title: Use and safety of denosumab in cancer patients.
abstract: Background Few data have been reported on the use and safety of denosumab in patients with solid tumors and bone metastasis in clinical practice. Objectives To describe the use of denosumab and to analyze its adverse effects (AE) in tertiary hospital cancer outpatients. Methods Retrospective study of patients who started denosumab between January 2013 and June 2015. We recorded demographic, clinical, and treatment-related variables, as well as the reasons for discontinuation and AE. Results The study population comprised 104 patients, of whom 86 (82.7%) were receiving concomitant outpatient cancer treatment and 39 (38%) had previously received zoledronate. At baseline, albumin-corrected calcium levels were available for 48 patients (46.2%), and 70 (67.3%) were receiving calcium/vitamin D supplements. The median number of denosumab doses was 7.5 (range, 1-29). The main reasons for treatment discontinuation were disease progression (20.2%) and AE (25%). Hypocalcaemia was recorded in 38.5% of patients and osteonecrosis of the jaw in 12.5%. Monitoring of calcium levels was poor at baseline and during follow-up. Conclusions We found a higher incidence of all-grade osteonecrosis of the jaw than reported in the literature. Adherence to published recommendations on calcium supplementation and guidelines on calcium monitoring was poor. In line with our findings, a protocol for use and monitoring of denosumab has been promoted in our hospital.
authors.affiliation: Pharmacy Department, Hospital Clinic de Barcelona, Villarroel 170, 08036, Barcelona, Spain. Alba2988@gmail.com.
authors.forename: Alba
authors.initials: A
authors.lastname: Manzaneque
authors.affiliation: Pharmacy Department, Hospital Clinic de Barcelona, Villarroel 170, 08036, Barcelona, Spain.
authors.forename: Cristian
authors.initials: C
authors.lastname: Chaguaceda
authors.affiliation: Pharmacy Department, Hospital Clinic de Barcelona, Villarroel 170, 08036, Barcelona, Spain.
authors.forename: Mireia
authors.initials: M
authors.lastname: Mensa
authors.affiliation: Pharmacy Department, Hospital Clinic de Barcelona, Villarroel 170, 08036, Barcelona, Spain.
authors.forename: Carla
authors.initials: C
authors.lastname: Bastida
authors.affiliation: Pharmacy Department, Hospital Clinic de Barcelona, Villarroel 170, 08036, Barcelona, Spain.
authors.forename: Natàlia
authors.initials: N
authors.lastname: Creus-Baró
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D059266:Bisphosphonate-Associated Osteonecrosis of the Jaw / Q000453:epidemiology; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D002118:Calcium / Q000008:administration & dosage; D000069448:Denosumab / Q000009:adverse effects / Q000627:therapeutic use*; D004164:Diphosphonates / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D019983:Guideline Adherence; D006801:Humans; D006996:Hypocalcemia / Q000139:chemically induced / Q000453:epidemiology; D007093:Imidazoles / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D062606:Tertiary Care Centers; D014807:Vitamin D / Q000008:administration & dosage; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D014807:Vitamin D; D000069448:Denosumab; D000077211:Zoledronic Acid; D002118:Calcium
keywords: Calcium monitoring; Denosumab; Hypocalcemia; Osteonecrosis