Randomised phase II study of cisplatin-etoposide versus infusional carboplatin in advanced non-small-cell lung cancer and mesothelioma.

Background:A randomised phase II study was performed to comparestandard combination chemotherapy containing cisplatin and etoposide withinfusional carboplatin.Patients and methods:One hundred twenty patients with locallyadvanced/metastatic non-small-cell lung cancer or mesothelioma were enrolled.All were chemotherapy-naïve and had a Karnofsky performance status of50. Patients were randomised to either four cycles of bolus therapy ofcisplatin 80 mg/m² day 1, etoposide 120 mg/m² day1–3, or continuous infusion of carboplatin 100/mg/m²/week forsix weeks.Results:No patients on infusional therapy incurred grade3–4 toxicity while in the bolus arm, grade 3 and grade 4 leucopeniaoccurred in 17% and 35% of patients, respectively. Grade 4thrombocytopenia occurred in 8% of patients and there were twoinstances of grade 3 renal toxicity. No responses occurred in the pump arm.Eight of forty-six patients with non-small-cell lung cancer responded totreatment (response rate 17.3%) with two complete responses and sixpartial responses. Only one patient with mesothelioma responded to bolustherapy. There was no difference in survival for the subset of NSCLC patients.Survival for mesothelioma patients in the pump arm was superior but this waslikely to be a result of early deaths in the bolus arm.Conclusions:The pump arm was well-tolerated but not active,whilst combination platinum-based therapy demonstrated activity butsignificantly more toxicity than the pump arm. Further studies of infusionalcarboplatin with this schedule are not warranted.