ORLANDOA randomized trial found that an implantable drug delivery system
(IDDS) was superior to comprehensive medical management (CMM) in reducing
pain among cancer patients and a quality of life analysis showed that
decreasing pain improved quality of life not only for patients but also for
"When the patient’s pain is relieved, the relief is felt by all," reported
Patrick J. Coyne, RN, MSN, at the 38th Annual Meeting of the American Society
of Clinical Oncology (abstract 1428).
Pain was reduced in both the IDDS and the CMM arms after 4 weeks, although
patients randomized to the IDDS arm did better, with 52% improving vs 39% in
the CMM arm, said Mr. Coyne, clinical director, Thomas Palliative Care Unit,
Virginia Commonwealth University Health System, Richmond. Opioid side effects
were reduced in 50% of patients in the IDDS arm vs 17% in the CMM arm.
The study involved 200 patients with pain not controlled by standard
treatment at 21 centers worldwide, including 5 outside the United States. The
patients were prospectively randomized to IDDS using the Medtronic
intrathecal drug delivery system (n = 101) or CMM (n = 99). Participating
centers had to have a comprehensive pain management team that used IDDS as
part of standard therapy, experience with Agency for Healthcare Research and
Quality (AHCQ) cancer pain guidelines, and a close relationship with an
Patients were well matched with respect to demographic characteristics.
"There was a high incidence of neuropathic and nociceptive pain, higher than
many people may appreciate," Mr. Coyne said. Cancer sites were essentially
comparable in both arms. The lung was the most common site (19.8% of the IDDS
arm and 25.5% of the CMM).
Patients had similar baseline opioid use, visual analogue scale (VAS)
scores for pain, and National Cancer Institute Common Toxicity Criteria (CTC)
scores. The morphine oral equivalent dose was 260 mg/d (range, 135 to 641)
for the IDDS arm and 280 mg/d (range, 120 to 686) for the CMM arm, with
patients in both arms taking an average of one adjunctive medication (range,
0 to 2).
Patients were assessed at baseline, 2, 4, 6, 8, 10, and 12 weeks, and then
monthly over 6 months. Crossover to the other arm was allowed 1 month after
enrollment for pain greater than 5 on the VAS or side effects.