Randomized Clinical Trial of an Implantable Drug Delivery System Compared With Comprehensive Medical Management for Refractory Cancer Pain: Impact on Pain, Drug-Related Toxicity, and Survival

• DOI: 10.1200/jco.2002.02.118
• Publication Date: 2002-09-26T18:22:56Z
• Authors: Thomas J. Smith; Peter S. Staats; Timothy Deer; Lisa J. Stearns; Richard L. Rauck; Richard L. Boortz...; Eric Buchser; Elena Català; David A. Bryce; Patrick J. Coyne; George E. Pool
• Keywords: Refractory (planetary science)

Implantable intrathecal drug delivery systems (IDDSs) have been used to manage refractory cancer pain, but there are no randomized clinical trial (RCT) data comparing them with comprehensive medical management (CMM).We enrolled 202 patients on an RCT of CMM versus IDDS plus CMM. Entry criteria included unrelieved pain (visual analog scale [VAS] scores >/= 5 a 0 10 scale). Clinical success was defined as 20% reduction in VAS scores, or equal toxicity. The main outcome measure control combined change toxicity, measured by the National Cancer Institute Common Toxicity Criteria, 4 weeks after randomization.Sixty 71 (84.5%) achieved compared 51 72 (70.8%, P =.05). more often both and toxicity (57.7% [41 71] v 37.5% [27 72], =.02). mean score fell from 7.81 4.76 (39% reduction); for group, 7.57 3.67 (52% reduction, =.055). 6.36 5.27 (17% 7.22 3.59 (50% =.004). group had significant reductions fatigue depressed level consciousness (P <.05). improved survival, 53.9% alive at 6 months 37.2% =.06).IDDSs control, reduced significantly relieved common toxicities, survival pain.