CISPLATIN-FOTEMUSTINE COMBINATION IN INOPERABLE NONSMALL CELL LUNG-CANCER - PRELIMINARY-REPORT OF A FRENCH MULTICENTER PHASE-II TRIAL

Fotemustine is a new nitrosourea derivative whose activity has been de monstrated on metastatic melanoma with specific activity on brain meta stases and also on poor prognosis lung cancers. Results of in vitro st udies of a cisplatin-fotemustine combination seem promising. In order to evaluate the efficacy and safety of this combination, we performed two trials. 6 patients entered a preliminary study whose schedule was cisplatin 120 mg/m(2) on day 1 and fotemustine 100 mg/m(2) on days 1 a nd 8. 22 patients were enrolled in a second study which added 120 mg/m (2) cisplatin on day 22 followed by a 4-week rest period. In both tria ls, maintenance therapy consisted of cisplatin 100 mg/m(2) and fotemus tine 100 mg/m(2) every 3 weeks until progression. Despite the poor pro gnostic factors which characterised our population (metastatic disease 86%, brain metastases 59%, less than or equal to 80% performance stat us 45%), the results remain attractive with a 23% partial response rat e (29% in non-pretreated patients). Moreover, 3 out of 8 patients with evaluable cerebral metastases achieved a partial response (37.5%). To xicity was mild and related to the cumulative dose of cisplatin (perip heral neuropathy and renal toxicity). We concluded that these results need to be confirmed in a randomised trial.