Annals of Oncology Advance Access originally published online on April 7, 2005
Annals of Oncology 2005 16(5):825-833; doi:10.1093/annonc/mdi156
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© 2005 European Society for Medical Oncology
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)
1 Massey Cancer Center of Virginia Commonwealth University and other institutions, Richmond, VA; 2 Baltimore, MD; 3 Charleston, WV; 4 Phoenix, AZ; 5 Winston-Salem, NC; 6 Minneapolis, MN, USA; 7 Morges, Switzerland; 8 Barcelona, Spain; 9 Marshfield, WI, USA; 10 Sydney, Australia
* Correspondence to: Dr T.J. Smith, Virginia Commonwealth University, Division of Hematology/Oncology and Palliative Care, MCV Box 980230, Richmond, VA 23298-0230, USA. Tel: +1-804-828-9723; Fax: +1-804-828-8079; Email: tsmith{at}hsc.vcu.edu
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.
Patients and 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 
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 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 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.
Key words: cancer, implantable devices, intraspinal therapy, intrathecal therapy, opioids, pain
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