Eva Quant1, Bengt Bergman. 1. Department of Respiratory Medicine, Göteborg University, Gothenburg, Sweden.
Abstract
BACKGROUND: Local reactions on the site of infusion are common with i.v. vinorelbine treatment. PURPOSE: The study aims were to evaluate whether an i.v. saline infusion or steroid injection, or the combination of these measures, could decrease vinorelbine-related local reactions and to study to what extent such reactions actually occur. METHODS:Patients with lung cancer andplanned chemotherapy containing i.v. vinorelbine were randomized in a 2 × 2 factorial design to receive either 4 mg betamethasone or placebo i.v. prior to and either 20 or 250 ml saline infusion following the vinorelbine infusion. Local infusion site signs and symptoms were recorded during and 1 h after the vinorelbine infusion and collected by a study-specific diary 24-48 h following each treatment course. RESULTS: A total of 79 patients were randomized and evaluable. Local infusion site signs, symptoms and reactions occurred in 63% of all patients (49% during vinorelbine monotherapy courses), with local pain being most frequently reported. Pre-treatment with i.v. betamethasone was associated with a reduced risk of local pain (5/38 vs. 20/39; p < 0.001) or any symptoms (14/38 vs. 29/39; p = 0.01) compared with placebo during the 48 h following the vinorelbine infusion. The reduced pain effect was seen both during vinorelbine monotherapy courses and during combination chemotherapy with carboplatin. In contrast, there was no difference between post-treatment infusion with 20 or 250 ml saline with regard to local signs or symptoms. CONCLUSION: Local infusion site side effects are common with i.v. vinorelbine. Pre-treatment with 4 mg betamethasone i.v. is associated with a reduced risk of local symptoms or reactions, local pain in particular.
RCT Entities:
BACKGROUND: Local reactions on the site of infusion are common with i.v. vinorelbine treatment. PURPOSE: The study aims were to evaluate whether an i.v. saline infusion or steroid injection, or the combination of these measures, could decrease vinorelbine-related local reactions and to study to what extent such reactions actually occur. METHODS:Patients with lung cancer and planned chemotherapy containing i.v. vinorelbine were randomized in a 2 × 2 factorial design to receive either 4 mg betamethasone or placebo i.v. prior to and either 20 or 250 ml saline infusion following the vinorelbine infusion. Local infusion site signs and symptoms were recorded during and 1 h after the vinorelbine infusion and collected by a study-specific diary 24-48 h following each treatment course. RESULTS: A total of 79 patients were randomized and evaluable. Local infusion site signs, symptoms and reactions occurred in 63% of all patients (49% during vinorelbine monotherapy courses), with local pain being most frequently reported. Pre-treatment with i.v. betamethasone was associated with a reduced risk of local pain (5/38 vs. 20/39; p < 0.001) or any symptoms (14/38 vs. 29/39; p = 0.01) compared with placebo during the 48 h following the vinorelbine infusion. The reduced pain effect was seen both during vinorelbine monotherapy courses and during combination chemotherapy with carboplatin. In contrast, there was no difference between post-treatment infusion with 20 or 250 ml saline with regard to local signs or symptoms. CONCLUSION: Local infusion site side effects are common with i.v. vinorelbine. Pre-treatment with 4 mg betamethasone i.v. is associated with a reduced risk of local symptoms or reactions, local pain in particular.
Authors: Maria Carmela Piccirillo; Gennaro Daniele; Massimo Di Maio; Jane Bryce; Gianfranco De Feo; Antonia Del Giudice; Francesco Perrone; Alessandro Morabito Journal: Expert Opin Drug Saf Date: 2010-05 Impact factor: 4.250
Authors: T Le Chevalier; D Brisgand; J Y Douillard; J L Pujol; V Alberola; A Monnier; A Riviere; P Lianes; P Chomy; S Cigolari Journal: J Clin Oncol Date: 1994-02 Impact factor: 44.544