title: Adverse events in the long-term follow-up of patients treated with samarium Sm 153 lexidronam for osseous metastases.
abstract: OBJECTIVE
  To investigate adverse events after samarium Sm 153 lexidronam and the effect of pre- and post-samarium Sm 153 lexidronam external beam radiation therapy (EBRT) and/or chemotherapy on myelosuppression in patients who received samarium Sm 153 lexidronam for osseous metastases.
  
  
  METHODS
  We performed a single-institution retrospective review of 139 patients treated with samarium Sm 153 lexidronam between November 1997 and February 2008. New-onset adverse events after samarium Sm 153 lexidronam were reported. The effect of samarium Sm 153 lexidronam on platelet and peripheral white blood cell counts and the duration of myelosuppression after samarium Sm 153 lexidronam plus EBRT and/or chemotherapy were calculated. Differences in the prevalence of adverse events among patients with varying treatment histories were evaluated with the Pearson chi-square test.
  
  
  RESULTS
  Hematologic follow-up was available for 103 patients. Chemotherapy and/or EBRT had no effect on the magnitude or duration of myelosuppression. The most common nonhematologic adverse events were acute lower extremity edema (n = 27) and acute and transient neuropathy (n = 29). Patients treated with chemotherapy after samarium Sm 153 lexidronam had a higher prevalence of lower extremity edema (9 of 18 [50%]) than those who were not treated with chemotherapy after samarium Sm 153 lexidronam (18 of 85 [21.2%]) (p = 0.01, chi-square test). No adverse events were correlated with EBRT.
  
  
  CONCLUSIONS
  Our observation of new-onset, acute and transient edema and neuropathy after samarium Sm 153 lexidronam and of a relationship between edema and post-samarium Sm 153 lexidronam chemotherapy suggests the need for re-examination of patients in past series or for a prospective investigation with nonhematologic adverse events as a primary endpoint.
authors.affiliation: Dartmouth Medical School, Hanover, NH 03755, USA. Anthony.J.Paravati@dartmouth.edu
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Paravati
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Russo
authors.forename: Candice
authors.initials: C
authors.lastname: Aitken
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001792:Blood Platelets / Q000187:drug effects / Q000528:radiation effects; D001853:Bone Marrow / Q000187:drug effects / Q000528:radiation effects; D001855:Bone Marrow Diseases / Q000209:etiology*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000532:radiotherapy* / Q000556:secondary*; D003131:Combined Modality Therapy / Q000379:methods; D004487:Edema / Q000139:chemically induced*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007866:Leg; D007962:Leukocytes / Q000187:drug effects / Q000528:radiation effects; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects* / Q000627:therapeutic use; D009943:Organophosphorus Compounds / Q000009:adverse effects* / Q000627:therapeutic use; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced*; D012189:Retrospective Studies
chemical_list: D009942:Organometallic Compounds; D009943:Organophosphorus Compounds; C061972:samarium Sm-153 lexidronam