Lenograstim: an update of its pharmacological properties and use in chemotherapy-induced neutropenia and related clinical settings

Lenograstim is the glycosylated recombinant form of human granulocyte colony stimulating factor. The drug is used to reduce the risk of life-threatening infection in patients with neutropenia, particularly after cytotoxic chemotherapy. Lenograstim accelerates neutrophil recovery significantly after chemotherapy, with beneficial effects on clinical end-points such as incidence of laboratory-confirmed infection and length of hospital stay. Chemotherapy dose intensity has also been increased in patients receiving lenograstim, notably those with breast or small cell lung cancer, although improvements in tumour response and survival have not been demonstrated. Lenograstim also assists neutrophil recovery in patients undergoing bone marrow transplantation, and stimulates the production of peripheral blood stem cells (PBSCs) for autologous transfusion after aggressive chemotherapy. Lenograstim also mobilises CD34+ cells more efficiently in unit dose terms than filgrastim and has been used successfully to mobilise PBSCs from healthy donors for allogeneic transplantation. Randomised trials have shown increases in rates of disease remission after lenograstim therapy in patients with acute myeloid leukaemia, with no evidence of stimulation of malignant blasts. The drug has also shown potential in the mobilisation of nonmalignant PBSCs for autotransplantation in patients with chronic myeloid leukaemia. Other studies show efficacy of lenograstim in patients with acute lymphoblastic leukaemia, aplastic anaemia, in children with severe chronic neutropenia and in the reversal of neutropenia related to antiviral therapy in patients with AIDS, although data are not extensive. Cost analyses of lenograstim have been carried out from a hospital perspective, although results have been inconclusive. Cost-effectiveness or cost-benefit data are lacking at present. Lenograstim is well tolerated, with bone pain and injection site reactions being reported most frequently in clinical trials. Conclusions: Lenograstim has been confirmed as a valuable adjunct to minimise the haematological toxicity of myelosuppressive chemotherapy in patients with malignant disease. The drug also enhances neutrophil recovery in patients undergoing stem cell rescue, and assists PBSC mobilisation. Data indicate clinical benefit with lenograstim in myeloid disorders, with no evidence of malignant blast cell proliferation. Further studies are required to assess more fully the pharmacoeconomic implications of the use of lenograstim and other recombinant growth factors, to provide more data on the efficacy of the drug in the management of disease-related neutropenia, and to clarify fully its position relative to filgrastim.     

Cytokines in haemopoietic progenitor mobilisation for peripheral blood stem cell transplantation

Haemopoietic progenitors mobilised into peripheral blood are now almost universally used in autologous haemopoietic stem cell transplantation in the treatment of a range of malignant and some nonmalignant disease. Although chemotherapy alone was initially used, all modern protocols now involve the use of cytokines, with or without chemotherapy. Important developments have included an in understanding of the importance of prior cancer therapy on progenitor yield, knowledge of the kinetics of mobilisation and development of necessary skills to collect and cryopreserve progenitors. More accurate measurement of haemopoietic progenitors and definitions of target cell yields for optimal haemopoietic recovery after high-dose therapy have also contributed to more predictable outcomes and provide a reference point for newer mobilisation approaches. Although G-CSF based regimens are usually successful, some patients either fail to mobilise sufficient progenitors or require an excessive number of collections. Clinical studies with the early acting cytokine, stem cell factor, in combination with G-CSF have demonstrated increased progenitor yields in a range of patients which may translate to clinical benefit in selected situations. In animal models and to a lesser extent in humans, other cytokines such as thrombopoietin and Flt-3 ligand or a number of engineered small molecules with single or dual agonist activity for cytokine receptors (IL-3, Flt-3L, TPO, G-CSF), have also been found to be promising mobilising agents. Further research into the relative importance of cell proliferation, cellular adhesion and the role of accessory cells and other signalling events is leading to an improved understanding of the underlying mechanisms of haemopoietic progenitor mobilisation. Administration of appropriate high-dose chemotherapy followed by re-infusion of haemopoietic progenitor cells capable of long-term reconstitution has long had a place in the treatment of a number of malignant (largely haematological) and non-malignant diseases. For many years these progenitor cells were obtained by direct aspiration of bone marrow under general anaesthetic, hence the term bone marrow transplantation. However, it has also been recognized that haemopoietic stem cells may be recovered from peripheral blood, albeit in low numbers, and also from umbilical cord blood. Further empirical observations showed that the number of haemopoietic progenitors circulating in the blood could be transiently augmented after chemotherapy and/or administration of one or more of a number of cytokines. Refinements to the clinical practice of progenitor mobilisation, collection and enumeration have proved very successful such that in many cases peripheral blood stem cells (PBSC) have largely replaced bone marrow as the preferred source.     

