Cancer Res Treat.  2013 Dec;45(4):263-269.

Effect of Dose Escalation with Single Opioid, Fentanyl Matrix in Patients Not Controlling Cancer Pain: A Multicenter, Prospective, Observational Study in Korea

• Koh SA
• Lee KH
• Kim MJ
• Lee KT
• Park SW
• Nam SH
• Ryoo HM

Abstract

PURPOSE
End-of-dose failure (EOD) is a clinically common observation and many cancer patients increase the frequency of opioid administration. Fentanyl matrix use is known to be effective in patients with chronic cancer pain. To measure the effectiveness of increase in a single dose of fentanyl matrix in patients whose pain was not controlled sufficiently, we perform this study.
MATERIALS AND METHODS
A multi-center, open-label, prospective, observational study was conducted in 30 hospitals in Korea, between August and December 2008.
RESULTS
A total of 452 patients were enrolled; 404 patients completed the study. The mean pain intensity decreased from 5.27 at the first visit to 3.37 at the end of the trial. There was a significant difference in pain intensity (p < 0.001) between the first and last visits. The percentage of pain intensity difference was 30.1%. The prevalence of EOD at the first visit was 73% from the 452 enrolled patients. After the use of fentanyl patch, EOD decreased from 73% to 56%. Pain intensity of patients experiencing EOD was 5.64 at the baseline compared to 4.27 in patients without EOD. On final visit, pain intensity in patients with and without EOD was 4.02 and 2.54, respectively. The observed adverse events were mainly nausea, asthenia, constipation and diarrhea.
CONCLUSION
This study demonstrated that increasing dose of fentanyl patch decreased pain intensity and decreased the rate of patients experiencing EOD. Thus, fentanyl patch may be an effective modality in cancer patients whose pain was previously not controlled sufficiently; the side effects were as could be expected with an opioid.

Keyword

Fentanyl; Neoplasms; Pain

MeSH Terms

Asthenia
Constipation
Diarrhea
Fentanyl*
Humans
Korea*
Nausea
Observational Study*
Prevalence
Prospective Studies*
Fentanyl

Figure

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  Fig. 1 Study design. On the first visit, we changed the previous opioid drug to fentanyl patch of equivalent doses. Further, we surveyed the demographic data and patients' primary tumor, metastasis, stage, and etc. Over a period of approximately one month, we adjusted the patients' daily dose of fentanyl matrix, depending on their pain relief. On the second visit (day 29±7), we performed a reevaluation of the items described above.

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  Fig. 2 Pain intensity and sleep disturbance scale on visit 1 and visit 2. The mean pain intensity of the first visit was 5.27 and that of the second visit was 3.37. A significant difference was observed in two pain intensities (p<0.001). Further, the mean sleep disturbance scale of the first visit and the second visit was 3.69 and 2.55, respectively. However, this was not statistically significant. NRS, numeric rating scale.

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  Fig. 3 The proportion of end-of-dose failure on visit 1 and visit 2. After the use of fentanyl patch, the proportion of end-of-dose failure showed a reduction, from 73% to 56.2%.

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  Fig. 4 The pain intensity and sleep disturbance scale with or without end-of-dose failure (EOD). Pain intensity of patients who had experienced EOD and those who had not experienced EOD was 5.64 and 4.27, respectively, on the first visit. On the second visit, the pain intensity of patients who had experienced EOD and those who had not experienced EOD was 4.02 and 2.54, respectively. The sleep disturbance scale of patients who had experienced EOD and those who had not experienced EOD was 4.15 and 2.43, respectively on the first visit. On second visit, the sleep disturbance scale of patients who had experienced EOD and those who had not experienced EOD was 3.15 and 1.77, respectively. Pain intensity and sleep disturbance in patients with EOD between that of patients without EOD was statistically significant on the first and second visits. NRS, numeric rating scale.

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  Fig. 5 Satisfaction rate of Investigator's Global Assessment and Patient's Global Assessment. The satisfaction rate of the Investigator's Global Assessment was 66.0%, and that of the Patient's Global Assessment was 63%.

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