title: Randomised study of single dose (8 Gy vs. 6 Gy) of analgesic radiotherapy plus zoledronic acid in patients with bone metastases.
abstract: OBJECTIVE
  To assess the effectiveness of a single dose of radio therapy (8 Gy vs. 6 Gy) plus zoledronic acid in cancer patients with bone metastases in treating pain; quality of life, time to onset of skeletal events and functional status.
  
  
  METHODS
  A total of 139 patients from 22 Spanish hospitals were randomly assigned to: Group A, administered a single dose of 8 Gy+zoledronic acid (4 mg iv, in 15-min infusions), and Group B, administered a single dose of 6 Gy+zoledronic acid (4 mg iv, in 15-min infusions). The main variable was pain, which was assessed with the Visual Analogue Pain Scale (VAS) in supine, seated and standing positions.
  
  
  RESULTS
  There was a total of 118 patients for intention to treat (n=67 in Group A and n=51 in Group B). The most frequent primary neoplasms were the lung (29.66%), prostate (22.03%) and breast (21.19%). Sixty patients were analysed per protocol, n=34 in group A and n=26 in group B. Improvements were observed in the VAS scores for pain in all three positions. The mean time to onset of the event was greater (p=0.0211) in Group A than in Group B (122 vs. 81.62 days). Functional status improved in Group A, and quality of life improved in both groups.
  
  
  CONCLUSIONS
  The two groups achieved similar levels of pain control in supine, seated and standing positions. Quality of life also improved in both groups. However, the higher dose (8 Gy dose) in combination with zoledronic acid is associated with a longer period without skeletal events.
authors.affiliation: Jefe del Servicio de Oncología Radioterápica, Hospital Universitario La Paz, Madrid, Spain. anamanas@telefonica.net
authors.forename: A
authors.initials: A
authors.lastname: Mañas
authors.forename: F
authors.initials: F
authors.lastname: Casas
authors.forename: J P
authors.initials: JP
authors.lastname: Ciria
authors.forename: C
authors.initials: C
authors.lastname: López
authors.forename: J
authors.initials: J
authors.lastname: Sáez
authors.forename: A
authors.initials: A
authors.lastname: Palacios
authors.forename: M
authors.initials: M
authors.lastname: de las Heras
authors.forename: C
authors.initials: C
authors.lastname: Porto
authors.forename: E
authors.initials: E
authors.lastname: Sánchez
authors.forename: C
authors.initials: C
authors.lastname: Martín
authors.forename: R
authors.initials: R
authors.lastname: Esco
authors.forename: C
authors.initials: C
authors.lastname: Veiras
authors.forename: J C
authors.initials: JC
authors.lastname: Martínez
authors.forename: M
authors.initials: M
authors.lastname: Márquez
authors.forename: A
authors.initials: A
authors.lastname: Ramos
authors.forename: F
authors.initials: F
authors.lastname: Calvo
authors.forename: J
authors.initials: J
authors.lastname: Fuertes
authors.forename: F J
authors.initials: FJ
authors.lastname: Andreu
authors.forename: J
authors.initials: J
authors.lastname: Contreras
authors.forename: L
authors.initials: L
authors.lastname: Pérez
authors.forename: J
authors.initials: J
authors.lastname: Romero
authors.forename: J
authors.initials: J
authors.lastname: Vayreda
authors.forename: C
authors.initials: C
authors.lastname: Victoria
mesh_terms: D000368:Aged; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D001859:Bone Neoplasms / Q000150:complications / Q000556:secondary* / Q000628:therapy*; D003131:Combined Modality Therapy; D004164:Diphosphonates / Q000008:administration & dosage*; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D059408:Pain Management; D010147:Pain Measurement; D011788:Quality of Life; D011878:Radiotherapy; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid