title: Oral ibandronate improves bone pain and preserves quality of life in patients with skeletal metastases due to breast cancer.
abstract: The objective of this study is to assess the effect of oral ibandronate on bone pain and quality of life in women with metastatic bone disease from breast cancer. In two double-blind, placebo-controlled studies, 564 patients were randomised to receive oral ibandronate, 50mg once daily, or placebo for up to 96 weeks. Throughout the studies, we assessed bone pain (on a 5-point scale from 0=none to 4=intolerable), analgesic use (7-point scale) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 [EORTC QLQ-C30], 100-point scale). Oral ibandronate significantly reduced and maintained bone-pain scores below baseline throughout the 96-week study period (at endpoint, -0.1 vs +0.2, P=0.001 vs placebo). Analgesic use increased in both groups; however, the increase was significantly less in the ibandronate group (0.60 vs 0.85, P=0.019). Although quality of life deteriorated during the study, the decrease in quality of life was significantly lower with ibandronate therapy (-8.3 vs -26.8, P=0.032). Drug-related adverse events were generally minor and as expected with oral bisphosphonates. Oral ibandronate had beneficial effects on bone pain and quality of life and was well tolerated. These results suggest that this treatment is of considerable clinical value as a co-analgesic to patients with painful bone metastases.
authors.affiliation: Institut Jules Bordet, Université Libre de Bruxelles, 1 Rue Héger-Bordet, 1000 Brussels, Belgium CGG-Klinik GmbH, Mannheim, Germany Andrew Love Cancer Center, Geelong, Vic., Australia Wilhelminenspital, Wien, Austria Cancer Research Center, Moscow, Russia Oncological Center, Barnaul, Russia University of California, San Francisco, CA, USA Hoffmann-La Roche Inc., Nutley, NJ, USA.
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Body
authors.forename: Ingo J
authors.initials: IJ
authors.lastname: Diel
authors.forename: Richard
authors.initials: R
authors.lastname: Bell
authors.forename: Martin
authors.initials: M
authors.lastname: Pecherstorfer
authors.forename: Michail R
authors.initials: MR
authors.lastname: Lichinitser
authors.forename: Alexander F
authors.initials: AF
authors.lastname: Lazarev
authors.forename: Debu
authors.initials: D
authors.lastname: Tripathy
authors.forename: Bengt
authors.initials: B
authors.lastname: Bergström
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000523:psychology / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D004164:Diphosphonates / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D018709:Statistics, Nonparametric
chemical_list: D004164:Diphosphonates; D000077557:Ibandronic Acid