Preventive effects of newquinolones for endogenous infection in patients receiving allogeneic hematopoietic stem cell transplantation--comparison between bone marrow transplantation, peripheral blood stem cell transplantation, and cord blood transplantation

We performed a retrospective study to examine the preventive effects of newquinolones for endogenous infection in patients receiving various allogeneic hematopoietic stem cell transplantation including bone marrow transplantation (BMT), peripheral blood stem cell transplantation (PBSCT), and cord blood transplantation (CBT). Forty-nine patients were enrolled. Ciprofloxacin or norfloxacin was orally administered for intestinal sterilization from day -14 until engraftment. As a result, the period from transplantation until engraftment was significantly longer in CBT group than in BMT group. The febrile index (the ratio of the febrile (> or =38.0 degrees C) period during neutropenia (< or =500 cells/mm(3)) and C-reactive protein (CRP)-positive index (the ratio of CRP-positive (> or =2.0 mg/dl) period during neutropenia) were comparable among the three groups. In addition, no gram-negative bacteria in stool was isolated in the three groups; that is, an endogenous infection of gram-negative bacteria, a potential pathogen, was well controlled by newquinolones. We should be careful when interpreting the results of this small study; however, newquinolones are clinically effective for endogenous infection of gram-negative bacteria in patients receiving not only BMT, but also PBSCT and CBT.     

异基因外周血干细胞移植治疗急性淋巴细胞白血病

目的应用异基因外周血干细胞移植（ａｌｌｏ－ＰＢＳＣＴ）对恶性血液病进行根治性治疗,观察造血重建及并发症情况。方法对一例急性淋巴细胞白血病完全缓解期的患者移植ＨＬＡ完全相配的其胞史外周血干细胞,移植单个核细胞合７．１４＊１０＾－８／ｋｇ,ＣＦｕ－ＧＭ２８．３２＊１０＾－４／ｋｇ,ＧＶＨＤ预防短疗程ＭＴＸ加小剂量ＣＳＡ。结果术后１４天中性核细胞〉０．５＊１０＾９／Ｌ（术后１５天〉２．０＊１０＾－９／Ｌ     

Antifungal chemoprophylaxis in children and adolescents with haematological malignancies and following allogeneic haematopoietic stem cell transplantation: review of the literature and options for clinical practice

Invasive opportunistic fungal infections are important causes of morbidity and mortality in children and adolescents with cancer or haematopoietic stem cell transplantation (HSCT). Difficulties in establishing the diagnosis continue to delay antifungal therapy, and this has been shown to adversely impact on survival. Apart from ongoing attempts to improve early recognition, effective chemoprophylaxis of invasive fungal infections remains a goal of high priority in populations with disease-related incidence rates of 10% or higher. These include patients with acute myeloid leukaemia, high-risk acute lymphoblastic leukaemias, recurrent leukaemias and those following allogeneic HSCT. Incidence rates in other paediatric cancer entities, including autologous HSCT, are considerably lower and do not justify the general implementation of antifungal prophylaxis. The difficulties in obtaining a timely diagnosis, the consequences of infectious morbidity on delaying anticancer treatment, and mortality rates >20% and >50% for invasive yeast and mould infections, respectively, provide a clear rationale for antifungal prophylaxis in high-risk populations. However, while antifungal prophylaxis has become part of infectious disease supportive care algorithms in most paediatric leukaemia and allogeneic transplantation programmes, antifungal prophylaxis remains a topic of controversy, with no clear consensus amongst different centres and groups. This is largely based on the limited paediatric data, with only a small number of meaningful studies, and on the fact that the scientific evidence for the benefit of antifungal prophylaxis has been generated exclusively by prospective, randomized, clinical phase III trials conducted in adults with comparable, but not similar conditions. In this article, we briefly review the epidemiology of invasive fungal infections in children and adolescents with cancer and following HSCT; delineate regulatory principles of paediatric drug development with relevant examples for their successful implementation with new antifungal compounds; provide information on the pharmacology and paediatric development of current antifungal compounds; discuss for each compound the evidence for effectiveness as primary or secondary antifungal prophylaxis in adults and the pertinent data published in paediatric patients; and conclude by providing practical options for prophylaxis in children and adolescents with haematological malignancies and following allogeneic HSCT.     

