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).

Eosinophilic fasciitis preceding relapse of peripheral T-cell lymphoma

Although eosinophilic fasciitis (EF) may precede hematologic malignancy or Hodgkin's disease, association with peripheral T-cell lymphoma (PTCL) is extremely rare. Only four cases of EF preceding or concomitant PTCL have been reported in the world literature. We experienced the first Korean case of EF complicated by the later relapse of peripheral T-cell lymphoma. A 63-year-old Korean male has been followed at our outpatient clinic periodically after treatment for stage IV PTCL. He had been in complete remission for seven and a half years when he developed edema of both lower extremities followed by sclerodermatous skin change in both hands with peripheral eosinophilia. Biopsy from the left hand showed fibrous thickening of the fascia with lymphoplasmacytic and eosinophilic infiltrate, consistent with EF. Twenty-five months later, a newly developed lymph node from the left neck showed recurrence of PTCL. EF may occur as a paraneoplastic syndrome associated with the relapse of PTCL. Therefore, in a patient with EF, the possibility of coexisting and/or future occurrence of hematologic neoplasm should be considered.

A Case of Primary Intestinal T-Cell Lymphoma Involving Entire Gastrointestinal Tract: Esophagus to Rectum

Primary intestinal T-cell lymphoma is a rare disease entity, which is approximately 10% to 25% of intestinal lymphomas, and most of the lymphomas occur in the small intestine. We report here a case of a 56-year-old woman who has been suffering from chronic diarrhea and weight loss for 6 months. Abdominal CT scan and small bowel series showed diffuse wall thickening of the small bowel. Gastroscopic examination showed diffuse erythematous lesions on the esophagus and small gastric ulcerations on the antrum of the stomach, and colonoscopic examination also showed multiple punched-out ulcerations and erosions on the entire colon, including the sigmoid colon to the terminal ileum. Diffuse infiltration of CD 3 positive lymphoma cells was found on biopsy. The patient was diagnosed as primary intestinal T-cell lymphoma with diffuse involvement of the entire gastrointestinal tracts from the esophagus to the rectum. Although the patient received systemic combination chemotherapy and achieved partial response initially, the lymphoma relapsed repeatedly.

A case of Kaposi's sarcoma in transplant patient / 대한신장학회잡지

No abstract available.