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 their caregivers.
"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 oncology program.
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(Drug information on 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.