外周血干细胞移植后出血性膀胱炎的防治策略

目的探讨外周血干细胞移植(PBSCT)后出血性膀胱炎(HC)的防治策略。方法对22例PB-SCT患者采用充分水化、碱化,加强利尿,应用美司钠及抗病毒药,对其疗效进行分析。结果3例出现迟发性HC,经水化、碱化、利尿及抗病毒联合治疗后痊愈。结论充分水化、碱化,加强利尿,使用美司钠及抗病毒药预防及治疗HC具有明显的疗效。     

Aprepitant: a review of its use in the prevention of chemotherapy-induced nausea and vomiting

Aprepitant (Emend) is the first commercially available drug from a new class of agents, the neurokinin NK(1) receptor antagonists. Oral aprepitant, in combination with other agents, is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with highly emetogenic chemotherapy in adults.In three randomised, double-blind, placebo-controlled trials comparing aprepitant (125 mg day 1, 80mg once daily on days 2 and 3 or 2-5) plus standard therapy (intravenous ondansetron and oral dexamethasone) with standard therapy plus placebo, overall complete responses (primary endpoint, defined as no emesis and no rescue therapy) were seen in significantly more patients in the aprepitant arms (63-73% versus 43-52%, p < 0.01 for all comparisons).Complete responses and complete protection during the acute and delayed phase, and overall complete protection were also observed in significantly more patients in the aprepitant arms. The difference between treatment groups was more marked in the overall and delayed phases than in the acute phase.The antiemetic efficacy of aprepitant plus standard therapy in the prevention of CINV was maintained for up to six cycles of chemotherapy.Where assessed, more patients in the aprepitant plus standard therapy arms than the standard therapy plus placebo arms reported no impact of CINV on daily life, as assessed by the Functional Living Index-Emesis.Aprepitant is generally well tolerated. The most common adverse events in randomised trials were asthenia or fatigue. Other adverse events experienced by aprepitant recipients include anorexia, constipation, diarrhoea, nausea (after day 5 of the study) and hiccups. In addition to being a substrate for cytochrome P450 (CYP) 3A4, aprepitant is also a moderate inhibitor and inducer of this isoenzyme as well as an inducer of CYP2C9. Thus, aprepitant has the potential to interact with other agents metabolised by hepatic CYP isoenzymes. In one trial, there was a higher incidence of serious infection or febrile neutropenia in the aprepitant plus standard therapy arm than the standard therapy plus placebo arm; this was attributed to a pharmacokinetic interaction between aprepitant and dexamethasone. In subsequent trials, a modified dexamethasone regimen was used.In conclusion, when added to standard therapy (a serotonin 5-HT(3) receptor antagonist and a corticosteroid), aprepitant is effective and generally well tolerated in the prevention of CINV associated with highly emetogenic chemotherapy in adults. Despite marked advances in the prevention of CINV, standard therapy does not protect all patients. The addition of aprepitant to standard therapy provides an advance in the prevention of both acute and delayed CINV in adults with cancer.     

Acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy: a short review

Peripheral neurotoxicity is a major complication associated with the use of chemotherapeutic agents such as platinum compounds, taxanes and vinca alkaloids. The neurotoxicity of chemotherapy depends not only on the anticancer agent(s) used, the cumulative dose and the delivery method, but also on the capacity of the nerve to cope with the nerve-damaging process. The sensory and motor symptoms and signs of neurotoxicity are disabling, and have a significant impact on the quality of life of cancer patients. Moreover, the risk of cumulative toxicity may limit the use of highly effective chemotherapeutic agents. Therefore, prophylaxis and treatment of peripheral neurotoxicity secondary to chemotherapy are major clinical issues. Acetyl-L-carnitine (ALC), the acetyl ester of L-carnitine, plays an essential role in intermediary metabolism. Some of the properties exhibited by ALC include neuroprotective and neurotrophic actions, antioxidant activity, positive actions on mitochondrial metabolism, and stabilisation of intracellular membranes. ALC has demonstrated efficacy and high tolerability in the treatment of neuropathies of various aetiologies, including chemotherapy-induced peripheral neuropathy (CIPN). In several experimental settings, the prophylactic administration of ALC prevented the occurrence of peripheral neurotoxicity commonly induced by chemotherapeutic agents. In animal models of CIPN, ALC administration promoted the recovery of nerve conduction velocity, restored the mechanical nociceptive threshold, and induced analgesia by up-regulating the expression of type-2 metabotropic glutamate receptors in dorsal root ganglia. These results, plus the favourable safety profile of ALC in neuropathies of other aetiologies, have led to the effects of ALC on CIPN being investigated in cancer patients. Preliminary results have confirmed the reasonably good tolerability profile and the efficacy of ALC on CIPN. The present studies support the use of ALC in cancer patients with persisting neurotoxicity induced by paclitaxel or cisplatin treatment.     

