title: An implantable drug delivery system (IDDS) for refractory cancer pain provides sustained pain control, less drug-related toxicity, and possibly better survival compared with comprehensive medical management (CMM).
abstract: BACKGROUND
  The randomized clinical trial of implantable drug delivery systems (IDDS) plus comprehensive medical management (CMM) versus CMM alone showed better clinical success at 4 weeks for IDDS patients. This 'as treated' analysis assessed if improvements in pain control, drug toxicity and survival were maintained over time.
  
  
  METHODS
  We compared those who received IDDS with those who did not receive IDDS (non-IDDS). All patients had Visual Analogue Scores (VAS) for pain > or =5/10 on at least 200 mg morphine or equivalent daily.
  
  
  RESULTS
  At 4 weeks, 46 of 52 (88.5%) IDDS patients achieved clinical success compared with 65 of 91 (71.4%; P=0.02) non-IDDS patients, and more often achieved > or =20% reduction in both pain VAS and toxicity [35 of 52 (67.3%) versus 33 of 91 patients (36.3%); P=0.0003]. By 12 weeks, 47 of 57 (82.5%) IDDS patients had clinical success compared with 35 of 45 (77.8%; P=0.55) non-IDDS patients, and more often had a > or =20% reduction in both pain VAS and toxicity [33 of 57 (57.9%) versus 15 of 45 patients (33.3%); P=0.01]. At 12 weeks the IDDS VAS pain scores decreased from 7.81 to 3.89 (47% reduction) compared with 7.21 to 4.53 for non-IDDS patients (42% reduction; P=0.23). The 12 week drug toxicity scores for IDDS patients decreased from 6.68 to 2.30 (66% reduction), and for non-IDDS patients from 6.73 to 4.13 (37% reduction; P=0.01). All individual drug toxicities improved with IDDS at both 4 and 12 weeks. At 6 months, only 32% of the group randomized to CMM and who did not cross over to IDDS were alive, compared with 52%-59% for patients in those groups who received IDDS.
  
  
  CONCLUSIONS
  IDDS improved clinical success, reduced pain scores, relieved most toxicity of pain control drugs, and was associated with increased survival for the duration of this 6 month trial.
authors.affiliation: Massey Cancer Center of Virginia Commonwealth University and other institutions, Richmond, VA 23298, USA. tsmith@hsc.vcu.edu
authors.forename: T J
authors.initials: TJ
authors.lastname: Smith
authors.forename: P J
authors.initials: PJ
authors.lastname: Coyne
authors.forename: P S
authors.initials: PS
authors.lastname: Staats
authors.forename: T
authors.initials: T
authors.lastname: Deer
authors.forename: L J
authors.initials: LJ
authors.lastname: Stearns
authors.forename: R L
authors.initials: RL
authors.lastname: Rauck
authors.forename: R L
authors.initials: RL
authors.lastname: Boortz-Marx
authors.forename: E
authors.initials: E
authors.lastname: Buchser
authors.forename: E
authors.initials: E
authors.lastname: Català
authors.forename: D A
authors.initials: DA
authors.lastname: Bryce
authors.forename: M
authors.initials: M
authors.lastname: Cousins
authors.forename: G E
authors.initials: GE
authors.lastname: Pool
mesh_terms: D000328:Adult; D000368:Aged; D000698:Analgesia / Q000379:methods*; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015918:Infusion Pumps, Implantable; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000175:diagnosis; D010147:Pain Measurement; D010148:Intractable Pain / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality*; D017060:Patient Satisfaction; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid