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Annals of Oncology Advance Access published online on April 7, 2005
Annals of Oncology, doi:10.1093/annonc/mdi156
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© 2005 European Society for Medical Oncology
Received September 6, 2004
Revised November 23, 2004
Accepted December 27, 2004

Original article

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)

T. J. Smith 1*, P. J. Coyne 1, P. S. Staats 2, T. Deer 3, L. J. Stearns 4, R. L. Rauck 5, R. L. Boortz-Marx 6, E. Buchser 7, E. Català 8, D. A. Bryce 9, M. Cousins 10, G. E. Pool 6, and for the Implantable Drug Delivery Systems Study Group

1 Massey Cancer Center of Virginia Commonwealth University and other institutions, Richmond, VA, USA
2 Massey Cancer Center of Virginia Commonwealth University and other institutions, Baltimore, MD, USA
3 Massey Cancer Center of Virginia Commonwealth University and other institutions, Charleston, WV, USA
4 Massey Cancer Center of Virginia Commonwealth University and other institutions, Phoenix, AZ, USA
5 Massey Cancer Center of Virginia Commonwealth University and other institutions, Winston-Salem, NC, USA
6 Massey Cancer Center of Virginia Commonwealth University and other institutions, Minneapolis, MN, USA
7 Massey Cancer Center of Virginia Commonwealth University and other institutions, Morges, Switzerland
8 Massey Cancer Center of Virginia Commonwealth University and other institutions, Barcelona, Spain
9 Massey Cancer Center of Virginia Commonwealth University and other institutions, Marshfield, WI, USA
10 Massey Cancer Center of Virginia Commonwealth University and other institutions, Sydney, Australia

* To whom correspondence should be addressed.
T. J. Smith, E-mail: tsmith{at}hsc.vcu.edu


  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.

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.

Keywords: cancer; implantable devices; intraspinal therapy; intrathecal therapy; opioids; pain.
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