The results demonstrate that BDR produces rapid and durable responses, along with high rates of response and complete remissions in WM. Herpes zoster prophylaxis is necessary with BDR, and reversible peripheral neuropathy was the most common toxicity leading to premature discontinuation of bortezomib in 61% of patients. Exploration of alternative schedules for bortezomib administration that includes weekly dosing should be pursued.
A real-time reverse transcriptase/polymerase chain reaction (RRT-PCR) assay was developed using hydrolysis probes for the detection of avian influenza virus (AIV) and the H5 and H7 subtypes. The AIV specific primers and probes were directed to regions of the AIV matrix gene that are conserved among most type A influenza viruses. The H5 and H7 primers and probes are directed to H5 and H7 hemagglutinin gene regions that are conserved among North American avian influenza viruses. The sensitivity and specificity of this RRT-PCR assay was compared to virus isolation (VI) in chicken embryos with 1550 clinical swab samples from 109 live-bird markets (LBMs) in New York and New Jersey. RRT-PCR detected influenza in samples from 61 of 65 (93.8%) of the LBMs that were the sources of VI positive samples. Of the 58 markets that were positive for H7 influenza by hemagglutination inhibition assay, RRT-PCR detected H7 influenza in 56 markets (96.5%). Too few H5 positive samples were obtained to validate the H5 RRT-PCR assay in this study. Although RRT-PCR was less sensitive than VI on an individual sample basis, this study demonstrated that the AIV and H7 RRT-PCR assays are good tools for the rapid screening of flocks and LBMs.
Purpose-To evaluate the toxicity and response rate of bortezomib with concurrent radiotherapy and temozolomide in the treatment of patients with CNS malignancies.
Patients andMethods-This open-label, dose-escalation, phase 1 clinical study evaluated the safety of 3 dose levels of intravenously administered bortezomib (0.7, 1.0, 1.3 mg/m 2 /dose) on days 1, 4, 8, 11 of a 21-day cycle, in addition to concurrent radiation therapy and temozolomide at a daily dose of 75 mg/m 2 starting on day 1. The primary endpoint was dose-limiting toxicity (DLT), defined as any Grade 4-5 toxicity or Grade 3 toxicity(ies) directly attributable to protocol treatment, requiring hospitalization and/or radiation interruption. Secondary endpoints included feasibility, non-doselimiting toxicity, and response.Results-Twenty-seven patients were enrolled, 23 of whom had a high grade glioma (ten recurrent and 13 newly diagnosed). There were no dose-limiting toxicities (DLTs) noted in any dose groups, including the highest dose level group (1.3 mg/m 2 /dose). The most frequent toxicities were grade 1 and 2 stomatitis, erythema, and alopecia. All 27 patients were evaluable for response. At a median follow-up of 15.0 months, 9 patients were still alive; median survival was 17.4 months for all patients and 15.0 months for patients with high-grade gliomas.Conclusion-Bortezomib administered at its typical "systemic" dose (1.3 mg/m 2 ) is well tolerated and safe in combination with temozolomide and radiation when used in the treatment of CNS malignancies. A phase II study to characterize efficacy is warranted.
Seven of eight patients with thrombotic thrombocytopenic purpura who were treated with both exchange plasmapheresis and antiplatelet agents (aspirin and dipyridamole) achieved complete remission. The eighth patient appeared to fail on this regimen but responded to corticosteroids and splenectomy. A ninth patient attained full remission after therapy with only aspirin and dipyridamole. The antiplatelet agents appeared to play an important role in the response of four patients. Eight patients received maintenance aspirin and dipyridamole. This maintenance therapy may have prevented relapses of thrombotic thrombocytopenic purpura in some patients as evidence of active, subclinical disease persisted for many weeks in most patients. Treatment with maintenance antiplatelet agents was discontinued in five patients after 7 to 18 months and no patient has relapsed. An effective therapeutic regimen for thrombotic throbocytopenic purpura would include initial therapy with exchange plasmapheresis, aspirin, and dipyridamole and maintenance therapy with antiplatelet agents.
In 2001, all 109 retail live-bird markets (LBMs) in New York and New Jersey were surveyed for the presence of avian influenza virus (AIV) by a real time reverse transcriptase/polymer chain reaction assay (RRT/PCR) and results compared to virus isolation (VI) in embryonating chicken eggs. The RRT/PCR had a 91.9% sensitivity and 97.9% specificity in detecting presence of AIV at the market level. However, the sensitivity at the sample level is 65.87%. The RRT/PCR is a reliable method to identify AIV at the market level. In addition, a cross-sectional epidemiologic study of the LBMs showed that, during the past 12 months, markets that were open 7 days per week and those that also sold rabbits had the highest risk for being positive for AIV. Markets that were closed one or more days per week and those that performed daily cleaning and disinfecting had the lowest risk for being AIV positive.
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