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
N. Levitan et al., 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, LUNG CANC, 22(3), 1998, pp. 227-234
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.