrospective Study ◽  
High Risk ◽  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Liposomal Cytarabine ◽  
Large B Cell Lymphoma ◽  
Large B Cell

Abstract Abstract 1663 Poster Board I-689 Introduction Lymphomatous meningitis (LM) in patients with Diffuse Large B Cell Lymphoma (DLBCL) is usually an early complication and with poor prognosis. Risk factors have been previously identified for this complication. DepoCyte is an extended released liposomal cytarabine formulation (LC) which has demonstrated better efficacy compared to standard cytarabine for the treatment of LM in one randomized clinical trial. Purpose and Methods A retrospective study was carried out in 24 Spanish sites including patients diagnosed of DLBCL and at risk of LM – defined by the presence of at least one of the following: retroperitoneal mass ≥ 10 cm; Waldeyer ring, sinus, vertebral or bone, and testicular involvement; LDH more than twice the upper normal limit; bone marrow involvement > 30% and serology VIH+. All patients had received LC as IT prophylaxis for LM in the period April 2005 – June 2009. Main endpoints were effectiveness (leptomeningeal involvement rate) and safety of the IT prophylaxis. Results Data from 80 patients were analyzed. Baseline characteristics were: Mean age 55 ± 16 years (range: 18-80 years). Males 74%; Ann Arbor stage IV 54%. All patients received alkylating based regimens, being R-CHOP as the most frequent one (88%). LC was administered as intrathecal prophylactic treatment for LM in all patients. 64 patients completed the IT prophylaxis treatment with a mean of 2,8 ± 0,83 administrations and a median follow up of 17 months (range: 3-40 months) (8 patient still on treatment and 8 patients died before finish prophylaxis). Just one patient (1,6%) had leptomeningeal spread: 76 years old man with primary testicular DLBCL, treated with R-CHOP regime, who did not reach complete response and died after 8 months of follow up due to respiratory failure. Twenty four patients out of eighty (30%) showed adverse events, being headache the most frequent side effect (27%), and 14% grade IV. Headache was reversible in all cases. Chemical arachnoiditis prophylaxis was given to 70 patients. Conclusions This retrospective study has shown that in DLBCL patients and high risk of LM, prophylaxis with LC was feasible and well tolerated. With a median follow up of 17 months (range: 3-40 months) the incidence of LM was 1,6 %. Prospective, randomized comparative studies versus conventional prophylaxis regimes are needed. Disclosures Off Label Use: DepoCyte is an extended released liposomal cytarabine formulation (LC) which has demonstrated better efficacy compared to standard cytarabine for the treatment of LM in one randomized clinical trial. Prphylaxis effectiveness..

scholarly journals Clinical efficacy and molecular biomarkers in a phase II study of tucidinostat plus R-CHOP in elderly patients with newly diagnosed diffuse large B-cell lymphoma

2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Mu-Chen Zhang ◽  
Ying Fang ◽  
Li Wang ◽  
Shu Cheng ◽  
Di Fu ◽  
...  
Keyword(s):  
Elderly Patients ◽  
B Cell ◽  
Response Rate ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Molecular Biomarkers ◽  
Newly Diagnosed ◽  
Large B Cell Lymphoma ◽  
Grade 3 ◽  
Large B Cell

Abstract Background Elderly patients with diffuse large B-cell lymphoma (DLBCL) present with poor clinical outcome and intolerance to intensive chemotherapy. Histone deacetylase inhibitors (HDACIs) show anti-lymphoma activities and can be applied to treat DLBCL. This study aimed to evaluate efficacy and safety of oral HDACI tucidinostat (formerly known as chidamide) plus R-CHOP (CR-CHOP) in elderly patients with newly diagnosed DLBCL (International Prognostic Index ≥ 2). Results Among 49 patients, the complete response rate was 86%, with overall response rate achieving 94%. The 2-year progression survival (PFS) and overall survival (OS) rates were 68% (95% CI 52–79) and 83% (95% CI 68–91). Comparing with historical control (NCT01852435), the 2-year PFS and OS rates of double-expressor lymphoma phenotype (DEL) were improved, and negative prognostic effect of histone acetyltransferases CREBBP/EP300 mutations was also mitigated by CR-CHOP. Grade 3–4 neutropenia was reported in 171, grade 3–4 thrombocytopenia in 27, and grade 3 anemia in 11 of 283 cycles. No grade 4 non-hematological adverse event was reported. Conclusion CR-CHOP is effective and safe in elderly patients with newly diagnosed DLBCL. Relevance of DEL phenotype and molecular biomarkers on CR-CHOP response warrants further investigation in DLBCL. Trial registration ClinicalTrial.gov, NCT02753647. Registered on April 28, 2016.

