Early results of a randomized phase III trial of platinum-containing doublets versus a nonplatinum doublet in the treatment of advanced non-small cell lung cancer: European Organization for Research and Treatment of Cancer 08975.

In the European Organization for Research and Treatment of Cancer randomized phase III trial (08975), 480 patients with advanced non-small cell lung cancer received the standard arm of cisplatin/paclitaxel or one of two experimental arms; gemcitabine/cisplatin or gemcitabine/paclitaxel. Cisplatin was given at 80 mg/m(2) on day 1, gemcitabine was administered at 1,250 mg/m(2) on days 1 and 8, and paclitaxel at 175 mg/m(2) as a 3-hour infusion on day 1, every 3 weeks. The cisplatin/paclitaxel and gemcitabine/cisplatin regimens were comparably active. The nonplatinum arm, gemcitabine/paclitaxel, was well tolerated, but had a trend toward lower median, 1-year, and progression-free survival compared with the standard arm. Further follow-up and analysis of quality of life may clarify this possible difference in treatment outcome.