© 2004 Foundation for Promotion of Cancer Research
Efficacy and Tolerability of Cancer Pain Management with Controlled-release Oxycodone Tablets in Opioid-naïve Cancer Pain Patients, Starting with 5 mg Tablets
1 Department of Gastroenterology, School of Medicine, East Hospital, Kitasato University, Sagamihara, Kanagawa, 2 Department of Urology, Kidney Center, Tokyo Women's Medical University, Tokyo, 3 Department of Otolaryngology, Nihon University School of Medicine, Tokyo, 4 First Department of Surgery, School of Medicine, Fukui Medical University, Fukui, 5 Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases, Sakai, Osaka, 6 Division of Thoracic Malignancy, Osaka Prefectural Habikino Hospital, Habikino, Osaka, 7 Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Osaka, 8 Department of Otolaryngology, 9 Department of Orthopedic Surgery and 10 Department of Thoracic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, 11 Department of Surgery, Okayama Saiseikai General Hospital, Okayama, 12 Department of Obstetrics and Gynecology, Kawasaki Medical School, Kurashiki, Okayama, 13 Second Department of Surgery, Tokuyama Central Hospital, Tokuyama, Yamaguchi, 14 Drug Safety Management Department, Shionogi & Co., Ltd, Osaka, 15 Department of Special Inpatient Division, National Cancer Center Hospital, Tokyo and 16 Comprehensive Regional Medicine, Saitama Medical School, Saitama, Japan
For reprints and all correspondence: Wasaburo Koizumi, Department of Internal Medicine, School of Medicine, Kitasato University, 2-1-1 Asamizodai Sagamihara Kanagawa 228-8520, Japan. E-mail: koizumi{at}med.kitasato-u.ac.jp
Received February 10, 2004; accepted August 13, 2004
Background: We conducted an open-label, dose titration study to assess the efficacy and tolerability of controlled-release oxycodone in the therapy of cancer pain management, starting with a newly developed 5 mg tablet every 12 h.
Methods: Twenty-two Japanese cancer patients with pain who had not been taking opioid analgesics over the previous 2 weeks were enrolled. The length of time and the dose needed to attain stable and adequate pain control were evaluated in addition to the assessment of analgesic efficacy and safety during the study period.
Results: Eighteen patients in the efficacy population (18 out of 20, 90%) attained stable, adequate pain control. Two-thirds of the patients attained stable, adequate pain control without any dose titration. The mean length of time was 1.2 days. In these patients, the pain was significantly reduced in intensity, even at 1 h after the initial dose intake. Fifteen patients (68%) reported at least one side effect, but only one patient had to withdraw from the study because of a side effect.
Conclusion: The results suggest that controlled-release oxycodone tablets offered stable and adequate pain control within a short period of time in most Japanese cancer patients who have not been taking opioid analgesics, and could be effectively titrated against pain from a starting dose of 5 mg every 12 h. This indicates that a lower strength controlled-release oxycodone formulation may make it possible to start and titrate the dose more appropriately and carefully in patients who are sensitive to opioid analgesics.
Key Words: oxycodone • 5 mg controlled-release tablets • titration • analgesia • cancer pain