title: Skeletal-related events in metastatic prostate cancer and the number needed to treat: a critical consideration.
abstract: OBJECTIVE
  With stage migration induced by early diagnosis of prostate-specific antigen, the course of disease for prostate cancer (PCa) patients has changed. Increasingly, patients undergo long-term androgen ablation with consecutive risks including osteoporosis and pathologic fractures. A recent randomized trial found that the RANK ligand inhibitor denosumab was more effective preventing skeletal-related events in patients with metastatic PCa as compared to treatment with the bisphosphonate zoledronic acid. This improved efficacy was linked to an increase of side effects.
  
  
  METHODS
  The present analysis compares results reported for both substances using a number needed to treat analysis approach. Based upon these findings, risk-benefit calculations were performed.
  
  
  RESULTS
  The results demonstrate that for patients with bone metastatic castration-resistant PCa, decision for or against treatment with either denosumab or zoledronic acid must not only consider efficacy but needs to balance the desired effects versus potential side effects. This is of specific relevance since life expectancy is limited in this patient cohort with end-stage disease.
  
  
  CONCLUSIONS
  Further scientific efforts are necessary to identify optimal dosing and application intervals for denosumab and zoledronic acid as well as to answer the question of optimal duration of treatment. These findings will directly impact the risk versus benefit relations for both therapeutic options.
authors: Urologie, EuromedClinic/Urologie, Fürth, Germany. bsd@euromed.de
authors: Bernd J
authors: BJ
authors: Schmitz-Dräger
authors: Claudia
authors: C
authors: Weiss
authors: Thomas
authors: T
authors: Ebert
authors: Joachim
authors: J
authors: Dörsam
authors: Ekkehardt
authors: E
authors: Bismarck
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001847:Bone Diseases / Q000139:chemically induced / Q000517:prevention & control*; D000069448:Denosumab; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008017:Life Expectancy; D008297:Male; D061366:Numbers Needed To Treat; D010024:Osteoporosis / Q000139:chemically induced / Q000517:prevention & control; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D018570:Risk Assessment; D012307:Risk Factors; D016103:Spinal Fractures / Q000139:chemically induced / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018931:Antineoplastic Agents, Hormonal; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000069448:Denosumab; D000077211:Zoledronic Acid