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

Background: A randomised phase II study was performed to compare standard c ombination chemotherapy containing cisplatin and etoposide with infusional carboplatin. Patients and methods: One hundred twenty patients with locally advanced/met astatic non-small-cell lung cancer or mesothelioma were enrolled. All were chemotherapy-naive and had a Karnofsky performance status of greater than o r equal to 50. Patients were randomised to either four cycles of bolus ther apy of cisplatin 80 mg/m(2) day 1, etoposide 120 mg/m(2) day 1-3, or contin uous infusion of carboplatin 100/mg/m(2)/week for six weeks. Results: No patients on infusional therapy incurred grade 3-4 toxicity whil e in the bolus arm, grade 3 and grade 4 leucopenia occurred in 17% and 35% of patients, respectively. Grade 4 thrombocytopenia occurred in 8% of patie nts and there were two instances of grade 3 renal toxicity. No responses oc curred in the pump arm. Eight of forty-six patients with non-small-cell lun g cancer responded to treatment (response rate 17.3%) with two complete res ponses and six partial responses. Only one patient with mesothelioma respon ded to bolus therapy. There was no difference in survival for the subset of NSCLC patients. Survival for mesothelioma patients in the pump arm was sup erior but this was likely to be a result of early deaths in the bolus arm. Conclusions: The pump arm was well-tolerated but not active, whilst combina tion platinum-based therapy demonstrated activity but significantly more to xicity than the pump arm. Further studies of infusional carboplatin with th is schedule are not warranted.