CISPLATIN 5-FLUOROURACIL IN SMALL-CELL LUNG-CANCER - A PHASE-II STUDYIN 109 PATIENTS

One hundred nine previously untreated patients with small cell lung ca ncer were treated for five consecutive days with 20 mg/m(2)/day of cis platin and 600 mg/m(2)/day of 5-fluorouracil. One cycle of chemotherap y was administered every three weeks. The patients received a median n umber of three cycles. Then they were transferred to CAE chemotherapy. A 77% overall response rate (95% confidence interval of 0.70-0.85) wa s observed after initial cisplatin-5FU treatment. Twenty-three complet e responses (21%) and 62 partial responses (56%) were obtained. In cer ebral metastases the response rate was high at 91% (21 out of 23), wit h 43% complete responses. In the limited forms, statistical survival a t 1 year was 25%. A Grade 3-4 thrombocytopaenia was observed in 10 pat ients (9%) and a Grade 2-3 leukopaenia in four patients. Three patient s suffered from a Grade 2 cardiac toxicity. The cisplatin-5-fluorourac il combination demonstrates promising initial response rate in small c ell lung cancers. Its main interest is in its important action on cere bral metastases and its moderate haematological toxicity.