RESUMEN
Good Post-Marketing Surveillance Practice (GPMSP) defines “post-marketing clinical trials” as industry-initiated studies constituting a part of Post-Marketing Surveillance (PMS). Post-marketing clinical studies play the role of gathering further information on appropriate drug use. This is why the proper conduct of medically required post-marketing clinical trials would facilitate the proposal of new treatments with improved efficacy and/or safety over existing therapies, thereby contributing to the promotion of EBM and to the advance of healthcare. In the case of anticancer drugs, in particular, post-marketing clinical trials are of great importance, because they also serve as Phase III studies. In reality, however, pharmaceutical companies are not very active in conducting these studies because of the many issues involved. To solve or alleviate these problems, the Japan Pharmaceutical Manufacturers Association and COTEC are making aggressive efforts.
RESUMEN
Backgrouad & Aims: Cyclophosphamide, adriamycin and cisplatin(CAP) combination chemo- therapy improved the response rate in the treatment of advanced epithelial ovarian cancer, and it has been the gold standard. However, adriamycin is a rather toxic drug, and there is still confusion concerning the choice of adriamycin to be included in optimal regimen. The present study was designed to compare the activity and toxicity of combination regimens in advanced epithelial ovarian cancer between CAP and CTP which substitutes adriamycin with pirarubicin(THP- adriamycin). PATIENTS AND METHODS: From March 1995 to December 1997, 47 patients with FIGO stage III-IV epithelial ovarian cancer who were diagnosed after initial cytoreductive surgery were divided into two groups at random: (1) The case group were treated with CTP(500/40/50 mg/m2) as a first line chemotherapy. (2) The control group were treated with CAP(500/50/50 mg/m2) as that of case group. Clinical characteristics, response rates and toxicities according to Gynecologic Oncology Group criteria were compared between those treated with CAP and CTP respectively. RESULTS: Forty one patients out of 47 were evaluable and the number of patients in case and control group was 22 and 19 respectively. There was no significant differences in patient characteristics such as age, stage, histologic type between two groups. Clinical complete response rate was 50.0%(11/22) in patients treated with CTP regimen and 47.4%(9/19) with CAP regimen and there was no significant difference between two groups. Second look operation was undergone in 10 patients of CTP group and 7 patients of CAP group who showed clinical complete response and the pathologic complete response rate was 27.3%(6/22) with CTP and 21.1%(4/19) with CAP. The incidence of leukocytopenia of grade 3 or 4 was more frequently occurred in CAP group(52.6%, 10/19) than CTP group(22.7%, 5/22). There was no significant difference in the incidence of other toxicitied such as hepatic, renal and G-I toxicities. Suspicious cardiac toxicity according to the finding of EKG was seen in 15.8%(3/19) only with CAP regimen and all of them showed decreased cardiac function in gated blood pool scan. There were no significant differences in risponse rates between two groups, but the incidence of cardiac toxicity and leukocytopenia o f grade 3 or 4 was more frequently occurred in CAP group than CTP group. CONCLUSION : CTP regimen has comparable response rates to CAP regimen, with lower incidence of hematolohic and cardiac toxicity.