scholarly journals Favourable outcomes for high-risk diffuse large B-cell lymphoma (IPI 3–5) treated with front-line R-CODOX-M/R-IVAC chemotherapy: results of a phase 2 UK NCRI trial

2020 ◽  
Vol 31 (9) ◽  
pp. 1251-1259 ◽  
Author(s):  
A.K. McMillan ◽  
E.H. Phillips ◽  
A.A. Kirkwood ◽  
S. Barrans ◽  
C. Burton ◽  
...  
Keyword(s):  
High Risk ◽  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Phase 2 ◽  
Front Line ◽  
Large B Cell Lymphoma ◽  
Large B Cell

scholarly journals A 70% cut-off for MYC protein expression in diffuse large B cell lymphoma identifies a high-risk group of patients

Haematologica ◽  
2020 ◽  
Vol 105 (11) ◽  
pp. 2667-2670 ◽  
Author(s):  
Marita Ziepert ◽  
Stefano Lazzi ◽  
Raffaella Santi ◽  
Federica Vergoni ◽  
Massimo Granai ◽  
...  
Keyword(s):  
High Risk ◽  
Protein Expression ◽  
B Cell ◽  
Cell Lymphoma ◽  
Risk Group ◽  
B Cell Lymphoma ◽  
High Risk Group ◽  
Large B Cell Lymphoma ◽  
Large B Cell

Front-Line Autologous Stem Cell Transplantation (ASCT) in Primary Mediastinal Large B-Cell Lymphoma: The GEL-TAMO Experience.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3056-3056 ◽  
Author(s):  
Jose Rodriguez ◽  
Eulogio Conde ◽  
Antonio Gutierrez ◽  
Juan Carlos Garcia-Ruiz ◽  
Juan Jose Lahuerta ◽  
...  
Keyword(s):  
High Risk ◽  
B Cell ◽  
Cell Lymphoma ◽  
Autologous Transplantation ◽  
B Cell Lymphoma ◽  
Front Line ◽  
Large B Cell Lymphoma ◽  
Peripheral Stem Cells ◽  
Large B Cell

Abstract From 1985 to 2006, 71 patients with primary mediastinal large B-cell lymphoma receiving induction doxorubicine-based chemotherapy followed by ASCT as front-line therapy were registered in the GEL-TAMO (Spanish Group for Lymphoma and Autologous Transplantation). Median age was 28 years, 56% of patients were female, 40% presented with an ECOG ≥ 2; B-symptoms at diagnosis were present in 25% of the patients. Most patients presented with high-risk clinical features: bulky tumours defined as ≥10 cms of diameter were observed in most patients (87%), high LDH in 72% and, as previously reported (Rodriguez et al, Ann Oncol, 1994), β2m was elevated only in 7% of the cases. Forty-seven percent of patients presented 2–3 risk factors of the a-IPI. At transplant, thirty-five patients (49%) in first complete remission (CR), 23 (33%) in partial response and 13 patients (18%) failing the first induction therapy were transplanted, respectively. Conditioning regimens were BEAM or BEAC in 90% of the patients. 39 patients received Radiotherapy: 19 prior and 20 after the transplant. Most patients (91%) received peripheral stem cells. Only a patient failed to engraft after the transplant. After the transplant 73% of the patients achieved a CR and 17 patients were refractory. With a median follow-up from transplantation of 46,5 months the OS, PFS and DFS are 68%, 59% and 81% respectively. Progression of the disease was the main cause of death (78%). A patient died of a second neoplasia and 3 patients died of sepsis. There were no deaths related to transplant toxicity. By multivariate survival analysis both status of the disease at transplant (CR vs PR vs failure) and the Tumor score (Rodriguez et al, Ann Oncol,1992 ) were the only independent variables associated with the OS and PFS, respectively. In conclusion our experience, with a prolonged follow-up, shows that patients with primary mediastinal large B-cell lymphoma presenting at diagnosis with high-risk features have an encouraging survival and PFS with front-line ASCT. However, patients who received the transplant having failed the induction regimen have a very poor prognosis and should be tested with another innovative approach.

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