PHASE-II STUDY OF NITROSOUREA FOTEMUSTINE AS SINGLE-DRUG CHEMOTHERAPYIN POOR-PROGNOSIS NON-SMALL-CELL LUNG-CANCER

A phase II study was designed to evaluate objective response rate and toxicity of fotemustine as single-drug chemotherapy in non-small-cell lung cancer. Eighty-seven patients with unresectable non-small-cell lu ng cancer took part in the study. Seventy-seven were evaluable for res ponse. Of these, 60% had received prior chemotherapy and 74% had metas tatic disease. Moreover, 22 patients had central nervous system metast ases (of whom 12 were evaluable for this site). Treatment consisted of fotemustine 100 mg m(-2) administered on days 1 and 8 followed by a 5 week rest period. Afterwards, responding or stabilised patients recei ved fotemustine 100 mg m(-2) every 3 weeks as a maintenance therapy. T oxicity and quality of life were recorded during therapy. Thirteen pat ients (17%; 95% CI 9-25%) had an objective response (11% for pretreate d, 26% for non-pretreated) with a median duration of 22 weeks (range 7 -41 weeks). Two objective responses were observed among the 12 patient s with evaluable brain metastases. No response was observed among the 14 patients with adenocarcinoma. Haematological, gastrointestinal, hep atic and renal toxicities were mild to moderate and manageable. The mo st frequent biological adverse reactions were delayed thrombocytopenia and neutropenia. Quality of life did not significantly decrease durin g the first 6 treatment weeks. Moreover, it remained stable during the study period in patients with response or stabilisation, whereas it s ignificantly decreased in patients who experienced progression of the disease. Fotemustine is feasible for single-drug chemotherapy in non-s mall-cell lung cancer even though poor prognostic variables such as br ain metastases are present. It can be administered on an outpatient ba sis and toxicity is moderate and manageable. Thus, fotemustine can be considered as a putative drug in further combinations.