R-METHUG-CSF SUPPORT TO IFOSFAMIDE, CISPLATIN, ETOPOSIDE CHEMOTHERAPYIN NON-SMALL-CELL LUNG-CANCER

Twenty patients with locally advanced or metastatic non-small cell lun g cancer entered a study of recombinant human methionyl G-CSF (r-metHu G-CSF) as an adjunct to ifosfamide, cisplatin and etoposide (IPE) regi men. Chemotherapy consisted of three courses of cisplatin 25 mg/m(2), ifosfamide 1.5 g/m(2) (with uroprotection) and etoposide 100 mg/m(2) g iven on days 1-4 of a 21-day cycle. r-metHuG-CSF, 5 mu g/kg, was admin istered subcutaneously from day 5 to day 14. Eighteen out of 20 patien ts completed the three courses (57 evaluable cycles). Grade 3-4 neutro penia affected 50, 42 and 22% of the patients during cycles 1, 2 and 3 , respectively, whereas thrombocytopenia was observed in 25% of the pa tients throughout the chemotherapy protocol. Haematological toxic even ts requiring transfusions and/or antibiotics were responsible for 11 u nplanned hospitalizations. Among these only three were exclusively dev oted to febrile neutropenia care, the remaining eight being mainly req uired for blood transfusions. There were no deaths during the study du ration. Dose reductions were needed in 65% of the patients and chemoth erapy a,as delayed by thrombocytopenia in five patients, The total rel ative dose intensity was 84%. Eleven (55%) patients responded (one com plete and 10 partial responses). Median survival was 9.5 months. We co ncluded that IPE combination chemotherapy can be administered safely w ith the support of r-metHuG-CSF inasmuch as neutropenia appears as mil d to moderate and manageable. Optimal delivery of chemotherapy is stil l limited by other toxicities, mainly thrombocytopenia, but the succes sful relative dose intensity observed herein deserves further studies designed to analyze a dose intensity-survival relationship in non-smal l cell lung cancer.