ORLANDO—Randomized clinical trial data presented at the 38th Annual Meeting of the American Society of Clinical Oncology (abstract 1436) show that pain control medications delivered through an implantable intrathecal drug delivery system (IDDS) are significantly more effective than similar drugs given as oral or injectable formulations.
Lead investigator Thomas J. Smith, MD, who presented the study as a poster at the meeting, told ONI: "Oncologists should start thinking about intrathecal drug delivery systems any time cancer patients have severe pain. Compared to comprehensive medical management, we found that the IDDS reduced pain scores by 52% and reduced drug side effects by one third." The improvement in drug-related side effects was particularly apparent in regard to fatigue and to problems with consciousness, he said.
"In this open-label, randomized study, patients treated with IDDS plus comprehensive medical management had about 2.5 months more good-quality life at the end of life than similar patients on comprehensive medical management alone," said Dr. Smith, chairman of the Division of Hematology/Oncology, Medical College of Virginia Hospitals, Richmond.
This trial included 99 patients randomized to comprehensive medical management (CMM) and 101 patients randomized to CMM plus IDDS. About 60% of patients in each group had mixed neuropathic and nociceptive pain. Baseline morphine(Drug information on morphine) oral equivalent doses were 280 mg/d in the CMM group and 260 mg/d in the IDDS group.
Baseline visual analog scale (VAS) score was 7.59 in the CMM group and 7.44 in the IDDS group. The trial included patients with lung, breast, prostate, colon, and pancreatic cancers. Crossover was allowed for VAS pain scores greater than 5 and for side effects. Patients were assessed at baseline, 2, 4, 6, 8, 10, and 12 weeks, then monthly for 6 months. Intrathecal therapy was delivered with the Medtronic SynchroMed EL Infusion System.
The study was powered to detect a greater than 20% improvement in VAS pain score and/or in National Cancer Institute (NCI) Common Toxicity Criteria score. Clinical success was defined as either a 20% improvement in VAS pain score with equal or reduced toxicity, or a 20% improvement in toxicity with equal or reduced VAS pain score.
Study Results
