Miyazaki, T., Hanaoka, K., Namiki, A., Ogawa, S., Kitajima, T., Hosokawa, T., . . . Mashimo, S. (2008). Efficacy, safety and pharmacokinetic study of a novel fentanyl-containing matrix transdermal patch system in Japanese patients with cancer pain. Clinical Drug Investigation, 28(5), 313–325.

To evaluate the safety, efficacy, and pharmacokinetic profile of a 12.5 mcg/hour transdermal matrix fentanyl patch used to manage the persistent pain of patients with cancer

On study day 1, the patch was applied. It was replaced every 3 days for a 10-day period. All patients initially received the 12.5 mcg/hour  dose. At the time of patch replacement, the dose could be increased according to pain intensity and rescue medication used. Use of opioid receptor antagonist analgesics and other opioid medication was prohibited. Patients received fast-acting morphine for breakthrough pain. Serum fentanyl levels were measured on days 4, 7, and 10. Physicians assessed global effect on day 10 or at the time of study discontinuation. Patients provided a global assessment on days 1, 4, and 7.

• The sample was composed of 85 patients.
• Of all patients, 75% were age 60 or older. The age range was 40 to older than 70.
• Of all patients, 47% were female and 53% were male. 
• Diagnoses included gastrointestinal cancer (which 40% of patients had), gynecologic cancer (10.6%), and hepatobiliary cancer (5.9%). The sample contained a mix of other cancer sites. At baseline, 69.4% of patients were taking oxycodone, 29.4% were taking morphine, and 1.2% were undergoing fentanyl injections for pain control.

• Single site
• Outpatient
• Japan

Open-label prospective trial

• Five-point scale (5 = very satisfied, 1 = very dissatisfied), to measure patient's global assessment of pain
• Dichotomous scale (1 = effective, 2 = ineffective), to measure physicians' global assessment
• Eastern Cooperative Group (ECOG) performance status

In 78 patients, a total of 316 adverse events occurred. The most frequent adverse events were nausea (which 36% of patients experienced), somnolence (30.2%), vomiting (25.6%), diarrhea (19.8%), constipation (16.3%), pyrexia (12.8%), and insomnia (10.5%). Three patients experienced evere adverse events: dyspnea and respiratory failure. Authors observed 12 cases of skin irritation at the patch site. Of all patients, 96% reported that they were satisfied or very satisfied with the 12.5 mcg/hour transdermal matrix fentanyl patch. According to global assessment by physicians, the 12.5 mcg/hour transdermal matrix fentanyl patch was as effective as the other treatments in 98% of cases.

The 12.5 mcg/hour transdermal matrix fentanyl patch appears to be a reasonable means of controlling persistent cancer pain in patients switching from low-dose morphine or oxycodone.

• The study had a small sample, with fewer than 100 participants.
• The study had a risk of bias due to no control or comparison group.
• Authors provided no specific severity rating of adverse effects.
• Distribution of final fentanyl doses associated with efficacy was not provided.
• Authors did not report how adverse events were defined or recorded.
• Authors did not report the use rescue medications.
• Authors stated the results of a visual analog scale over time; however, they did not describe the scale or how it was used.

No firm conclusions can be drawn from this study.