[Nedaplatin].

Nedaplatin is a derivative of cisplatin which produced less nausea & vomiting and nephrotoxicity. In the phase I study, the MTD was 120 mg/m2 and the DLF was a bone marrow suppression. The optimal dose in a phase II study was judged to be 100 mg/m2 repeated every 4 weeks. In the phase II studies, response rates obtained were 42.2% for head & neck ca., 40.9% for small cell lung ca. (SCLC), 20.5% for non-SCLS (NSCLC), 12.5% for breast ca., 51.7% for esophageal ca., 8.3% for stomach cancer. 0 for colon ca., 38.1% for bladder ca., 14.3% for pyelo-ureter tract ca., 18.8% for prostatic ca., 80.0% for testicular tumor, 37.3% for ovarian ca., 46.3% for cervical ca. Grade 3.4 thrombocytopenia, leukopenia, anemia and nausea &; vomiting were found in 28.5%, 21.1%, 16.8% and 18.5% respectively. In an additional phase II study for cervical ca. at a dose reduced to 80 mg/m2, a response rate was comparable together with less thrombocytopenia. In a randomized controlled study of nedaplatin plus vindesine vs. cisplatin plus vindesine in NSCLC, there was no significant difference in response, however mephro and G.I. toxicity were significantly less in the nedaplatin group. Thrombocytopenia was found more frequently in the nedaplatin groups. Based on the results, the indication was approved in ca. of the head & neck, SCLC, NSCLC, esophagus, bladder, testicular tumor, ovary and cervix. Dose schedule is 80 - 100 mg/m2 every 4 weeks at more 1,000 mL drip infusion repeated.

RCT Entities:   Population Interventions Outcomes