自体外周血造血干细胞移植治疗恶性血液病23例临床分析

目的观察自体外周血造血干细胞移植（APBSCT）治疗恶性血液病（恶性淋巴瘤、多发性骨髓瘤）的初期疗效。方法共23例，其中NHL18例；HD3例；MM2例。动员方案为化疗（MOEP）＋rhG—CSF。经1-2次采集，获得MNC中位数为（4．48&#177;1．73）&#215;10^8／kg，CD34^＋细胞为（4．46&#177;0．96）&#215;10^6／kg，预处理方案，NHL，HD患者采用CTX＋TBI和CTX＋VP-16＋Ara-C＋CCNU，MM患者采用MeL．结果所有患者移植后均重建造血。外周血WBC于移植后3．91&#177;0．73d降至0，PLT于7．87&#177;0．97d降至10&#215;10^9／L以下。WBC〉1．0&#215;10^9/L，中性粒细胞〉0．5&#215;10^9／L，PLT〉20&#177;10^9／L，分别为8．04&#177;1．36d，8．40&#177;1．73d，9．57&#177;1．34d，1例患者于移植后2月死于疾病复发；4例患者在移植6月内复发；其余18例患者均无病存活6—12个月，疗效仍在近一步随访中。结论APBSCT对恶性血液病是一种安全有效的治疗方法。     

Clinical outcome of high-dose chemotherapy combined with peripheral blood stem cell transplantation for male germ cell tumors

Peripheral blood stem cell transplantation (PBSCT) is widely performed currently instead of bone marrow transplantation (BMT) because bone marrow reconstruction is better and the procedure is less invasive. We applied 26 courses of high-dose chemotherapy (1250 mg/m2 of carboplatin, 1500 mg/m2 of etoposide and 7.5 g/m2 of ifosfamide) to 14 male patients with germ cell tumors. Eleven patients underwent high-dose chemotherapy as induction after two to three courses of conventional BEP therapy. The remaining three patients had recurrent disease after conventional chemotherapies. Peripheral blood stem cells were harvested during previous chemotherapy and sufficient CD34+ cells were harvested for transplantation. Although all patients had grade 4 hematotoxicity, the white blood cell count recovered to more than 1000/microl within 8-11 days after PBSCT. No treatment-related death was found. Nine of 14 patients (64.3%) remain disease free at 18 months of median follow up time (range 12-60). We conclude that high-dose chemotherapy is a safe and effective means of treating advanced or refractory germ cell tumors in male patients.     

Everolimus: a review of its use in renal and cardiac transplantation

Everolimus (Certican) is an orally administered mammalian target of rapamycin inhibitor (proliferation signal inhibitor) derived from sirolimus (rapamycin), which is used as part of immunosuppressant therapy in kidney and heart transplantation. When evaluated as part of triple therapy with ciclosporin and corticosteroids, everolimus showed equivalent efficacy to mycophenolate mofetil after renal transplantation, and superiority to azathioprine in cardiac transplant recipients, in terms of reducing efficacy failure after transplantation. Everolimus potentiates ciclosporin-associated nephrotoxicity, and it is recommended that concentration-controlled everolimus is used with reduced-dosage ciclosporin in order to limit renal toxicity while retaining immunosuppressive efficacy. Ongoing trials with everolimus, such as the evaluation of ciclosporin-withdrawal strategies, should help clarify its optimal usage. The use of everolimus may be associated with reduced rates of cytomegalovirus (CMV) infection and of cardiac allograft vasculopathy. Available data suggest that everolimus may be cost-neutral for healthcare providers.     

