A brief intensive cisplatin-based outpatient chemotherapy regimen with filgrastim and megestrol acetate support for advanced non-small cell lung cancer: results of a phase II trial

To evaluate the efficacy and toxicity of a brief, intensive cisplatin-based outpatient chemotherapy regimen with filgrastim and megestrol acetate supp ort for patients with stage IIIB and IV non-small cell lung cancer (NSCLC) and a favorable performance status. Thirty patients with no prior chemother apy were enrolled in this phase II protocol. Patients received cisplatin 50 mg/m(2), ifosfamide 2 g/m(2), mesna, and a 7-day course of oral etoposide beginning on days 1, 15, 29, 43, and 57 for a total treatment duration of 1 0 weeks. Filgrastim was administered for 7 days after each course of oral e toposide. Megestrol acetate 250 mg PO was administered throughout the durat ion of chemotherapy. Thirty patients were evaluable for toxicity and 27 for response. Among those evaluable for response, partial remission occurred i n 11 (41'%) patients, and median survival was 10.5 months. Nadir neutrophil count of < 500/mm(3) occurred in 19 (63%) patients. Weight loss occurred i n only nine patients (median 3.4 kg, range 1.6-7.3). There was no differenc e between pre- and post-treatment weights (P = 0.35). Two patients develope d pulmonary embolism. Grade 3 or 4 non-hematologic toxicity occurred infreq uently. This regimen appears to be similar in efficacy to the most active r egimens reported by other investigators. Innovative features of the regimen include the brief treatment duration, the use of serial 7-day courses of f ilgrastim to facilitate weekly chemotherapy treatments, and the use of mege strol acetate to minimize constitutional symptoms. However the use of meges trol acetate in this setting may be associated with an increased risk of th romboembolic complications. This may provide a model for other palliative r egimens specifically designed for patients with a favorable performance sta tus and advanced NSCLC. (C) 1998 Elsevier Science Ireland Ltd. All rights r eserved.