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This study assessed the safety and efficacy of a single-daily dose antibiotic regimen potentially suited to outpatient administration, compared with a triple antibiotic regimen using traditional dosing in febrile neutropenic recipients of autologous peripheral blood progenitor cell transplants. This was a randomized, comparative trial performed in a bone marrow transplant inpatient unit at a 925-bed academic medical center. Eighty patients with breast cancer, Hodgkin's disease, non-Hodgkin's lymphoma, or other cancers receiving autologous peripheral blood progenitor cell transplants were enrolled in the trial. At the time of first episode of neutropenic fever, patients were randomized to receive either CipoTV (single-daily-dose vancomycin 1.5 g/d plus single-daily dose tobramycin 5 tng/kg/d plus oral ciprofloxacin 750 mg po BID) versus Cef/TV (vancomycin 1 g IV q 12h plus tobramycin 2 mg/kg IV load, then 1.4 mg/kg q 8h, plus ceftazidime 1 g IV q 8h). Positive blood cultures, serum creatinine, neutropenic days, total antibiotic days, documented infection, rash, diarrhea, and length of stay all were not significantly different between CipTV and CetTV. There were no deaths in either group. There was a trend toward more febrile days and more changes in regimen in the CipTV group. Changes in dosing were more frequent in the CipTV group (43% vs. 18%, p = 0.02, OR 3.32), largely reflecting change from single-daily to standard dosing. Comparison of CipTV and CefTV showed no significant differences in outcome, but both regimens were changed frequently. In particular, inability to continue oral ciprotloxacin in patients with mucositis, and clinician tendency to seek alternative gram-negative and expanded anaerobic coverage, may make such a regimen impractical for outpatient administration. [ABSTRACT FROM AUTHOR]

Background: Pivotal phase studies of telaprevir (TLV) and boceprevir (BOV) showed 10-56% rates of early treatment interruption. However, there have been no reports on the sustained virological response (SVR) rates of these patients., Aim: To assess the SVR rate in a large cohort of patients who discontinued triple therapy with TLV or BOV for reasons other than stopping rules and to identify variables predicting SVR., Material and Method: A survey was sent to 15 hospitals in Catalonia asking them to report all TLV/BOV treatments finished by 31 May 2014. Demographic, clinical, laboratory, liver fibrosis and therapeutic data were recorded for treatments with early discontinuation. Logistic regression analysis, ROC curves and prognostic assessment of the variables identified were calculated., Results: Twelve hospitals responded to the survey, representing 467 treatments and 121 (21.2%) early discontinuations, 76 (62.8%) due to stopping rules and 45 (37.2%) for other reasons. Early discontinuation was more frequent with BOV [38.2% (50/131) versus 21.1% (71/336) p<0.005], mainly due to stopping rules [78% (39/50) versus 52.1% (37/71); p=0.004]. SVR was achieved in 21/121 patients (17.4%), 19/71 (26.8%) treated with TLV and 2/50 (4.0%) treated with BOV. In patients discontinuing treatment for reasons other than stopping rules, SVR was achieved in 19/37 (55.9%) treated with TLV and in 2/11 (18.2%) treated with BOV. The SVR rate in patients treated with TLV who discontinued due to a severe adverse event was 61.5% (16/26). A logistic regression analysis was performed only with triple therapy with TLV and early discontinuation. The predictive variables of SVR were undetectable HCV-RNA at treatment week 4 and treatment length longer than 11 weeks. Treatment duration longer than 11 weeks showed the best accuracy (0.794), with a positive predictive value of 0.928., Conclusions: Early discontinuation of TLV-based triple therapy due to reasons other than stopping rules still have a significant SVR rate (55.9%). Undetectable HVC-RNA at week 4 of treatment and treatment duration longer than 11 weeks are predictive of SVR in this subset of patients., (Copyright © 2015 Elsevier España, S.L.U. y AEEH y AEG. All rights reserved.)

Purpose: The serotonin receptor antagonists effectively prevent emesis with little toxicity when employed with standard doses of emetogenic chemotherapy. The optimal approach to the prevention of the emesis associated with the high doses of chemotherapy used for autologous stem cell transplantation is not known. A randomized controlled trial was designed to assess the relative efficacy and toxicity of granisetron compared to ondansetron in the setting of autologous stem cell transplantation., Methods: A group of 48 patients with breast cancer were randomized in a double-blind fashion to receive either (1) granisetron as a 0.5-mg i.v. bolus 30 min. before chemotherapy followed by a continuous infusion of 0.04 mg/h (1 mg/day) for 7 days or (2) ondansetron as an 8-mg i.v. bolus 30 min before chemotherapy followed by a continuous infusion of 1 mg/h (24 mg/day) for 7 days. All patients also received 10 mg dexamethasone/day i.v. for 7 days. Chemotherapy consisted of 1500 mg cyclophosphamide per m2/day, 125 mg thiotepa m(-2) day(-1), and 200 mg carboplatin per m2/day all as a continuous infusion for 4 consecutive days. The two study arms were then compared for the incidence and severity of nausea, incidence of emesis, number of salvage anti-emetics required, cost, and toxicity., Results: A total of 46 patients were evaluable. The treatment arms were well-balanced for known risk factors for chemotherapy-induced nausea and vomiting. Compliance with self-reporting of nausea and vomiting was poor but indicated no difference between the two treatment arms. The average number of anti-emetics required was 15.8 in both treatment arms and the average time to the first dose of a salvage anti-emetic was 2.8 days in the granisetron arm and 2.9 days in the ondansetron arm. The incidence of headache was 36 % in the granisetron arm and 39 % in the ondansetron arm. None of these differences was statistically significant. The use of granisetron resulted in a cost saving of 6.5 %., Conclusion: There was no significant difference between granisetron and ondansetron in either efficacy or toxicity. At our institution, the use of granisetron resulted in a moderate cost saving.