Designated E1594, this trial was designed to compare three
platinum-based combination regimens containing third-generation drugs
active against nonsmall-cell lung cancer to a reference regimen
of cisplatin (Platinol) 75 mg/m² day 1 plus paclitaxel (Taxol)
175/mg/m²/24 h (arm A). The experimental regimens were as
follows: gemcitabine (Gemzar) 1,000 mg/m² days 1, 8, 15 plus
cisplatin 100 mg/m² day 1 (arm B); docetaxel (Taxotere) 75
mg/m² day 1 plus cisplatin 75 mg/m² day 1 (arm C); and
paclitaxel 225 mg/m²/3 h day 1 plus carboplatin (Paraplatin) at
an area under the concentration-time curve of 6 (AUC in mg/mL ·
min) day 1 (arm D). Arms A, C, and D were repeated every 21 days and
arm B every 28 days.
Eligible patients were required to have measurable or evaluable
disease, to have a performance status (PS) of 02, and to have
stage IIIB (malignant pleural effusion) or stage IV disease. The
protocol was later amended to restrict entry to PS 0/1. A total of
1,207 patients were registered between October 1996 and May 1999,
1,146 of whom were eligible (PS 0/1 = 1,083; PS 2 = 63; stage IIIB =
98; stage IV = 968). Toxicity results are as follows:
In general, the four regimens have comparable toxicities. Grade 4
thrombocytopenia was more common in arm B. Fever and neutropenia were
less frequent in arms B and D. Nausea was least common in arm D.
Overall median survival is 7.8 months. As of November 1999, 743 of
the 1,070 deaths needed for final analysis have occurred.
CONCLUSION: The overall response rates and survival results of the
individual arms were to be presented at the 2000 ASCO meeting.