title: Safety and pain palliation of zoledronic acid in patients with breast cancer, prostate cancer, or multiple myeloma who previously received bisphosphonate therapy.
abstract: An open-label study conducted in community centers assessed the safety of zoledronic acid 4 mg intravenously over 15 minutes every 3-4 weeks as treatment of bone metastases in patients with multiple myeloma, breast cancer, or prostate cancer with and without previous bisphosphonate exposure. Adverse events (AEs), pain, and quality-of-life (QOL) scores were recorded, and serum creatinine (SCr) levels were measured before each infusion. Of 638 patients, 415 patients (65%) had received prior bisphosphonate therapy. Fatigue, nausea, and arthralgia were the most frequent AEs. Nausea was more common in bisphosphonate-naive patients. SCr levels increased notably in 6.6% of patients: 7.7% of patients who received prior bisphosphonate therapy and 4.5% of bisphosphonate-naive patients. Treatment was delayed because of SCr-level increases in 1.4% of patients with prior bisphosphonate exposure and 0.4% of bisphosphonate-naive patients. SCr-level increases and treatment delays did not correlate with duration of prior bisphosphonate therapy. There was a trend towards more treatment discontinuations in patients with prior bisphosphonate exposure compared with bisphosphonate-naive patients. Pain scores decreased from baseline; total QOL scores remained constant. The results of this study suggest that, with proper SCr-level monitoring, cancer patients with bone metastases who have previously received intravenous bisphosphonate treatment can be safely converted to zoledronic acid therapy.
authors.affiliation: Cancer Research Network, 350 NW 84th Avenue, Suite 305, Plantation, Florida 33324, USA. drcvogel@aol.com
authors.forename: Charles L
authors.initials: CL
authors.lastname: Vogel
authors.forename: Ronald H
authors.initials: RH
authors.lastname: Yanagihara
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Wood
authors.forename: Frederick M
authors.initials: FM
authors.lastname: Schnell
authors.forename: Charles
authors.initials: C
authors.lastname: Henderson
authors.forename: Barry H
authors.initials: BH
authors.lastname: Kaplan
authors.forename: Malcolm H
authors.initials: MH
authors.lastname: Purdy
authors.forename: Richard
authors.initials: R
authors.lastname: Orlowski
authors.forename: Jodi L
authors.initials: JL
authors.lastname: Decker
authors.forename: Leo
authors.initials: L
authors.lastname: Lacerna
authors.forename: John A
authors.initials: JA
authors.lastname: Hohneker
mesh_terms: D000368:Aged; D018771:Arthralgia / Q000139:chemically induced; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D001862:Bone Resorption / Q000517:prevention & control; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology; D003404:Creatinine / Q000097:blood; D004164:Diphosphonates / Q000627:therapeutic use*; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000473:pathology; D009325:Nausea / Q000139:chemically induced; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000473:pathology; D011788:Quality of Life; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D003404:Creatinine