Use of biosimilar filgrastim compared with lenograstim in autologous haematopoietic stem-cell transplant and in sibling allogeneic transplant.

OBJECTIVES: Biosimilar filgrastim was compared with lenograstim for autologous haematopoietic stem-cell transplant (HSCT) in patients with haematological malignancies. Data from a separate group of sibling donors who underwent allogeneic HSCT are also reported. METHODS: Patients with lymphoma or multiple myeloma (MM) who underwent autologous HSCT with biosimilar filgrastim were compared with a historical control group of patients who received lenograstim. Peripheral blood (PB) cells counts were monitored after 7-8 consecutive days of granulocyte-colony stimulating factor (G-CSF) injection and apheresis was performed on day 8 if PB CD34+ cell count was ⩾10 cells/µl. The target PB CD34+ cell doses were ⩾2.0 × 10(6)/kg (lymphoma), ⩾4.0 × 10(6)/kg (MM ⩾60 years old) or ⩾8.0 × 10(6)/kg (MM <60 years old). RESULTS: A total of 259 patients were included in the autologous HSCT comparison (biosimilar filgrastim, n = 104; lenograstim, n = 155). In patients with lymphoma and older MM patients (⩾60 years old), no significant differences were observed between groups with regard to stem-cell mobilization parameters. However, in MM patients <60 years old, all parameters were significantly superior in the biosimilar filgrastim group, including the need for 1 rather than 2 apheresis procedures. No significant differences were observed between groups in median number of days to absolute neutrophil count (ANC) or platelet recovery. In the allogeneic setting, 47 sibling donors received biosimilar filgrastim. Mean CD34+ count at the first apheresis was 6.1 × 10(6)/kg. A total of 13 donors needed a second apheresis and 4 required a third. Among recipients, median days to ANC recovery was 16 (10-28) and to platelet recovery was 13 (9-54). CONCLUSIONS: Biosimilar filgrastim is as effective as lenograstim for autologous HSCT in patients with lymphoma or MM patients ⩾60 years old. However, mobilization with biosimilar filgrastim appeared to be superior to that with lenograstim in younger MM patients.S.A. has received support for meetings and unrestricted educational grants from Amgen, Chugai and SandozPDF version submitted- requires post print - withdraw

Approximate reciprocal relationship between two cause-specific hazard ratios in COVID-19 data with mutually exclusive events

COVID-19 survival data presents a special situation where not only the time-to-event period is short, but also the two events or outcome types, death and release from hospital, are mutually exclusive, leading to two cause-specific hazard ratios (csHR d and csHR r ). The eventual mortality/release outcome is also analyzed by logistic regression to obtain odds-ratio (OR). We have the following three empirical observations: (1) The magnitude of OR is an upper limit of the csHR d : |log(OR)| ≥ |log(csHR d )|. This relationship between OR and HR might be understood from the definition of the two quantities; (2) csHR d and csHR r point in opposite directions: log(csHR d ) ⋅ log(csHR r ) < 0; This relation is a direct consequence of the nature of the two events; and (3) there is a tendency for a reciprocal relation between csHR d and csHR r : csHR d ∼ 1/csHR r . Though an approximate reciprocal trend between the two hazard ratios is in indication that the same factor causing faster death also lead to slow recovery by a similar mechanism, and vice versa, a quantitative relation between csHR d and csHR r in this context is not obvious. These results may help future analyses of data from COVID-19 or other similar diseases, in particular if the deceased patients are lacking, whereas surviving patients are abundant

Multicenter retrospective analysis regarding the clinical manifestations and treatment results in patients with hairy cell leukemia: Twenty-four year Turkish experience in cladribine therapy

PubMedID: 25393847In this multicenter retrospective analysis, we aimed to present clinical, laboratory and treatment results of 94 patients with Hairy cell leukemia diagnosed in 13 centers between 1990 and 2014. Sixty-six of the patients were males and 28 were females, with a median age of 55. Splenomegaly was present in 93.5% of cases at diagnosis. The laboratory findings that came into prominence were pancytopenia with grade 3 bone marrow fibrosis. Most of the patients with an indication for treatment were treated with cladribine as first-line treatment. Total and complete response of cladribine was 97.3% and 80.7%. The relapse rate after cladribine was 16.6%, and treatment related mortality was 2.5%. Most preferred therapy (95%) was again cladribine at second-line, and third line with CR rate of 68.4% and 66.6%, respectively. The 28-month median OS was 91.7% in all patients and 25-month median OS 96% for patients who were given cladribine as first-line therapy. In conclusion, the first multicenter retrospective Turkish study where patients with HCL were followed up for a long period has revealed demographic characteristics of patients with HCL, and confirmed that cladribine treatment might be safe and effective in a relatively large series of the Turkish study population. © 2015 John Wiley & Sons, Ltd

Effects of fullerenol nanoparticles on kidney tissue in sevoflurane-treated rats

WOS: 000508930100003PubMed: 32115963AIM: The aim of this study is to demonstrate whether fullerenol C60 protects renal injury in sevoflurane-administered rats. METHOD: Rats (n: 24) were randomly divided into four groups: Control (Group C), Fullerenol C60 (Group F), Sevoflurane (Group S), Fullerenol C60-Sevoflurane (Group FS). Thirty minutes before the procedure, Fullerenol C60, 100 mg/kg, was administered intraperitoneally. Sevoflurane (2.3 %) was applied for 3 hours to rats in S and FS groups. Biochemical and histopathological parameters were analyzed in renal tissue samples. Kruskal-Wallis and Mann-Whitney U tests were used in statistical analyzes. RESULTS: Malondialdehyde (MDA) level and catalase (CAT) enzyme activity in Group S were significantly higher than that in all other groups. Paraoxanase (PON) enzyme activity in Group S was significantly lower than in Groups C and FS. The histopathological examination showed that vascular vacuolization and hypertrophy (VVH) and lymphocyte infiltration (LI) were significantly higher in the Group S compared to the Group C. CONCLUSION: Renal histopathology revealed that the administration of Fullerenol C60 prior to sevoflurane inhalation reduced oxidative stress and partially corrected the damage caused by anesthesia. We concluded that Fullerenol C60 has a renal protective effect in rats when administered before sevoflurane anesthesia.Gazi University Scientific Research Committee [01/2019-42]This study was supported by Gazi University Scientific Research Committee (Scientific Research Project No. 01/2019-42)