Search results for "Peni"
showing 10 items of 1692 documents
A phase I-II study of cyclophosphamide, epidoxorubicin, levofolinic acid/5-fluorouracil and recombinant human granulocyte colony stimulating factor i…
1994
Thirty patients with measurable metastatic breast carcinoma were treated with a combination of cyclophosphamide 600 mg/m2 on day 1, levofolinic acid 100 mg/m2 plus 5-fluorouracil 375 mg/m2 on days 1-3, and epidoxorubicin (EDXR) in three refracted doses on days 1-3 with G-CSF rescue for 10 days. In the phase I part of the study, groups of 3 patients received EDXR 20, 25, 30, 35, and 40 mg/m2/day until the dose limiting toxicity (DLT) was reached. At the dose of 40mg/m2/day prolonged grade 4 leukopenia, severe proctitis, and grade 3 diarrhea represented the DLT. All subsequent partients were treated at the maximal tolerated dose of EDXR (35 mg/m2/day). In the group of 18 patients treated at 3…
First-Line Treatment with Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) (FCR) Improves Overall Survival (OS) in Previously Untreated Patie…
2009
Abstract Abstract 535 Introduction: In 2008, first results of a multicenter, international randomized phase III trial (CLL8) were presented, showing superiority of FCR chemoimmunotherapy for response rates and progression-free survival (PFS) when compared to FC chemotherapy. We now report updated results with a longer median observation time of 37.7 months (mo). Methods and Patients: 817 treatment-naïve patients (pts) with good physical fitness and CD20-positive CLL randomly (1:1) received treatment with 6 courses of either FCR or FC therapy. Both treatment arms were well balanced with regard to sex, age, stage, genomic aberrations and IGVH gene status. The median age was 61 years (range 3…
Y-90 Ibritumomab Tiuxetan as Consolidation Following Three Cycles of Fludarabine-Cyclophosphamide-Rituximab Chemoimmunotherapy in Patients with Relap…
2007
Abstract BACKGROUND: Tumed sequential treatment with fludarabine/cyclophosphamide/rituximab (FC-R) followed by Y-90 ibritumomab tiuxetan (IT) radioimmunotherapy may improve progression-free survival in patients (pts) with CD20+ NHL. However, even unpretreated pts submitted to four to six cycles of a fludarabine-containing combination and then IT at an Y-90 activity of 15 MBq/kg will experience severe prolonged, transfusion-dependent and only partially reversible pancytopenia, thus limiting its use in a non-curative setting (Jurczak et al., ASH 2005). AIM: We report on a trial including anthracycline-pretreated pts with relapsing CD20+ lymphoma > age 50 and unsuitable for myeloablative tr…
Splenic Marginal Zone Lymphoma: French Registries Population-Based Treatment and Survival Analyses (2002-2014)
2020
Background. Splenic Marginal Zone Lymphoma (SMZL) is a rare indolent B-cell lymphoma characterized by a massive splenomegaly and a moderate lymphocytosis. There is no standard of care for SMZL so far. The treatment is indicated if constitutional symptoms, massive splenomegaly and/or cytopenia, after a watch and wait period that is highly variable. Rituximab with or without chemotherapy, chemotherapy, and splenectomy are valid treatment approaches. Our objectives were to describe the characteristics of the patients with SMZL retrospectively collected from a French population database, to analyze the treatments received in first line (Tt1) and in second line (Tt2) in term of efficacy, and to …
Ruxolitinib Plus Pomalidomide in Myelofibrosis: Updated Results from the Mpnsg-0212 Trial (NCT01644110)
2016
Abstract Background: Although ruxolitinib (RUX) reduces constitutional symptoms and splenomegaly in myelofibrosis (MF) therapy options for anemia are limited. In our prior MPNSG-0109 trial of pomalidomide (POM) in MF with cytopenia, anemia responses were reported in 14% and 29% of subjects receiving POM 0.5 mg/d and 2 mg/d, respectively (Schlenk RF et al., ASH 2013, abstract #2822). We designed a phase-Ib/-II combination study of RUX plus POM to evaluate synergistic effects in subjects with anemia and splenomegaly (MPNSG-0212 trial, NCT01644110; Stegelmann et al., ASH 2015, abstract #826). Study Design: Primary endpoints are response rate after 12 treatment cycles (28 days each) according t…
