[Phase II-III- study of cis-diaminodichloroplatinum (cisplatinum) (author's transl)]

A phase II-III study with cisplatinum alone or in combination was carried in 227 patients with advanced tumors. 21 received cisplatinum at 20 mg/mg2 daily five days. The other 206 patients received cisplatinum in different dosage and combination. In both groups of patients cisplatinum was given with hydratation and mannitol forced diuresis. There were 4 partial responders (19%) in the first group of patients and 117 responses (56,7%) in the other group with 43 complete responses in 35 germ cell tumors and 6 small cell lung cancer. Toxicity included 2 irreversible renal failure (0,8%), one in each group of patients. Clearance creatinine was below 50 ml/min before treatment in 22/227 (9,6%) of patients. Other toxic effects included gastrointestinal (100%) neurologic with paresthesias and electrophysiologic changes and hematologic suppression. We concluded that cisplatinum is a new effective agent in the treatment pf malignant diseases to be used every time in combination with other anticancer drugs.