Efficacy and safety of liposomal cytarabine in lymphoma patients with central nervous system involvement from lymphoma

García-Marco, José A.; Panizo, Carlos; García, Eva Sánchez; Debén, Guillermo; Alvarez‐Larrán, Alberto; Barca, Eva González; Sancho, Juan‐Manuel; Peñarrubia, María Jesús; García-Cerecedo, Tomás; Vela, J. A. Garcia

doi:10.1002/cncr.24204

Cited by 32 publications

(22 citation statements)

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“…This is comparable to our results where 12 out of 51 patients (23.5%) developed leukopenia grade 3-4 and 80.4% of patients received a concomitant chemotherapy [11]. However, in several trials, there is a lack of information concerning hematological side effects [5,18]. The reported low incidence of nausea and vomiting in our study was in accordance with the reported incidence of several other prospective studies.…”

Section: Discussionsupporting

confidence: 81%

“…It occurs most often in patients with advanced-stage breast cancer (up to 5% of patients), lung cancer (up to 11% of patients), and melanoma (up to 20% of patients) [2]. Regarding hematological malignancies, two multicenter trials in adults with newly diagnosed acute lymphoblastic leukemia showed an incidence of approximately 10% [3,][4], whereas the reported incidence of NM in patients with lymphomas ranges between 7 and 10% [5]. …”

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy of Liposomal Cytarabine in the Treatment of Neoplastic Meningitis

et al. 2015

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Objectives: Although rare, neoplastic meningitis (NM) has been increasingly observed in patients with cancer due to the prolonged course of the disease. Intrathecal chemotherapy with methotrexate or cytarabine with repeating injection schedules of 2-3 times per week is currently the mainstay of treatment. An efficacious and comfortable treatment alternative might be represented by liposomal cytarabine. Methods: In this retrospective study, we reviewed all patients with NM due to solid tumors or hematological malignancies treated with liposomal cytarabine at our institution between March 2004 and September 2011. The primary endpoint was treatment response, which was defined as improvement in neurological symptoms and/or conversion of the initial cerebrospinal fluid cytology and/or response in the radiological findings. The main secondary endpoint was safety. Results: Fifty-one adult patients were evaluable for safety and 44 patients for efficacy. In 36 patients (81.8%), a treatment response was achieved. The median overall survival after diagnosis of NM was 11 months (95% confidence interval 8.8-13.2). Adverse events grade 1-4 occurred in 31 patients (60.8%), whereas grade 3-4 occurred in 18 patients (35.3%). Conclusion: The encouraging efficacy and safety data obtained in our analysis and the convenient administration schedule make intrathecal liposomal cytarabine a favorable treatment option for NM patients.

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Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

Safety and Efficacy of Liposomal Cytarabine in the Treatment of Neoplastic Meningitis

et al. 2015

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“…103,104 The superiority of LC over conventional cytarabine in the treatment of lymphomatous meningitis has been demonstrated in a randomized clinical trial, 76 and several studies have shown significant efficacy of LC. [104][105][106] In terms of safety, LC should be administered with concurrent dexamethasone therapy, 107,108 maintaining an adequate interval between LC administration and that of other potential neurotoxic cytostatic drugs, especially intravenous HD-MTX and HD-cytarabine. 78,107 Intraventricular or IT administration of rituximab may be of value in the treatment of patients with recurrent CD20-positive CNSL.…”

Section: Intrathecal Therapymentioning

confidence: 99%

Guidelines for diagnosis, prevention and management of central nervous system involvement in diffuse large B-cell lymphoma patients by the Spanish Lymphoma Group (GELTAMO)

et al. 2016

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Several factors hinder the identification of risk factors for central nervous system (CNS) involvement in diffuse large B-cell lymphoma (DLBCL), including the retrospective nature of most studies, the relatively low frequency of CNS relapse in DLBCL, and the heterogeneity of CNS prophylaxis methods used in these studies. Moreover, the impact of newly developed diagnostic tools (such as multiparameter flow cytometry [FCM]) and new treatments introduced in the last decade, in particular rituximab, has still not been fully clarified.Several studies 4,5,[7][8][9][10] and a recent meta-analysis 1 have described a decrease in rates D iffuse large B-cell lymphoma patients have a 5% overall risk of central nervous system events (relapse or progression), which account for high morbidity and frequently fatal outcomes, 1 and shortened overall survival of <6 months.2 Early diagnosis of central nervous system events is critical for successful treatment and improved prognosis. Identification of patients at risk of central nervous system disease is critical to accurately identify candidates for central nervous system prophylaxis vs. therapy. [3][4][5] This report by the Spanish Lymphoma Group (GELTAMO) aims to provide useful guidelines and recommendations for the prevention, diagnosis, and treatment of central nervous system diffuse large B-cell lymphoma patients with, or at risk of, leptomeningeal and/or brain parenchyma lymphoma relapse. A panel of lymphoma experts working on behalf of GELTAMO reviewed all data published on these topics available in PubMed up to May 2016. Recommendations were classified according to the Grading of Recommendations Assessment Development and Evaluation (GRADE) approach. 6 A practical algorithm based on the proposed recommendations was then developed (Figure 1 have concluded that the incidence of CNS relapse decreased after the introduction of rituximab (Table 1). The identification of risk factors has been the major goal of many studies of CNS involvement. Several large retrospective studies conducted in the pre-rituximab era [12][13][14][15] reported higher rates of CNS relapse in patients with increased serum lactate dehydrogenase (LDH) levels and/or involvement of >1 extranodal site, although these factors failed to predict CNS relapse in more than half of all cases.12 In addition to the involvement of >1 extranodal site and increased LDH, International Prognostic Index (IPI) score was also identified as an independent predictor for CNS relapse in other studies.13,16 A post-rituximab era study of 399 DLBCL patients, randomized to R-CHOP or CHOP chemotherapy, 3 identified an age-adjusted IPI (aaIPI) >1 as the only risk factor for CNS involvement, although a high aaIPI score was recorded for more than 60% of the patients. When aaIPI was excluded from the analysis, elevated LDH and a poor performance status (PS >1) were identified as independent predictive factors for CNS relapse. Similarly, in the randomized RICOVER-60 trial, 4 the combination of increased LDH levels, the involvement of >1 ex...

