A PHASE-II TRIAL OF FOTEMUSTINE AND CISPLATIN IN CENTRAL-NERVOUS-SYSTEM METASTASES FROM NON-SMALL-CELL LUNG-CANCER

A phase II study was conducted in order to determine the feasibility a nd toxicity of cisplatin combined with the nitrosourea fotemustine in central nervous system metastases from non-small cell lung cancer. 31 chemotherapy-naive patients were included between November 1990 and Ap ril 1993. Computed tomography scan-documented tumour regression in bra in metastases was observed in 7 of the 25 evaluable patients, but only 4 of these (16%) lasted more than 4 weeks. In 2 of these 4 patients, the response on central nervous system metastases was considered as co mplete. The median duration of response was 20.5 weeks and the median survival was 16 weeks overall and 28.5 weeks for responding patients. The limiting toxicity of this regimen was haematological. 2 patients d ied from infectious pneumonitis while in neutropenia. Treatment delays due to haematological toxicity occurred in 57% of patients. Despite t he rather encouraging response rate, such toxicity appears too high wh en compared to the overall bad prognosis of this population of patient s. Cranial radiotherapy remains the standard treatment in this setting and should only be compared in the future to less aggressive schedule s.