Randomized Controlled Open Labelled, Phase III Trials, Comparing the Efficacy between Fentas(R) and Durogesic(R) Patches in Controlling Cancer Pain: Multicenter Trial / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: Fentanyl is a synthetic opioid and transdermal therapeutic system (TTS), designed to release the drug into the skin at a constant rate, ranging from 25 to 100 microgram/hr, for up to 3 days. For the control of chronic cancer pain, Durogesic(R) patches (Janssen Co., USA) are now widely used. Recently, the Hana Company in Korea developed a new fentanyl patch, Fentas(R) using a different method. To compare the efficacy, and safety, of the fentanyl patch manufactured in Korea (Hana Pharm. Co. Ltd), with the Durogesic(R) patch, in controlling cancer pain, we performed randomized controlled, open labelled, phase III studies. MATERIALS AND METGODS: From January 2000 to April 2001, 85 patients were enrolled, 69 of whom (42 in D arm and 43 in F arm) completed the study, and were therefore assessable for per protocol (PP) analyses. RESULTS: There were no significant differences between the two groups in baseline characteristics, with the exception of age. The primary end point was to show the therapeutic equivalence of the two patches. In these clinical trials, the confidence interval of difference, between the test drug (Fentas(R)) and the control (Durogesic(R)), was 0.027~ +0.124 by intention to treat (ITT) analysis. Even if the upper confidence interval exceeds + 0.1, the test drug is not superior to the control drug, because the confidence interval includes 0. However, by PP analysis, the confidence interval lies exactly within +/- 0.1. Therefore, we could conclude the two patches are therapeutically equivalent. The second endpoint was the difference of visual analog scale (VAS) between the baseline and the average of three measurements after treatment. The difference in VAS was 50.44+/-10.28 for the F arm, and 44.69+/-11.00 for the D arm. By PP analysis the test drug was superior to the control (p=0.028). The rescue morphine amount was 81.21+/-124.76 for F arm and 66.19+/-115.9 for D arm, and there was no significant difference between the two groups (p=0.6063). The most common adverse effects of both fentanyl patches were nausea or vomiting (55.3%), somnolence (50.0%), constipation (39.5%), gastrointestinal discomfort (57.9%) and headaches (25.0%). In general there was no significant difference in side effects or laboratory data between the two groups. CONCLUSION: These findings suggest that Fentas(R) patches, administered every 3 days, are effective, safe, and well tolerated for the treatment of most patients with cancer pain and is as effective or better than Durogesic(R).

Venous Irritation Incidence Associated with Vinorelbine Tartrate Injection Time / 대한암학회지

PURPOSE: This study was to determine the incidence and severity of venous irriation in patients receiving vinorelbine tartrate (Navelbine ) in combination chemotherapy. MATERIAL AND METHODS: Twenty four patients histologically confirmed non-small cell lung cancer were enrolled in this study who receiving vinorelbine in combination chemotherapy through a peripheral vein from Oct. 1997 to Mar. 1999 with retrospective study design method. One group was 6~10 minutes infusion rate, the other was 10~20 minutes infusion rate with the same free-flow intravenous infusion. RESULTS: A total of 126 infusions were observed in this study. Sixty-two infusions were admi nistered at the 6~10 minutes, and 64 infusions were administered at the 10~20 minutes. The incidence of any venous irritation was 3.2% (2/62) in the group that received the infusion in 6~10 minutes and 10.9% (7/64) in 10~20 minutes (p=0.164), so we could not acquire any statistical significance. However the incidence of severe venous irritation (grade 3, 4) was 0% (0/62) in 6~10 minutes infusion group and 9.4% (6/64) in 10~20 minutes infusion group. There was a significant difference between two groups (p=0.028) CONCLUSION: Our results suggest that venous irritation associated with vinorelbine tartrate infusion can be reduced by shorter duration of administration and vinorelbine tartrate might be recom mended to administer at 6~10 minutes infusion in clinical practice.