Coverage of urethroplasty in pediatric hypospadias: Randomized comparison between different flaps
2013
Objectives The use of covering urethroplasty with flaps in hypospadias surgery has been well recommended. Various techniques have been described for flap harvesting. The aim of the present study was to compare the outcome and complication rate of dorsal preputial flaps and ventral dartos flaps. Methods A total of 130 patients were prospectively evaluated from January 2008 to December 2011. Using the tubularized incised plate urethroplasty procedure, urethroplasty was carried out by a single surgeon. Patients were randomly divided in two groups: group A (57 patients), in which a preputial flap was carried out using three different techniques; and group B (73 patients), in which a single or a…
Efficacy and Safety of IQYMUNE®, a Ten Percent Intravenous Immunoglobulin in Adult Patients With Chronic, Primary Immune Thrombocytopenia
2018
Background: Intravenous immunoglobulin (IVIG) IQYMUNE® is a highly purified 10% IVIG that was assessed using the new stringent definition of response described in the revised guideline on the clinical investigation of IVIG. The efficacy and the safety of IQYMUNE® were investigated in adult patients with chronic primary immune thrombocytopenia (ITP). Methods: In this phase III multinational, multicentre, prospective, uncontrolled, open-label, single-arm study, adult patients with a baseline platelet count < 30 × 10 9 /L were treated with IVIG 10% at a dose of 2 g/kg body weight administered over 2 consecutive days. The primary endpoint was Response over the study period and was defined accor…
Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis
2021
Abstract The efficacy and safety of caplacizumab in individuals with acquired thrombotic thrombocytopenic purpura (aTTP) have been established in the phase 2 TITAN and phase 3 HERCULES trials. Integrated analysis of data from both trials was conducted to increase statistical power for assessing treatment differences in efficacy and safety outcomes. Caplacizumab was associated with a significant reduction in the number of deaths (0 vs 4; P &lt; .05) and a significantly lower incidence of refractory TTP (0 vs 8; P &lt; .05) vs placebo during the treatment period. Consistent with the individual trials, treatment with caplacizumab resulted in a faster time to platelet count response (ha…
Epidemiology and social costs of hip fracture.
2018
Hip fracture is an important and debilitating condition in older people, particularly in women. The epidemiological data varies between countries, but it is globally estimated that hip fractures will affect around 18% of women and 6% of men. Although the age-standardised incidence is gradually falling in many countries, this is far outweighed by the ageing of the population. Thus, the global number of hip fractures is expected to increase from 1.26 million in 1990 to 4.5 million by the year 2050. The direct costs associated with this condition are enormous since it requires a long period of hospitalisation and subsequent rehabilitation. Furthermore, hip fracture is associated with the devel…
TH-302 + Gemcitabine (G + T) vs Gemcitabine (G) in Patients with Previously Untreated advanced Pancreatic Cancer (PAC)
2012
ABSTRACT Background TH-302 is a hypoxia targeted prodrug with a hypoxia-triggered 2-nitroimidazole component designed to release the DNA alkylator, bromo-isophosphoramide mustard (Br-IPM), when reduced in severe hypoxia. A randomized Phase 2B study (NCT01144455) was conducted to assess the benefit of G + T to standard dose G as first-line therapy of PAC. Materials and methods An open-label multi-center study of two dose levels of TH-302 (240 mg/m2 or 340 mg/m2) in combination with G versus G alone (randomized 1:1:1). G (1000 mg/m2) and T were administered IV over 30-60 minutes on Days 1, 8 and 15 of a 28-day cycle. Patients on the G could crossover after progression and be randomized to a G…