Venous damage prevention by defibrotide in vinorelbine-treated patients

Mare, Marzia; Maisano, R.; Caristi, N.; Adamo, Vincenzo; Altavilla, Giuseppe; Carboni, R; Munaò, Stefania; Torre, Francesco La

doi:10.1007/s00520-003-0479-z

Cited by 10 publications

(6 citation statements)

References 16 publications

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“…On the basis of their results, we used the administration of 6 min infusion of vinorelbine as the control arm in this study. The use of defibrotide [12,13] as another anti-thrombotic drug, or cimetidine [14], which was reported to inhibit histamine actions in endothelial cells by vinorelbine [15], have been investigated in an attempt to reduce the incidence of local venous toxicity of vinorelbine. However, there have been no randomized controlled trials to verify the benefit of these methods, and thus a randomized controlled study is needed to draw definitive conclusions about their efficacy.…”

Section: Discussionmentioning

confidence: 99%

Randomized trial of drip infusion versus bolus injection of vinorelbine for the control of local venous toxicity

et al. 2007

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Section: Discussionmentioning

confidence: 99%

Randomized trial of drip infusion versus bolus injection of vinorelbine for the control of local venous toxicity

et al. 2007

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“…Recently, vascular access models are being well used because chronic intravenous administration via the tail vain in rat is sometimes - (Charvát et al, 2006;Ang et al, 2000;Strum et al, 1986;Niederhuber et al, 1982). Some chemotherapeutic agents irritate and thus are inadequate for a peripheral venous approach and repeated access to a peripheral vein has the risk of leakage (Mare et al, 2003). Clinical patients have marked stress from repeated vein puncture and the risk of drug extravasation (Coates et al, 1983;Griffin et al, 1996).…”

Section: Discussionmentioning

confidence: 99%

Application of an indwelling vascular access port for intravenous administration in a repeated and intermittent dose toxicity study in rats

et al. 2009

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-Totally implantable catheter animal models are considered useful for pharmacological and toxicological studies. In this report, we assessed the feasibility of using an indwelling vascular access port (VAP) in rats for long-term evaluation of repeated and intermittent dose toxicity studies. In Experiment 1, the VAP devices were implanted in male and female rats and a saline solution administered intravenously via the posterior vena cava for 2 weeks (4 ml/kg, 2 ml/min, 5 times/week, 10 times total). General conditions, body weight and blood chemistry showed no toxicological changes compared with the rats in the non-implanted, non-treated group. Hematology changes such as transient increases in peripheral blood reticulocytes and eosinophils were noted post-implantation. In pathology, proliferation of the -nophils in lung were noted at the end of the treatment period. Moreover, we found that the lumbar area is more suitable for VAP implantation than the back of neck for young, still growing rats. Experiment 2 included a 1-month intravenous intermittent dose (4 ml/kg, 2 ml/min, 1 time/week, 5 times total) toxicity study in VAP-implanted rats followed by a 1-month recovery period conducted under Good Laboratory Practice (GLP) regulations. The results suggested that an animal model with implanted VAP is useful for intermittent intravenous dosing of drugs. Moreover, VAP implantation in animals is expected to be extrapolated to use VAP in humans in clinical studies.

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“…Similarly, grade 3/4 non-hematological events were typical of the cytotoxic agents used, e.g. alopecia with docetaxel and vinorelbine [26], hand-foot syndrome with capecitabine [22], and venous irritation with vinorelbine [27]. Trastuzumab administered once weekly is generally well tolerated [4].…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Trastuzumab Every 3 Weeks Combined with Cytotoxic Chemotherapy in Patients with HER2-Positive Recurrent Breast Cancer: Findings from a Case Series

Ardavanis

Tryfonopoulos²,

Orfanos³

et al. 2005

Oncol Res Treat

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Background: Trastuzumab has been repeatedly shown to result in significant clinical benefits and was subsequently accepted as the treatment of choice for HER2-positive advanced breast cancer - particularly as first-line treatment in combination with taxanes and as monotherapy in the second-line or third-line setting. Trastuzumab is currently licensed as a weekly treatment, although a 3-weekly schedule could be used conveniently in combination with other cytotoxic agents that are administered on a 3-weekly basis in metastatic breast cancer. Patients and Methods: We determined the safety of i.v. trastuzumab (8 mg/kg followed by 6 mg/kg) every 3 weeks in combination with chemotherapeutic agents administered in 3-weekly courses (docetaxel, vinorelbine and capecitabine) in 31 patients with HER2-positive recurrent locoregional and/or metastatic breast cancer. Results: 3-weekly trastuzumab appeared to be as well tolerated as the standard once-weekly schedule. All myelosuppressive adverse events and the majority of non-hematological adverse events were typical and characteristic of the individual concomitant cytotoxic agents. Transient trastuzumab-related infusion reactions occurred in 5 patients and 1 patient developed cardiac dysfunction, which recovered after discontinuation of trastuzumab. Efficacy appeared favourable: 18 clinical responses (3 complete and 15 partial) and 8 disease stabilizations gave an overall response rate of 58% (70% in the 20 patients receiving first-line therapy). Median progression-free and overall survival times were 9.9 months (95% CI: 6.3-13.5) and 23.1 months (95% CI: 19.2-27.0), respectively. Conclusions: These findings will likely encourage further evaluation of this more convenient 3-weekly trastuzumab regimen in patients with HER2-positive metastatic breast cancer.

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Venous damage prevention by defibrotide in vinorelbine-treated patients

Abstract: Our findings support the use of defibrotide as an effective, safe and low-cost means for preventing vinorelbine-related venous damage.

Cited by 10 publications

References 16 publications

Randomized trial of drip infusion versus bolus injection of vinorelbine for the control of local venous toxicity

Randomized trial of drip infusion versus bolus injection of vinorelbine for the control of local venous toxicity

Application of an indwelling vascular access port for intravenous administration in a repeated and intermittent dose toxicity study in rats

Safety and Efficacy of Trastuzumab Every 3 Weeks Combined with Cytotoxic Chemotherapy in Patients with HER2-Positive Recurrent Breast Cancer: Findings from a Case Series

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