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New Agents in Combination Regimens

New Agents in Combination Regimens

Designated E1594, this trial was designed to compare three platinum-based combination regimens containing third-generation drugs active against non–small-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 0–2, 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.

Click here for Dr. Vincent A. Miller’s commentary on this abstract.

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