title: Prophylactic treatment of local reactions to i.v. vinorelbine: a randomized study.
abstract: BACKGROUND
  Local reactions on the site of infusion are common with i.v. vinorelbine treatment.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Respiratory Medicine, Göteborg University, Gothenburg, Sweden.
authors.forename: Eva
authors.initials: E
authors.lastname: Quant
authors.forename: Bengt
authors.initials: B
authors.lastname: Bergman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects*; D001623:Betamethasone / Q000008:administration & dosage; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous / Q000009:adverse effects; D016015:Logistic Models; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000517:prevention & control*; D010147:Pain Measurement; D012965:Sodium Chloride / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000893:Anti-Inflammatory Agents; D000972:Antineoplastic Agents, Phytogenic; D012965:Sodium Chloride; D014747:Vinblastine; D001623:Betamethasone; D000077235:Vinorelbine