Cancer pain management with hydromorphone OROS in Korean cancer patients: Evaluation of its clinical usefulness in reduction of breakthrough pain medication frequency: Multicenter, prospective, open-label study.

Abstract

e19566 Background: A majority of patients with cancer experience cancer pain of higher than moderate severity during the progression of cancer. Of these, 2/3 of patients with cancer have been reported to be inflicted with breakthrough pain. Methods: The primary objective is to evaluate the clinical usefulness of hydromorphone OROS in reduction of breakthrough pain medication frequency in Korean patients. Subjects include patients who are given strong oral narcotic analgesics for the treatment of cancer pain. This study enrolled only patients who took immediate-release analgesics more than twice a day on average for the treatment of breakthrough pain during a 3-day period prior to Visit 2. When patients selected, patients were switched to test drug using a 2.5: 1 conversion ratio of controlled release oxycodone equivalent to hydromorphone hydrochloride, with no washout or overlap of previous opioid therapy and study medication. Results: Total 117 patients received the investigational drug and only 98 patients completed the last fourth assessment. The frequency of the use of immediate- release analgesics for the management of breakthrough pain was decreased from 2.93 times to 2.00 times (p<0.000). The incidence of breakthrough pain was also decreased from 3.67 times to 2.44 times (p<0.0001). K-BPI score was also decreased from 3.6 to 3.2. In 61.2% of patients had a satisfaction with the pain treatment. In regard to the preference to test drug in 83.7% of patients who completed the treatment, 82.95% of patients preferred test drug because ‘the cancer pain could be controlled with a one-time treatment'. 25.5% of patients showed improvement of CGI-I. In EORTC QLQ-C30 analysis, only pain and diarrhea among the symptom scales improved. In 91.2% of patients who used analgesics, the side effects occurred in such an order as constipation, drowsiness and dizziness. But there were no cases of uncontrolled specific side effects. Conclusions: A 24-hr sustained-release type of hydromorphone OROS tablet significantly diminished the use of immediate-release analgesics and the incidence of breakthrough pain. No significant financial relationships to disclose.