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“…[3][4][5][6][7] Previously, the efficacy of liposomal cytarabine had been reported in individual cases or case series with mixed hematologic malignancies. Complete response rates ranged between 60% and 100% for adult and pediatric ALL, [15][16][17] various lymphomas, 18 human immunodeficiency virus-associated lymphoma, 19 acute myeloid leukemia 20 and chronic myeloid leukemia in myeloid blast crisis. 21 The populations of patients and the treatments were not very well defined in these retrospective case series.…”

Section: Patients Cyclesmentioning

confidence: 99%

“…In several studies, liposomal cytarabine was administered in combination with systemic therapy including high-dose cytarabine 20,26 or high-dose methotrexate. 18 With frequent administrations in combination with the hyper-CVAD regimen a number of severe neurotoxicities was observed 24 whereas liposomal cytarabine was well tolerated given less frequently 27 and not in combination with systemic high-dose cycles.…”

Section: Patients Cyclesmentioning

confidence: 99%

Liposomal cytarabine is effective and tolerable in the treatment of central nervous system relapse of acute lymphoblastic leukemia and very aggressive lymphoma

Gökbuget

Hartog²,

Bassan³

et al. 2010

Haematologica

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BackgroundTreatment of central nervous system relapse in adult acute lymphoblastic leukemia is a challenge and outcome is poor. Liposomal cytarabine has a prolonged half-life and, given intrathecally, has produced high response rates in patients with central nervous system relapse of non-Hodgkin's lymphoma. The aim of this study was to evaluate the efficacy and tolerability of liposomal cytarabine in central nervous system relapse of acute lymphoblastic leukemia or Burkitt's lymphoma/leukemia. Design and MethodsLiposomal cytarabine (50 mg) was given intrathecally together with systemic or intrathecal dexamethasone once every 2 weeks in a phase II European trial. The primary end-point, cytological response in the cerebrospinal fluid after one or two cycles, was evaluated at the time of next treatment. ResultsNineteen heavily pretreated patients (median age, 53 years; range 24-76 years) were evaluable: 14 with acute lymphoblastic leukemia and 5 with Burkitt's lymphoma/leukemia). Complete cytological remission as best response after two cycles of liposomal cytarabine was confirmed in 74% of the patients: 86% of those with acute lymphoblastic leukemia and 40% of those with Burkitt's lymphoma/leukemia). Nine of the 14 patients who achieved complete remission relapsed after a median of 7 months. The median overall survival was 11 months. Adverse events were observed in 89% of the patients (57% of cycles). Grade III-IV events with potential correlation to liposomal cytarabine occurred in 32% of the patients. The most frequent adverse event was headache. One patient developed severe neurological complications with loss of vision and a conus syndrome. ConclusionsOverall, liposomal cytarabine showed excellent antileukemic activity. Toxicity was acceptable but appeared to increase with the number of cycles. Future evaluation in prophylaxis is of interest (ClinicalTrials.gov Identifier:NCT00199108) Key words: liposomal cytarabine, acute lymphoblastic leukemia, aggressive lymphoma, CNS relapse, adults.Citation: Gökbuget N, Hartog C-M, Bassan R, Derigs H-G, Dombret H, Greil R, Hernández-Rivas J-M, Huguet F, Intermesoli T, Jourdan E, Junghanss C, Leimer L, Moreno M-J, Reichle A, Ribera J, Schmid M, Serve H, Stelljes M, Stuhlmann R, and Hoelzer D

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Efficacy and safety of liposomal cytarabine in lymphoma patients with central nervous system involvement from lymphoma

Cited by 32 publications

References 44 publications

Safety and Efficacy of Liposomal Cytarabine in the Treatment of Neoplastic Meningitis

Safety and Efficacy of Liposomal Cytarabine in the Treatment of Neoplastic Meningitis

Guidelines for diagnosis, prevention and management of central nervous system involvement in diffuse large B-cell lymphoma patients by the Spanish Lymphoma Group (GELTAMO)

Liposomal cytarabine is effective and tolerable in the treatment of central nervous system relapse of acute lymphoblastic leukemia and very aggressive lymphoma

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