Currently, only a few chemotherapeutic agents have consistently produc
ed single agent response rates greater than 15% in patients with non-s
mall-cell lung cancer (NSCLC). Taxol has been reported in two phase II
studies to have significant activity in NSCLC with response rates of
21% and 24%. Schedule infusion of 24 hours has been used to reduce all
ergic reactions. The study reported here was a phase II trial of Taxol
given by 3-hour intravenous infusions at a 210 mg/m(2) dose every thr
ee weeks in outpatients setting. It was conducted simultaneously at th
ree centers on chemotherapy-naive patients with unresectable stage III
or metastatic NSCLC. Sixty-two patients were initially enrolled; all
were premedicated with dexametasone (20 mg), cimetidine (330 mg) and d
iphenilhydramine (50 mg), given prior to initiation of paclitaxel infu
sion. Fifty patients were evaluated for toxic effects and 47 for respo
nse. Sixteen partial responses (34) and one complete response (2%) wer
e observed, for an overall response rate of 36% (95% confidence interv
al, 22% to 50%). Taxol was well-tolerated and none of the patients exp
erienced allergic reaction. Granulocytopenia was generally mild. Thera
py was interrupted in only two patients because of the development of
grade 3 neuropathy. In our experience Taxol is one of the most active
cytotoxic drugs targeting non-small-cell lung cancer.