Efficacy and safety of moxifloxacin as antibacterial prophylaxis for patients receiving autologous haematopoietic stem cell transplantation: a randomised trial

Patients receiving high-dose chemotherapy with autologous peripheral blood stem cell transplantation (PBSCT) are at high risk of infections, especially bacteraemia. A prospective, double-blind, randomised, placebo-controlled, single-centre, pilot study was performed on oral moxifloxacin 400mg versus placebo for preventing bacteraemia in PBSCT recipients. Patients received moxifloxacin or placebo for the duration of neutropenia or until emergence of fever or other infections necessitating intravenous antibiotic treatment. Of 68 patients included in the trial, 2 were excluded from the trial before taking their first dose. The remaining 66 patients were eligible for evaluation in the intention-to-treat analysis set. Neutropenia with an absolute neutrophil count of <500cells/μL developed in 30 moxifloxacin-treated patients (88.2%) and 21 patients in the placebo group (65.6%) (P<0.03). Nine patients (26.5%) and eight patients (25.0%), respectively, were prematurely discontinued from study treatment. Breakthrough bacteraemia occurred in 3 moxifloxacin-treated patients (8.8%) and 9 patients in the placebo group (28.1%) (P=0.042). The time period until fever was 9.5 days [95% confidence interval (CI) 8.06-10.94 days) and 7.69 days (95% CI 6.51-8.85 days), respectively (P=0.0499). There was no difference in adverse events or toxicities between the groups. Moxifloxacin prevented bacteraemia and shortened febrile episodes in patients receiving autologous PBSCT. No significant increase of adverse events in the moxifloxacin arm was observed, possibly due to the rather small sample size.     

Muromonab CD-3: a review of its pharmacology, pharmacokinetics, and clinical use in transplantation

Muromonab CD-3 (OKT-3) is a monoclonal antibody that is highly effective in the treatment of acute rejection in solid organ transplants. Due to its monoclonal nature, each molecule is identical because it is derived from a single antibody-producing clone. OKT-3 is administered only by intravenous injection and has a harmonic half-life of approximately 18 hours. It binds specifically to the CD-3 complex, which is involved in antigen recognition and cell stimulation, on the surface of T lymphocytes. Immediately after administration CD-3-positive T lymphocytes are abruptly removed from the circulation. The route of metabolism for OKT-3 is not clear; it may be removed by opsonization by the reticuloendothelial system when bound to T lymphocytes, or by human antimurine antibody production. The agent has been effective in reversing corticosteroid-resistant acute rejection in renal, liver, and cardiac transplant recipients. Its use in pancreatic and bone marrow recipients is inconclusive. OKT-3 has a considerable number of initial side effects, and some life-threatening reactions may occur. This drug should not be administered to any patient who is greater than 3% usual body weight because of the potential for the development of severe pulmonary edema. OKT-3 may also be associated with a high rate of infection, especially of the viral type. The usual dose is 5 mg administered as an intravenous bolus over 2-4 minutes daily for 10-14 days. Approximately 85% of patients treated with OKT-3 develop reactive human antimurine antibodies that, over time, may lead to tachyphylaxis and neutralization of the murine antibody OKT-3. OKT-3 is potent immunosuppressive agent and is an important prototype of future monoclonal antibodies.     

A clinical comparison of the efficacy and safety of biosimilar G-CSF and originator G-CSF in haematopoietic stem cell mobilization

BackgroundRecombinant granulocyte colony-stimulating factor (G-CSF) is widely used to mobilize haematopoietic stem cells. We compared the efficacy and safety of a biosimilar G-CSF (Zarzio^®, Sandoz Biopharmaceuticals) with the originator G-CSF (Neupogen^®, Amgen) in patients with haematological malignancies.MethodsA total of 108 patients were included in this study, 59 of whom were female (49 male), with an overall median age of 51 years (range 19–69). Patients had multiple myeloma (n = 46), non-Hodgkin's lymphoma (n = 28), Hodgkin's lymphoma (n = 26), or other diagnosis (n = 8). After administration of mobilizing regimens (primarily high-dose etoposide, high-dose cyclophosphamide, intermediate-dose Ara-C or ESHAP), patients were randomized to a standard daily 10 μg/kg dose of biosimilar G-CSF (n = 54) or originator G-CSF (n = 54).ResultsMedian duration of G-CSF administration was 8 days with both biosimilar G-CSF (range 4–17) and originator G-CSF (range 4–14). Both groups had a median of one apheresis with a median time until first apheresis of 11 days. There were no statistically significant differences between groups in the mean ± SD number of mobilized CD34+ cells/μL in peripheral blood or the number of CD34+ cells/kg body weight. Five patients (9%) in the originator G-CSF group and six patients in the biosimilar G-CSF group (11%) did not mobilize sufficient CD34+ cells. The adverse event profile was similar between groups.ConclusionsA biosimilar G-CSF (Zarzio^®) demonstrated similar efficacy and safety as the reference originator G-CSF (Neupogen^®) in hematopoietic stem cell mobilization in patients with haematological malignancies.     

