title: Randomized trial of drip infusion versus bolus injection of vinorelbine for the control of local venous toxicity.
abstract: Vinorelbine is a moderate vesicant that is well known to cause local venous toxicity such as drug induced-phlebitis. We conducted a prospective randomized trial to determine whether a 1-min bolus injection (1 min bolus) of vinorelbine reduced the incidence of local venous toxicity compared with a 6-min drip infusion (6 min infusion). Non-small cell lung cancer patients who were to receive chemotherapy containing vinorelbine were randomly assigned to receive either 6 min infusion or 1 min bolus of the drug. All infusions were administered through a peripheral vein. Local venous toxicity was evaluated at each infusion up to two cycles. Eighty-three patients were randomized into the study and 81 of them assessable for analysis. One hundred thirty-eight infusions to 40 patients in 6 min infusion and 135 infusions to 41 patients in 1 min bolus were delivered. Vinorelbine induced-local venous toxicity was observed in 33% of patients in 6 min infusion and 24% in 1 min bolus. There was no statistically significant difference between the two arms (P=0.41). The incidence of local venous toxicity per infusions was 16% (22 of 138 infusions) in 6 min infusion and 11% (15 of 135 infusions) in 1 min bolus (P=0.47). No severe local venous toxicity was seen in either arm. In this study, the administration of in 1 min bolus of vinorelbine did not significantly reduce the incidence of local venous toxicity compared with 6 min infusion. Further studies for the control of local venous toxicity of vinorelbine are warranted.
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. kyoh@east.ncc.go.jp <kyoh@east.ncc.go.jp>
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Yoh
authors.forename: Seiji
authors.initials: S
authors.lastname: Niho
authors.forename: Koichi
authors.initials: K
authors.lastname: Goto
authors.forename: Hironobu
authors.initials: H
authors.lastname: Ohmatsu
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kubota
authors.forename: Ryutaro
authors.initials: R
authors.lastname: Kakinuma
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Nishiwaki
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D016015:Logistic Models; D017116:Low Back Pain / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010689:Phlebitis / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine