title: Implantable drug delivery systems (IDDS) after failure of comprehensive medical management (CMM) can palliate symptoms in the most refractory cancer pain patients.
abstract: BACKGROUND
  A randomized clinical trial of implantable drug delivery system (IDDS) plus comprehensive medical management (CMM) versus CMM alone in 200 patients with refractory cancer pain showed better clinical success with IDDS. The objective of this study was to evaluate whether IDDS could help the most refractory patients failed by expert CMM.
  
  
  METHODS
  This was a planned longitudinal prospective analysis of 30 of 99 (30%) patients for whom CMM failed who crossed over to IDDS by 6 months, as part of the randomized clinical trial. Patients had a pain visual analogue scale (VAS) score of 5 or more despite CMM with 320 mg or morphine-equivalent opioids and adjunct drugs for 1 month. The intervention was an implantable intrathecal programmable pump with opioids and local anesthetics. Clinical success was measured as a 20% change in pain VAS score and NCI CTEP drug toxicity scales.
  
  
  RESULTS
  Clinical success was achieved with pain scores and drug toxicity scores significantly reduced by 27% (p = 0.011) and 51% (p < 0.0001). Median survival was 103 days after IDDS implant, similar to IDDS patients who received implantation as part of the initial randomization.
  
  
  CONCLUSIONS
  CMM patients who crossed over to IDDS for the most refractory pain had significant reductions in pain and drug toxicity. The survival time of 3 months may be long enough for the IDDS implant to be cost effective. In this prospective longitudinal study, patients with refractory cancer pain despite comprehensive medical management derived benefit from IDDS.
authors.affiliation: Thomas Palliative Care Unit, Division of Hematology/Oncology and Palliative Care, Virginia Commonwealth University, MCV Box 980230, Richmond, VA 23298-0230, USA. tsmith@hsc.vcu.edu
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Smith
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Coyne
mesh_terms: D000368:Aged; D015331:Cohort Studies; D005260:Female; D006801:Humans; D015918:Infusion Pumps, Implantable; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000503:physiopathology*; D010148:Intractable Pain / Q000188:drug therapy* / Q000209:etiology; D010166:Palliative Care; D011446:Prospective Studies