Feasibility and usefulness of high-dose chemotherapy (high-dose ifosfamide, carboplatin and etoposide) combined with peripheral blood stem cell transplantation for male germ cell tumor: a single-institute experience

Although the usefulness of high-dose chemotherapy with peripheral blood stem cell transplantation for advanced germ cell tumor is still under evaluation in phase III randomized controlled studies, this approach is currently used as one treatment option for relapsed or advanced male germ cell tumor. Clinical outcomes of high-dose chemotherapy for a single institute from Japan are presented herein. We administered 63 courses of high-dose ifosfamide, carboplatin and etoposide chemotherapy (1250 mg/m carboplatin; 1500 mg/m etoposide; 7.5 g/m ifosfamide) to 34 men with germ cell tumors. Of these, 27 patients underwent high-dose ifosfamide, carboplatin and etoposide as first-line therapy after 2-3 courses of conventional bleomycin, etoposide and cisplatin chemotherapy, and seven patients underwent high-dose ifosfamide, carboplatin and etoposide for relapsed germ cell tumor. Peripheral blood stem cells were harvested during previous chemotherapy and sufficient CD34 cells were harvested for transplantation. Although all patients experienced grade 4 hemotoxicity, leukocyte counts recovered to above 1000/mul within 8-11 days after peripheral blood stem cell transplantation. No treatment-related deaths occurred. After a mean follow-up of 45 months (range 12-118 months), 23 of 34 patients (67.6%) remained disease-free. High-dose ifosfamide, carboplatin and etoposide could be performed safely, and could offer an effective means of treating advanced or refractory germ cell tumors in men.     

Basiliximab: a review of its use as induction therapy in renal transplantation

Basiliximab (Simulect), a chimeric (human/murine) monoclonal antibody, is indicated for the prevention of acute organ rejection in adult and paediatric renal transplant recipients in combination with other immunosuppressive agents.Basiliximab significantly reduced acute rejection compared with placebo in renal transplant recipients receiving dual- (cyclosporin microemulsion and corticosteroids) or triple-immunotherapy (azathioprine- or mycophenolate mofetil-based); graft and patient survival rates at 12 months were similar. Significantly more basiliximab than placebo recipients were free from the combined endpoint of death, graft loss or acute rejection 3 years, but not 5 years, after transplantation.The incidence of adverse events was similar in basiliximab and placebo recipients, with no increase in the incidence of infection, including cytomegalovirus (CMV) infection. Malignancies or post-transplant lymphoproliferative disorders after treatment with basiliximab were rare, with a similar incidence to that seen with placebo at 12 months or 5 years post-transplantation. Rare cases of hypersensitivity reactions to basiliximab have been reported.The efficacy of basiliximab was similar to that of equine antithymocyte globulin (ATG) and daclizumab, and similar to or greater than that of muromonab CD3. Basiliximab was as effective as rabbit antithymocyte globulin (RATG) in patients at relatively low risk of acute rejection, but less effective in high-risk patients. Numerically or significantly fewer patients receiving basiliximab experienced adverse events considered to be related to the study drug than ATG or RATG recipients. The incidence of infection, including CMV infection, was similar with basiliximab and ATG or RATG.Basiliximab plus baseline immunosuppression resulted in no significant differences in acute rejection rates compared with baseline immunosuppression with or without ATG or antilymphocyte globulin in retrospective analyses conducted for small numbers of paediatric patients. Limited data from paediatric renal transplant recipients suggest a similar tolerability profile to that in adults. Basiliximab appears to allow the withdrawal of corticosteroids or the use of corticosteroid-free or calcineurin inhibitor-sparing regimens in renal transplant recipients.Basiliximab did not increase the overall costs of therapy in pharmacoeconomic studies.CONCLUSION: Basiliximab reduces acute rejection without increasing the incidence of adverse events, including infection and malignancy, in renal transplant recipients when combined with standard dual- or triple-immunotherapy. The overall incidence of death, graft loss or acute rejection was significantly reduced at 3 years; there was no significant difference for this endpoint 5 years after transplantation. Malignancy was not increased at 5 years. The overall efficacy, tolerability, ease of administration and cost effectiveness of basiliximab make it an attractive option for the prophylaxis of acute renal transplant rejection.